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Cystadane

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Overview

What is Cystadane?



What does Cystadane look like?



What are the available doses of Cystadane?

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What should I talk to my health care provider before I take Cystadane?

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How should I use Cystadane?

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What interacts with Cystadane?

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What are the warnings of Cystadane?

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What are the precautions of Cystadane?

General

Therapy with Cystadane should be directed by physicians knowledgeable in the management of patients with homocystinuria.

Hypermethioninemia

Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations. Treatment with Cystadane may further increase methionine concentrations due to the remethylation of homocysteine to methionine. Cerebral edema has been reported in patients with hypermethioninemia, including a few patients treated with Cystadane. Plasma methionine concentrations should be monitored in patients with CBS deficiency. Plasma methionine concentrations should be kept below 1,000 umol/L through dietary modification and, if necessary, a reduction of Cystadane dose.

Information for patients









          Always replace the cap tightly after using. Protect from moisture.

          Carcinogenesis, mutagenesis, impairment of fertility

          Long-term carcinogenicity and fertility studies have not been conducted on betaine. No evidence of genotoxicity was demonstrated in the following tests: Metaphase Analysis of Human Lymphocytes; Bacterial Reverse Mutation Assay; and Mouse Micronucleus Test.

          Pregnancy

          Pregnancy Category C. Animal reproduction studies have not been conducted with betaine. It is also not known whether betaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystadane (betaine anhydrous for oral solution) should be given to a pregnant woman only if clearly needed.

          Nursing mothers

          It is not known whether betaine is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk). Because many drugs are excreted in human milk, caution should be exercised when Cystadane is administered to a nursing woman.

          Pediatric use

          The majority of case studies of homocystinuria patients treated with betaine have been pediatric patients. The disorder, in its most severe form, can be manifested within the first months or years of life by lethargy, failure to thrive, developmental delays, seizures, or optic lens displacement. Patients have been treated successfully without adverse effects within the first months or years of life with dosages of 6 grams per day or more of betaine with resultant biochemical and clinical improvement. However, dosage titration may be preferable in pediatric patients (see ).


          What are the side effects of Cystadane?

          Adverse reactions to betaine have been minimal. In a survey study of physicians who had treated a total of 111 homocystinuria patients with betaine, the types of adverse effects and the number of patients experiencing them were as follows:

          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 : .

          Nausea2“Caused odor”1
          GI distress2Questionable psychological changes1
          Diarrhea1“Aspirated the powder”1
          Unspecified problem1



          What should I look out for while using Cystadane?

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          What might happen if I take too much Cystadane?

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          How should I store and handle Cystadane?

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          Clinical Information

          Chemical Structure

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          Clinical Pharmacology

          Non-Clinical Toxicology
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          Reference

          This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
          "https://dailymed.nlm.nih.gov/dailymed/"

          While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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          Professional

          Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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          Interactions

          Interactions

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