Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for:

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Magnesium Sulfate in 5% Dextrose Injection is:

Magnesium Sulfate in 5% Dextrose Injection does not require dilution prior to intravenous administration.

After removing the overwrap, check for minute leaks by squeezing the container fully. Do not administer Magnesium Sulfate in 5% Dextrose Injection if there is a leak or there is greater than 2 mL of water in the overwrap [see Description (11)].

Do not administer Magnesium Sulfate in 5% Dextrose Injection with incompatible drugs through the same intravenous line [see Dosage and Administration (2.4)]. Do not use Magnesium Sulfate in 5% Dextrose Injection in series connections.

Magnesium Sulfate in 5% Dextrose Injection is not compatible with administration of a variety of solutions and forms precipitates of magnesium salts. Before using Magnesium Sulfate in 5% Dextrose Injection with another parenteral product, investigate potential incompatibilities. Incompatible products that should not be coadministered include salicylates and alkali carbonates.

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear and colorless to slightly yellow solution supplied in single-dose, single port bag:

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection, USP is a clear and colorless to slightly yellow solution supplied in single-dose, single port bag:" }

{ "type": "", "children": [], "text": "" }

Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection.

{ "type": "p", "children": [], "text": "Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection." }

Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients:

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients:" }

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Continuous administration of magnesium sulfate beyond 5 to 7 days in pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported.

Neonates of women receiving Magnesium Sulfate in 5% Dextrose Injection (especially with prolonged maternal use) are at risk for magnesium toxicity including hyporeflexia, hypotonia, and respiratory depression. There is one reported case of neonatal death as the result of magnesium toxicity after transplacental exposure.

The shortest duration of magnesium sulfate treatment that can lead to fetal harm is not known. Administration of Magnesium Sulfate in 5% Dextrose Injection beyond 5 to 7 days is not recommended.

Patients receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity including respiratory depression, acute renal failure and rarely, pulmonary edema.

Monitor clinical signs of magnesium toxicity (for example, facial edema, diminished strength of deep tendon reflexes, respiratory depression) and magnesium concentrations during infusions of Magnesium Sulfate in 5% Dextrose Injection. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more per minute). Serum magnesium concentrations usually sufficient to control convulsions range from 3 to 6 mg per 100 mL (2.5 to 5 mEq per liter). The strength of the deep tendon reflexes begins to diminish when serum magnesium concentrations exceed 4 mEq per liter. Reflexes may be absent at concentration of 10 mEq per liter, at which point respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium toxicity in patients with preeclampsia and eclampsia. If there is significant magnesium toxicity, stop the Magnesium Sulfate in 5% Dextrose Injection infusion and recheck serum magnesium concentration.

Patients with renal impairment are at greater risk of magnesium toxicity because magnesium is excreted by the body solely by the kidneys [see Use in Specific Populations (8.6)]. Urine output should be maintained at a level of 100 mL per 4 hours. Monitoring serum magnesium levels and the patient's clinical status is essential to avoid the consequences of overdosage in patients with preeclampsia. Discontinuation of the magnesium infusion is recommended when urine output is less than 100 mL every 4 hours to avoid magnesium toxicity, especially if serum creatinine is increasing progressively.

Solutions containing dextrose should be used with caution in patients with known prediabetes or diabetes mellitus given the risk of elevated blood glucose.

Do not use Magnesium Sulfate in 5% Dextrose Injection with unapproved tocolytics (e.g., beta adrenergic agents such as terbutaline, or with calcium channel blockers such as nifedipine). Serious adverse events including pulmonary edema and hypotension have occurred [see Drug Interactions (7)].

Magnesium Sulfate in 5% Dextrose Injection contains aluminum that may be toxic (Magnesium Sulfate in 5% Dextrose Injection contains less than 25 mcg/L of aluminum). Aluminum may reach toxic concentrations with prolonged parenteral administration in patients with renal impairment.

Patients with renal impairment who receive parenteral concentrations of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at concentrations associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with known myasthenia gravis.

Use of magnesium sulfate in patients with underlying myasthenia gravis can precipitate a myasthenic crisis. Myasthenic crisis is a life-threatening condition characterized by neuromuscular respiratory failure. Symptoms of myasthenic crisis may include difficulty swallowing, ptosis, facial droop, weakness and/or difficulty breathing that may require intubation.

If myasthenic crisis is suspected, discontinue use of Magnesium Sulfate in 5% Dextrose Injection immediately. Secure the patient's airway. Consider intensive care unit admission and elective intubation, if respiratory failure is anticipated. Once the airway is secure, confirm the diagnosis. Therapies include plasmapheresis and plasma exchange or intravenous immunoglobulin (IVIG) and immunomodulating therapy in addition to high-dose glucocorticoids.

The following adverse reactions have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

{ "type": "p", "children": [], "text": "The following adverse reactions have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure." }

<div class="scrollingtable"><table width="75%"> <col width="27%"/> <col width="60%"/> <tbody class="Headless"> <tr class="First"> <td class="Toprule" valign="top"> <p class="First">Cardiovascular:</p> </td><td class="Toprule" valign="top"> <p class="First">hypotension, circulatory collapse, cardiac depression including bradycardia</p> </td> </tr> <tr> <td valign="top"> <p class="First">Central Nervous System:</p> </td><td valign="top"> <p class="First">central nervous system depression leading to respiratory paralysis, visual disturbances, flushing, sweating, hypothermia</p> </td> </tr> <tr> <td valign="top"> <p class="First">Metabolic:</p> </td><td valign="top"> <p class="First">hypocalcemia with signs of tetany, hypermagnesemia</p> </td> </tr> <tr> <td valign="top"> <p class="First">Neurologic:</p> </td><td valign="top"> <p class="First">lethargy, sedation, somnolence, myasthenic crisis</p> </td> </tr> <tr> <td valign="top"> <p class="First">Neuromuscular:</p> </td><td valign="top"> <p class="First">depressed deep tendon reflexes, flaccid paralysis</p> </td> </tr> <tr class="Last"> <td class="Botrule" valign="top"> <p class="First">Pulmonary:</p> </td><td class="Botrule" valign="top"> <p class="First">decreased respiratory rate, pulmonary edema</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"75%\">\n<col width=\"27%\"/>\n<col width=\"60%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">Cardiovascular:</p>\n</td><td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">hypotension, circulatory collapse, cardiac depression including bradycardia</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Central Nervous System:</p>\n</td><td valign=\"top\">\n<p class=\"First\">central nervous system depression leading to respiratory paralysis, visual disturbances, flushing, sweating, hypothermia</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Metabolic:</p>\n</td><td valign=\"top\">\n<p class=\"First\">hypocalcemia with signs of tetany, hypermagnesemia</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Neurologic:</p>\n</td><td valign=\"top\">\n<p class=\"First\">lethargy, sedation, somnolence, myasthenic crisis</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Neuromuscular:</p>\n</td><td valign=\"top\">\n<p class=\"First\">depressed deep tendon reflexes, flaccid paralysis</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule\" valign=\"top\">\n<p class=\"First\">Pulmonary:</p>\n</td><td class=\"Botrule\" valign=\"top\">\n<p class=\"First\">decreased respiratory rate, pulmonary edema</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Table 1 presents the potential clinical impact of medications that may be commonly administered concomitantly with Magnesium Sulfate in 5% Dextrose Injection in the clinical setting.

