Magnesium Sulfate 40mg/ml Inj, 50ml

Manufacturer BAXTER Active Ingredient Magnesium Sulfate Injection(mag NEE zhum SUL fate) Pronunciation mag NEE zhum SUL fate
It is used to treat or prevent low magnesium levels.It is used to prevent and control seizures during pregnancy.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Electrolyte, Anticonvulsant, Tocolytic, Antiarrhythmic
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Pharmacologic Class
Mineral, CNS Depressant, Smooth Muscle Relaxant
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Pregnancy Category
Not applicable (Risk Summary)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Magnesium sulfate is a mineral given by injection to treat certain medical conditions. It can help relax muscles, prevent seizures, and correct low magnesium levels in the body. It's often used in hospitals for serious conditions like severe asthma attacks, certain heart problems, or to prevent seizures in pregnant women with pre-eclampsia.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Report any unusual symptoms immediately to your healthcare provider.
  • Do not take any other medications, especially sedatives or muscle relaxants, without consulting your doctor, as they can increase the risk of side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication.

Condition-Specific Dosing:

Eclampsia/Pre-eclampsia (IV/IM): Loading dose: 4-6 g IV over 15-20 min, followed by maintenance: 1-2 g/hr IV infusion. OR 10 g IM (5g in each buttock) followed by 5g IM every 4 hours.
Hypomagnesemia (Severe, IV): 4-8 g IV over 2-4 hours, then 1-2 g/hr IV infusion. Total daily dose up to 30-40 g.
Hypomagnesemia (Mild-Moderate, IV/IM): 1-4 g IV/IM in single or divided doses.
Torsades de Pointes (IV): 1-2 g IV over 5-20 min, may repeat once.
Acute Severe Asthma (IV): 2 g IV over 20 min (adjunctive therapy).
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Pediatric Dosing

Neonatal: Hypomagnesemia: 25-50 mg/kg/dose IV over 1-2 hours, repeat every 8-12 hours for 2-3 doses if needed. Max 200 mg/kg/day.
Infant: Hypomagnesemia: 25-50 mg/kg/dose IV over 1-2 hours, repeat every 8-12 hours for 2-3 doses if needed. Max 200 mg/kg/day.
Child: Hypomagnesemia: 25-50 mg/kg/dose IV over 1-2 hours, repeat every 8-12 hours for 2-3 doses if needed. Max 200 mg/kg/day. Acute Severe Asthma: 25-50 mg/kg IV over 10-20 min (max 2 g).
Adolescent: Hypomagnesemia: 25-50 mg/kg/dose IV over 1-2 hours, repeat every 8-12 hours for 2-3 doses if needed. Max 200 mg/kg/day. Acute Severe Asthma: 2 g IV over 20 min.
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Dose Adjustments

Renal Impairment:

Mild: Monitor closely; consider lower end of dosing range.
Moderate: Reduce dose by 25-50% and/or extend dosing interval. Monitor serum magnesium levels closely.
Severe: Contraindicated or significantly reduced dose (e.g., 50-75% reduction) with continuous monitoring of serum magnesium, deep tendon reflexes, and respiratory rate. Risk of toxicity is high.
Dialysis: Use with extreme caution; dose reduction required. Magnesium is dialyzable, but accumulation can occur between sessions. Avoid if possible.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Magnesium is an essential cofactor for many enzyme systems, including those involved in ATP production, nucleic acid synthesis, and muscle contraction. As a CNS depressant, it blocks neuromuscular transmission by decreasing acetylcholine release at the motor end plate. It also has a direct depressant effect on the CNS. In smooth muscle (e.g., uterus, bronchi, vasculature), it acts as a physiological calcium antagonist, leading to relaxation. In cardiac muscle, it slows the rate of SA node impulse formation and prolongs conduction time through the myocardium.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM)
Tmax: Immediate (IV); 1 hour (IM)
FoodEffect: Not applicable (parenteral)

Distribution:

Vd: Not readily quantifiable; distributed throughout the body, with about 50-60% in bone, 39-49% intracellular, and 1% extracellular.
ProteinBinding: Approximately 30% (to albumin)
CnssPenetration: Limited (crosses blood-brain barrier slowly, but can achieve therapeutic levels in CSF)

Elimination:

