Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/60
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Magnesium Sulfate in Dextrose (Injection, Solution)
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Magnesium Sulfate in 5% Dextrose Injection, USP 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 5% Dextrose Injection, USP may be administered
intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute,
or 7.5 mL of a 2% 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 1-2 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 recommended 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 5% Dextrose Injection, USP is a sterile,
nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water
for injection. Each 100 mL contains 1 or 2 g magnesium sulfate heptahydrate
and dextrose, hydrous 5 g 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 1% and 2% 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. Dextrose,
USP is chemically designated D-glucose, monohydrate (CHO���HO), a hexose sugar freely soluble in water. It has the following
structural formula: Molecular weight 198.17. 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 temperaturesabove 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 5% Dextrose Injection, USP is supplied
in single-dose flexible plastic containers as follows: *As the heptahydrate. 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: July, 2006 ��Hospira
2006 EN-1247 Printed in USA HOSPIRA,
INC., LAKE FOREST, IL 60045 USA
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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 5% Dextrose Injection, USP should be administered slowly to avoid
producing hypermagnesemia.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with Magnesium Sulfate in 5% Dextrose Injection,
USP 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 5% Dextrose Injection, USP is administered
to a nursing woman.
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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 in Dextrose (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 signsof 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 5% Dextrose Injection, USP 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 in Dextrose
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