{ "type": "p", "children": [], "text": "Table 1 presents the potential clinical impact of medications that may be commonly administered concomitantly with Magnesium Sulfate in 5% Dextrose Injection in the clinical setting." }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1: Potential Clinically Significant Drug Interactions with Magnesium Sulfate in 5% Dextrose Injection<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></span> </caption> <col width="30%"/> <col width="70%"/> <tfoot> <tr> <td align="left" colspan="2"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>For drug incompatibility information [see <span class="Italics"><a href="#S2.4">Dosage and Administration (2.4)</a></span>].</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Neuromuscular Blocking Agents</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents <span class="Italics">[see <a href="#S12.2">Clinical Pharmacology (12.2)</a>]</span>.</dd> <dt>•</dt> <dd>The underlying mechanism of this interaction may involve suppression of peripheral neuromuscular function by decreasing acetylcholine release, reduction of endplate sensitivity, and decreased muscle fiber excitability with magnesium sulfate therapy.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor respiration and the depth of neuromuscular blockade frequently (e.g., train-of-four monitoring) when a neuromuscular blocking agent is used concomitantly with Magnesium Sulfate in 5% Dextrose Injection.</dd> <dt>•</dt> <dd>Adjust the dosage of the neuromuscular blocking agent accordingly to maintain the desired level of musculoskeletal activity. The amount of reversal agent(s) required to achieve adequate reversal of the neuromuscular blocking agent(s) may also be increased.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Depolarizing neuromuscular blockers: succinylcholine</dd> <dt>•</dt> <dd>Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Narcotics and/or Propofol</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Potentiation and prolongation of analgesia and CNS depression is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with narcotics and/or propofol. The potential for magnesium sulfate to affect other CNS depressants is unknown <span class="Italics">[see <a href="#S12.2">Clinical Pharmacology (12.2)</a>]</span>.</dd> <dt>•</dt> <dd>The underlying mechanism of this interaction may involve antagonism of N-methyl-D-aspartate (NMDA) by magnesium sulfate therapy.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor the depth of CNS depression frequently using a reliable instrument.</dd> <dt>•</dt> <dd>Adjust the narcotic and/or propofol dosage accordingly to maintain the desired level of analgesia and sedation.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Narcotics and propofol</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Dihydropyridine Calcium Channel Blockers</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>An exaggerated hypotensive response is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with dihydropyridine calcium channel blockers. The potential for magnesium sulfate to affect other calcium channel blockers (e.g., diltiazem and verapamil) is unknown <span class="Italics">[see <a href="#S12.2">Clinical Pharmacology (12.2)</a>]</span>.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor vital signs (heart rate, blood pressure, respiration) frequently.</dd> <dt>•</dt> <dd>Supportive care and/or discontinuation of the calcium channel blocker may be required.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Drugs that May Induce Magnesium Loss</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Reduced magnesium concentrations may impact efficacy</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor magnesium concentrations frequently and adjust the Magnesium Sulfate in 5% Dextrose Injection dosage to maintain concentrations in the target range <span class="Italics">[see <a href="#S2">Dosage and Administration (2)</a>]</span>.</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics</dd> </dl> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 1: Potential Clinically Significant Drug Interactions with Magnesium Sulfate in 5% Dextrose Injection<a class=\"Sup\" href=\"#footnote-1\" name=\"footnote-reference-1\">*</a></span>\n</caption>\n<col width=\"30%\"/>\n<col width=\"70%\"/>\n<tfoot>\n<tr>\n<td align=\"left\" colspan=\"2\">\n<dl class=\"Footnote\">\n<dt>\n<a href=\"#footnote-reference-1\" name=\"footnote-1\">*</a>\n</dt>\n<dd>For drug incompatibility information [see <span class=\"Italics\"><a href=\"#S2.4\">Dosage and Administration (2.4)</a></span>].</dd>\n</dl>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Neuromuscular Blocking Agents</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents <span class=\"Italics\">[see <a href=\"#S12.2\">Clinical Pharmacology (12.2)</a>]</span>.</dd>\n<dt>•</dt>\n<dd>The underlying mechanism of this interaction may involve suppression of peripheral neuromuscular function by decreasing acetylcholine release, reduction of endplate sensitivity, and decreased muscle fiber excitability with magnesium sulfate therapy.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor respiration and the depth of neuromuscular blockade frequently (e.g., train-of-four monitoring) when a neuromuscular blocking agent is used concomitantly with Magnesium Sulfate in 5% Dextrose Injection.</dd>\n<dt>•</dt>\n<dd>Adjust the dosage of the neuromuscular blocking agent accordingly to maintain the desired level of musculoskeletal activity. The amount of reversal agent(s) required to achieve adequate reversal of the neuromuscular blocking agent(s) may also be increased.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Depolarizing neuromuscular blockers: succinylcholine</dd>\n<dt>•</dt>\n<dd>Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Narcotics and/or Propofol</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Potentiation and prolongation of analgesia and CNS depression is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with narcotics and/or propofol. The potential for magnesium sulfate to affect other CNS depressants is unknown <span class=\"Italics\">[see <a href=\"#S12.2\">Clinical Pharmacology (12.2)</a>]</span>.</dd>\n<dt>•</dt>\n<dd>The underlying mechanism of this interaction may involve antagonism of N-methyl-D-aspartate (NMDA) by magnesium sulfate therapy.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor the depth of CNS depression frequently using a reliable instrument.</dd>\n<dt>•</dt>\n<dd>Adjust the narcotic and/or propofol dosage accordingly to maintain the desired level of analgesia and sedation.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Narcotics and propofol</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Dihydropyridine Calcium Channel Blockers</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>An exaggerated hypotensive response is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with dihydropyridine calcium channel blockers. The potential for magnesium sulfate to affect other calcium channel blockers (e.g., diltiazem and verapamil) is unknown <span class=\"Italics\">[see <a href=\"#S12.2\">Clinical Pharmacology (12.2)</a>]</span>.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor vital signs (heart rate, blood pressure, respiration) frequently.</dd>\n<dt>•</dt>\n<dd>Supportive care and/or discontinuation of the calcium channel blocker may be required.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Drugs that May Induce Magnesium Loss</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Reduced magnesium concentrations may impact efficacy</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor magnesium concentrations frequently and adjust the Magnesium Sulfate in 5% Dextrose Injection dosage to maintain concentrations in the target range <span class=\"Italics\">[see <a href=\"#S2\">Dosage and Administration (2)</a>]</span>.</dd>\n</dl>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics</dd>\n</dl>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

Magnesium Sulfate in 5% Dextrose Injection is indicated in pregnant women for the prevention of eclampsia in women with preeclampsia and the treatment of seizures and prevention of recurrent seizures in women with eclampsia. Fetal, neonatal, and maternal risks are discussed throughout the labeling.

Clinical Considerations

Labor or Delivery:

Magnesium Sulfate in 5% Dextrose Injection is not approved for the treatment of pre-term labor.

Administration of Magnesium Sulfate in 5% Dextrose Injection to pregnant women longer than 5 to 7 days may lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia [see Warnings and Precautions (5.1)].

The use of intravenous magnesium in pregnant women increases human milk magnesium concentrations only slightly and oral absorption of magnesium by the infant is poor. The effect of intravenous magnesium on milk production is unknown. The developmental and health benefits to the neonate of breastfeeding should be considered along with the mother's clinical need for Magnesium Sulfate in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Magnesium Sulfate in 5% Dextrose Injection or from the underlying maternal condition.

The safety and effectiveness of Magnesium Sulfate in 5% Dextrose Injection have been established for the prevention of eclampsia in adolescents with preeclampsia and the treatment of seizures and prevention of recurrent seizures in adolescents with eclampsia. Dosing recommendation in pregnant adolescent patients are the same as for pregnant adult patients [see Dosage and Administration (2.2)].

