Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W)
Lukare Medical, LLC
ORAL
PRESCRIPTION DRUG
Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: None. Risk Summary Available data from a limited number of published case reports and postmarketing experience with Betaine Anhydrous for Oral Solution use in pregnancy have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with betaine. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Risk Summary There are no data on the presence of betaine in hum
Betaine Anhydrous for Oral Solution is available in plastic bottles containing 180 grams of betaine anhydrous as a white, granular, hygroscopic powder. Each bottle is equipped with a plastic child-resistant cap and is supplied with a polypropylene measuring scoop. One level scoop (1.5 mL) is equal to 1 gram of betaine anhydrous powder. NDC 55792-002-01 180 g/bottle Betaine Anhydrous for Oral Solution can be ordered by calling Lukare Medical, LLC., Customer service at 1-855-752-9317. 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 moisture.
Abbreviated New Drug Application
BETAINE ANHYDROUS FOR ORAL SOLUTION- BETAINE POWDER, FOR SOLUTION LUKARE MEDICAL, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BETAINE ANHYDROUS FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETAINE ANHYDROUS FOR ORAL SOLUTION. BETAINE ANHYDROUS FOR ORAL SOLUTION INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Betaine Anhydrous for Oral Solution is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. Included within the category of homocystinuria are (1): • • • DOSAGE AND ADMINISTRATION ADULTS AND PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER • PEDIATRIC PATIENTS LESS THAN 3 YEARS OF AGE • • • PREPARATION AND ADMINISTRATION INSTRUCTIONS • DOSAGE FORMS AND STRENGTHS For oral solution: in bottles containing 180 grams of betaine anhydrous. (3) CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • Betaine Anhydrous for Oral Solution may worsen elevated plasma methionine concentrations and cerebral edema has been reported. Monitor plasma methionine concentrations in patients with CBS deficiency. Keep plasma methionine concentrations below 1,000 micromol/L through dietary modification and, if necessary, a reduction of Betaine Anhydrous for Oral Solution dosage. (5.1) ADVERSE REACTIONS Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey. (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUKARE MEDICAL, LLC AT 1-855-752-9317, OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 5/2020 Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. (2.1) The recommended starting dosage is 100 mg/kg/day, administer Baca dokumen lengkapnya