Doxorub-50 mg

Doxorub 50

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Product Description

Description
Doxorub® (Doxorubicin Hydrochloride USP), is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var.caesius. Chemically, it is-5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy -α-L-lyxo-hexopyranosyl)oxy] -7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1- methoxy-, hydrochloride (8S-cis)-. Doxorub is a sterile red-orange lyophilized powder. Its molecular formula is C27H29NO11.HCl and molecular weight is 579.99. The structural formula of Doxorub is:

Composition
Doxorub® powder for injection contains 10 mg and 50 mg, of Doxorubicin Hydrochloride USP. Doxorub 0.1%, injection contains 1 mg/mL doxorubicin hydrochloride.

Mechanism of action
Doxorub® is known to interact with DNA by intercalation and inhibition of macromolecular biosynthesis. This inhibits the progression of the enzyme topoisomerase II which unwinds DNA for transcription. Doxorub stabilizes the topoisomerase II complex after it has broken
the DNA chain for replication, preventing the DNA double helix from being resealed and thereby stopping the process of replication.

Pharmacokinetics
Bioavailability N/A
Metabolism CYP3A4
Half-life 12-18.5 hours when released from liposomes
Excretion Biliary and fecal Inj.
Doxorubicin Hydrochloride USP 10 mg & 50 mg

Indications
Doxorub® is commonly used to treat some leukemias, Hodgkin’s and non-Hodgkin’s lymphomas, osteosarcoma, Ewing sarcoma, adult soft tissue sarcoma, metastatic mammacarcinoma, gastric carcinoma, small-cell lung cencer, neuroblastoma, Wilms tumor and bladder carcinoma, multiple myeloma and others. Doxorub may be used intravesically as single agent for treatment and prophylaxis of superficial bladder carcinoma.

Dosage and administration
Usual dosage and schedule 60 to 75 mg/m2 I.V. every 3 weeks(or as 96-hr continuous infusion). 30 mg/m2 I.V. on days 1 and 8 every 4 weeks (in combination with other drugs). 9 mg/m2 I.V. daily for 4 days as a continuous infusion (in myeloma). 15 to 20 mg/m2 I.V. weekly . 50 to 60 mg instilled into the bladder weekly for 4 weeks then every 4 weeks for 6 cycles.
Dosage in children
Doxorub is used as single agent a dose of 75-90 mg/m2 is recommended.
In combination with other oncolytics doses of 50-75 mg/m2 are administered.

Possible side effects
Mild to moderate myelosuppression and cardiotoxicity, cardiomyopathy, mucositis (stomatitis or esophagitis), urticaria and anaphylaxis, thrombophlebitis, stranguria and pollakisuria, hematuria may occur.

Contraindications
Myelosuppression, pre-existing heart disease, previous treatment with complete cumulative doses of doxorubicin or other anthracyclines. Doxorubicin should not be used intravesically for the treatment of bladder carcinoma in patient with urethral stenosis who cannot be catheterized.

Drug interactions
When doxorubicin is taken with drugs such as zidovudine, cyclosporine, digoxin, phenobarbital, phenytoin, progesterones, streptozocin, verapamil, liver virus vaccines interactions may potentially occur.

Special precautions
Administer over several minutes into the sidearm of a running I.V. infusion (except when given as a continuous infusion),taking care to avoid extravasation. Do not give if patient has significantly impaired cardiac function (ejection fraction less than 45%),angina pectoris,
cardiac arrhythmia or recent myocardial infarction. Reduce or hold dose if patient has impaired liver functiona. For serum bilirubin of 1.2 to 3.0 mg/dL, give one half life the normal dose.
b. For serum bilirubin of more than 3.0mg/dL, give one-fourth the normal dose.

Reconstitution
Doxorub® 10 mg lyophilized powder for injection should be reconstituted with 5 mL of sodium chloride solution (0.9%) or water for injection.
Doxorub® 50 mg lyophilized power for injection should be reconstituted with 25 mL of sodium chloride solution (0.9%) or water for injection. The commonly recommended dosage schedule as single agent is 60-75 mg/m2 by I.V., once every three weeks, or 20 mg/m2 I.V., during three consecutive days, once every three weeks.

Stability
The reconstituted solution is stable for 7 days at (15oC-25oC) and 15 days under refrigeration (2oC-8oC).

Storage
Product should be stored below 30oC and protected from light.

Presentations
Doxorub® 50 mg injection.: Each vial contains Doxorubicine USP 50 mg lyophilized powder for injection.

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