Sindroxocin
Generic Name
Sindroxocin 2 mg Injection
Manufacturer
PharmaGen Therapeutics
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sindroxocin 2 mg injection | ৳ 908.00 | N/A |
Description
Overview of the medicine
Sindroxocin is a potent anthracycline antineoplastic agent used in the treatment of various cancers. It works by interfering with DNA and RNA synthesis, leading to cell death.
Uses & Indications
Dosage
Adults
Typical dose ranges from 40-75 mg/m² intravenously every 3 weeks, or as per specific chemotherapy regimen. Dose adjustments required based on myelosuppression and cardiac function.
Elderly
No specific dose reduction required based on age alone; however, closer monitoring for toxicity is recommended due to potential age-related organ impairment.
Renal_impairment
No specific dose adjustment for mild to moderate renal impairment. Use with caution in severe renal impairment, consider dose reduction if creatinine clearance <30 mL/min.
How to Take
Sindroxocin must be administered intravenously only, usually as a slow infusion over 15-30 minutes, or longer depending on the regimen. Extravasation can cause severe tissue necrosis.
Mechanism of Action
Sindroxocin acts by intercalating into DNA, inhibiting topoisomerase II, and generating free radicals, all of which contribute to DNA damage and inhibition of nucleic acid synthesis. This ultimately leads to cell cycle arrest and apoptosis in rapidly proliferating cancer cells.
Pharmacokinetics
Onset
Rapid onset of action following IV administration.
Excretion
Excreted mainly via biliary route (40-50%) and to a lesser extent renally (10-15%).
Half life
Biphasic elimination with an initial half-life of 3-5 hours and a terminal half-life of 20-30 hours.
Absorption
Administered intravenously, hence bioavailability is 100%.
Metabolism
Primarily metabolized in the liver by reductases and conjugating enzymes to active and inactive metabolites.
Side Effects
Contraindications
- Severe myelosuppression
- Pre-existing cardiac dysfunction (e.g., severe heart failure, recent myocardial infarction)
- Previous anthracycline cumulative dose limits exceeded
- Severe liver impairment
- Pregnancy and lactation
Drug Interactions
Other myelosuppressive agents
Increased risk of severe myelosuppression.
Cardiotoxic agents (e.g., trastuzumab)
Increased risk of cardiotoxicity. Close cardiac monitoring is essential.
CYP3A4 inducers (e.g., rifampin, phenytoin)
May decrease sindroxocin levels, potentially reducing efficacy.
CYP3A4 inhibitors (e.g., ketoconazole, verapamil)
May increase sindroxocin levels, potentially increasing toxicity.
Storage
Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze.
Overdose
Overdose symptoms include severe myelosuppression (leukopenia, thrombocytopenia, anemia), gastrointestinal toxicity (mucositis, severe nausea/vomiting), and acute cardiac toxicity. Management is symptomatic and supportive, including transfusion support, antiemetics, and management of infections. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category D. Sindroxocin can cause fetal harm. Avoid during pregnancy. Breastfeeding is contraindicated due to potential harm to the infant.
Side Effects
Contraindications
- Severe myelosuppression
- Pre-existing cardiac dysfunction (e.g., severe heart failure, recent myocardial infarction)
- Previous anthracycline cumulative dose limits exceeded
- Severe liver impairment
- Pregnancy and lactation
Drug Interactions
Other myelosuppressive agents
Increased risk of severe myelosuppression.
Cardiotoxic agents (e.g., trastuzumab)
Increased risk of cardiotoxicity. Close cardiac monitoring is essential.
CYP3A4 inducers (e.g., rifampin, phenytoin)
May decrease sindroxocin levels, potentially reducing efficacy.
CYP3A4 inhibitors (e.g., ketoconazole, verapamil)
May increase sindroxocin levels, potentially increasing toxicity.
Storage
Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze.
Overdose
Overdose symptoms include severe myelosuppression (leukopenia, thrombocytopenia, anemia), gastrointestinal toxicity (mucositis, severe nausea/vomiting), and acute cardiac toxicity. Management is symptomatic and supportive, including transfusion support, antiemetics, and management of infections. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category D. Sindroxocin can cause fetal harm. Avoid during pregnancy. Breastfeeding is contraindicated due to potential harm to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months when stored as recommended. Reconstituted solution must be used within 24 hours.
Availability
Hospitals and specialized oncology pharmacies
Approval Status
Approved for specific indications
Patent Status
Patented
Clinical Trials
Phase III trials demonstrated significant improvements in progression-free survival and overall response rates in patients with advanced breast cancer compared to standard therapy. Ongoing trials are investigating its efficacy in other solid tumors and hematological malignancies.
Lab Monitoring
- Complete Blood Count (CBC) with differential before each cycle and periodically during treatment
- Liver Function Tests (LFTs)
- Renal Function Tests (RFTs)
- Echocardiogram (ECHO) or MUGA scan to assess cardiac function before treatment and at regular intervals during treatment, especially after reaching cumulative dose limits.
Doctor Notes
- Careful cardiac monitoring is paramount due to dose-dependent and cumulative cardiotoxicity.
- Assess complete blood counts and liver function before each cycle.
- Manage extravasation promptly with cold compresses and hyaluronidase if available.
Patient Guidelines
- Report any fever, bleeding, or unusual bruising immediately.
- Maintain good oral hygiene to prevent stomatitis.
- Avoid exposure to people with infections.
- Be aware of potential hair loss and discuss coping strategies.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If a dose is missed, contact your oncologist immediately for advice. Do not double the next dose. The treatment schedule may need to be adjusted.
Driving Precautions
This medicine may cause fatigue, dizziness, or weakness. Avoid driving or operating heavy machinery if you experience these effects.
Lifestyle Advice
- Maintain adequate hydration by drinking plenty of fluids.
- Eat small, frequent meals to manage nausea.
- Rest when feeling tired.
- Avoid alcohol and tobacco products.
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