Paxoll

Paxoll

paclitaxel

Manufacturer:

Venus Remedies

Distributor:

Cosma Medical
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
Metastatic carcinoma of the ovary after failure of 1st-line or subsequent chemotherapy. Breast cancer after failure of combination chemotherapy for metastatic disease or relapse w/in 6 mth of adjuvant chemotherapy. 1st-line treatment of NSCLC in patients who are not candidates for potentially curative surgery or radiation therapy in combination w/ cisplatin. 2nd-line treatment of AIDS-related Kaposi's sarcoma (KS).
Dosage/Direction for Use
Ovarian cancer/carcinoma of the breast, NSCLC 175 mg/m2 IV over 3 hr every 3 wk. AIDS-related KS 135 mg/m2 IV over 3 hr every 3 wk or 100 mg/m2 over 3 hr every 2 wk. Hepatic impairment 24-hr infusion: <10x ULN, 1.6-7.5 mg/dL 50 mg/m2, 2 to <10x ULN, ≤1.5 mg/dL 100 mg/m2, <2x ULN, ≤1.5 mg/dL 135 mg/m2. 3-hr infusion: <10x ULN, 2.01-5 ULN 90 mg/m2, <10x ULN, 1.26-2x ULN 135 mg/m2, <10x ULN, ≤1.25 mg/ULN 175 mg/m2.
Contraindications
Hypersensitivity to paclitaxel or polyoxyethylated castor oil. Patients w/ baseline neutrophil counts of <1,500 cells/mm3 (solid tumors) & <1,000 cells/mm3 (AIDS-related KS). Pregnancy & lactation.
Special Precautions
Monitor blood counts, cardiac monitoring in patients who develop significant conduction abnormalities, occurence of myelotoxicity during treatment. Severe neutropenia (<500 cells/mm3). Discontinue treatment if severe CV events occur. Hepatic impairment. May affect ability to drive or operate machinery. Childn.
Adverse Reactions
Severe neutropenia, febrile neutropenia, opportunistic infections; bone marrow suppression, fever, episodes of sepsis, pneumonia, peritonitis, UTI, upper resp infections, anemia; hypersensitivity reactions; hypotension, bradycardia, syncope, rhythm abnormalities, venous thrombosis, arrhythmias, ECG abnormalities, peripheral neuropathy; renal toxicity; nausea/vomiting, diarrhea, mucositis; inj site reaction; alopecia, nail changes, edema.
Drug Interactions
Myelosuppression w/ cisplatin. Concomitant use w/ CYP2C8 & CYP3A4 inducers or inhibitors. Increased plasma levels of doxorubicin.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD01 - paclitaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.
Presentation/Packing
Form
Paxoll inj 100 mg/16.7 mL
Packing/Price
1's
Form
Paxoll inj 260 mg/43.4 mL
Packing/Price
1's
Form
Paxoll inj 30 mg/5 mL
Packing/Price
1's
Form
Paxoll inj 300 mg/50 mL
Packing/Price
1's
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