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Rx Item-Leukeran 2Mg Tab 25 By Prasco Pharma

NDC 76388-0635-50 UPC/GTIN No.3-76388-63550-9 Mfg.Part No.63550BRAND: LEUKERAN NDC: 76388-0635-25,76388063525 UPC: 376388-635258,376388635258 Prasco Llc / BrandedOnly 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-Leukeran 2Mg Tab 25 By Prasco Pharma

$795.52$722.79

Item No.:RX559308 NDC No.76388063525 UPC No.:376388635258 NDC No. 76388-0635-25 76388-635-25 UPC/GTIN No. 3-76388-63525-8 MPN 63525 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx559308 Leukeran 2mg Tab 25 by Prasco Pharma / Item No. 3559308 559308 NDC No. 76388063525 7638863525 UPC No. 376388-6

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LEUKERAN- chlorambucil tablet, film coated
GlaxoSmithKline LLC

WARNING

LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS).

DESCRIPTION

LEUKERAN (chlorambucil) was first synthesized by Everett et al. It is a bifunctional alkylating agent of the nitrogen mustard type that has been found active against selected human neoplastic diseases. Chlorambucil is known chemically as 4-[bis(2-chlorethyl)amino]benzenebutanoic acid and has the following structural formula:

chlorambucil chemical structure
(click image for full-size original)


Chlorambucil hydrolyzes in water and has a pKa of 5.8.

LEUKERAN (chlorambucil) is available in tablet form for oral administration. Each film-coated tablet contains 2 mg chlorambucil and the inactive ingredients colloidal silicon dioxide, hypromellose, lactose (anhydrous), macrogol/PEG 400, microcrystalline cellulose, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide.

CLINICAL PHARMACOLOGY

Chlorambucil is rapidly and completely absorbed from the gastrointestinal tract. After single oral doses of 0.6 to 1.2 mg/kg, peak plasma chlorambucil levels (Cmax ) are reached within 1 hour and the terminal elimination half-life (t� ) of the parent drug is estimated at 1.5 hours. Chlorambucil undergoes rapid metabolism to phenylacetic acid mustard, the major metabolite, and the combined chlorambucil and phenylacetic acid mustard urinary excretion is extremely low - less than 1% in 24 hours. In a study of 12 patients given single oral doses of 0.2 mg/kg of LEUKERAN, the mean dose (12 mg) adjusted (� SD) plasma chlorambucil Cmax was 492 � 160 ng/mL, the AUC was 883 � 329 ng�h/mL, t� was 1.3 � 0.5 hours, and the tmax was 0.83 � 0.53 hours. For the major metabolite, phenylacetic acid mustard, the mean dose (12 mg) adjusted (� SD) plasma Cmax was 306 � 73 ng/mL, the AUC was 1204 � 285 ng�h/mL, the t� was 1.8 � 0.4 hours, and the tmax was 1.9 � 0.7 hours.

Chlorambucil and its metabolites are extensively bound to plasma and tissue proteins. In vitro, chlorambucil is 99% bound to plasma proteins, specifically albumin. Cerebrospinal fluid levels of chlorambucil have not been determined. Evidence of human teratogenicity suggests that the drug crosses the placenta.

Chlorambucil is extensively metabolized in the liver primarily to phenylacetic acid mustard, which has antineoplastic activity. Chlorambucil and its major metabolite spontaneously degrade in vivo forming monohydroxy and dihydroxy derivatives. After a single dose of radiolabeled chlorambucil (14 C), approximately 15% to 60% of the radioactivity appears in the urine after 24 hours. Again, less than 1% of the urinary radioactivity is in the form of chlorambucil or phenylacetic acid mustard. In summary, the pharmacokinetic data suggest that oral chlorambucil undergoes rapid gastrointestinal absorption and plasma clearance and that it is almost completely metabolized, having extremely low urinary excretion.

INDICATIONS AND USAGE

LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin's disease. It is not curative in any of these disorders but may produce clinically useful palliation.

NDC 76388-0635-50 UPC/GTIN No.3-76388-63550-9 Mfg.Part No.63550
RX ITEM-Leukeran 2Mg Tab 25 By Prasco Ph
NDC 76388-0635-50 UPC/GTIN No.3-76388-63550-9 Mfg.Part No.63550

BRAND: LEUKERAN NDC: 76388-0635-25,76388063525 UPC: 376388-635258,376388635258 Prasco Llc / Branded
Leukeran 2Mg Tab 25 By Prasco Pharma
BRAND: LEUKERAN NDC: 76388-0635-25,76388063525 UPC: 376388-635258,376388635258 Prasco Llc / Branded

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
CHLORAMBUCIL ORAL TABLET
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.