Magnesium Sulfate 20gm/500ml Inj

Manufacturer FRESENIUS KABI USA 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
Anticonvulsant; Electrolyte Supplement; Tocolytic
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Pharmacologic Class
Mineral; Electrolyte; CNS Depressant; Smooth Muscle Relaxant
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Pregnancy Category
Category D
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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 low magnesium levels, prevent seizures in pregnant women with severe pre-eclampsia, or treat certain heart rhythm problems and severe asthma attacks. It works by relaxing muscles and calming the nervous system.
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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. It is essential to follow the dosage instructions carefully. This medication can be administered in two ways: as an injection into a muscle or as an infusion into a vein, which is given 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 best way to store it.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next. They will provide guidance on how to get back on schedule with your medication.
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Lifestyle & Tips

  • Report any unusual symptoms immediately to your healthcare provider.
  • Do not take other magnesium-containing products (e.g., antacids, laxatives) without consulting your doctor while receiving this medication.
  • Maintain adequate hydration as advised by your healthcare team.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For pre-eclampsia/eclampsia: Loading dose 4-6 grams IV over 15-30 minutes, followed by maintenance 1-2 grams/hour continuous IV infusion. For hypomagnesemia (severe): 8-12 grams IV over 24 hours. For Torsades de Pointes: 1-2 grams IV over 5-60 minutes.
Dose Range: 1 - 12 mg

Condition-Specific Dosing:

Pre-eclampsia/Eclampsia: Loading: 4-6 grams IV over 15-30 min. Maintenance: 1-2 grams/hour continuous IV infusion. (Note: 20gm/500ml = 40mg/ml. 1g/hr = 25ml/hr)
Hypomagnesemia (severe): 8-12 grams IV over 24 hours (e.g., 1-2 grams/hour).
Torsades de Pointes: 1-2 grams IV over 5-60 minutes, may repeat.
Acute Asthma (severe): 2 grams IV over 20 minutes.
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., neonatal seizures, meconium aspiration syndrome) may use 25-50 mg/kg/dose IV over 1-2 hours, repeated as needed.
Infant: Not established for routine use; specific indications (e.g., severe asthma) may use 25-50 mg/kg/dose IV over 1-2 hours, repeated as needed.
Child: Acute severe asthma: 25-50 mg/kg IV (max 2 grams) over 20-30 minutes. Hypomagnesemia: 25-50 mg/kg/dose IV (max 2 grams) over 2-4 hours, repeated every 6 hours for 3-4 doses.
Adolescent: Acute severe asthma: 2 grams IV over 20 minutes. Hypomagnesemia: 25-50 mg/kg/dose IV (max 2 grams) over 2-4 hours, repeated every 6 hours for 3-4 doses. Dosing for pre-eclampsia/eclampsia not applicable.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum magnesium and renal function closely.
Moderate: Reduce dose by 25-50% or extend dosing interval. Monitor serum magnesium, DTRs, and respiratory rate closely. Target serum magnesium levels may need to be lower.
Severe: Contraindicated or significantly reduced dose (e.g., 50-75% reduction) with extreme caution and continuous monitoring. Risk of hypermagnesemia is high. Consider alternative therapies.
Dialysis: Generally avoided due to risk of accumulation. If used, administer post-dialysis and monitor serum magnesium levels frequently. Dialysis can remove magnesium, but accumulation between sessions is a risk.

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 and protein synthesis, and muscle contraction. As a CNS depressant, it blocks neuromuscular transmission by decreasing acetylcholine release at the motor end plate. It also depresses the excitability of the motor nerve and muscle fiber. In smooth muscle, it acts as a physiological calcium channel blocker, causing vasodilation and uterine relaxation. It also has antiarrhythmic properties by slowing the rate of SA node impulse formation and prolonging conduction time through the myocardium.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Immediate (IV)
FoodEffect: Not applicable (IV)

Distribution:

Vd: 0.2-0.3 L/kg
ProteinBinding: Approximately 30% (to albumin)
CnssPenetration: Limited (crosses blood-brain barrier slowly, but higher concentrations can cause CNS depression)

Elimination:

HalfLife: Approximately 2-4 hours (normal renal function); significantly prolonged in renal impairment.
Clearance: Primarily renal excretion; rate depends on glomerular filtration rate.
ExcretionRoute: Renal (urine)
Unchanged: Nearly 100%
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Pharmacodynamics

OnsetOfAction: Immediate (IV)
PeakEffect: Minutes (IV)
DurationOfAction: Approximately 30 minutes (IV bolus); continuous infusion maintains effect as long as infused.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While 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 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 passing out
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 eyesight
+ 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
Trouble chewing or swallowing
Trouble breathing
Droopy eyelids
* Changes in eyesight, such as blurred vision or double vision

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor or seek medical help.

Reporting Side Effects

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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
  • Muscle weakness
  • Difficulty breathing or slow breathing
  • Feeling dizzy or lightheaded
  • Blurred vision
  • Slurred speech
  • Nausea or vomiting
  • Flushing or feeling warm
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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 allergic reaction you experienced, including any symptoms that occurred.
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 all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication in conjunction with your other treatments.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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 discussing the results.

This medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use. This risk is higher if you have kidney problems or if you are a premature infant. Your doctor will need to monitor you closely to minimize this risk.

