CYSTADANE- betaine powder, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Rare Disease Therapeutics, Inc.

INN (Διεθνής Όνομα):

BETAINE

Σύνθεση:

BETAINE 6 g

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Cystadane® (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels.  Included within the category of homocystinuria are:   - Cystathionine beta-synthase (CBS) deficiency - 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency - Cobalamin cofactor metabolism (cbl) defect None. Pregnancy Category C: Animal reproduction studies have not been conducted with Cystadane.  It is also not known whether Cystadane can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Cystadane should be given to a pregnant woman only if clearly needed. It is not known whether Cystadane is excreted in human milk.  Use only if clearly needed. The majority of case studies of homocystinuria patients treated with Cystadane 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

Περίληψη προϊόντος:

Cystadane is available in plastic bottles containing 180 grams of betaine anhydrous.  Each bottle is equipped with a plastic child-resistant cap and is supplied with a polystyrene measuring scoop.  One level scoop (1.7 mL) is equal to 1 gram of betaine anhydrous powder. NDC 66621-4000-1    180 g/bottle Cystadane can be ordered by calling AnovoRx Group, LLC, Customer service at 1-888-487-4703 Store at room temperature, 15 – 30 ˚C (59 – 86 ˚F).  Protect from moisture.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

CYSTADANE - BETAINE POWDER, FOR SOLUTION
RARE DISEASE THERAPEUTICS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYSTADANE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CYSTADANE.
CYSTADANE (BETAINE ANHYDROUS FOR ORAL SOLUTION) POWDER
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Changes of Address 08/2008
Address of adverse reactions 07/2010
Change of distributor 07/2014
Manufactured For / Under License From 07/2014
INDICATIONS AND USAGE
Cystadane is a methylating agent indicated for the treatment of
homocystinuria to decrease elevated homocysteine blood
levels. Included within the category of homocystinuria are (1):
Cystathionine beta-synthase (CBS) deficiency
5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
Cobalamin cofactor metabolism (cbl) defect
DOSAGE AND ADMINISTRATION
Usual dose in adult and pediatric patients is 6 grams per day,
administered orally in divided doses of 3 grams two times
a day.(2)
In children less than 3 years of age, may initiate dosing at 100
mg/kg/day, divided in twice daily doses, and then
increased weekly by 50 mg/kg increments.(2)
Dose can be gradually increased until plasma total homocysteine is
undetectable or present only in small amounts.(2)
Monitor patient response by plasma homocysteine levels.(2)
Prescribed amount of Cystadane should be measured with the measuring
scoop provided and then dissolved in 4 to 6
ounces of water, juice, milk, or formula, or mixed with food for
immediate ingestion.(2)
DOSAGE FORMS AND STRENGTHS
Powder for oral solution available in bottles containing 180 grams of
betaine anhydrous.(3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypermethioninemia: Cystadane may worsen elevated plasma methionine
concentrations in patients with CBS
deficiency. Cerebral edema has been reported in patients receiving
Cystadane.( 5.1)
Monitoring: Monitor plasma methionine concentrations in patients with
CBS deficiency. Keep plasma methionine
concentrations belo