Magnesium is excreted solely by the kidneys. Patients with severe renal impairment (urine output less than 100 mL per 4 hours) are at greater risk for increased magnesium concentrations that may lead to magnesium toxicity [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. In patients with severe renal impairment, dosage reduction is recommended and the maximum recommended dosage is lower than patients with normal renal function [see Dosage and Administration (2.3)].

Manifestations of magnesium toxicity include a drop in blood pressure, difficulty breathing, and disappearance of the patellar reflex. As serum magnesium rises above 4 mEq per liter, the deep tendon reflexes decrease. As the serum magnesium level approaches 10 mEq per liter, the tendon reflexes disappear and respiratory paralysis may occur [see Warnings and Precautions (5.2)]. Other signs and symptoms of magnesium overdosage include flushing, sweating, hypotension, weakness, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis, cardiac arrest, and prolongation of PR and QRS intervals. Patients with renal impairment and underlying neuromuscular diseases such as myasthenia gravis may experience magnesium intoxication at lower magnesium concentrations (Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with myasthenia gravis).

{ "type": "p", "children": [], "text": "Manifestations of magnesium toxicity include a drop in blood pressure, difficulty breathing, and disappearance of the patellar reflex. As serum magnesium rises above 4 mEq per liter, the deep tendon reflexes decrease. As the serum magnesium level approaches 10 mEq per liter, the tendon reflexes disappear and respiratory paralysis may occur [see Warnings and Precautions (5.2)]. Other signs and symptoms of magnesium overdosage include flushing, sweating, hypotension, weakness, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis, cardiac arrest, and prolongation of PR and QRS intervals. Patients with renal impairment and underlying neuromuscular diseases such as myasthenia gravis may experience magnesium intoxication at lower magnesium concentrations (Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with myasthenia gravis)." }

If patient is experiencing magnesium toxicity, immediately discontinue Magnesium Sulfate in 5% Dextrose Injection. Artificial respiration may be required. Administer an injectable calcium salt to counteract the potential hazards of magnesium toxicity [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "If patient is experiencing magnesium toxicity, immediately discontinue Magnesium Sulfate in 5% Dextrose Injection. Artificial respiration may be required. Administer an injectable calcium salt to counteract the potential hazards of magnesium toxicity [see Warnings and Precautions (5.2)]." }

Hypermagnesemia in the newborn (after administration of Magnesium Sulfate in 5% Dextrose Injection to the mother) may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

{ "type": "p", "children": [], "text": "Hypermagnesemia in the newborn (after administration of Magnesium Sulfate in 5% Dextrose Injection to the mother) may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium." }

Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of magnesium sulfate heptahydrate and dextrose, hydrous 5 grams in water for injection [see How Supplied/Storage and Handling (16)]. Magnesium Sulfate in 5% Dextrose Injection, USP may contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5).

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of magnesium sulfate heptahydrate and dextrose, hydrous 5 grams in water for injection [see How Supplied/Storage and Handling (16)]. Magnesium Sulfate in 5% Dextrose Injection, USP may contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). " }

Magnesium Sulfate, USP heptahydrate is chemically known as sulfuric acid magnesium salt (1:1), heptahydrate and chemically designated MgSO4 ∙ 7H2O, with a molecular weight of 246.47. It occurs as colorless crystals or white powder freely soluble in water.

{ "type": "p", "children": [], "text": "Magnesium Sulfate, USP heptahydrate is chemically known as sulfuric acid magnesium salt (1:1), heptahydrate and chemically designated MgSO4 ∙ 7H2O, with a molecular weight of 246.47. It occurs as colorless crystals or white powder freely soluble in water." }

Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. The molecular formula is C6H12O6 ∙ H2O and the molecular weight is 198.17. It has the following structural formula:

{ "type": "p", "children": [], "text": "Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. The molecular formula is C6H12O6 ∙ H2O and the molecular weight is 198.17. It has the following structural formula:" }

Water for Injection, USP is chemically designated H2O.

{ "type": "p", "children": [], "text": "Water for Injection, USP is chemically designated H2O." }

Water can permeate from inside the flexible plastic container (polyvinylchloride) into the overwrap [see Dosage and Administration (2.1)] but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

{ "type": "p", "children": [], "text": "Water can permeate from inside the flexible plastic container (polyvinylchloride) into the overwrap [see Dosage and Administration (2.1)] but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period." }

Magnesium prevents seizures in patients with preeclampsia and controls seizures in patients with eclampsia by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Magnesium has a depressant effect on the central nervous system [see Drug Interactions (7)]. Magnesium acts peripherally to produce vasodilation.

With intravenous administration of magnesium sulfate the onset of anticonvulsant action is immediate and lasts about 30 minutes. The estimated magnesium concentration (above baseline) required to elicit half-maximum effect (EC50) on systolic and diastolic blood pressure in pregnant women with preeclampsia that received intravenous magnesium sulfate therapy was reported to be 1.5 and 1.8 mEq per liter (1.9 and 2.2 mg per dL), respectively, in a published study. Effective anticonvulsant serum concentrations range from 2.5 to 7.5 mEq per liter.

Drug Interaction Studies

The following information is based upon published case reports and clinical studies that could not be confirmed by an adequately controlled study, but still warrant consideration given the potential risks involved [see Drug Interactions (7)].

Neuromuscular Blocking Agents:

Potentiation and prolongation of neuromuscular blockade requiring modification of the neuromuscular blocking agent dosage and/or increased reversal agent requirements were reported in preeclamptic women who received magnesium sulfate treatment who underwent subsequent surgery (for example, caesarian section) with anesthesia that included either a depolarizing (d-tubocurarine, succinylcholine) or nondepolarizing neuromuscular blocking agent (vecuronium, rocuronium).

Narcotics and/or Propofol:

Potentiation and prolongation of analgesic and/or sedative effects as well as a reduced requirement for an intravenous narcotic (fentanyl, sufentanil, tramadol), intrathecal narcotic (fentanyl), and/or intravenous propofol was reported in magnesium sulfate treated patients who required surgery or intensive care that also included narcotic and/or propofol therapy.

Dihydropyridine Calcium Channel Blockers:

An exaggerated hypotensive response (blood pressure 80–93/49–60 mm Hg) was reported in preeclamptic women who received oral nifedipine in addition to magnesium sulfate treatment. Blood pressure returned to previous levels within approximately 30 minutes with supportive care.

Distribution

Approximately 1 to 2% of total body magnesium is located in the extracellular fluid space. Magnesium is 30% bound to albumin.

Elimination

The average half-life and systemic clearance of magnesium sulfate in preeclamptic women is approximately 4 to 5 hours and 4 to 5 liters per hour, respectively.

Excretion:

Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

Specific Populations

Patients with Renal Impairment:

Plasma magnesium concentrations of 7 to 12.3 mEq per liter (8.6 to 15.1 mg per dL) were reported in preeclamptic women with a urine output less than 100 mL per 4 hours that received 20 grams of magnesium sulfate intravenously over 2 to 8 hours in a published study [see Dosage and Administration (2.3) and Use in Specific Populations (8.6)].

Studies with Magnesium Sulfate in 5% Dextrose Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Storage

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING

Fetal-Neonatal Toxicity Reported With Prolonged Use

Continuous administration of Magnesium Sulfate in 5% Dextrose Injection in pregnant women beyond 5 to 7 days can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported [see Warnings and Precautions (5.1)].

