A few cases of cerebral edema have been reported secondary to severe hypermethioninemia in patients with cystathionine beta-synthase (CBS) deficiency treated with Cystadane. See PRECAUTIONS: Hypermethioninemia.

OVERDOSAGE

In an acute toxicology study in rats, death frequently occurred at doses equal to or greater than 10,000 mg/kg.

DOSAGE AND ADMINISTRATION

The usual dosage used in adult and pediatric patients is 6 grams per day administered orally in divided doses of 3 grams two times per day. Dosages of up to 20 grams per day have been necessary to control homocysteine levels in some patients. In pediatric patients less than 3 years of age, dosage may be started at 100 mg/kg/day and then increased weekly by 50 mg/kg increments. In one study by Matthewsi et al., pharmacokinetic and pharmacodynamic simulation indicated minimal benefit from exceeding a twice-daily dosing schedule and a 150 mg/kg/day dosage for betaine. Dosage in all patients can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts. Plasma methionine concentrations should be monitored in patients with CBS-deficiency. See PRECAUTIONS: Hypermethioninemia.

The prescribed amount of Cystadane (betaine anhydrous for oral solution) should be measured with the measuring scoop provided (one level 1.7 cc scoop is equal to 1 gram of betaine anhydrous powder) and then dissolved in 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula, or mixed with food for immediate ingestion.

HOW SUPPLIED

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 cc) is equal to 1 gram of betaine anhydrous powder.

NDC 68727-400-01

180g/bottle

DIN 02238526

Store at room temperature, 15° - 30°C (59° - 86°F).

For questions of a medical nature in the U.S. or Canada, call
1-888-867-7426.

Cystadane® can be ordered by calling Jazz Pharmaceuticals, Inc. Customer Service at 1-800-359-4304 or by contacting your local wholesaler.

Distributed in the U.S. by:

Jazz Pharmaceuticals, Inc.

Palo Alto, CA 94304

Distributed in Canada by:

Jazz Pharmaceuticals, Inc.

Scarborough, Ontario

M1H 2W4

Revision Date: August 2006

Part No. CYS PI-8585

iMatthews A, Johnson TN, Rostami-Hodjegan A, Chakrapani A, et al. An indirect response model of homocysteine suppression by betaine: optimizing the dosage regimen of betaine in homocystinuria. Br J Clin Pharmacol 2002; 54:140-146.
 

Cystadane (betaine, anhydrous)

PRODUCT INFO Product Code 68727-400 Dosage Form POWDER, FOR SOLUTION Route Of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength betaine, an 以下是“全球医药”详细资料 Tags： 责任编辑：admin 首页 上一页 1 2 3 4 下一页 尾页 3/4/4 【大 中 小】【打印】 【繁体】【投稿】【收藏】 【推荐】【举报】【评论】 【关闭】 【返回顶部】 分享到:  上一篇：Cystadane 下一篇：Cystadane (betaine anhydrous fo..