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 must 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 to ensure their safety.
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Overdose Information

Overdose Symptoms:

  • Absent deep tendon reflexes
  • Severe drowsiness or coma
  • Profound muscle weakness or paralysis
  • Slow or shallow breathing (respiratory depression)
  • Very low blood pressure (hypotension)
  • Slow heart rate (bradycardia)
  • Cardiac arrest

What to Do:

Immediately stop the magnesium infusion. Administer intravenous calcium gluconate (10 mL of 10% solution) slowly to reverse cardiac and respiratory depression. Provide respiratory support (e.g., mechanical ventilation) if needed. In severe cases, hemodialysis may be necessary to remove excess magnesium. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Neuromuscular blockers (e.g., rocuronium, vecuronium): Potentiates and prolongs neuromuscular blockade, leading to increased risk of respiratory depression or paralysis.
  • Calcium channel blockers (e.g., nifedipine, verapamil): Increased risk of hypotension and bradycardia.
  • CNS depressants (e.g., opioids, benzodiazepines, barbiturates): Additive CNS depression, increased risk of respiratory depression and sedation.
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Moderate Interactions

  • Digoxin: Magnesium deficiency can increase digoxin toxicity; however, high magnesium levels can also affect digoxin levels or action.
  • Diuretics (loop and thiazide): May increase renal excretion of magnesium, potentially leading to hypomagnesemia (if not already present).
  • Aminoglycosides: May enhance neuromuscular blockade.
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Minor Interactions

  • Tetracyclines/Quinolones: Oral magnesium can chelate these antibiotics, reducing absorption (not relevant for IV magnesium sulfate).

Monitoring

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Baseline Monitoring

Serum Magnesium

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

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: Magnesium is primarily renally excreted; impaired renal function increases risk of accumulation and 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: To establish baseline and monitor for signs of hypermagnesemia (loss of DTRs).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Magnesium

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

Target: 4-7 mg/dL (for pre-eclampsia/eclampsia); 1.8-2.5 mg/dL (for hypomagnesemia correction).

Action Threshold: >7 mg/dL (loss of DTRs), >10 mg/dL (respiratory depression), >12 mg/dL (cardiac arrest).

Deep Tendon Reflexes (DTRs)

Frequency: Hourly during continuous infusion, or every 1-2 hours.

Target: Present (2+)

Action Threshold: Absent DTRs (sign of hypermagnesemia); reduce or hold infusion.

Respiratory Rate

Frequency: Hourly during continuous infusion, or every 1-2 hours.

Target: >12 breaths/min

Action Threshold: <12 breaths/min (sign of hypermagnesemia); reduce or hold infusion, consider calcium gluconate.

Urine Output

Frequency: Hourly during continuous infusion.

Target: >25-30 mL/hour or >100 mL/4 hours

Action Threshold: <25 mL/hour (indicates impaired renal excretion and increased risk of toxicity); reduce or hold infusion.

Blood Pressure

Frequency: Hourly during continuous infusion.

Target: Within target range for indication (e.g., pre-eclampsia)

Action Threshold: Significant hypotension; reduce or hold infusion.

ECG (if high risk or toxicity suspected)

Frequency: As clinically indicated.

Target: Normal rhythm, PR/QRS/QT intervals

Action Threshold: Prolonged PR, QRS, QT intervals, heart block, bradycardia (signs of hypermagnesemia).

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Symptom Monitoring

  • Lethargy
  • Drowsiness
  • Muscle weakness
  • Slurred speech
  • Nausea
  • Vomiting
  • Flushing
  • Sweating
  • Hypotension
  • Bradycardia
  • Respiratory depression
  • Absent deep tendon reflexes

Special Patient Groups

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Pregnancy

Category D. Magnesium sulfate is commonly used for the prevention and treatment of seizures in severe pre-eclampsia and eclampsia. However, prolonged use (more than 5-7 days) during pregnancy, especially during the third trimester, has been associated with fetal bone abnormalities (e.g., osteopenia, fractures) and neonatal hypocalcemia. Use only when clearly needed and the potential benefits outweigh the potential risks to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, generally not used for prolonged periods.
Second Trimester: Limited data, generally not used for prolonged periods.
Third Trimester: Risk of fetal bone abnormalities (osteopenia, fractures) and neonatal hypocalcemia with prolonged exposure (>5-7 days). Risk of neonatal respiratory depression and hypotonia if administered close to delivery.
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Lactation

L3 (Moderately Safe). Magnesium is naturally present in breast milk. While IV magnesium sulfate can increase magnesium levels in breast milk, the amount transferred to the infant is generally considered low and unlikely to cause adverse effects in a healthy, full-term infant. Monitor the infant for signs of diarrhea or sedation, especially if the infant has renal impairment.

Infant Risk: Low risk for healthy, full-term infants. Monitor for diarrhea or sedation.
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Pediatric Use

Use with caution. Dosing is weight-based and varies significantly by indication. Close monitoring of serum magnesium, DTRs, and respiratory status is crucial due to the narrow therapeutic index and potential for toxicity, especially in neonates and infants with immature renal function.

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Geriatric Use

Use with caution. Elderly patients may have age-related decline in renal function, increasing the risk of magnesium accumulation and toxicity. Lower doses or extended dosing intervals may be necessary. Close monitoring of renal function, serum magnesium levels, and clinical signs of toxicity is essential.

Clinical Information

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Clinical Pearls

  • Always have calcium gluconate (10 mL of 10% solution) readily available as an antidote for magnesium toxicity.
  • Monitor urine output closely; oliguria significantly increases the risk of magnesium toxicity.
  • Assess deep tendon reflexes (DTRs) and respiratory rate frequently. Loss of DTRs is an early sign of toxicity, followed by respiratory depression.
  • Magnesium sulfate can cause a feeling of warmth or flushing upon administration, which is usually transient.
  • Ensure IV infusion pumps are used for accurate administration, especially for continuous infusions.
  • In pre-eclampsia/eclampsia, magnesium sulfate is given to prevent seizures, not to lower blood pressure (though it may have a mild hypotensive effect).
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Alternative Therapies

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

Average Cost: Varies widely, typically low cost for generic IV solutions. per 500ml bag
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. 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 your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.