Product Elements:
50% magnesium sulfate 50% magnesium sulfate sodium hydroxide magnesium sulfate heptahydrate magnesium cation water sulfuric acid
Indications and Usage:
Indications and usage magnesium sulfate injection, usp is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. in such cases, the serum magnesium (mg++) level is usually below the lower limit of normal (1.5 to 2.5 meq/liter) and the serum calcium (ca++) level is normal (4.3 to 5.3 meq/liter) or elevated. in total parenteral nutrition (tpn), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. magnesium sulfate injection, usp is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.
Warnings:
Warnings 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 calciu
Read more...m 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 at even lower rates of administration. parenteral use in the presence of renal insufficiency may lead to magnesium intoxication. intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.
Dosage and Administration:
Dosage and administration dosage of magnesium sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained. both intravenous and intramuscular administration are appropriate. intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. the rate of intravenous injection should generally not exceed 150 mg/minute (1.5 ml of a 10% concentration or its equivalent), except in severe eclampsia with seizures (see below). continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. solutions for intravenous infusion must be diluted to a concentration of 20% or less prior to administration. the diluents commonly used are 5% dextrose injection, usp and 0.9% sodium chloride injection, usp. deep
Read more...intramuscular injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children. in magnesium deficiency in the treatment of mild magnesium deficiency, the usual adult dose is 1 gram, equivalent to 8.12 meq of magnesium (2 ml of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 meq of magnesium per 24 hours). for severe hypomagnesemia, as much as 250 mg (approximately 2 meq) per kg of body weight (0.5 ml of the 50% solution) may be given intramuscularly within a period of four hours if necessary. alternatively, 5 grams, (approximately 40 meq) can be added to one liter of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp for slow intravenous infusion over a three-hour period. in the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity. in hyperalimentation in tpn, maintenance requirements for magnesium are not precisely known. the maintenance dose used in adults ranges from 8 to 24 meq (1 gram to 3 grams) daily; for infants, the range is 2 to 10 meq (0.25 gram to 1.25 grams) daily. in pre-eclampsia or eclampsia in severe pre-eclampsia or eclampsia, the total initial dose is 10 grams to 14 grams of magnesium sulfate. intravenously, a dose of 4 grams to 5 grams in 250 ml of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp may be infused. simultaneously, intramuscular doses of up to 10 grams (5 grams or 10 ml of the undiluted 50% solution in each buttock) are given. alternatively, the initial intravenous dose of 4 grams may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 ml of a 10% solution or 20 ml of a 20% solution) may then be injected intravenously over a period of three to four minutes. subsequently, 4 grams to 5 grams (8 to 10 ml of the 50% solution) are injected intramuscularly into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. alternatively, after the initial intravenous dose, some clinicians administer 1 gram to 2 grams/hour by constant intravenous infusion. therapy should continue until paroxysms cease. a serum magnesium level of 6 mg/100 ml is considered optimal for control of seizures. a total daily (24 hr) dose of 30 grams to 40 grams should not be exceeded. in the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained. continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. other uses in counteracting the muscle-stimulating effects of barium poisoning, the usual dose of magnesium sulfate is 1 gram to 2 grams given intravenously. for controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 gram administered intramuscularly or intravenously. in paroxysmal atrial tachycardia, magnesium should be used only if simpler measures have failed and there is no evidence of myocardial damage. the usual dose is 3 grams to 4 grams (30 to 40 ml of a 10% solution) administered intravenously over 30 seconds with extreme caution. for reduction of cerebral edema, 2.5 grams (25 ml of a 10% solution) is given intravenously. incompatibilities magnesium sulfate in solution may result in a precipitate formation when mixed with solutions containing: alcohol (in high heavy metals concentrations) hydrocortisone sodium alkali carbonates and succinate bicarbonates phosphates alkali hydroxides polymixin b sulfate arsenates procaine hydrochloride barium salicylates calcium strontium clindamycin phosphate tartrates the potential incompatibility will often be influenced by the changes in the concentration of reactants and the ph of the solutions. it has been reported that magnesium may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.
Adverse Reactions:
Adverse reactions 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 central nervous system depression proceeding to respiratory paralysis. hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.
Overdosage:
Overdosage magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication. in the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of magnesium. for treatment of overdose artificial respiration is often required. intravenous calcium, 10 to 20 ml of a 5% solution (diluted if desirable with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. subcutaneous physostigmine, 0.5 to 1 mg may be helpful. hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.
Description:
Description magnesium sulfate injection, usp is a sterile solution of magnesium sulfate heptahydrate in water for injection, usp administered by the intravenous or intramuscular routes as an electrolyte replenisher or anticonvulsant. must be diluted before intravenous use. may contain sulfuric acid and/or sodium hydroxide for ph adjustment. the ph is 5.5 to 7.0. the 50% concentration has an osmolarity of 4.06 mosmol/ml (calc.). the solution contains no bacteriostat, antimicrobial agent or added buffer (except for ph adjustment) and is intended only for use as a single-dose injection. when smaller doses are required the unused portion should be discarded with the entire unit. magnesium sulfate, usp heptahydrate is chemically designated mgso4 ⢠7h2o with molecular weight of 246.48 and occurs as colorless crystals or white powder freely soluble in water. the plastic syringe is molded from a specially formulated polypropylene. water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. 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 syringe material.
Clinical Pharmacology:
Clinical pharmacology magnesium (mg++) 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/liter) 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 en
Read more...d 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/liter. as plasma magnesium rises above 4 meq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 meq/liter. 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 intravenous administration of calcium. pharmacokinetics with intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. following intramuscular 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/liter. magnesium is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.
How Supplied:
How supplied 50% magnesium sulfate injection, usp is supplied in the following dosage forms. ndc 51662-1235-1 50% magnesium sulfate injection, usp 5grams/10ml ansyr syr ndc 51662-1235-2 50% magnesium sulfate injection, usp 5grams/10ml ansyr syr in a pouch ndc 51662-1235-3 case of 10 of 50% magnesium sulfate injection, usp 5grams/10ml ansyr syr in a pouch hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms magnesium sulfate injection, usp is supplied in single-dose containers as follows: do not administer unless solution is clear and container is undamaged. discard unused portion. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] how supplied
Package Label Principal Display Panel:
Principle disply panel, serialized label serialized label
Principle display panel, syringe carton 10 ml ndc 0409-1754-10 rx only 50% magnesium sulfate injection, usp 5 g/10 ml (500 mg/ml) (4 meq mg++/ml) ansyr⢠single-dose syringe caution: must be diluted for intravenous use. hospira â press and pull to open â¶ carton
Principle display panel, syringe label 50% magnesium sulfate 5 g/10 ml (500 mg/ml) rx only ndc 0409-1754-10 10 ml single-dose syringe 50% magnesium sulfate injection, usp 5 g/10 ml (500 mg/ml) (4 meq mg++/ml) must be diluted for intravenous use. for intravenous or intramuscular use. sterile. 4.06 mosmol/ml (calc.). contains no more than 75 mcg/l of aluminum. hospira, inc., lake forest, il 60045 usa hospira rl-6891 syringe label
Principal display panel - ndc 51662-1235-1 - serialized label serialized label
Principal display panel - ndc 0409-1754-15 carton label carton
Principal display panel - ndc 0409-1754-15 syringe label syringe
Principal display panel - 51662-1235-2 pouch 51662-1235-2 pouch labeling pouch labeling box syringe label
Principal display panel 51662-1235-3 case labeling 51662-1235-3 case label case rfid labeling