GMP Certified / Paclitaxel Injection

• Customization: Available
• Quality Standard: USP, Bp
• Factory Certified: GMP
• Model NO.: injection
• Ctd: Available
• Transport Package: Sea Transportation
• Specification: 5ml: 30mg 10ml: 60mg 16.7ml: 100mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100, 000, 000 Per Year

Product Description

Paclitaxel Injection
 

Generic name	Paclitaxel Injection
Strength	5ml:30mg 10ml:60mg 16.7ml:100mg
Standard	BP
Shelf life	2 Years
Packing form	1 vial/box

Composition:

Each vial contains:

• Paclitaxel .........… (specified strength, e.g., 30mg, 100mg, 300mg)
• Excipients: Cremophor EL (polyoxyethylated castor oil), ethanol

Description:

Paclitaxel is a plant-derived chemotherapeutic agent from the Taxus brevifolia (Pacific Yew tree). It is an antimicrotubule agent that stabilizes microtubules, inhibiting their depolymerization, thereby blocking cell division and inducing apoptosis in cancer cells.

Indications:

Paclitaxel Injection is indicated for the treatment of:

• Ovarian cancer (Advanced/metastatic and first-line combination with platinum-based therapy)
• Breast cancer (Adjuvant treatment after surgery, metastatic breast cancer)
• Non-small cell lung cancer (NSCLC) (Combination with platinum agents)
• Kaposi's sarcoma (AIDS-related)
• Head and neck cancers, bladder cancer, esophageal cancer (off-label use)

Dosage & Administration:

Standard Dosage Regimens:

(Dose adjustments may be needed based on patient factors)

• Ovarian Cancer:
  • First-line: 175 mg/m² IV over 3 hours, followed by Cisplatin 75 mg/m² every 3 weeks
  • Second-line: 135-175 mg/m² IV every 3 weeks
• Breast Cancer:
  • Metastatic: 175 mg/m² IV over 3 hours every 3 weeks
  • Adjuvant (post-surgery): 175 mg/m² IV every 3 weeks for 4 courses after doxorubicin/cyclophosphamide
• NSCLC:
  • 175 mg/m² IV over 3 hours, followed by Cisplatin 80 mg/m² every 3 weeks
• Kaposi's Sarcoma:
  • 100 mg/m² IV over 3 hours every 2 weeks

Administration Instructions:

• Dilute in 0.9% Sodium Chloride or 5% Dextrose Injection
• Use non-PVC IV bags and tubing (due to Cremophor EL interactions)
• Administer via infusion pump with a 0.22-micron inline filter
• Premedicate with:
  • Diphenhydramine 50 mg IV
  • H2-antagonist (Ranitidine 50 mg IV or Famotidine 20 mg IV)

Contraindications:

• Severe hypersensitivity to Paclitaxel, Cremophor EL (polyoxyethylated castor oil)
• Neutrophil count < 1500 cells/mm³ (except in AIDS-related Kaposi's sarcoma)
• Severe liver impairment

Warnings & Precautions:

• Severe hypersensitivity reactions may occur (anaphylaxis, angioedema) → Requires pre-medication
• Bone marrow suppression (Monitor blood counts before each cycle)
• Peripheral neuropathy (dose-limiting)
• QT prolongation & cardiac effects (Use with caution in patients with heart disease)
• Hepatic impairment (Adjust dose in liver dysfunction)
• Avoid pregnancy (Teratogenic effects)

Adverse Reactions:

• Very Common: Myelosuppression (neutropenia, anemia), nausea, vomiting, alopecia, peripheral neuropathy
• Serious: Anaphylaxis, cardiotoxicity (arrhythmia, hypotension), hepatotoxicity, mucositis, severe neutropenia with fever (febrile neutropenia)

Drug Interactions:

• Cisplatin: Increases risk of myelosuppression
• Doxorubicin: Increased cardiotoxicity risk
• Warfarin: Increased bleeding risk
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): Increase Paclitaxel toxicity
• CYP3A4 inducers (e.g., rifampin, phenytoin): Reduce Paclitaxel effectiveness

Overdose & Management:

• Symptoms: Severe myelosuppression, neuropathy, mucositis
• Treatment: Supportive care (growth factors, IV hydration, antiemetics)

Storage Conditions:

• Store below 25°C, protect from light
• Do not refrigerate (may cause precipitation)

Sinolead Pharmaceutical (Hangzhou) Co., Ltd. is a leading supplier for human medicine, health supplements, veterinary products, medical supplies & equipment. Working with the highest levels of government and local distributors alike, we aim to not only expand our business scale and scope but also have a special interest in serving the needs of the end users who requires our products the most. To this end, we have a presence in 5 continents with an expanding product range to meet the demand of our main markets, especially in middle east, Commonwealth of Independent States (CIS), Southeast Asia and Africa.
At Sinolead Pharma, our manufacturing facilities follow GMP regulations. We have intergraded all GMP guidelines into internal procedures improving the degree to which results are consistently exceeding expectations. As one of the best pharmaceutical companies in China, we take our ethical obligation to improving access to high quality and affordable WHO essential drugs seriously. This is the ethical basis our company was founded on.