Risk of Magnesium Toxicity

Pregnant women receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity, including facial edema, diminished strength of deep tendon reflexes, and respiratory depression [see Warnings and Precautions (5.2)].

Manufactured for: WG Critical Care, LLC Paramus, NJ 07652

{ "type": "p", "children": [], "text": "Manufactured for:\nWG Critical Care, LLC\nParamus, NJ 07652" }

Made in Switzerland

{ "type": "p", "children": [], "text": "Made in Switzerland" }

NDC 44567-410-24 100 mL

{ "type": "p", "children": [], "text": "\nNDC 44567-410-24 100 mL\n" }

Magnesium Sulfatein 5% Dextrose Injection, USP(0.081 mEq Mg++/mL) 10 mg/mL

{ "type": "p", "children": [], "text": "\nMagnesium Sulfatein 5% Dextrose Injection, USP(0.081 mEq Mg++/mL) 10 mg/mL\n" }

1 g Total

{ "type": "p", "children": [], "text": "1 g Total" }

Magnesium Sulfate in 5% Dextrose Injection is indicated for:

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection is indicated for: " }

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Magnesium Sulfate in 5% Dextrose Injection is:

Magnesium Sulfate in 5% Dextrose Injection does not require dilution prior to intravenous administration.

After removing the overwrap, check for minute leaks by squeezing the container fully. Do not administer Magnesium Sulfate in 5% Dextrose Injection if there is a leak or there is greater than 2 mL of water in the overwrap [see Description (11)].

Do not administer Magnesium Sulfate in 5% Dextrose Injection with incompatible drugs through the same intravenous line [see Dosage and Administration (2.4)]. Do not use Magnesium Sulfate in 5% Dextrose Injection in series connections.

Magnesium Sulfate in 5% Dextrose Injection is not compatible with administration of a variety of solutions and forms precipitates of magnesium salts. Before using Magnesium Sulfate in 5% Dextrose Injection with another parenteral product, investigate potential incompatibilities. Incompatible products that should not be coadministered include salicylates and alkali carbonates.

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear and colorless to slightly yellow solution supplied in single-dose bags:

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection, USP is a clear and colorless to slightly yellow solution supplied in single-dose bags: " }

{ "type": "", "children": [], "text": "" }

Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection.

{ "type": "p", "children": [], "text": "Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection." }

Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients:

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients: " }

{ "type": "", "children": [], "text": "" }

Continuous administration of magnesium sulfate beyond 5 to 7 days in pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported.

Neonates of women receiving Magnesium Sulfate in 5% Dextrose Injection (especially with prolonged maternal use) are at risk for magnesium toxicity including hyporeflexia, hypotonia, and respiratory depression. There is one reported case of neonatal death as the result of magnesium toxicity after transplacental exposure.

The shortest duration of magnesium sulfate treatment that can lead to fetal harm is not known. Administration of Magnesium Sulfate in 5% Dextrose Injection beyond 5 to 7 days is not recommended.

Patients receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity including respiratory depression, acute renal failure and rarely, pulmonary edema.

Monitor clinical signs of magnesium toxicity (for example, facial edema, diminished strength of deep tendon reflexes, respiratory depression) and magnesium concentrations during infusions of Magnesium Sulfate in 5% Dextrose Injection. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more per minute). Serum magnesium concentrations usually sufficient to control convulsions range from 3 to 6 mg per 100 mL (2.5 to 5 mEq per liter). The strength of the deep tendon reflexes begins to diminish when serum magnesium concentrations exceed 4 mEq per liter. Reflexes may be absent at concentration of 10 mEq per liter, at which point respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium toxicity in patients with preeclampsia and eclampsia. If there is significant magnesium toxicity, stop the Magnesium Sulfate in 5% Dextrose Injection infusion and recheck serum magnesium concentration.

Patients with renal impairment are at greater risk of magnesium toxicity because magnesium is excreted by the body solely by the kidneys [see Use in Specific Populations (8.6)]. Urine output should be maintained at a level of 100 mL per 4 hours. Monitoring serum magnesium levels and the patient’s clinical status is essential to avoid the consequences of overdosage in patients with preeclampsia. Discontinuation of the magnesium infusion is recommended when urine output is less than 100 mL every 4 hours to avoid magnesium toxicity, especially if serum creatinine is increasing progressively.

Solutions containing dextrose should be used with caution in patients with known prediabetes or diabetes mellitus given the risk of elevated blood glucose.

Do not use Magnesium Sulfate in 5% Dextrose Injection with unapproved tocolytics (e.g., beta adrenergic agents such as terbutaline, or with calcium channel blockers such as nifedipine). Serious adverse events including pulmonary edema and hypotension have occurred [see Drug Interactions (7)].

Magnesium Sulfate in 5% Dextrose Injection contains aluminum that may be toxic (Magnesium Sulfate in 5% Dextrose Injection contains less than 25 mcg/L of aluminum). Aluminum may reach toxic concentrations with prolonged parenteral administration in patients with renal impairment.

Patients with renal impairment who receive parenteral concentrations of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at concentrations associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with known myasthenia gravis.

Use of magnesium sulfate in patients with underlying myasthenia gravis can precipitate a myasthenic crisis. Myasthenic crisis is a life-threatening condition characterized by neuromuscular respiratory failure. Symptoms of myasthenic crisis may include difficulty swallowing, ptosis, facial droop, weakness and/or difficulty breathing that may require intubation.

If myasthenic crisis is suspected, discontinue use of Magnesium Sulfate in 5% Dextrose Injection immediately. Secure the patient’s airway. Consider intensive care unit admission and elective intubation, if respiratory failure is anticipated. Once the airway is secure, confirm the diagnosis. Therapies include plasmapheresis and plasma exchange or intravenous immunoglobulin (IVIG) and immunomodulating therapy in addition to high-dose glucocorticoids.

The following adverse reactions have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

{ "type": "p", "children": [], "text": "The following adverse reactions have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. " }

<div class="scrollingtable"><table width="100%"> <col width="22%"/> <col width="78%"/> <tbody class="Headless"> <tr class="First"> <td class="Toprule" valign="top"> <p class="First">Cardiovascular:</p> </td><td class="Toprule" valign="top"> <p class="First">hypotension, circulatory collapse, cardiac depression including bradycardia</p> </td> </tr> <tr> <td valign="top"> <p class="First">Central Nervous System:</p> </td><td valign="top"> <p class="First">central nervous system depression leading to respiratory paralysis, visual <br/>disturbances, flushing, sweating, hypothermia</p> </td> </tr> <tr> <td valign="top"> <p class="First">Metabolic:</p> </td><td valign="top"> <p class="First">hypocalcemia with signs of tetany, hypermagnesemia</p> </td> </tr> <tr> <td valign="top"> <p class="First">Neurologic:</p> </td><td valign="top"> <p class="First">lethargy, sedation, somnolence, myasthenic crisis</p> </td> </tr> <tr> <td valign="top"> <p class="First">Neuromuscular:</p> </td><td valign="top"> <p class="First">depressed deep tendon reflexes, flaccid paralysis</p> </td> </tr> <tr class="Last"> <td class="Botrule" valign="top"> <p class="First">Pulmonary:</p> </td><td class="Botrule" valign="top"> <p class="First">decreased respiratory rate, pulmonary edema</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"22%\"/>\n<col width=\"78%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">Cardiovascular:</p>\n</td><td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">hypotension, circulatory collapse, cardiac depression including bradycardia</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Central Nervous System:</p>\n</td><td valign=\"top\">\n<p class=\"First\">central nervous system depression leading to respiratory paralysis, visual <br/>disturbances, flushing, sweating, hypothermia</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Metabolic:</p>\n</td><td valign=\"top\">\n<p class=\"First\">hypocalcemia with signs of tetany, hypermagnesemia</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Neurologic:</p>\n</td><td valign=\"top\">\n<p class=\"First\">lethargy, sedation, somnolence, myasthenic crisis</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">Neuromuscular:</p>\n</td><td valign=\"top\">\n<p class=\"First\">depressed deep tendon reflexes, flaccid paralysis</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule\" valign=\"top\">\n<p class=\"First\">Pulmonary:</p>\n</td><td class=\"Botrule\" valign=\"top\">\n<p class=\"First\">decreased respiratory rate, pulmonary edema</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Table 1 presents the potential clinical impact of medications that may be commonly administered concomitantly with Magnesium Sulfate in 5% Dextrose Injection in the clinical setting.

