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Estaelto

Estaelto

rivaroxaban

Manufacturer:

Zentiva
Information is sourced from publicly available references. The information is for educational purpose of healthcare professionals and we are not liable for any loss or damage.
Core Prescribing Info
Contents
Rivaroxaban
Indications/Uses
DVT & pulmonary embolism (PE) in adults. Prevention of recurrent DVT & PE in adults. 15 mg & 20 mg: VTE. Prevention of stroke & systemic embolism in adult patients w/ non-valvular atrial fibrillation. 10 mg: Prevention in VTE in patients undergoing total hip or knee replacement surgery. 15 mg: Prevention of VTE recurrence in childn & adolescents <18 yr & weighing 30-50 kg after at least 5 days of initial parenteral anticoagulation treatment. 20 mg: Prevention of VTE recurrence in childn & adolescents weighing >50 kg after at least 5 days of initial parenteral anticoagulation treatment.
Dosage/Direction for Use
DVT, PE & prevention of recurrent DVT & PE Adult Day 1-21: 15 mg bd; total daily dose: 30 mg. Day 22 onwards: 20 mg once daily; total daily dose: 20 mg. Moderate (CrCl 30-49 mL/min) or severe (CrCl 15-29 mL/min) renal impairment 15 mg bd for the 1st 3 wk. Reduce recommended dose of 20 mg once daily to 15 mg once daily if risk for bleeding outweighs risk for recurrent DVT & PE. Extended prevention of recurrent DVT & PE (following completion of at least 6 mth therapy) Adult 10 mg or 20 mg once daily. Prevention of VTE Patient undergoing total hip or knee replacement surgery 10 mg once daily. Take initial dose w/in 6-10 hr after surgery. Duration of treatment:5 wk for major hip surgery; 2 wk for major knee surgery. VTE & prevention of VTE recurrence Childn & adolescent weighing ≥50 mg 20 mg once daily. Max daily dose: 20 mg, 30-50 kg 15 mg once daily. Max daily dose: 15 mg.
Administration
10 mg: May be taken with or without food.. 15 & 20 mg: Should be taken with food: May crush/mix w/ water or apple puree & administer orally or through gastric tubes in patients who are unable to swallow whole tab.
Contraindications
Hypersensitivity. Active clinically significant bleeding. Lesion or condition including current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment w/ any other anticoagulants [eg, unfractionated heparin, LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, apixaban)]. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk including cirrhotic patients w/ Child-Pugh B & C. Pregnancy & lactation.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Estaelto FC tab 10 mg
Packing/Price
1's
Form
Estaelto FC tab 15 mg
Packing/Price
1's
Form
Estaelto FC tab 20 mg
Packing/Price
1's
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