Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W)
Eton Pharmaceuticals, Inc.
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: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect None. 8.1 Pregnancy Risk Summary Available data from a limited number of published case reports and post-marketing 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. 8.2 Lactation Risk Summary There are no data on the presence of betaine in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Betaine Anhydrous for Oral Solution and any potential adverse effects on the breastfed child from Betaine Anhydrous for Oral Solution or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of Betaine Anhydrous for Oral Solution have been established in pediatric patients. The majority of case studies of homocystinuria patients treated with Betaine Anhydrous for Oral Solution have been pediatric patients, including patients ranging in age from 24 days to 17 years [see Clinical Studies (14)]. Children younger than 3 years of age may benefit from dose titration [ see Dosage and Administration (2.1) ].
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 childresistant cap and is supplied with a polypropylene measuring scoop. One level scoop (1.5 cc) is equal to 1 gram of betaine anhydrous powder. NDC 71863-115-18 (180 g/bottle) Storage Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [ See USP Controlled Room Temperature ]. Protect from moisture.
Abbreviated New Drug Application
BETAINE ANHYDROUS- BETAINE ANHYDROUS POWDER, FOR SOLUTION ETON PHARMACEUTICALS, INC. ---------- 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 (1) (1) 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: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect (1) DOSAGE AND ADMINISTRATION Adults and Pediatric Patients 3 Years of Age and Older • The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. (2.1) Pediatric Patients Less than 3 Years of Age • The recommended starting dosage is 100 mg/kg/day, administered orally in divided doses of 50 mg/kg twice daily, and then increased weekly by 50 mg/kg increments. (2.1) • Monitor patient response by plasma homocysteine concentrations. (2.1) • Increase the dosage gradually until the plasma total homocysteine concentration is undetectable or present only in small amounts. (2.1) Preparation and Administration Instructions • Prescribed amount of Betaine Anhydrous for Oral Solution should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula until completely dissolved, or mixed with food for immediate ingestion. (2.2) (2) DOSAGE FORMS AND STRENGTHS For oral solution: in bottles containing 180 grams of betaine anhydrous. (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Hypermethioninemia in Patients with CBS Deficiency: Betaine Anhydrous for Oral Solution may worsen elevated plasma methi Perskaitykite visą dokumentą