Andorivaban 10 mg

Trade Name:

Andorivaban 10 mg

Composition

Each tablet contains:

Rivaroxaban 10 mg

Inactive ingredients:

microcrystalline cellulose, croscarmellose sodium, hypromellose hydroxypropyl methylcellulose E5, talc, lactose monohydrate, magnesium stearate, sodium lauryl sulfate.

Properties

Rivaroxaban is a highly selective direct factor Xa inhibitor with high oral bioavailability.

Activation of factor X to form factor Xa via the intrinsic and extrinsic coagulation pathways plays a central role in the coagulation cascade. Factor Xa is a component of the emerging prothrombinase complex, the action of which leads to the conversion of prothrombin to thrombin. As a result, these reactions lead to the formation of a fibrin thrombus and activation of platelets by thrombin. One factor Xa molecule catalyzes the formation of more than 1000 thrombin molecules, which is called the «thrombin explosion». The reaction rate of factor Xa bound in prothrombinase increases by 300,000 times compared to that of free factor Xa, which provides a sharp jump in the level of thrombin. Selective factor Xa inhibitors can stop the «thrombin burst». Thus, rivaroxaban affects the results of some specific or general laboratory tests used to evaluate clotting systems.

Indications

— prevention of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation;

-treatment of deep vein thrombosis and pulmonary embolism and prevention of recurrence of DVT and PE.

Dosage and administration

Prevention of venous thromboembolism (VTE) in adult patients with elective hip or knee replacement.

The recommended dose of the drug is 1 tablet Andorivaban® 10 mg 1 time per day. The first dose should be taken 6-10 hours after surgery, provided hemostasis has been achieved.

The duration of treatment is determined by the type of major orthopedic surgery and depends on the patient’s individual risk of developing VTE.

Contraindications

— hypersensitivity to rivaroxaban or any excipients contained in the tablet;

— clinically significant active bleeding (for example, intracranial bleeding, gastrointestinal bleeding);

— an injury or condition associated with an increased risk of major bleeding (for example, an existing or recent gastrointestinal ulcer, the presence of malignant neoplasms with a high risk of bleeding, recent trauma to the brain or spinal cord, recent surgery on the brain, spinal cord or eyes, recent intracranial hemorrhage, diagnosed or suspected esophageal varicose veins, arteriovenous malformations, vascular aneurysms or large anomalies in the structure of the vessels of the brain or spinal cord);

Side effects

-anemia (including relevant laboratory parameters)

— hemorrhage in the eye (including hemorrhage in the conjunctiva)

— pain in the gastrointestinal tract, dyspepsia, nausea, constipation, diarrhea, vomiting, bleeding gums, gastrointestinal bleeding (including rectal bleeding)

Storage

Store at a temperature not exceeding 30°C in a dry place.

Package:

Carton box contains 2 blisters of 10 tablets.