Xanoxiban 10 mg 10 tablets
Hikma Pharmaceuticals
Hikma Pharmaceuticals
Composition
Each tablet contains
Rivaroxaban 10 mg.
Excipients
Microcrystalline cellulose, croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, sodium lauryl sulfate.
Product Description
Xanoxiban is a highly selective direct inhibitor of Factor Xa with high oral bioavailability.
Inhibition of Factor Xa prevents thrombin formation and fibrin clot development, reducing the risk of thrombosis.
Properties
Highly selective inhibition of Factor Xa.
Prevention of the “thrombin burst.”
Influence on laboratory coagulation parameters.
Indications for Use
Prevention of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Prevention of recurrent DVT and PE.
Method of Administration and Dosage
The preparation should be taken with food.
Stroke and thromboembolism prevention: 20 mg once daily.
Patients with renal impairment (CrCl 30–49 ml/min): 15 mg once daily.
Treatment of acute DVT/PE: 15 mg twice daily for 3 weeks, then 20 mg once daily.
After ≥6 months of therapy: 10 mg or 20 mg once daily depending on risk balance.
Contraindications
Hypersensitivity to rivaroxaban or excipients.
Active bleeding.
Conditions with high bleeding risk (ulcers, tumors, CNS trauma).
Concomitant use of other anticoagulants (except transition schemes).
Liver disease with coagulopathy.
Severe renal impairment (CrCl <15 ml/min).
Pregnancy and breastfeeding.
Age under 18 years.
Hereditary lactose intolerance.
Precautions
Not recommended with strong CYP3A4 and P-glycoprotein inhibitors (ketoconazole, ritonavir).
Use with caution in moderate renal impairment.
Possible interaction with azole antifungals (fluconazole has less pronounced effect).
Adverse Reactions
Anemia, bleeding (eye, GI, urogenital tract, nosebleeds).
Dyspepsia, nausea, diarrhea, constipation, vomiting.
Fever, peripheral edema, weakness.
Elevated transaminases.
Headache, dizziness.
Skin reactions: itching, rash, ecchymosis.
Arterial hypotension, hematoma.
Pregnancy and Lactation
Contraindicated during pregnancy and breastfeeding.
Storage Conditions
Store at temperatures not exceeding 30°C in a dry place.
Packaging
Cardboard box containing 1 blister of 10 tablets.