Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)
WG Critical Care, LLC
MAGNESIUM SULFATE HEPTAHYDRATE
MAGNESIUM SULFATE HEPTAHYDRATE 1 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Magnesium Sulfate in 5% Dextrose Injection, USP 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 effect of intravenous magnesium on milk production is unknown. The developmental and health benefits to the neonate of breastfeeding should be considered along with the mother's clinical need for Magnesium Sulfate in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Magnesium Sulfate in 5% Dextrose Injection or from the underlying maternal condition. The safety and effectiveness of Magnesium Sulfate in 5% Dextrose Injection have been established for the prevention of eclampsia in adolescents with preeclampsia and the treatment of seizures and prevention of recurrent seizures in adolescents with eclampsia. Dosing recommendation in pregnant adolescent patients are the same as for pregnant adult patients [see Dosage and Administration (2.2)] . Magnesium is excreted solely by the kidneys. Patients with severe renal impairment (urine output less than 100 mL per 4 hours) are at greater risk for increased magnesium concentrations that may lead to magnesium toxicity [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)] . In patients with severe renal impairment, dosage reduction is recommended and the maximum recommended dosage is lower than patients with normal renal function [see Dosage and Administration (2.3)] .
Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single-dose, single port bag with an aluminum overwrap. The infusion bags and ports are not made with natural rubber latex. 44567-410-24 24 bags per carton 100 mL 1 gram 8.1 mEq 0.01 grams/mL (1%) 8.1 mEq/100 mL 333 mOsmol/ liter Storage WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING
Abbreviated New Drug Application
MAGNESIUM SULFATE IN DEXTROSE- MAGNESIUM SULFATE INJECTION WG CRITICAL CARE, LLC ---------- 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, USP is indicated for (1): • • DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS Supplied in a single-dose, single port bag: (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 WG CRITICAL CARE, LLC AT 1-866-562- 4708 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • 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 ho Läs hela dokumentet