BETAINE ANHYDROUS FOR ORAL SOLUTION- betaine powder, for solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Lukare Medical, LLC

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

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.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

BETAINE ANHYDROUS FOR ORAL SOLUTION- BETAINE POWDER, FOR SOLUTION
LUKARE MEDICAL, 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):
•
•
•
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