Apixan
Generic Name
Apixaban
Manufacturer
Local Pharmaceutical Co. (Example)
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
apixan 25 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Apixaban is an anticoagulant medication used to prevent and treat blood clots (thrombosis). It belongs to a class of drugs called direct Factor Xa inhibitors, which work by blocking a key protein involved in blood clotting.
Uses & Indications
Dosage
Adults
For NVAF: 5 mg orally twice daily. For specific patients (e.g., ≥80 years old, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL), a dose of 2.5 mg orally twice daily may be considered. For DVT prophylaxis after hip/knee surgery: 2.5 mg orally twice daily for 12 days (hip) or 35 days (knee). For treatment of DVT/PE: Initially 10 mg orally twice daily for 7 days, followed by 5 mg orally twice daily. For reduction in risk of recurrent DVT/PE: 2.5 mg orally twice daily after at least 6 months of treatment for DVT/PE.
Elderly
No specific dose adjustment based on age alone. Consider 2.5 mg BID for NVAF if at least two of the following criteria are met: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL.
Renal_impairment
For NVAF, if serum creatinine ≥1.5 mg/dL and age ≥80 years or body weight ≤60 kg, reduce dose to 2.5 mg twice daily. For other indications, no dose adjustment is generally needed for mild to moderate renal impairment. Use with caution in severe renal impairment and avoid in end-stage renal disease (ESRD) on dialysis for NVAF.
How to Take
Take orally, with or without food, as directed by your doctor. Swallow the tablet whole. For patients unable to swallow whole tablets, Apixaban tablets may be crushed and suspended in water, 5% dextrose in water (D5W), or apple juice, or mixed with apple puree and administered immediately.
Mechanism of Action
Apixaban is a selective, reversible, direct inhibitor of Factor Xa. By inhibiting Factor Xa, it prevents thrombin generation and thrombus development. It does not require antithrombin III for its antithrombotic activity.
Pharmacokinetics
Onset
Anticoagulant effect usually observed within a few hours of the first dose.
Excretion
Approximately 27% of the administered dose is recovered in urine, mainly as unchanged drug. The remaining is eliminated via biliary/fecal route.
Half life
Approximately 12 hours.
Absorption
Rapidly absorbed with peak plasma concentrations occurring 3-4 hours after oral administration. Bioavailability is approximately 50%.
Metabolism
Metabolized primarily via CYP3A4 and P-glycoprotein. Approximately 25% is renally excreted, with the majority (around 75%) eliminated via biliary/fecal excretion.
Side Effects
Contraindications
- Active pathological bleeding (e.g., active gastric ulcer, intracranial hemorrhage).
- Severe hypersensitivity to apixaban or any component of the formulation.
- Significant liver disease associated with coagulopathy and clinically relevant bleeding risk.
Drug Interactions
Other anticoagulants, antiplatelet agents (e.g., aspirin, clopidogrel), NSAIDs
Increased risk of bleeding.
Strong dual inducers of CYP3A4 and P-glycoprotein (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
May decrease apixaban exposure, potentially reducing efficacy. Avoid concomitant use.
Strong dual inhibitors of CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir)
May increase apixaban exposure, increasing bleeding risk. Reduce apixaban dose to 2.5 mg twice daily for NVAF patients if also taking strong dual inhibitors.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of apixaban increases the risk of bleeding. Management includes discontinuation of apixaban and initiating appropriate supportive care, such as surgical hemostasis or transfusion of blood products (e.g., fresh frozen plasma). For life-threatening bleeding, a specific reversal agent (andexanet alfa) may be considered where available.
Pregnancy & Lactation
Pregnancy Category B. Limited data on use in pregnant women. Not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. It is unknown if apixaban is excreted in human milk, so caution is advised, and a decision should be made whether to discontinue nursing or the drug, considering the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, specific to lot.
Availability
Available in pharmacies worldwide
Approval Status
Approved by regulatory bodies worldwide (e.g., FDA, EMA, DGDA)
Patent Status
Patented, generic versions may be available in some regions
Clinical Trials
Apixaban has been extensively studied in large-scale clinical trials such as ARISTOTLE (for NVAF) and AMPLIFY (for VTE treatment), demonstrating its efficacy and safety compared to standard therapies.
Lab Monitoring
- No routine monitoring of coagulation parameters (e.g., INR) is required. Regular assessment of renal function (creatinine clearance) and hepatic function, and complete blood count (CBC) are recommended.
Doctor Notes
- Emphasize the importance of consistent dosing and avoiding abrupt discontinuation.
- Educate patients on bleeding precautions and symptoms of hemorrhage.
- Assess renal and hepatic function periodically, especially in elderly and high-risk patients.
- Review concomitant medications for potential drug interactions, particularly other anticoagulants/antiplatelets and strong CYP3A4/P-gp inhibitors/inducers.
Patient Guidelines
- Take Apixan exactly as prescribed by your doctor.
- Do not stop taking Apixan without consulting your doctor, as this may increase your risk of blood clots.
- Inform all healthcare providers (including dentists) that you are taking Apixan before any surgery or procedure.
- Report any unusual bleeding or bruising immediately to your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Apixaban is not known to affect the ability to drive or operate machinery. However, if you experience side effects like dizziness or vision changes, avoid driving or operating machinery.
Lifestyle Advice
- Avoid activities that may increase your risk of bleeding or injury.
- Be cautious when using sharp objects (e.g., razors, knives) and during sports activities.
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