Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/538
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Magnesium Sulfate (Injection, Solution)
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Magnesium Sulfate in Water for Injection is intended
for intravenous use only. For the management of pre-eclampsia or eclampsia,
intravenous infusions of dilute solutions of magnesium (1% to 8%)
are often given in combination with intramuscular injections of 50%
Magnesium Sulfate Injection, USP. Therefore, in the clinical conditions
cited below, both forms of therapy are noted, as appropriate. In Eclampsia In severe pre-eclampsia or eclampsia, the total initial
dose is 10 to 14 g of magnesium sulfate. To initiate therapy, 4 g
of Magnesium Sulfate in Water for Injection may be administered intravenously.
The rate of I.V. infusion should generally not exceed 150 mg/minute,
or 3.75 mL of a 4% concentration (or its equivalent) per minute, except
in severe eclampsia with seizures. Simultaneously, 4 to 5 g (32.5
to 40.6 mEq) of magnesium sulfate may be administered intramuscularly
into each buttock using undiluted 50% Magnesium Sulfate Injection,
USP. After the initial I.V. dose, some clinicians administer 1 to
2 g/hour by constant I.V. infusion. Subsequent
intramuscular doses of 4 to 5 g of magnesium sulfate may be injected
into alternate buttocks every four hours, depending on the continuing
presence of the patellar reflex, adequate respiratory function, and
absence of signs of magnesium toxicity. 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 magnesium sulfate should not be exceeded.
In the presence of severe renal insufficiency, frequent serum magnesium
concentrations must be obtained and the maximum dosage of magnesium
sulfate is 20 g per 48 hours. Parenteral drug
products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. Do not administer unless solution is clear. Discard unused
portion.
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Magnesium Sulfate in Water for Injection is a sterile,
nonpyrogenic solution of magnesium sulfate heptahydrate in water for
injection. May contain sulfuric acid and/or sodium hydroxide for pH
adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and
8% concentrations. See HOW SUPPLIED section for the content and characteristics
of available dosage forms and sizes. Magnesium
Sulfate, USP heptahydrate is chemically designated MgSO���7HO, colorless crystals or white powder freely
soluble in water. Water for Injection, USP is
chemically designated HO. The flexible
plastic container is fabricated from a specially formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but
not in amounts sufficient to affect the solution significantly. 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 plastic container materials.
Exposure to temperatures above 25��C/77��F during transport
and storage will lead to minor losses in moisture content. Higher
temperatures lead to greater losses. It is unlikely that these minor
losses will lead to clinically significant changes within the expiration
period.
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Magnesium (Mg) is an important cofactor
for enzymatic reactions and plays an important role in neurochemical
transmission and muscular excitability. 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, but it does not adversely affect
the mother, fetus or neonate when used as directed in eclampsia or
pre-eclampsia. Normal serum magnesium levels range from 1.3 to 2.1
mEq/liter. As serum magnesium rises above 4
mEq/liter, the deep tendon reflexes are first decreased and then disappear
as the serum level approaches 10 mEq/liter. At this level respiratory
paralysis may occur. Heart block also may occur at this or lower serum
levels of magnesium. 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. 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. Pharmacokinetics: Absorption: Intravenously administered
magnesium is immediately absorbed. Distribution: Approximately 1-2% of total
body magnesium is located in the extracellular fluid space. Magnesium
is 30% bound to albumin. Metabolism: Magnesium is not metabolized. Excretion: Magnesium is excreted
solely by the kidney at a rate proportional to the serum concentration
and glomerular filtration. Special Populations: Renal Insufficiency: Magnesium
is excreted solely by the kidney. In patients with severe renal insufficiency,
the dose should be lower and frequent serum magnesium levels must
be obtained (see DOSAGE AND ADMINISTRATION). Hepatic Insufficiency: Magnesium is excreted solely by the kidney. No dosing adjustments
are necessary in hepatic insufficiency. Drug-Drug Interactions: Drug induced renal
losses of magnesium occur with the following drugs or drug classes:
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Intravenous magnesium should not be given to mothers
with toxemia of pregnancy during the two hours preceding delivery.
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Magnesium Sulfate in Water for Injection is supplied
in single-dose flexible plastic containers as follows: WARNING: DO NOT USE FLEXIBLE
CONTAINER IN SERIES CONNECTIONS. Store
at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.]
Protect from freezing. Revised: June, 2007
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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 every four hours. 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).
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 serum 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
salt should be immediately available to counteract the potential hazards
of magnesium intoxication in eclampsia. Magnesium
Sulfate in Water for Injection should be administered slowly to avoid
producing hypermagnesemia.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with Magnesium Sulfate in Water for Injection
have not been performed to evaluate carcinogenic potential, mutagenic
potential or effects on fertility.<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 solution
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:: It is not known whether this drug is excreted in
human milk. Because many drugs are excreted in human milk, caution
should be exercised when Magnesium Sulfate in Water for Injection
is administered to a nursing mother.
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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. In adults
intravenous administration of 5 to 10 mEq of 10% calcium gluconate
will usually reverse respiratory depression or heart block due to
magnesium intoxication. In extreme cases, peritoneal or hemodialysis
may be required. 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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| dailymed-instance:adverseRe... |
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.
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Magnesium Sulfate in Water for Injection is indicated
for use as an intravenous anticonvulsant for the prevention and control
of seizures (convulsions) in severe toxemia of pregnancy. When used
judiciously 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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