Rivaroxaban 2.5 mg

Areleto 2.5

Each filmcoated tablet contains 2.5 mg rivaroxaban

Therapeautic indications

Rivaroxaban is indicated for prevention of atherothrombotic events in adult patients

After an acute coronary syndrome (ACS) with elevated cardiac biomarkers.

Rivaroxaban ,CO-administered with acetylsalicylic (ASA) is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischemic events.

Posology and Method of administration

Posology

The recommended dose is 2.5 mg twice daily

Method of administration

Rivaroxaban is for oral use.

The tablets can be taken with or without food.

For patients who are unable to swallow whole tablets, Rivaroxaban tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally.The crushed Rivaroxaban tablet may also be given through gastric tubes after confirmation of the correct gastric placement of the tube. The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients that used in rivaroxaban.

Active clinically significant bleeding.

Lesion or condition, if considered to be a significant risk 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, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

Special warnings and precautions for use

Haemorrhagic risk

As with other anticoagulants, patients taking Rivaroxaban are to be carefully observed for signs of bleeding. It is recommended to be used with caution in conditions with increased risk of hemorrhage. Rivaroxaban administration should be discontinued if severe hemorrhage occurs.

Renal impairment

In patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average) which may lead to an increased bleeding risk.

Interaction with other medicinal products and other forms of interaction

It is not recommended in patient receiving concomitant systemic treatment with azole -anti mycotic( such as ketoconazole itraconazole , voriconazole and posoconazole ) or HIV-protese inhibitor ( ritonavir). The concurrent use of rivaroxaban with other anticoagulants such as heparin and warfarin ,antiplatelet agents such as clopidogrel, and nonsteroidal anti-inflammatory agents such as asprin and naproxen   is expected to increase the risk of bleeding in comparison to use of rivaroxaban alone

it is not recommended to use this medicine with anti epilepticdrugs  such as carbamazepine & phenytoin

Fertility, pregnancy and lactation

Pregnancy

The safety and efficacy of Rivaroxaban have not been established in pregnant women. Studies in animals have shown reproductive toxicity. Due to the potential reproductive toxicity, the intrinsic risk of bleeding, and the evidence that rivaroxaban passes the placenta, Rivaroxaban is contraindicated during pregnancy.

Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.

Breast-feeding

Safety and efficacy of Rivaroxaban have not been established in breast-feeding women. Data from animals indicate that rivaroxaban is secreted into milk. ThereforeRivaroxaban is contraindicated during breast-feeding. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.

Adverse effects

Common side effects of rivaroxaban include is bleeding complication, including major bleeding events.

Other side effects of Rivaroxaban include: fainting , itching , pain in arms and legs, muscle pain, and muscle spasms

Rivaroxaban side effects that are severe are spinal hematomas that may develop after spinal surgery with this drug.

Pharmacological properties

Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF01

Mechanism of action

Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and the development of thrombi. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine. However, if clinically indicated, rivaroxaban levels can be measured by calibrated quantitative anti-factor-Xa tests

Storage

Store below 30 C. keep in the original package and protect from light and moisture.

Keep out of the reach and sight of children.

Marketing Authorization Holder:

Darou Darman Arang. Tehran – Iran