Rx Item-Matulane 50Mg Cap 100 By Sigma Tau Pharma Rx

MATULANE- procarbazine hydrochloride capsule
Sigma-Tau Pharmaceuticals, Inc.


WARNING

It is recommended that MATULANE be given only by or under the supervision of a physician experienced in the use of potent antineoplastic drugs. Adequate clinical and laboratory facilities should be available to patients for proper monitoring of treatment.

DESCRIPTION

Matulane (procarbazine hydrochloride), a hydrazine derivative antineoplastic agent, is available as capsules containing the equivalent of 50 mg procarbazine as the hydrochloride. Each capsule also contains cornstarch, mannitol and talc. Gelatin capsule shells contain parabens (methyl and propyl), potassium sorbate, titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10.



Chemically, procarbazine hydrochloride is N -isopropyl-α-(2-methylhydrazino)-p -toluamide monohydrochloride. It is a white to pale yellow crystalline powder which is soluble but unstable in water or aqueous solutions. The molecular weight of procarbazine hydrochloride is 257.76

CLINICAL PHARMACOLOGY

The precise mode of cytotoxic action of procarbazine has not been clearly defined. There is evidence that the drug may act by inhibition of protein, RNA and DNA synthesis. Studies have suggested that procarbazine may inhibit transmethylation of methyl groups of methionine into t-RNA. The absence of functional t-RNA could cause the cessation of protein synthesis and consequently DNA and RNA synthesis. In addition, procarbazine may directly damage DNA. Hydrogen peroxide, formed during the auto-oxidation of the drug, may attack protein sulfhydryl groups contained in residual protein which is tightly bound to DNA
INDICATIONS AND USAGE

Matulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen.

RX ITEM-Matulane 50Mg Cap 100 By Sigma T
NDC 54482-0053-01 UPC/GTIN No.3-54482-05301-7 Mfg.Part No.5301 MATULANE, logo and sigma-tau capsule , off-white , oblong oblong Black ink

Matulane 50Mg Cap 100 By Sigma Tau Pharm
BRAND: MATULANE NDC: 54482-0053-01,54482005301 UPC: 3-54482-05301-7,354482053017 Sigma/Tau Pharma/Brand Rx

PROCARBAZINE HCL ORAL CAP
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