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Paclitaxel Injection 16.7mL: 100mg
Composition:
Each mL contains:
- Paclitaxel 6 mg
- Polyoxyethylated castor oil (Cremophor EL) and dehydrated alcohol as solvents
Each 16.7 mL vial contains 100 mg of Paclitaxel.
Description:
Paclitaxel is a microtubule-stabilizing agent derived from the Pacific yew tree (Taxus brevifolia). It disrupts the normal breakdown of microtubules, inhibiting cell division and leading to apoptosis (programmed cell death) in tumor cells.
Indications:
Paclitaxel Injection is indicated for the treatment of:
- Ovarian Cancer (First-line with cisplatin or second-line monotherapy)
- Breast Cancer (Adjuvant therapy, metastatic cases, or in combination with trastuzumab or capecitabine)
- Non-Small Cell Lung Cancer (NSCLC) (in combination with cisplatin)
- Kaposi's Sarcoma (AIDS-related) (in patients who have failed other treatments)
Dosage & Administration:
Recommended Dosage (Adults Only):
Ovarian Cancer:
- First-line therapy (with cisplatin):
- 175 mg/m² IV over 3 hours, followed by cisplatin 75 mg/m² IV every 3 weeks
- OR 135 mg/m² IV over 24 hours, followed by cisplatin 75 mg/m² IV every 3 weeks
- Second-line therapy (monotherapy):
- 135-175 mg/m² IV over 3 hours every 3 weeks
Breast Cancer:
- Adjuvant therapy (after anthracycline-containing chemotherapy):
- 175 mg/m² IV over 3 hours every 3 weeks (4 cycles)
- Metastatic breast cancer (monotherapy or combination):
- 175 mg/m² IV over 3 hours every 3 weeks
Non-Small Cell Lung Cancer (NSCLC) (with cisplatin):
- 175 mg/m² IV over 3 hours, followed by cisplatin 75 mg/m² IV every 3 weeks
Kaposi's Sarcoma (AIDS-related):
- 100 mg/m² IV over 3 hours every 2 weeks
Administration:
- Paclitaxel MUST be administered via IV infusion using an in-line filter (≤0.22 microns)
- Dilution required before administration
- Dilute in 0.9% sodium chloride, 5% dextrose, or lactated Ringer's solution
- Premedication REQUIRED to prevent hypersensitivity reactions:
- Diphenhydramine 50 mg IV 30-60 min before infusion
- H2-receptor antagonist (e.g., ranitidine 50 mg IV or famotidine 20 mg IV) 30-60 min before infusion
Dose Adjustments:
- Neutropenia (ANC <1,500/mm³) or severe neuropathy: Delay or reduce dose
- Hepatic Impairment:
- Mild to moderate: Reduce dose
- Severe dysfunction: Not recommended
Contraindications:
- Severe hypersensitivity to Paclitaxel, Cremophor EL (polyoxyethylated castor oil), or any excipient
- Severe neutropenia (ANC <1,500/mm³ in solid tumors, <1,000/mm³ in AIDS-related Kaposi's Sarcoma)
- Pregnancy & breastfeeding (Category D-may cause fetal harm)
Precautions:
- Severe Hypersensitivity Reactions: Anaphylaxis and severe reactions have been reported
- Bone Marrow Suppression: Monitor neutrophil and platelet counts
- Peripheral Neuropathy: May require dose reduction or discontinuation
- Cardiotoxicity: Caution in patients with prior anthracycline treatment
- Hepatic Impairment: Increased toxicity risk
Adverse Reactions:
- Common: Neutropenia, alopecia, nausea, vomiting, mucositis, arthralgia, myalgia
- Serious: Hypersensitivity reactions, peripheral neuropathy, cardiotoxicity, hepatotoxicity
Drug Interactions:
- Cisplatin: Increased myelosuppression-administer Paclitaxel BEFORE Cisplatin
- Doxorubicin: Higher toxicity-administer Paclitaxel AFTER Doxorubicin (interval ≥24 hours)
- CYP3A4 & CYP2C8 inhibitors (e.g., ketoconazole, erythromycin): May increase Paclitaxel toxicity
Overdose & Management:
- Symptoms: Severe bone marrow suppression, neuropathy, mucositis
- Treatment: Supportive care, blood transfusions, colony-stimulating factors (G-CSF)
Storage Conditions:
- Store below 25°C, protect from light
- Do not refrigerate-may cause precipitation
- Use within 6 hours after dilution
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