Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)
Hospira, Inc.
MAGNESIUM SULFATE HEPTAHYDRATE
MAGNESIUM SULFATE HEPTAHYDRATE 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Magnesium Sulfate in 5% Dextrose Injection is indicated for: Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients: 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 fetus, including skeletal demineralization and osteopenia [see Warnings and Precautions (5.1)] . The use of intravenous magnesium in pregnant women increases human milk magnesium concentrations only slightly and oral absorption of magnesium by the infant is poor. The
Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in single-dose flexible plastic containers (see Table 2). NDC 0409-6727-23 Case of 24 single-dose flexible plastic containers 1 g/100 mL (10 mg/mL) 1 g 8.1 mEq 0.01 g/mL (1%) 8.1 mEq/100 mL 333 mOsmol/liter NDC 0409-6727-50 Case of 50 single-dose flexible plastic containers 1 g/100 mL (10 mg/mL) 1 g 8.1 mEq 0.01 g/mL (1%) 8.1 mEq/100 mL 333 mOsmol/liter Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
New Drug Application
MAGNESIUM SULFATE IN DEXTROSE- MAGNESIUM SULFATE IN DEXTROSE INJECTION, SOLUTION HOSPIRA, INC. ---------- 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): • • DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS Supplied in premixed single-dose flexible plastic containers: (3) • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS The most common adverse reactions are flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system (CNS) depression proceeding to respiratory paralysis and hypocalcemia. Bradycardia, pulmonary edema, decreased respiratory rate, lethargy, sedation, somnolence, visual disturbances, and hypermagnesemia are also reported (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER INC., AT 1-800-438-1985 OR FDA AT Prevention of eclampsia in patients with preeclampsia (1) Treatment of seizures and prevention of recurrent seizures in patients with eclampsia (1) 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 2 Прочитајте комплетан документ