Thromban Tablets

Class: Anticoagulant

Manufacturer: Cadila Healthcare Limited, Kundaim Industrial Estate, Plot No. 203-213, Kundaim, Goa – 403 115, India.

Dosage Form: Tablet

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Uses:

Prevention of venous thromboembolic event (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II)

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults

Dosage:

Prevention of VTE (VTEp) elective hip or knee replacement surgery

The recommended dose of apixaban is 2.5mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.

Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risk of post-surgical bleeding in deciding on the time of administration within this time window.

In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days.

In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days.

Prevention of stroke and systemic embolism in patients win non-valvular atrial fibrillation (NVAF)

The recommended dose of apixaban is 5mg taken orally twice daily.

Dose reduction: the recommended dose of apixaban is 2.5mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60kg, or serum creatinine ≥ 1.5mg/dL (133 micromole/L).

Therapy should be continued long-term.

Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE(VTEt)

The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10mg taken orally twice daily for the first 7 days followed by 5mg taken orally twice daily. As per available medical guidelines, short duration of treatment (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilization).

The recommended dose of apixaban for the prevention of recurrent DVT and PE is 2.5mg taken orally twice daily. When prevention of recurrent DVT and PE is indicated, the 2.5mg twice daily dose should be initiated following completion of 6 months of treatment with apixaban 5mg twice daily or with another anticoagulant as indicated in below table.

	Dosing Schedule	Maximum daily dose
Treatment of DVT or PE	10mg twice daily for the first 7 days	20mg
	Followed by 5mg twice daily	10mg
Prevention of recurrent DVT and/or PE following completion of 6 months of treatment for DVT or PE	2.5mg twice daily	5mg

The duration of overall therapy should be individualized after careful assessment of the treatment benefit against the risk for bleeding.

Method of administration

Oral use

Apixaban tablets should be swallowed with water, with or without food.

For patients who are unable to swallow whole tablets, apixaban tablets may be crushed and suspended in water, or 5% dextrose in water (D5W), or apple juice or mixed with apple puree and immediately administered orally. Alternatively, apixaban tablets may be crushed and suspended in 60mL of water or D5W and immediately delivered through a nasogastric tube.

Crushed apixaban tablets are stable in water, D5W, apple juice, and apple puree for up to 4 hours.

Side Effects:

Common: anaemia, Haemorrhage, haematoma, nausea, confusion

Warnings & Precautions:

Hemorrhage risk, interaction of other medicine affecting hemostasis (SSRIs, NSAIDs, platelet aggregation inhibitors), use of thrombolytic agents for the treatment of acute ischemic stroke, patients with prosthetic heart valves, surgery and invasive procedures, temporary discontinuation, spinal/epidural anesthesia or puncture, haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy, patient with active cancer, patients with renal impairment, elderly patients, low body weight (< 60kg) may increase haemorrhagic risk, patients with hepatic impairment, interactions with inhibitors of both cytochrome P450 3A4 (CYP3A4) and p-glycoproteing (p-gp), interaction with inducers of both CYP3A4 and p-gp, hip fracture surgery, Laboratory parameter (clotting tests),

Information about excipients: Apixaban tablets contains lactose. Patients with rare hereditary problems of galctose intolerance, the lapp lactase deficiency or glucose-galctose malabsorption should not take this medicinal product.

Pregnancy & Lactation:

There is no data from the use of apixaban in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Apixaban is not recommended during pregnancy.

Breast feeding

It is unknown whether apixaban or its metabolites are excreted in human milk.

Drug Interactions:

• Inhibitors of CYP3A4 and p-gp (e.g ketoconazole, itraconazole, voriconazole, and posaconazole)
• Inducers of CYP3A4 and p-gp (e.g rifampicin)
• Anticoagulants, platelets aggregation inhibitors, SSRIs/SNRIs and NSAIDs

Contraindications:

• Hypersensitivity to the active substance or to any of the excipients.
• Active clinically significant bleeding.
• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
• Lesion or condition if considered a significant risk factor for major bleeding, this may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, spinal or ophthalmic surgery, recent intracranial haemorrhage, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
• Concomitant treatment with any other anticoagulant agent e.g., unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives, etc, oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter.

Price: Ksh 1,600

Notes:

Zydus Cadila

Pack size 30’s