Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3636
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Magnesium Sulfate (Injection, Solution)
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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 I.V. doses will provide a therapeutic level
almost immediately. The rate of I.V. 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). 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 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 g, 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 g, (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 total parenteral nutrition,
maintenance requirements for magnesium are not precisely known. The maintenance
dose used in adults ranges from 8 to 24 mEq (1 to 3 g) daily; for infants,
the range is 2 to 10 mEq (0.25 to 1.25 g) daily. In Eclampsia In severe pre-eclampsia
or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. Intravenously,
a dose of 4 to 5 g 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 g (5 g or 10 mL of the undiluted 50% solution in each buttock)
are given. Alternatively, the initial intravenous dose of 4 g 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 to 5
g (8 to 10 mL of the 50% solution) are injected intramuscularly into alternate
buttocks every four hours, depending on the continuing presence of the patellar
reflex and adequate respiratory function. Alternatively, after the initial
I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. 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 to 40 g 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. Other Uses In counteracting
the muscle-stimulating effects of barium poisoning, the usual dose of magnesium
sulfate is 1 to 2 g given I.V. For controlling seizures
associated with epilepsy, glomerulonephritis or hypothyroidism, the usual
adult dose is 1 g administered I.M. or I.V. 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
to 4 g (30 to 40 mL of a 10% solution) administered I.V. over 30 seconds with extreme caution. For
reduction of cerebral edema, 2.5 g (25 mL of a 10% solution) is given I.V. Incompatibilities Magnesium
sulfate in solution may result in a precipitate formation when mixed with
solutions containing: 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.
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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 I.V. use. May contain sulfuric acid and/or sodium hydroxide
for pH adjustment. The pH is 6.0 (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 MgSO���7HO 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.
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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 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 mother, 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
kidney at a rate proportional to the plasma concentration and glomerular filtration.
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Parenteral administration of the drug is contraindicated
in patients with heart block or myocardial damage.
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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 controlled
room temperature 15��to 30��C (59��to 86��F). [See USP.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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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/liter). The strength of the deep tendon reflexes begins to
diminish when magnesium levels exceed 4 mEq/liter. Reflexes may be absent
at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard.
An injectable calcium saltshould be immediately available to counteract the
potential hazards of magnesium intoxication in eclampsia. 50%
Magnesium Sulfate Injection, USP must be diluted to a concentration of 20%
or less prior to I.V. 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 intramuscular injection in infants and children.<br/>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.<br/>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.<br/>Pregnancy Category A.: Studies in pregnant women have not shown that magnesium sulfate
injection increases the risk of fetal abnormalities if administered during
all trimesters of pregnancy. If this drug is used during pregnancy, the possibility
of fetal harm appears remote. However, because studies cannot rule out the
possibility of harm, magnesium sulfate injection should be used during pregnancy
only if clearly needed. When administered by continuous
intravenous infusion (especially for more than 24 hours preceding delivery)
to control convulsions in toxemic mothers, the newborn may show signs of magnesium
toxicity, including neuromuscular or respiratory depression. See OVERDOSAGE.<br/>Nursing Mothers: Since magnesium is distributed into milk during parenteral
magnesium sulfate administration, the drug should be used with caution in
nursing women.<br/>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.
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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.
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Magnesium Sulfate
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Magnesium Sulfate (Injection, Solution)
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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.
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Intravenous use in eclampsia should be reserved for immediate
control of life-threatening convulsions. Parenteral
use in the presence of renal insufficiency may lead to magnesium intoxication. WARNING:
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 ofadministration.
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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 as a parenteral anticonvulsant for the prevention and control
of seizures (convulsions) in severe toxemia of pregnancy. It effectively prevents
and controls the convulsions of eclampsia without producing deleterious depression
of the central nervous system of the mother or infant. However, other effective
drugs are available for this purpose.
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Magnesium Sulfate
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