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Rx Item-Cystadane- Betaine Powder For Oral Solution 180Gm

CYSTADANE- betaine powder, for ORAL solution 180GM BY RECORDATI/ORPHAN DRUGS  Generic Name:
BETAINE

 Description:
CYSTADANE PW 180GM 
 Alt Item #: 
3938578

 NDC:
68727-0400-01

 UPC:
368727-400016
 BRAND: CYSTADANE NDC: RX52276-0400-01 ,RX52276040001  UPC: 352276-400016,352276400016 CYSTADANE- betaine powder, for ORAL solution 180GM BY RECORDATI/ORPHAN DRUGS  Generic Name:
BETAINE

 Description:Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Cystadane- Betaine Powder For Oral Solution 180Gm

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item No.:RX52276-0400-01 NDC No.RX52276040001 UPC No.:352276400016 Item No.:RX52276-0400-01 CYSTADANE- betaine powder, for ORAL solution 180GM BY RECORDATI/ORPHAN DRUGS Generic Name:
BETAINE
Description:
CYSTADANE PW 180GM
Alt Item #:
3938578
NDC:
68727-0400-01
UPC:
368727-400016
Contract:
Contract Alias:
Strength:
Form:
POWDER
Size:
1X180 GM Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopat

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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 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 below 1,000 �mol/L through dietary modification and, if necessary, a reduction of Cystadane dose. ( 5.1) ADVERSE REACTIONS � Most common adverse reactions (incidence > 2%) were nausea and gastrointestinal distress, based on physician survey. To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH. USE IN SPECIFIC POPULATIONS � Pregnancy: Animal reproduction studies have not been conducted with Cystadane. Use only if clearly needed. ( 8.1) � Nursing women: It is not known whether Cystadane is excreted in human milk. Use only if clearly needed. ( 8.3) � Pediatrics: Pediatric patients ranging in age from 24 days to 17 years have been treated with Cystadane. Children younger than 3 years of age may benefit from dose titration. See 17 for PATIENT COUNSELING INFORMATION. Revised: 4/2017

CYSTADANE- betaine powder, for ORAL solution 180GM BY RECORDATI/ORPHAN DRUGS  Generic Name:
BETAINE

 Description:
CYSTADANE PW 180GM 
 Alt Item #: 
3938578

 NDC:
68727-0400-01

 UPC:
368727-400016
RX ITEM-Cystadane- Betaine Powder For Or
CYSTADANE- betaine powder, for ORAL solution 180GM BY RECORDATI/ORPHAN DRUGS Generic Name: BETAINE Description: CYSTADANE PW 180GM Alt Item #: 3938578 NDC: 68727-0400-01 UPC: 368727-400016

BRAND: CYSTADANE NDC: RX52276-0400-01 ,RX52276040001  UPC: 352276-400016,352276400016 CYSTADANE- betaine powder, for ORAL solution 180GM BY RECORDATI/ORPHAN DRUGS  Generic Name:
BETAINE

 Description:
RECORDATI/Orphan Europe, SARL
BRAND: CYSTADANE NDC: RX52276-0400-01 ,RX52276040001 UPC: 352276-400016,352276400016 CYSTADANE- betaine powder, for ORAL solution 180GM BY RECORDATI/ORPHAN DRUGS Generic Name: BETAINE Description:

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.