Magnesium Sulfate 50% Inj, 2ml

Manufacturer FRESENIUS 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.
đŸˇī¸
Drug Class
Anticonvulsant; Electrolyte Supplement; Tocolytic
đŸ§Ŧ
Pharmacologic Class
Mineral; CNS Depressant; Smooth Muscle Relaxant
🤰
Pregnancy Category
Category D
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Magnesium sulfate is a mineral given by injection to treat certain medical conditions. It can help prevent seizures in pregnant women with severe high blood pressure (pre-eclampsia/eclampsia), treat low magnesium levels, or help with severe asthma attacks. It works by relaxing muscles and calming the nervous system.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's 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 period of time.

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 method.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next.
💡

Lifestyle & Tips

  • Report any unusual symptoms immediately, especially difficulty breathing, muscle weakness, or feeling very sleepy.
  • Inform healthcare providers about all medications you are taking, including over-the-counter drugs and supplements.
  • Avoid alcohol and other sedatives while receiving magnesium sulfate, as they can increase drowsiness and breathing problems.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Highly variable based on indication. For eclampsia: 4-6 g IV over 15-20 min, followed by 1-2 g/hour IV infusion.

Condition-Specific Dosing:

Eclampsia/Pre-eclampsia: Loading dose: 4-6 g IV over 15-20 minutes, followed by 1-2 g/hour IV infusion. Alternatively, 10 g IM (5 g in each buttock) followed by 5 g IM every 4 hours.
Hypomagnesemia (severe): 1-2 g IV over 15-60 minutes, then 1 g/hour IV infusion for 6-24 hours, or as needed based on serum magnesium levels and clinical response.
Torsades de Pointes: 1-2 g IV over 5-20 minutes, may repeat once.
Acute Severe Asthma: 2 g IV over 20 minutes.
đŸ‘ļ

Pediatric Dosing

Neonatal: Hypomagnesemia: 25-50 mg/kg/dose IV over 2-4 hours, repeat every 8-12 hours as needed. Max 100 mg/kg/day.
Infant: Hypomagnesemia: 25-50 mg/kg/dose IV over 2-4 hours, repeat every 8-12 hours as needed. Max 100 mg/kg/day.
Child: Hypomagnesemia: 25-50 mg/kg/dose IV over 2-4 hours, repeat every 8-12 hours as needed. Max 100 mg/kg/day. Acute Severe Asthma: 25-50 mg/kg IV over 10-20 minutes (max 2 g).
Adolescent: Hypomagnesemia: 25-50 mg/kg/dose IV over 2-4 hours, repeat every 8-12 hours as needed. Max 100 mg/kg/day. Acute Severe Asthma: 2 g IV over 20 minutes.
âš•ī¸

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 extreme caution and continuous monitoring of serum magnesium, deep tendon reflexes, and respiratory rate.
Dialysis: Use with extreme caution. Magnesium is dialyzable. Avoid if possible or use very low doses with frequent monitoring. May be used to treat hypomagnesemia in dialysis patients, but risk of hypermagnesemia is high.

Hepatic Impairment:

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

Pharmacology

đŸ”Ŧ

Mechanism of Action

Magnesium is an essential cofactor for numerous enzymatic reactions, including those involved in energy production, nucleic acid synthesis, and protein synthesis. As a CNS depressant, it blocks neuromuscular transmission by decreasing acetylcholine release at the motor end plate and reducing the excitability of the motor end plate. It also depresses the CNS directly. As a smooth muscle relaxant, it directly relaxes uterine and bronchial smooth muscle. In the heart, it acts as a physiological calcium channel blocker, reducing calcium influx and stabilizing myocardial cell membranes.
📊

Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not readily quantifiable; widely distributed to bone (50-60%), muscle, and soft tissues. Crosses placenta and enters breast milk.
ProteinBinding: Approximately 30% (to albumin)
CnssPenetration: Limited (does not readily cross intact blood-brain barrier, but can enter CNS with high doses or impaired barrier)

Elimination:

