BETAINE ANHYDROUS powder, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W)

から入手可能:

Eton Pharmaceuticals, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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) ].

製品概要:

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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

BETAINE ANHYDROUS- BETAINE ANHYDROUS POWDER, FOR SOLUTION
ETON PHARMACEUTICALS, INC.
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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