HalfLife: Approximately 4 hours (in patients with normal renal function)
Clearance: Primarily renal clearance; rate depends on glomerular filtration rate.
ExcretionRoute: Renal (urine)
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Immediate (IV); 1 hour (IM)
PeakEffect: Immediate (IV); 1 hour (IM)
DurationOfAction: Approximately 30 minutes (IV); 3-4 hours (IM)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high magnesium levels, including:
+ Confusion
+ Feeling sluggish
+ Slow movements
+ Shortness of breath
+ Upset stomach
+ Severe dizziness or fainting
Signs of low calcium levels, such as:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Other severe side effects, including:
+ Slow heartbeat
+ Flushing
+ Inability to move
+ Changes in vision
+ Feeling cold
+ Excessive sweating

If you experience any of the following symptoms, seek medical help immediately, as they could be signs of a life-threatening muscle problem:
New or worsening muscle weakness
Difficulty chewing or swallowing
Trouble breathing
Droopy eyelids
* Changes in vision, such as blurred vision or double vision

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any side effects that bother you or persist.

Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Feeling very tired or drowsy
  • Difficulty breathing or slow breathing
  • Muscle weakness or feeling floppy
  • Blurred or double vision
  • Slurred speech
  • Feeling dizzy or lightheaded
  • Nausea or vomiting
  • Decreased urine output
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a heart block or any pre-existing heart problems.
If you are currently taking nifedipine or terbutaline, as these medications may interact with this drug.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

Your doctor and pharmacist need this information to assess potential interactions and determine whether it is safe for you to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are following a low-magnesium diet, consult with your doctor to discuss any potential interactions.

Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to follow your doctor's instructions for scheduling these tests and discuss any concerns or questions you may have.

This medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use. This risk is particularly higher if you have kidney problems or if you are a premature infant. It is crucial to discuss this potential risk with your doctor.

Do not take this medication if you have myasthenia gravis, as it can cause severe and potentially life-threatening breathing problems in people with this condition.

If you are pregnant or become pregnant while taking this medication, you should contact your doctor immediately, as it may harm the unborn baby.

If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby and determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Loss of deep tendon reflexes (e.g., knee jerk)
  • Profound muscle weakness
  • Respiratory depression (slow, shallow breathing)
  • Hypotension (low blood pressure)
  • Bradycardia (slow heart rate)
  • ECG changes (prolonged PR, QRS, QT intervals)
  • Coma
  • Cardiac arrest

What to Do:

Immediate discontinuation of magnesium sulfate. Administer 10% Calcium Gluconate (10-20 mL IV slowly) as an antidote to reverse respiratory depression and cardiac effects. Provide ventilatory support if needed. In severe cases, hemodialysis may be required to remove excess magnesium. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., rocuronium, vecuronium): Potentiates and prolongs neuromuscular blockade, leading to increased risk of respiratory depression/paralysis.
  • Calcium channel blockers (e.g., nifedipine, amlodipine): Additive hypotensive and bradycardic effects, increased risk of AV block.
  • CNS depressants (e.g., opioids, benzodiazepines, barbiturates, general anesthetics): Additive CNS depression, increased risk of respiratory depression and sedation.
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Moderate Interactions

  • Digoxin: May increase risk of cardiac conduction abnormalities (e.g., AV block) in patients with hypermagnesemia.
  • Diuretics (loop and thiazide): May increase renal excretion of magnesium, potentially leading to hypomagnesemia (if not already hypermagnesemic).
  • Aminoglycosides: May potentiate neuromuscular blockade.

Monitoring

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Baseline Monitoring

Serum Magnesium Level

Rationale: To establish baseline and guide initial dosing, especially in hypomagnesemia or renal impairment.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: Magnesium is renally excreted; impaired renal function increases risk of toxicity.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: Magnesium can cause hypotension.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Magnesium Level

Frequency: Every 4-6 hours during continuous infusion, or as clinically indicated.

Target: Therapeutic range varies by indication (e.g., 4-7 mEq/L for eclampsia, 1.5-2.5 mEq/L for hypomagnesemia).

Action Threshold: Levels > 8-10 mEq/L indicate toxicity; > 12 mEq/L risk of respiratory depression; > 15 mEq/L risk of cardiac arrest.

Deep Tendon Reflexes (DTRs)

Frequency: Hourly during continuous infusion, or every 2-4 hours.

Target: Present but not hyperactive.

Action Threshold: Loss of patellar reflex (knee jerk) indicates impending toxicity (Mg levels typically > 8-10 mEq/L).

