Hetero Labs


Concise Prescribing Info
1st-line chemotherapy of advanced carcinoma of the ovary or w/ residual disease (>1 cm) after initial laparotomy in combination w/ cisplatin or carboplatin. 2nd-line chemotherapy of metastatic carcinoma of the ovary after failure of standard, platinum-containing therapy. Node +ve breast carcinoma following anthracycline & cyclophosphamide therapy. Non-small cell lung carcinoma (NSCLC) for potentially curative surgery &/or radiation therapy w/ cisplatin. Failed advanced AIDS-related Kaposi's sarcoma (KS)  prior to liposomal anthracycline therapy.
Dosage/Direction for Use
Premed all patients w/ oral or IV dexamethasone (20 mg) approx 12 & 6 hr before paclitaxel administration, IV diphenhydramine (50 mg) 30-60 min before paclitaxel administration, & either IV cimetidine (300 mg) or IV ranitidine (50 mg) 30-60 min before paclitaxel administration. 1st-line ovarian carcinoma Paclitaxel 175 mg/m2 IV over 3 hr followed by cisplatin 75 mg/m2 every 3 wk or paclitaxel 135 mg/m2 IV in a 24 hr infusion followed by cisplatin 75 mg/m2 w/ 3 wk interval bet courses. 2nd-line ovarian carcinoma 175 mg/m2 for 3 hr w/ 3 wk interval. 1st-line breast carcinoma Paclitaxel 220 mg/mIV for 3 hr w/ doxorubicin 50 mg/m2. 2nd-line breast carcinoma 175 mg/m2 for 3 hr w/ 3 wk interval. Adjuvant chemotherapy breast carcinoma 175 mg/m2 for 3 hr every 3 wk for 4 courses. Advanced NSCLC Paclitaxel 175 mg/m2 for 3 hr followed by cisplatin 80 mg/m2 w/ 3 wk interval. AIDS-related KS 100 mg/m2 for 3-hr IV infusion every 2 wk.
Severe hypersensitivity to paclitaxel or polyoxyethylated castor oil. Lactation. Concurrent, serious, uncontrolled infections.
Special Precautions
Hypersensitivity; bone marrow suppression; hepatic impairment; severe cardiac conduction abnormalities; peripheral neuropathy; pseudomembranous colitis. Pregnancy.
Adverse Reactions
Hypersensitivity; bone marrow suppression; thrombocytopenia, anaemia; peripheral neuropathy; arthralgia; inj site reaction.
Drug Interactions
Increased risk of renal failure w/ cisplatin in gynecological cancers. Caution when in concomitant w/ CYP2C8 or CYP3A4 inhibitors eg, erythromycin, fluoxetine, gemfibrozil; CYP2C8 or CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb, efavirenz, nevirapine; protease inhibitors. Significantly lowered systemic clearance w/ nelfinavir & ritonavir.
ATC Classification
L01CD01 - paclitaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.
Paclitero inj 6 mg/mL
(100 mg/16.7 mL) 20 mL x 1's; (30 mg/5 mL) 5 mL x 1's; (300 mg/50 mL) 50 mL x 1's
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