Description
Product Name
Apigat 2.5 Tablet
Generic Name
Apixaban 2.5 mg
Strength & Dosage Form
- Strength: 2.5 mg
- Dosage form: Film-coated tablet
- Route of administration: Oral
Composition
Each film-coated tablet contains:
- Apixaban …………………………………… 2.5 mg
- Excipients q.s. (For film coating and tablet core)
Description
Apigat 2.5 Tablet is a novel oral anticoagulant belonging to the class of direct Factor Xa inhibitors. It acts to prevent the formation of blood clots by selectively inhibiting Factor Xa, thereby reducing thrombin generation and thrombus formation. It is indicated for various thromboembolic conditions.
Indications
- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF).
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of their recurrence.
- Prevention of DVT (which may lead to PE) in patients who have undergone elective hip or knee replacement surgery.
Key Specifications
- Dosage Form: Tablet (Film-coated)
- Strength: 2.5 mg
- Route: Oral
- Packing: Strips/blisters (e.g., 10’s, 30’s, etc)
- Storage: Store below 30 °C, protect from light & moisture.
Mode of Action
Apixaban inhibits Factor Xa, an essential enzyme in the coagulation cascade, thereby reducing thrombin formation and subsequent clot generation.
Usage & Administration
- To be taken as prescribed by a physician.
- Swallow the tablet whole with a glass of water; do not chew, crush or break unless instructed.
- May be taken with or without food; try to take at about the same time every day.
- Do not stop the medicine abruptly without consulting your doctor as this may increase risk of clot formation.
Contraindications & Warnings
- Contraindicated in patients with active pathological bleeding or severe hepatic impairment with coagulopathy.
- Use with caution (or dose adjustment) in patients with renal impairment or other bleeding risk factors.
- Pregnancy & Breastfeeding: Use only if benefits outweigh risks; consult physician.
- Inform your physician if you are to undergo surgery or invasive procedure, as the drug may need discontinuation to reduce bleeding risk.
Side Effects
Common side-effects may include:
- Bleeding (nosebleeds, gum bleeding, blood in urine/stools)
- Bruising, hematoma
- Anaemia
- Nausea
Less common but serious side-effects: major bleeding (cerebral, gastrointestinal, etc).
Drug/Drug & Drug/Disease Interactions
- Concomitant use with other anticoagulants, antiplatelet agents (eg: aspirin, clopidogrel), NSAIDs increases bleeding risk.
- Strong inhibitors or inducers of CYP3A4 and P-glycoprotein may alter apixaban levels; dose adjustment or monitoring required.
- Use with caution in patients with hepatic or renal dysfunction, or other comorbidities that increase bleeding risk.
Storage & Handling
- Store in a cool, dry place below 30 °C.
- Protect from light and moisture.
- Keep out of reach of children.
- Do not use after expiry date.
Packaging Options
Typically available in blister packs of 10’s, 30’s, etc (depending on manufacturer / market).
Manufacturer / Marketing Information
(Here you may insert Manufacturer name, brand owner, license number, etc as per your product.)
For example: Manufactured by [Manufacturer Name], marketed under brand “Apigat”.
Additional Notes
- This product is Prescription only.
- The user must be instructed to adhere strictly to physician’s dosage regimen and follow-up monitoring.
- Lifestyle modifications (e.g., diet, exercise, stopping smoking) may complement the therapy in appropriate cases.
- Patients should be informed about signs of bleeding and advised to contact physician immediately if they occur.
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