HalfLife: Approximately 2-4 hours (in patients with normal renal function)
Clearance: Primarily renal clearance; rate depends on glomerular filtration rate.
ExcretionRoute: Renal (urine)
Unchanged: 100%
âąī¸

Pharmacodynamics

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

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

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, call your doctor immediately, as they could be signs of a life-threatening muscle problem:
New or worsening muscle weakness
Difficulty chewing or swallowing
Breathing problems
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 have any symptoms 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Difficulty breathing or slow breathing
  • Feeling very sleepy or difficult to wake up
  • Severe muscle weakness or inability to move limbs
  • Blurred vision or double vision
  • Slurred speech
  • Feeling dizzy or lightheaded
  • Severe flushing or sweating
  • No urine output
📋

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 allergic reaction you experienced, including any symptoms that occurred.
If you have a heart block or any other heart problems, as these conditions may affect the safety and efficacy of this medication.
* If you are currently taking nifedipine or terbutaline, as these medications may interact with this drug.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, to your doctor and pharmacist. This information will help them assess potential interactions and ensure safe treatment.

To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
âš ī¸

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.
🆘

Overdose Information

Overdose Symptoms:

  • Hypotension (low blood pressure)
  • Nausea
  • Vomiting
  • Flushing
  • Drowsiness
  • Hyporeflexia (decreased or absent deep tendon reflexes)
  • Muscle weakness
  • Respiratory depression (slow or shallow breathing)
  • Bradycardia (slow heart rate)
  • Cardiac arrest

What to Do:

Immediate medical attention is required. The antidote is intravenous calcium gluconate. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical care immediately.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Calcium gluconate (relative contraindication in some cases, but used as antidote)
  • Nifedipine (in pre-eclampsia, can cause severe hypotension and neuromuscular blockade)
🔴

Major Interactions

  • Neuromuscular blockers (e.g., rocuronium, vecuronium): Potentiates and prolongs neuromuscular blockade, leading to increased risk of respiratory depression/paralysis.
  • CNS depressants (e.g., opioids, benzodiazepines, barbiturates, general anesthetics): Additive CNS depression, increased risk of respiratory depression and sedation.
  • Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of hypotension and bradycardia.
  • Digoxin: Increased risk of cardiac conduction abnormalities (though magnesium can be used to treat digoxin-induced arrhythmias).
🟡

Moderate Interactions

  • Diuretics (loop and thiazide): May increase renal excretion of magnesium, potentially leading to hypomagnesemia (though magnesium sulfate is given for hypomagnesemia).
  • Aminoglycosides: May potentiate neuromuscular blockade.
  • Tetracyclines/Quinolones (oral forms): Reduced absorption if given concurrently (not relevant for IV/IM magnesium sulfate).
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

Baseline Monitoring

Serum Magnesium Level

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

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.

Deep Tendon Reflexes (DTRs)

Rationale: Loss of DTRs is an early sign of magnesium toxicity.

Timing: Prior to initiation of therapy.

Respiratory Rate

Rationale: Respiratory depression is a serious sign of magnesium toxicity.

Timing: Prior to initiation of therapy.

Urine Output

Rationale: Adequate urine output is essential for magnesium excretion.

Timing: Prior to initiation of therapy.

📊

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).

Action Threshold: If > 7 mEq/L, consider reducing or holding dose. If > 10 mEq/L, anticipate toxicity and prepare for intervention.

Deep Tendon Reflexes (DTRs)

Frequency: Hourly during continuous infusion, or every 1-4 hours depending on patient stability.

Target: Present (2+)

Action Threshold: Absent DTRs indicate toxicity; hold dose and consider calcium gluconate.

Respiratory Rate

Frequency: Hourly during continuous infusion, or every 1-4 hours depending on patient stability.

Target: > 12 breaths/min

Action Threshold: < 12 breaths/min indicates toxicity; hold dose and consider calcium gluconate.

Blood Pressure

Frequency: Hourly during continuous infusion, or every 1-4 hours depending on patient stability.

Target: Within patient's normal range, or target for condition (e.g., pre-eclampsia).

Action Threshold: Significant hypotension; consider reducing or holding dose.

Urine Output

Frequency: Hourly (minimum 25-30 mL/hour) during continuous infusion.

