Oxator
Generic Name
Oxaliplatin
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
oxator 5 mg injection | ৳ 3,000.00 | N/A |
Description
Overview of the medicine
Oxator 5 mg Injection contains Oxaliplatin, a platinum-based chemotherapy drug. It is used in combination with other chemotherapy agents for the treatment of advanced colorectal cancer and other solid tumors. Oxaliplatin works by interfering with the growth of cancer cells, which are eventually destroyed by the body.
Uses & Indications
Dosage
Adults
Metastatic Colorectal Cancer: 85 mg/m² IV infusion over 2-6 hours on day 1, repeated every 2 weeks. Adjuvant Colon Cancer: 85 mg/m² IV infusion over 2-6 hours on day 1, repeated every 2 weeks for 12 cycles.
Elderly
No specific dose adjustments are required for elderly patients, but careful monitoring for toxicities is recommended.
Renal_impairment
For mild to moderate renal impairment, dose adjustment may not be necessary. For severe renal impairment, dose reduction or discontinuation might be required; consult prescribing information.
How to Take
Oxator 5 mg Injection is for intravenous infusion only. It must be administered by a qualified healthcare professional, usually diluted in 250-500 mL of 5% Dextrose Injection and infused over 2 to 6 hours. It should not be mixed with sodium chloride or other chloride-containing solutions.
Mechanism of Action
Oxaliplatin is an antineoplastic agent that forms DNA adducts, leading to inter- and intra-strand cross-links. This inhibits DNA synthesis and replication, ultimately inducing apoptosis and cell death in rapidly dividing cancer cells.
Pharmacokinetics
Onset
Rapid distribution into tissues following intravenous infusion.
Excretion
Primarily excreted in urine (about 50% within 48 hours) and to a lesser extent via feces. Minimal excretion of unchanged oxaliplatin.
Half life
The terminal half-life of platinum in plasma is approximately 39 hours (range 32 to 47 hours).
Absorption
Administered intravenously, resulting in 100% systemic bioavailability.
Metabolism
Undergoes rapid and extensive non-enzymatic biotransformation in plasma to form active and inactive derivatives. Not metabolized by cytochrome P450 enzymes.
Side Effects
Contraindications
- Hypersensitivity to oxaliplatin or other platinum-containing compounds.
- Pre-existing myelosuppression (neutrophil counts <2 x 10^9/L and/or platelet counts <100 x 10^9/L) before the first course.
- Pre-existing peripheral sensory neuropathy with functional impairment.
Drug Interactions
Live vaccines
Avoid live vaccines due to immunosuppressive effects.
Nephrotoxic drugs
Potential for increased nephrotoxicity when combined with other nephrotoxic agents.
Myelosuppressive agents
Increased risk of bone marrow suppression when co-administered with other myelosuppressive agents.
Storage
Store intact vials at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not refrigerate or freeze. Reconstituted and diluted solutions should be used immediately or stored as per manufacturer guidelines.
Overdose
There is no known antidote for oxaliplatin overdose. Management of overdose should involve supportive care and symptomatic treatment of adverse reactions (e.g., myelosuppression, neurotoxicity, gastrointestinal toxicity).
Pregnancy & Lactation
Pregnancy Category D. Oxaliplatin can cause fetal harm when administered to a pregnant woman. It is not known whether Oxaliplatin is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment and for a specified period after the last dose.
Side Effects
Contraindications
- Hypersensitivity to oxaliplatin or other platinum-containing compounds.
- Pre-existing myelosuppression (neutrophil counts <2 x 10^9/L and/or platelet counts <100 x 10^9/L) before the first course.
- Pre-existing peripheral sensory neuropathy with functional impairment.
Drug Interactions
Live vaccines
Avoid live vaccines due to immunosuppressive effects.
Nephrotoxic drugs
Potential for increased nephrotoxicity when combined with other nephrotoxic agents.
Myelosuppressive agents
Increased risk of bone marrow suppression when co-administered with other myelosuppressive agents.
Storage
Store intact vials at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not refrigerate or freeze. Reconstituted and diluted solutions should be used immediately or stored as per manufacturer guidelines.
Overdose
There is no known antidote for oxaliplatin overdose. Management of overdose should involve supportive care and symptomatic treatment of adverse reactions (e.g., myelosuppression, neurotoxicity, gastrointestinal toxicity).
Pregnancy & Lactation
Pregnancy Category D. Oxaliplatin can cause fetal harm when administered to a pregnant woman. It is not known whether Oxaliplatin is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment and for a specified period after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture when stored under recommended conditions. Refer to the product packaging for the exact expiry date.
Availability
Available in hospitals, oncology centers, and specialized pharmacies
Approval Status
FDA and DGDA Approved
Patent Status
Patent expired, generic versions available
WHO Essential Medicine
YesClinical Trials
Oxaliplatin has been extensively studied in numerous clinical trials for the treatment of colorectal cancer, including large Phase III trials like MOSAIC and XELOX. Ongoing research explores its use in other malignancies and in combination with novel targeted therapies.
Lab Monitoring
- Complete blood count (CBC) with differential before each cycle.
- Liver function tests (LFTs) periodically.
- Renal function tests (creatinine, BUN) periodically.
- Neurological examination for peripheral neuropathy symptoms before each cycle.
Doctor Notes
- Administer antiemetics proactively to manage nausea and vomiting.
- Closely monitor patients for signs of peripheral neuropathy and hypersensitivity reactions, especially during and immediately after infusion.
- Ensure adequate hydration before, during, and after treatment.
- Dosage adjustments may be necessary based on hematologic and neurologic toxicities.
Patient Guidelines
- Report any unusual sensations like numbness, tingling, or pain in hands and feet immediately.
- Inform your doctor about any throat tightness, difficulty breathing, or swallowing that occurs during or after the infusion.
- Stay well-hydrated throughout your treatment.
- Avoid contact with sick people, as your immune system may be weakened.
Missed Dose Advice
As Oxator is administered by a healthcare professional in a clinical setting, a missed dose is unlikely. If a scheduled dose is missed, contact your oncologist immediately to reschedule.
Driving Precautions
Oxaliplatin may cause fatigue, dizziness, or visual disturbances. Patients should be advised to avoid driving or operating machinery if they experience these effects.
Lifestyle Advice
- Maintain good oral hygiene to prevent stomatitis.
- Eat a balanced diet and get adequate rest.
- Avoid exposure to extreme cold, which can exacerbate neuropathy symptoms.
- Consult your doctor before taking any new medications, supplements, or herbal products.
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