{ "type": "p", "children": [], "text": "\nTable 1 presents the potential clinical impact of medications that may be commonly administered concomitantly with Magnesium Sulfate in 5% Dextrose Injection in the clinical setting." }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1 : Potential Clinically Significant Drug Interactions with Magnesium Sulfate in 5% Dextrose Injection*</span> </caption> <col width="23%"/> <col width="77%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Neuromuscular Blocking Agents</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents <span class="Italics"><a href="#ID_a0cfb7a0-d057-423f-ad59-007020a1b1c4">[see Clinical Pharmacology (12.2)]</a></span>. </dd> <dt>•</dt> <dd>The underlying mechanism of this interaction may involve suppression of peripheral neuromuscular function by decreasing acetylcholine release, reduction of endplate sensitivity, and decreased muscle fiber excitability with magnesium sulfate therapy.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor respiration and the depth of neuromuscular blockade frequently (e.g., train-of-four monitoring) when a neuromuscular blocking agent is used concomitantly with Magnesium Sulfate in 5% Dextrose Injection. </dd> <dt>•</dt> <dd>Adjust the dosage of the neuromuscular blocking agent accordingly to maintain the desired level of musculoskeletal activity. The amount of reversal agent(s) required to achieve adequate reversal of the neuromuscular blocking agent(s) may also be increased.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Depolarizing neuromuscular blockers: succinylcholine </dd> <dt>•</dt> <dd>Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Narcotics and/or Propofol</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Potentiation and prolongation of analgesia and CNS depression is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with narcotics and/or propofol. The potential for magnesium sulfate to affect other CNS depressants is unknown <span class="Italics"><a href="#ID_a0cfb7a0-d057-423f-ad59-007020a1b1c4">[see Clinical Pharmacology (12.2)]</a></span>. </dd> <dt>•</dt> <dd>The underlying mechanism of this interaction may involve antagonism of N-methyl-D-aspartate (NMDA) by magnesium sulfate therapy.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor the depth of CNS depression frequently using a reliable instrument.</dd> <dt>•</dt> <dd>Adjust the narcotic and/or propofol dosage accordingly to maintain the desired level of analgesia and sedation.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Narcotics and propofol</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Dihydropyridine Calcium Channel Blockers</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>An exaggerated hypotensive response is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with dihydropyridine calcium channel blockers. The potential for magnesium sulfate to affect other calcium channel blockers (e.g., diltiazem and verapamil) is unknown <span class="Italics"><a href="#ID_a0cfb7a0-d057-423f-ad59-007020a1b1c4">[see Clinical Pharmacology (12.2)]</a>.</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor vital signs (heart rate, blood pressure, respiration) frequently.</dd> <dt>•</dt> <dd>Supportive care and/or discontinuation of the calcium channel blocker may be required.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <span class="Bold">Drugs that May Induce Magnesium Loss</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Clinical Impact:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Reduced magnesium concentrations may impact efficacy</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Intervention:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Monitor magnesium concentrations frequently and adjust the Magnesium Sulfate in 5% Dextrose Injection dosage to maintain concentrations in the target range <span class="Italics"><a href="#ID_7bbe5f94-423b-4ff0-8262-c2d7a6b05001">[see Dosage and Administration (2)]</a></span>.</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Italics">Examples:</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics</dd> </dl> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 1 : Potential Clinically Significant Drug Interactions with Magnesium Sulfate in 5% Dextrose Injection*</span>\n</caption>\n<col width=\"23%\"/>\n<col width=\"77%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Neuromuscular Blocking Agents</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents <span class=\"Italics\"><a href=\"#ID_a0cfb7a0-d057-423f-ad59-007020a1b1c4\">[see Clinical Pharmacology (12.2)]</a></span>. </dd>\n<dt>•</dt>\n<dd>The underlying mechanism of this interaction may involve suppression of peripheral neuromuscular function by decreasing acetylcholine release, reduction of endplate sensitivity, and decreased muscle fiber excitability with magnesium sulfate therapy.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor respiration and the depth of neuromuscular blockade frequently (e.g., train-of-four monitoring) when a neuromuscular blocking agent is used concomitantly with Magnesium Sulfate in 5% Dextrose Injection. </dd>\n<dt>•</dt>\n<dd>Adjust the dosage of the neuromuscular blocking agent accordingly to maintain the desired level of musculoskeletal activity. The amount of reversal agent(s) required to achieve adequate reversal of the neuromuscular blocking agent(s) may also be increased.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Depolarizing neuromuscular blockers: succinylcholine </dd>\n<dt>•</dt>\n<dd>Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Narcotics and/or Propofol</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Potentiation and prolongation of analgesia and CNS depression is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with narcotics and/or propofol. The potential for magnesium sulfate to affect other CNS depressants is unknown <span class=\"Italics\"><a href=\"#ID_a0cfb7a0-d057-423f-ad59-007020a1b1c4\">[see Clinical Pharmacology (12.2)]</a></span>. </dd>\n<dt>•</dt>\n<dd>The underlying mechanism of this interaction may involve antagonism of N-methyl-D-aspartate (NMDA) by magnesium sulfate therapy.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor the depth of CNS depression frequently using a reliable instrument.</dd>\n<dt>•</dt>\n<dd>Adjust the narcotic and/or propofol dosage accordingly to maintain the desired level of analgesia and sedation.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Narcotics and propofol</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Dihydropyridine Calcium Channel Blockers</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>An exaggerated hypotensive response is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with dihydropyridine calcium channel blockers. The potential for magnesium sulfate to affect other calcium channel blockers (e.g., diltiazem and verapamil) is unknown <span class=\"Italics\"><a href=\"#ID_a0cfb7a0-d057-423f-ad59-007020a1b1c4\">[see Clinical Pharmacology (12.2)]</a>.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor vital signs (heart rate, blood pressure, respiration) frequently.</dd>\n<dt>•</dt>\n<dd>Supportive care and/or discontinuation of the calcium channel blocker may be required.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Drugs that May Induce Magnesium Loss</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Clinical Impact:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Reduced magnesium concentrations may impact efficacy</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Intervention:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Monitor magnesium concentrations frequently and adjust the Magnesium Sulfate in 5% Dextrose Injection dosage to maintain concentrations in the target range <span class=\"Italics\"><a href=\"#ID_7bbe5f94-423b-4ff0-8262-c2d7a6b05001\">[see Dosage and Administration (2)]</a></span>.</dd>\n</dl>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Italics\">Examples:</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics</dd>\n</dl>\n</td>\n</tr>\n</tbody>\n</table></div>" }

*For drug incompatibility information [see Dosage and Administration (2.4)].

