BETAINE ANHYDROUS for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novitium Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 majo

Product summary:

Betaine Anhydrous for Oral Solution is available in plastic bottles containing 180 grams of betaine anhydrous as a white to off-white crystalline, hygroscopic powder. Each bottle is equipped with a plastic child-resistant cap and is supplied with a polypropylene measuring scoop. One level scoop (1.9cc) is equal to 1 gram of betaine anhydrous powder. NDC 70954-331-10 (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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAINE ANHYDROUS - BETAINE ANHYDROUS FOR SOLUTION
NOVITIUM PHARMA LLC
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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
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): (1)
Cystathionine beta-synthase (CBS) deficiency
5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
Cobalamin cofactor metabolism (cbl) defect
DOSAGE AND ADMINISTRATION
Adults and Pediatric Patients 3 Years of Age and Older (2)
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 (2)
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 (2)
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)
DOSAGE FORMS AND STRENGTHS
For oral solution: in bottles containing 180 grams of betaine
anhydrous. (3) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypermethioninemia in Patients with CBS Deficiency:
Betaine Anhydrous for Oral Solution may worsen elevated plasma
methionine concentrations and
cerebral edem