Target: > 25-30 mL/hour

Action Threshold: < 25-30 mL/hour indicates impaired excretion and increased risk of toxicity; hold dose.

ECG (if cardiac concerns)

Frequency: As clinically indicated, especially with high doses or renal impairment.

Target: Normal rhythm, PR/QRS/QT intervals.

Action Threshold: Prolonged PR/QRS/QT, heart block, bradycardia.

đŸ‘ī¸

Symptom Monitoring

  • Flushing
  • Sweating
  • Drowsiness
  • Muscle weakness
  • Slurred speech
  • Blurred vision
  • Nausea
  • Vomiting
  • Hypotension
  • Bradycardia
  • Respiratory depression
  • Loss of deep tendon reflexes
  • Cardiac arrest

Special Patient Groups

🤰

Pregnancy

Category D. Used for the prevention and control of seizures in severe pre-eclampsia and eclampsia. Also used as a tocolytic (off-label) to suppress pre-term labor, though prolonged use (>5-7 days) for this indication is associated with fetal bone abnormalities (osteopenia, fractures). Benefits must outweigh risks.

Trimester-Specific Risks:

First Trimester: Generally avoided unless critically indicated due to limited data and potential for fetal harm.
Second Trimester: Used for pre-eclampsia/eclampsia if indicated. Prolonged use for tocolysis carries risk of fetal bone abnormalities.
Third Trimester: Used for pre-eclampsia/eclampsia if indicated. Prolonged use for tocolysis carries risk of fetal bone abnormalities. Can cause neonatal hypotonia, respiratory depression, and hypocalcemia if administered close to delivery.
🤱

Lactation

L3 (Moderately Safe). Magnesium is naturally present in breast milk. While maternal magnesium sulfate administration increases milk magnesium levels, the amount ingested by the infant is generally considered low and unlikely to cause adverse effects in healthy, full-term infants. Monitor infant for signs of sedation or diarrhea.

Infant Risk: Low risk for healthy, full-term infants. Potential for mild sedation or diarrhea in sensitive infants. Monitor for signs of hypermagnesemia.
đŸ‘ļ

Pediatric Use

Dosing is weight-based and varies by indication. Close monitoring of serum magnesium levels, vital signs, and reflexes is crucial due to the narrow therapeutic index and potential for toxicity, especially in neonates and infants with immature renal function.

👴

Geriatric Use

Use with caution due to potential for age-related decline in renal function, which increases the risk of magnesium accumulation and toxicity. Start with lower doses and monitor closely for signs of toxicity (e.g., hypotension, CNS depression, respiratory depression, loss of reflexes).

Clinical Information

💎

Clinical Pearls

  • Always have calcium gluconate (10% solution, 10 mL IV over 3-5 minutes) readily available as an antidote for magnesium toxicity.
  • Monitor deep tendon reflexes (DTRs) as a key indicator of magnesium toxicity; loss of DTRs precedes respiratory depression.
  • Ensure adequate urine output (at least 25-30 mL/hour) before and during magnesium administration, as renal excretion is the primary elimination route.
  • Magnesium sulfate can cause a sensation of warmth or flushing upon rapid IV administration.
  • In pre-eclampsia/eclampsia, magnesium sulfate is given for seizure prophylaxis/treatment, not primarily for blood pressure control (though it has some vasodilatory effects).
  • Avoid concomitant use with other CNS depressants or neuromuscular blockers unless absolutely necessary and with extreme caution and close monitoring.
🔄

Alternative Therapies

  • For eclampsia/pre-eclampsia: Other anticonvulsants (e.g., phenytoin, benzodiazepines) are less preferred but may be used if magnesium is contraindicated or ineffective.
  • For hypomagnesemia: Oral magnesium supplements for less severe cases.
  • For acute severe asthma: Beta-agonists, corticosteroids, anticholinergics.
  • For Torsades de Pointes: Isoproterenol, overdrive pacing (if magnesium is ineffective or contraindicated).
💰

Cost & Coverage

Average Cost: Inexpensive per vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
📚

General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the best disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.