MAGNESIUM SULFATE IN DEXTROSE- magnesium sulfate heptahydrate injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)

Verfügbar ab:

B. Braun Medical Inc.

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Magnesium Sulfate in 5% Dextrose Injection is indicated for: - Prevention of eclampsia in patients with preeclampsia - Treatment of seizures and prevention of recurrent seizures in patients with eclampsia Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients: - with heart block or myocardial damage - in diabetic coma - with myasthenia gravis [see Warnings and Precautions (5.6)] Risk Summary Magnesium Sulfate in 5% Dextrose Injection is indicated in pregnant women for the prevention of eclampsia in women with preeclampsia and the treatment of seizures and prevention of recurrent seizures in women with eclampsia. Fetal, neonatal, and maternal risks are discussed throughout the labeling. Clinical Considerations Labor or Delivery: Magnesium Sulfate in 5% Dextrose Injection is not approved for the treatment of pre-term labor. Administration of Magnesium Sulfate in 5% Dextrose Injection to pregnant women longer than 5 to 7 days may lead to hypocalcemia and bone abnormalities in the developing fe

Produktbesonderheiten:

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in single-dose 100 mL fill PAB® containers packaged 24 per case (see Table 2). PAB is a registered trademark of B. Braun Medical Inc. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from freezing. Handling Directions For Use of PAB® Container CAUTION: DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE. Aseptic technique is required. Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date. Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Single dose plastic container. Discard unused portion. Consult Package Insert for complete product information. WARNING: DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. 1. Identify Two Ports (See Figure A). 2. To Attach Administration Set To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure B Steps 1 and 2 . 3. Push spike through the diaphragm of the port (See Figure C) . Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use. PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MAGNESIUM SULFATE IN DEXTROSE- MAGNESIUM SULFATE
HEPTAHYDRATE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MAGNESIUM SULFATE IN
5% DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION.
MAGNESIUM SULFATE IN DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1941
INDICATIONS AND USAGE
Magnesium Sulfate in 5% Dextrose Injection is indicated for (1):
Prevention of eclampsia in patients with preeclampsia (1)
Treatment of seizures and prevention of recurrent seizures in patients
with eclampsia (1)
DOSAGE AND ADMINISTRATION
Administer via intravenous infusion pump (2.1)
Recommended loading dosage is 4 to 6 grams over 15 minutes followed by
a recommended
maintenance dosage of 1 to 2 grams every hour; maximum recommended
dosage is 30 to 40 grams
over 24 hours (2.2)
Obtain serum magnesium concentrations and assess clinical status to
adjust the dose (2.2)
Administration beyond 5 to 7 days is not recommended (2.2, 5.1)
In patients with severe renal impairment and/or urine output less than
0.5 mL/kg/hour, administer a 4
gram loading dose followed by a maintenance dosage of 1 gram every
hour; do not exceed the
maximum recommended dosage of 20 grams over 48 hours (2.3)
Do not administer Magnesium Sulfate in 5% Dextrose Injection with
incompatible drugs through the
same intravenous line, specifically with salicylates and alkali
carbonates (2.4)
DOSAGE FORMS AND STRENGTHS
Supplied in premixed single-dose bags: (3)
0.01 grams/mL (1%) in 100 mL bag containing 1 gram of magnesium
sulfate in 5% dextrose injection
CONTRAINDICATIONS
Heart block or myocardial damage (4)
Diabetic coma (4)
Myasthenia gravis (4, 5.6)
WARNINGS AND PRECAUTIONS
Fetal-neonatal toxicity with prolonged use: Administration beyond 5 to
7 days is not recommended and
can lead to hypocalcemia and bone abnormalities (2.2, 5.1)
Risk of magnesium toxicity: Monitor magnesium conce