Magnesium

Magnesium is used as a dietary supplement for individuals who are deficient in magnesium. Although a balanced diet usually supplies all the magnesium a person needs, magnesium supplements may be needed by patients who have lost magnesium because of illness or treatment with certain medicines.

Lack of magnesium may lead to irritability, muscle weakness, and irregular heartbeat.

Injectable magnesium is given only by or under the supervision of a health care professional. Some oral magnesium preparations are available only with a prescription. Others are available without a prescription.

• It is used to treat or prevent low magnesium levels.

• If you have an allergy to magnesium or any other part of magnesium.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take magnesium. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Magnesium is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

As a nutritional adjunct in hyperalimentation, the precise mechanism of action for Magnesium is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/L) may develop as early as three to four days or within weeks.

Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of Magnesium. While there are large stores of Magnesium present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Magnesium therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

Magnesium prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end-plate by the motor nerve impulse. Magnesium is said to have a depressant effect on the central nervous system (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal plasma Magnesium levels range from 1.5 to 2.5 mEq/L.

As plasma Magnesium rises above 4 mEq/L, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/L. At this level respiratory paralysis may occur. Heart block also may occur at this or lower plasma levels of Magnesium. Serum Magnesium concentrations in excess of 12 mEq/L may be fatal.

Magnesium acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of Magnesium poisoning are antagonized to some extent by IV administration of calcium.

Pharmacokinetics

With IV administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following IM administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/L. Magnesium is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

Fetal Harm

Continuous administration of Magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If Magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of Magnesium sulfate beyond 5 to 7 days may cause fetal abnormalities.

Aluminum Toxicity

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

Parenteral use in the presence of renal insufficiency may lead to Magnesium intoxication. IV use in eclampsia should be reserved for immediate control of life-threatening convulsions.

General

Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with Magnesium, their dosage should be adjusted with caution because of additive CNS depressant effects of Magnesium.

Because Magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Monitoring serum Magnesium levels and the patient's clinical status is essential to avoid the consequences of overdosage in toxemia. 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/minute). When repeated doses of the drug are given parenterally, knee jerk reflexes should be tested before each dose and if they are absent, no additional Magnesium should be given until they return. Serum Magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/L). The strength of the deep tendon reflexes begins to diminish when Magnesium levels exceed 4 mEq/L. Reflexes may be absent at 10 mEq Magnesium/L, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of Magnesium intoxication in eclampsia.

Magnesium sulfate injection (50%) must be diluted to a concentration of 20% or less prior to IV infusion. Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. The 50% solution also should be diluted to 20% or less for IM injection in infants and children.

Laboratory Tests

Magnesium sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Magnesium is monitored. The normal serum level is 1.5 to 2.5 mEq/L.

Drug Interactions

CNS Depressants When barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants are to be given in conjunction with Magnesium, their dosage should be adjusted with caution because of additive CNS depressant effects of Magnesium. CNS depression and peripheral transmission defects produced by Magnesium may be antagonized by calcium.

Neuromuscular Blocking Agents Excessive neuromuscular block has occurred in patients receiving parenteral Magnesium sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.

Cardiac Glycosides Magnesium sulfate should be administered with extreme caution in digitalized patients, because serious changes in cardiac conduction which can result in heart block may occur if administration of calcium is required to treat Magnesium toxicity.

Pregnancy

Teratogenic Effects

Pregnancy Category D (See WARNINGS and PRECAUTIONS)

See WARNINGS and PRECAUTIONS.

Magnesium sulfate can cause fetal abnormalities when administered beyond 5-7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization, osteopenia and other skeletal abnormalities with continuous maternal administration of Magnesium sulfate for more than 5 to 7 days.1-10 Magnesium sulfate injection should be used during pregnancy only if clearly needed. If this drug is used during pregnancy, the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects

When administered by continuous IV infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of Magnesium toxicity, including neuromuscular or respiratory depression. (See OVERDOSAGE).

Labor and Delivery

Continuous administration of Magnesium sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Magnesium sulfate outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Nursing Mothers

Since Magnesium is distributed into milk during parenteral Magnesium sulfate administration, the drug should be used with caution in nursing women.

Geriatrics

Geriatric patients often require reduced dosage because of impaired renal function. In patients with severe impairment, dosage should not exceed 20 g in 48 hours. Serum Magnesium should be monitored in such patients.

The adverse effects of parenterally administered Magnesium usually are the result of Magnesium intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and CNS depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to Magnesium sulfate therapy for eclampsia has been reported.