{ "type": "p", "children": [], "text": "*For drug incompatibility information [see Dosage and Administration (2.4)]." }

Risk Summary Magnesium Sulfate in 5% Dextrose Injection is indicated in pregnant women for the prevention of eclampsia in women with preeclampsia and the treatment of seizures and prevention of recurrent seizures in women with eclampsia. Fetal, neonatal, and maternal risks are discussed throughout the labeling.

Clinical Considerations Labor or Delivery: Magnesium Sulfate in 5% Dextrose Injection is not approved for the treatment of pre-term labor.

Administration of Magnesium Sulfate in 5% Dextrose Injection to pregnant women longer than 5 to 7 days may lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia [see Warnings and Precautions (5.1)].

The use of intravenous magnesium in pregnant women increases human milk magnesium concentrations only slightly and oral absorption of magnesium by the infant is poor. The effect of intravenous magnesium on milk production is unknown. The developmental and health benefits to the neonate of breastfeeding should be considered along with the mother’s clinical need for Magnesium Sulfate in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Magnesium Sulfate in 5% Dextrose Injection or from the underlying maternal condition.

The safety and effectiveness of Magnesium Sulfate in 5% Dextrose Injection have been established for the prevention of eclampsia in adolescents with preeclampsia and the treatment of seizures and prevention of recurrent seizures in adolescents with eclampsia. Dosing recommendation in pregnant adolescent patients are the same as for pregnant adult patients [see Dosage and Administration (2.2)].

Magnesium is excreted solely by the kidneys. Patients with severe renal impairment (urine output less than 100 mL per 4 hours) are at greater risk for increased magnesium concentrations that may lead to magnesium toxicity [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. In patients with severe renal impairment, dosage reduction is recommended and the maximum recommended dosage is lower than patients with normal renal function [see Dosage and Administration (2.3)].

Manifestations of magnesium toxicity include a drop in blood pressure, difficulty breathing, and disappearance of the patellar reflex. As serum magnesium rises above 4 mEq per liter, the deep tendon reflexes decrease. As the serum magnesium level approaches 10 mEq per liter, the tendon reflexes disappear and respiratory paralysis may occur [see Warnings and Precautions (5.2)]. Other signs and symptoms of magnesium overdosage include flushing, sweating, hypotension, weakness, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis, cardiac arrest, and prolongation of PR and QRS intervals. Patients with renal impairment and underlying neuromuscular diseases such as myasthenia gravis may experience magnesium intoxication at lower magnesium concentrations (Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with myasthenia gravis).

{ "type": "p", "children": [], "text": "Manifestations of magnesium toxicity include a drop in blood pressure, difficulty breathing, and disappearance of the patellar reflex. As serum magnesium rises above 4 mEq per liter, the deep tendon reflexes decrease. As the serum magnesium level approaches 10 mEq per liter, the tendon reflexes disappear and respiratory paralysis may occur [see Warnings and Precautions (5.2)]. Other signs and symptoms of magnesium overdosage include flushing, sweating, hypotension, weakness, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis, cardiac arrest, and prolongation of PR and QRS intervals. Patients with renal impairment and underlying neuromuscular diseases such as myasthenia gravis may experience magnesium intoxication at lower magnesium concentrations (Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients with myasthenia gravis). " }

If patient is experiencing magnesium toxicity, immediately discontinue Magnesium Sulfate in 5% Dextrose Injection. Artificial respiration may be required. Administer an injectable calcium salt to counteract the potential hazards of magnesium toxicity [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "If patient is experiencing magnesium toxicity, immediately discontinue Magnesium Sulfate in 5% Dextrose Injection. Artificial respiration may be required. Administer an injectable calcium salt to counteract the potential hazards of magnesium toxicity [see Warnings and Precautions (5.2)]. " }

Hypermagnesemia in the newborn (after administration of Magnesium Sulfate in 5% Dextrose Injection to the mother) may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

{ "type": "p", "children": [], "text": "Hypermagnesemia in the newborn (after administration of Magnesium Sulfate in 5% Dextrose Injection to the mother) may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium." }

Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of magnesium sulfate heptahydrate and dextrose, hydrous 5 grams in water for injection [see How Supplied/Storage and Handling (16)]. Magnesium Sulfate in 5% Dextrose Injection, USP may contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5).

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of magnesium sulfate heptahydrate and dextrose, hydrous 5 grams in water for injection [see How Supplied/Storage and Handling (16)]. Magnesium Sulfate in 5% Dextrose Injection, USP may contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). " }

Magnesium Sulfate, USP heptahydrate is chemically known as sulfuric acid magnesium salt (1:1), heptahydrate and chemically designated MgSO4 • 7H2O, with a molecular weight of 246.47. It occurs as colorless crystals or white powder freely soluble in water.

{ "type": "p", "children": [], "text": "Magnesium Sulfate, USP heptahydrate is chemically known as sulfuric acid magnesium salt (1:1), heptahydrate and chemically designated MgSO4 • 7H2O, with a molecular weight of 246.47. It occurs as colorless crystals or white powder freely soluble in water. " }

Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. The molecular formula is C6H12O6 • H2O and the molecular weight is 198.17. It has the following structural formula:

{ "type": "p", "children": [], "text": "Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. The molecular formula is C6H12O6 • H2O and the molecular weight is 198.17. It has the following structural formula:" }

Water for Injection, USP is chemically designated H2O.

{ "type": "p", "children": [], "text": "Water for Injection, USP is chemically designated H2O. " }

Water can permeate from inside the Baxter VIAFLO flexible plastic container [composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE)] into the overwrap [see Dosage and Administration (2.1)] but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

{ "type": "p", "children": [], "text": "Water can permeate from inside the Baxter VIAFLO flexible plastic container [composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE)] into the overwrap [see Dosage and Administration (2.1)] but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period." }

Magnesium prevents seizures in patients with preeclampsia and controls seizures in patients with eclampsia by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Magnesium has a depressant effect on the central nervous system [see Drug Interactions (7)]. Magnesium acts peripherally to produce vasodilation.

With intravenous administration of magnesium sulfate the onset of anticonvulsant action is immediate and lasts about 30 minutes. The estimated magnesium concentration (above baseline) required to elicit half-maximum effect (EC50) on systolic and diastolic blood pressure in pregnant women with preeclampsia that received intravenous magnesium sulfate therapy was reported to be 1.5 and 1.8 mEq per liter (1.9 and 2.2 mg per dL), respectively, in a published study. Effective anticonvulsant serum concentrations range from 2.5 to 7.5 mEq per liter.

Drug Interaction Studies The following information is based upon published case reports and clinical studies that could not be confirmed by an adequately controlled study, but still warrant consideration given the potential risks involved [see Drug Interactions (7)].

Neuromuscular Blocking Agents: Potentiation and prolongation of neuromuscular blockade requiring modification of the neuromuscular blocking agent dosage and/or increased reversal agent requirements were reported in preeclamptic women who received magnesium sulfate treatment who underwent subsequent surgery (for example, caesarian section) with anesthesia that included either a depolarizing (d-tubocurarine, succinylcholine) or nondepolarizing neuromuscular blocking agent (vecuronium, rocuronium).

Narcotics and/or Propofol: Potentiation and prolongation of analgesic and/or sedative effects as well as a reduced requirement for an intravenous narcotic (fentanyl, sufentanil, tramadol), intrathecal narcotic (fentanyl), and/or intravenous propofol was reported in magnesium sulfate treated patients who required surgery or intensive care that also included narcotic and/or propofol therapy.

