Pacli-One 30/Pacli-One 100

Pacli-One 30/Pacli-One 100

paclitaxel

Manufacturer:

Stallion Labs

Distributor:

OneGen

Marketer:

Ambica
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
Palliative treatment of stage 3 or 4 advanced local carcinoma of the ovary after surgical resection, in combination w/ cisplatin. Palliative management of metastatic carcinoma of the ovary after failure of 1st-line or subsequent chemotherapy. Metastatic carcinoma of the breast after failure of combination chemotherapy or relapse w/in 6 mth of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Palliative treatment of advanced NSCLC in patients who are not candidates for potentially curative surgery &/or RT.
Dosage/Direction for Use
IV Primary treatment of ovarian carcinoma Combination regimen: 135 mg/m3 administered over 24 hr, followed by cisplatin 75 mg every 3 wk. Paclitaxel should be administered before cisplatin. Secondary treatment of ovarian carcinoma 175 mg/m3 administered IV over 3 hr every 3 wk in patients w/ metastatic carcinoma of the ovary or breast after the failure of 1st-line or subsequent chemotherapy. Palliative treatment of advanced NSCLC175 mg/m3 over a period of 3 hr followed by platinum compd w/ 3-wk interval between courses. Should not be readministered until neutrophil is at least 1,500/mm3 & platelet is at least 100,000/mm3. Patient who experience severe neutropenia (neutrophil count <500/mm3) or moderate to severe peripheral neuropathy Dose reduction of 20% for subsequent courses. All patients must be premedicated w/ corticosteroids, antihistamines & H2 antagonists prior to paclitaxel administration eg, dexamethasone 20 mg orally approx 12 & 6 hr before paclitaxel, promethazine 25 IV 30-60 min before paclitaxel.
Contraindications
Hypersensitivity to paclitaxel or other drugs w/ polyoxyethylated castor oil. Patients w/ baseline neutrophils <1,500/mm3.
Special Precautions
Adverse Reactions
Peripheral neuropathy, neutropenia, bone & muscle aches, hair loss, fatigue, nausea, vomiting, mild diarrhea, mucositis, amenorrhea, changes in nails (brittle or yellowed).
Drug Interactions
Administer paclitaxel before cisplatin. Concomitant use w/ known substrates or inhibitors of CYP450 isoenzymes CYP2C8 & CYP3A4.
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
Pacli-One 100 soln for infusion 100 mg/16.7 mL
Packing/Price
20 mL x 1's
Form
Pacli-One 30 soln for infusion 30 mg/5 mL
Packing/Price
5 mL x 1's
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