Respiratory Rate

Frequency: Hourly during continuous infusion, or every 2-4 hours.

Target: > 12-14 breaths/min.

Action Threshold: < 12 breaths/min indicates significant toxicity, requiring immediate intervention.

Urine Output

Frequency: Hourly during continuous infusion, or every 2-4 hours.

Target: > 25-30 mL/hr (adults).

Action Threshold: < 25 mL/hr indicates impaired renal excretion and increased risk of toxicity.

Blood Pressure

Frequency: Hourly during continuous infusion, or every 2-4 hours.

Target: Maintain within target range for indication.

Action Threshold: Significant hypotension.

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Symptom Monitoring

  • Lethargy
  • Drowsiness
  • Muscle weakness
  • Flushing
  • Sweating
  • Hypotension
  • Bradycardia
  • Nausea
  • Vomiting
  • Slurred speech
  • Double vision
  • Respiratory depression
  • Cardiac arrest

Special Patient Groups

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Pregnancy

Magnesium sulfate is commonly used in obstetrics for the prevention and treatment of seizures in pre-eclampsia and eclampsia, and for neuroprotection in preterm labor. While historically classified as Pregnancy Category D, current labeling uses a 'Risk Summary' approach. It crosses the placenta. Prolonged maternal administration (more than 5-7 days) may result in fetal bone abnormalities (osteopenia) and neonatal hypocalcemia and hypermagnesemia, leading to hypotonia and respiratory depression in the neonate. Use should be for short-term indications when benefits outweigh risks.

Trimester-Specific Risks:

First Trimester: Generally avoided unless critically indicated due to lack of data, but not known to be teratogenic.
Second Trimester: Used for pre-eclampsia/eclampsia and neuroprotection in preterm labor. Risk of fetal bone abnormalities with prolonged use.
Third Trimester: Commonly used for pre-eclampsia/eclampsia and neuroprotection. Risk of neonatal hypotonia, respiratory depression, and hypocalcemia with prolonged or high-dose use near delivery.
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Lactation

Magnesium is a normal component of breast milk. While magnesium sulfate is excreted into breast milk, the amount is generally considered low and unlikely to cause adverse effects in a healthy, full-term infant. It is generally considered compatible with breastfeeding, especially for short-term use.

Infant Risk: Low risk. Monitor infant for signs of diarrhea or sedation, though unlikely.
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Pediatric Use

Dosing is weight-based. Close monitoring of serum magnesium levels, vital signs, and reflexes is crucial due to potential for toxicity, especially in neonates and infants. Used for hypomagnesemia and acute severe asthma.

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Geriatric Use

Elderly patients are at increased risk of magnesium toxicity due to age-related decline in renal function. Lower doses and careful monitoring of renal function, serum magnesium levels, and clinical signs of toxicity (e.g., decreased DTRs, respiratory depression) are essential.

Clinical Information

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Clinical Pearls

  • Magnesium sulfate is the drug of choice for preventing and treating seizures in pre-eclampsia and eclampsia.
  • The antidote for magnesium toxicity is intravenous calcium gluconate (10 mL of 10% solution given slowly).
  • Always monitor deep tendon reflexes, respiratory rate, and urine output closely during magnesium infusion. Loss of DTRs is an early sign of toxicity.
  • Ensure adequate urine output before and during magnesium administration, as it is renally excreted.
  • Administer IV infusions slowly to avoid sudden drops in blood pressure and other adverse effects.
  • In acute severe asthma, IV magnesium sulfate can be a useful adjunctive therapy, particularly in patients unresponsive to standard bronchodilators.
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Alternative Therapies

  • For eclampsia/pre-eclampsia: Other anticonvulsants (e.g., phenytoin, diazepam) are less preferred.
  • For hypomagnesemia: Oral magnesium supplements (for less severe cases).
  • For torsades de pointes: Electrical cardioversion, isoproterenol, overdrive pacing.
  • For acute severe asthma: Beta-agonists, corticosteroids, anticholinergics.
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Cost & Coverage

Average Cost: Highly variable per 50ml vial
Generic Available: Yes
Insurance Coverage: Generally covered by most insurance plans as a generic injectable medication, often Tier 1 or 2.
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to consult your doctor for further evaluation and guidance.

To ensure safe use, do not share your prescription medications with others, and never take medication that has been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Properly dispose of unused or expired medications. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best disposal method, as some communities may offer drug take-back programs.

Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion to ensure prompt and effective treatment.