Dihydropyridine Calcium Channel Blockers: An exaggerated hypotensive response (blood pressure 80-93/49-60 mm Hg) was reported in preeclamptic women who received oral nifedipine in addition to magnesium sulfate treatment. Blood pressure returned to previous levels within approximately 30 minutes with supportive care.

Distribution Approximately 1 to 2% of total body magnesium is located in the extracellular fluid space. Magnesium is 30% bound to albumin.

Elimination The average half-life and systemic clearance of magnesium sulfate in preeclamptic women is approximately 4 to 5 hours and 4 to 5 liters per hour, respectively.

Excretion: Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

Specific Populations Patients with Renal Impairment: Plasma magnesium concentrations of 7 to 12.3 mEq per liter (8.6 to 15.1 mg per dL) were reported in preeclamptic women with a urine output less than 100 mL per 4 hours that received 20 grams of magnesium sulfate intravenously over 2 to 8 hours in a published study [see Dosage and Administration (2.3) and Use in Specific Populations (8.6)].

Studies with Magnesium Sulfate in 5% Dextrose Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in VIAFLO single-dose flexible plastic containers (see Table 2).

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in VIAFLO single-dose flexible plastic containers (see Table 2)." }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2 : How Supplied Information</span> </caption> <col width="17%"/> <col width="11%"/> <col width="12%"/> <col width="14%"/> <col width="14%"/> <col width="17%"/> <col width="16%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Magnesium Sulfate* Concentration </span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">NDC Number </span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Container </span> <br/> <span class="Bold">Size </span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Total Magnesium </span> <br/> <span class="Bold">Sulfate* </span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Total Magnesium Ion </span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Magnesium Ion Concentration </span> </p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Osmolarity** </span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">0.01 grams/mL (1%) </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">0338-1709-40 </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">100 mL </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">1 gram </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">8.1 mEq </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">8.1 mEq/100 mL </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">333 mOsmol/liter </p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 2 : How Supplied Information</span>\n</caption>\n<col width=\"17%\"/>\n<col width=\"11%\"/>\n<col width=\"12%\"/>\n<col width=\"14%\"/>\n<col width=\"14%\"/>\n<col width=\"17%\"/>\n<col width=\"16%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Magnesium Sulfate* Concentration </span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">NDC Number </span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Container </span>\n<br/>\n<span class=\"Bold\">Size </span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Total Magnesium </span>\n<br/>\n<span class=\"Bold\">Sulfate* </span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Total Magnesium Ion </span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Magnesium Ion Concentration </span>\n</p>\n</td><td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Osmolarity** </span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0.01 grams/mL (1%) </p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0338-1709-40 </p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">100 mL </p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">1 gram </p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">8.1 mEq </p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">8.1 mEq/100 mL </p>\n</td><td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">333 mOsmol/liter </p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.

{ "type": "p", "children": [], "text": "VIAFLO container is not made with natural rubber latex, DEHP, or PVC." }

Storage

{ "type": "p", "children": [], "text": "Storage " }

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

{ "type": "p", "children": [], "text": "Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing." }

Magnesium Sulfate in 5% Dextrose Injection is typically administered to pregnant women in emergent situations. When feasible, advise the patient and family of the following:

{ "type": "p", "children": [], "text": "Magnesium Sulfate in 5% Dextrose Injection is typically administered to pregnant women in emergent situations. When feasible, advise the patient and family of the following: " }

Fetal-Neonatal Toxicity Reported With Prolonged Use Continuous administration of Magnesium Sulfate in 5% Dextrose Injection in pregnant women beyond 5 to 7 days can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "\nFetal-Neonatal Toxicity Reported With Prolonged Use \nContinuous administration of Magnesium Sulfate in 5% Dextrose Injection in pregnant women beyond 5 to 7 days can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported [see Warnings and Precautions (5.1)]. " }

Risk of Magnesium Toxicity Pregnant women receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity, including facial edema, diminished strength of deep tendon reflexes, and respiratory depression [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "\nRisk of Magnesium Toxicity\nPregnant women receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity, including facial edema, diminished strength of deep tendon reflexes, and respiratory depression [see Warnings and Precautions (5.2)]." }

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "\nBaxter Logo\nBaxter Healthcare CorporationDeerfield, IL 60015 USA" }

Made in Spain

{ "type": "p", "children": [], "text": "Made in Spain" }

Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries.

{ "type": "p", "children": [], "text": "Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries." }

SA-30-02-892

{ "type": "p", "children": [], "text": "SA-30-02-892" }

{ "type": "", "children": [], "text": "" }

100 mL NDC 0338-1709-40

{ "type": "p", "children": [], "text": "\n100 mL\n\nNDC 0338-1709-40\n" }

Magnesium Sulfate in 5% Dextrose Injection, USP

{ "type": "p", "children": [], "text": "\nMagnesium Sulfate\nin 5% Dextrose Injection, USP" }

1 g/ 100 mL (10 mg/mL)

{ "type": "p", "children": [], "text": "1 g/ 100 mL (10 mg/mL)" }

1 g TOTAL

{ "type": "p", "children": [], "text": "\n1 g\nTOTAL" }

Each 100 mL of sterile, nonpyrogenic solution contains: Magnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) and dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment.

{ "type": "p", "children": [], "text": "\nEach 100 mL of sterile, nonpyrogenic solution contains:\nMagnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) and dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. " }

pH 4.5 (3.5 to 6.5) 333 mOsmol/Liter (calc.)

{ "type": "p", "children": [], "text": "pH 4.5 (3.5 to 6.5) 333 mOsmol/Liter (calc.)" }

Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only ifsolution is clear and container is undamaged. Must not be usedin series connections. Store at 20 to 25°C (68 to 77°F). [See USPControlled Room Temperature.] Protect from freezing.

{ "type": "p", "children": [], "text": "Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only ifsolution is clear and container is undamaged. Must not be usedin series connections. Store at 20 to 25°C (68 to 77°F). [See USPControlled Room Temperature.] Protect from freezing." }

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.

{ "type": "p", "children": [], "text": "VIAFLO container is not made with natural rubber latex, DEHP, or PVC." }

Rx OnlyNumber 07 plastics symbol 0

{ "type": "p", "children": [], "text": "Rx OnlyNumber 07 plastics symbol 0" }

Bar code(01) 00303381709402

{ "type": "p", "children": [], "text": "Bar code(01) 00303381709402" }

Baxter Healthcare Corporation Deerfield, IL 60015 USAMade in Ireland

{ "type": "p", "children": [], "text": "\nBaxter Healthcare Corporation\nDeerfield, IL 60015 USAMade in Ireland" }

EZPE8501CB-35-04-890

{ "type": "p", "children": [], "text": "EZPE8501CB-35-04-890" }

DO NOT USE THIS PORT symbol

{ "type": "p", "children": [], "text": "\nDO NOT USE \n\nTHIS PORT symbol" }

Lot Exp

{ "type": "p", "children": [], "text": "\nLot\n\nExp\n" }

{ "type": "", "children": [], "text": "" }

100 mL TO OPEN – TEAR AT NOTCH NDC 0338-1709-40

{ "type": "p", "children": [], "text": "100 mL\nTO OPEN – TEAR AT NOTCH\nNDC 0338-1709-40" }

Magnesium Sulfate in 5% Dextrose Injection, USP

{ "type": "p", "children": [], "text": "\nMagnesium Sulfate\nin 5% Dextrose Injection, USP" }

1 g/100 mL (10 mg/mL)

{ "type": "p", "children": [], "text": "1 g/100 mL (10 mg/mL)" }

1g Total

{ "type": "p", "children": [], "text": "\n1g\nTotal" }

Each 100 mL of sterile, nonpyrogenic solution contains:Magnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) anddextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/orsodium hydroxide for pH adjustment.

{ "type": "p", "children": [], "text": "Each 100 mL of sterile, nonpyrogenic solution contains:Magnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) anddextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/orsodium hydroxide for pH adjustment." }

333 mOsmol/Liter (calc.) pH 4.5 (3.5 to 6.5)

{ "type": "p", "children": [], "text": "333 mOsmol/Liter (calc.) pH 4.5 (3.5 to 6.5)" }

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE.

{ "type": "p", "children": [], "text": "\nDO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE\n\nCENTRAL ROUTE.\n" }

Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only if solution isclear and container is undamaged. After removing the overwrap, check forminute leaks by squeezing container firmly. If leaks are found, discard unit assterility may be impaired. Must not be used in series connections.

{ "type": "p", "children": [], "text": "Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only if solution isclear and container is undamaged. After removing the overwrap, check forminute leaks by squeezing container firmly. If leaks are found, discard unit assterility may be impaired. Must not be used in series connections." }

The overwrap is a moisture barrier. Do not remove unit from overwrap untilready for use. Use unit promptly when pouch is opened.

{ "type": "p", "children": [], "text": "The overwrap is a moisture barrier. Do not remove unit from overwrap untilready for use. Use unit promptly when pouch is opened." }

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC.

{ "type": "p", "children": [], "text": "Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC." }

2D Barcode(91)CB1001219

{ "type": "p", "children": [], "text": "2D Barcode(91)CB1001219" }

Rx OnlyEZPE8501CB-10-01-219

{ "type": "p", "children": [], "text": "Rx OnlyEZPE8501CB-10-01-219" }

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in Ireland(See Solution Container for Lot and Exp)

{ "type": "p", "children": [], "text": "\nBaxter Logo\nBaxter Healthcare CorporationDeerfield, IL 60015 USAMade in Ireland(See Solution Container for Lot and Exp)" }

Barcode(01) 00303381709402

{ "type": "p", "children": [], "text": "Barcode(01) 00303381709402" }

{ "type": "", "children": [], "text": "" }

100 mL NDC 0338-1709-40

{ "type": "p", "children": [], "text": "\n100 mL\n\nNDC 0338-1709-40\n" }

Magnesium Sulfate in 5% Dextrose Injection, USP

{ "type": "p", "children": [], "text": "\nMagnesium Sulfate\nin 5% Dextrose Injection, USP" }

1 g/ 100 mL (10 mg/mL)

{ "type": "p", "children": [], "text": "1 g/ 100 mL (10 mg/mL)" }

1 g TOTAL

{ "type": "p", "children": [], "text": "\n1 g\nTOTAL" }

Each 100 mL of sterile, nonpyrogenic solution contains: Magnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) and dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment.

{ "type": "p", "children": [], "text": "\nEach 100 mL of sterile, nonpyrogenic solution contains:\nMagnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) and dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. " }

pH 4.5 (3.5 to 6.5) 333 mOsmol/Liter (calc.)

{ "type": "p", "children": [], "text": "pH 4.5 (3.5 to 6.5) 333 mOsmol/Liter (calc.)" }

Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only ifsolution is clear and container is undamaged. Must not be usedin series connections. Store at 20 to 25°C (68 to 77°F). [See USPControlled Room Temperature.] Protect from freezing.

{ "type": "p", "children": [], "text": "Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only ifsolution is clear and container is undamaged. Must not be usedin series connections. Store at 20 to 25°C (68 to 77°F). [See USPControlled Room Temperature.] Protect from freezing." }

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.

{ "type": "p", "children": [], "text": "VIAFLO container is not made with natural rubber latex, DEHP, or PVC." }

Rx OnlyNumber 07 plastics symbol 0

{ "type": "p", "children": [], "text": "Rx OnlyNumber 07 plastics symbol 0" }

Bar code(01) 00303381709402

{ "type": "p", "children": [], "text": "Bar code(01) 00303381709402" }

Baxter Healthcare Corporation Deerfield, IL 60015 USAMade in Spain

{ "type": "p", "children": [], "text": "\nBaxter Healthcare Corporation\nDeerfield, IL 60015 USAMade in Spain" }

UE8501UN-35-04-602

{ "type": "p", "children": [], "text": "UE8501UN-35-04-602" }

DO NOT USE THIS PORT symbol

{ "type": "p", "children": [], "text": "\nDO NOT USE \n\nTHIS PORT symbol" }

Lot Exp

{ "type": "p", "children": [], "text": "\nLot\n\nExp\n" }

{ "type": "", "children": [], "text": "" }

100 mL TO OPEN – TEAR AT NOTCH NDC 0338-1709-40

{ "type": "p", "children": [], "text": "100 mL\nTO OPEN – TEAR AT NOTCH\nNDC 0338-1709-40" }

Magnesium Sulfate in 5% Dextrose Injection, USP

{ "type": "p", "children": [], "text": "\nMagnesium Sulfate\nin 5% Dextrose Injection, USP" }

1 g/100 mL (10 mg/mL)

{ "type": "p", "children": [], "text": "1 g/100 mL (10 mg/mL)" }

1g Total

{ "type": "p", "children": [], "text": "\n1g\nTotal" }

Each 100 mL of sterile, nonpyrogenic solution contains:Magnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) anddextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/orsodium hydroxide for pH adjustment.

{ "type": "p", "children": [], "text": "Each 100 mL of sterile, nonpyrogenic solution contains:Magnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) anddextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/orsodium hydroxide for pH adjustment." }

333 mOsmol/Liter (calc.) pH 4.5 (3.5 to 6.5)

{ "type": "p", "children": [], "text": "333 mOsmol/Liter (calc.) pH 4.5 (3.5 to 6.5)" }

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE.

{ "type": "p", "children": [], "text": "\nDO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE\n\nCENTRAL ROUTE.\n" }

Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only if solution isclear and container is undamaged. After removing the overwrap, check forminute leaks by squeezing container firmly. If leaks are found, discard unit assterility may be impaired. Must not be used in series connections.

{ "type": "p", "children": [], "text": "Single-Dose Container – Discard unused portion. For Intravenous Use.Recommended dosage: See prescribing information. Use only if solution isclear and container is undamaged. After removing the overwrap, check forminute leaks by squeezing container firmly. If leaks are found, discard unit assterility may be impaired. Must not be used in series connections." }

The overwrap is a moisture barrier. Do not remove unit from overwrap untilready for use. Use unit promptly when pouch is opened.

{ "type": "p", "children": [], "text": "The overwrap is a moisture barrier. Do not remove unit from overwrap untilready for use. Use unit promptly when pouch is opened." }

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC.

{ "type": "p", "children": [], "text": "Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Protect from freezing. VIAFLO container is not made with natural rubber latex, DEHP, or PVC." }

2D Barcode(91)SA1001003

{ "type": "p", "children": [], "text": "2D Barcode(91)SA1001003" }

Rx OnlyUN8501SA-10-01-003

{ "type": "p", "children": [], "text": "Rx OnlyUN8501SA-10-01-003" }

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USAMade in Spain(See Solution Container for Lot and Exp)

{ "type": "p", "children": [], "text": "\nBaxter Logo\nBaxter Healthcare CorporationDeerfield, IL 60015 USAMade in Spain(See Solution Container for Lot and Exp)" }

Barcode(01) 00303381709402

{ "type": "p", "children": [], "text": "Barcode(01) 00303381709402" }