Registered Kenya · PPB

ROXICLOT 10MG TABLET

RIVAROXIBAN

H2021/CTD8299/18124 EACH FILM COATED TABLETS CONTAINS:RIVAROXIBAN 10MG. GENERIC/BIOSIMILARS

What it does

Rivaroxaban is a medication that helps prevent blood clots, reducing the risk of serious conditions such as stroke and heart attack.

Commonly used for: prevention of blood clots in patients with atrial fibrillation (irregular heartbeat), treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), prevention of blood clots after certain surgeries

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2021/CTD8299/18124
Registration date
2021-05-26 19:13:31
Expiry date
-
Status
Registered
Active ingredient
RIVAROXIBAN
Strength
-
Pack size
BLISTER PACKS OF 3 X 10’S, PACKED IN A UNIT BOXES, WITH LITERATURE INSERT.
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Dawa
Applicant / LTR
DAWA LIMITED
Country of origin
LOCAL
Manufacturer location
Baba Dogo Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:56:22 · updated 2026-08-03 03:05:40

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Rivaroxaban is a medication that helps prevent blood clots, reducing the risk of serious conditions such as stroke and heart attack.

What it treats

  • prevention of blood clots in patients with atrial fibrillation (irregular heartbeat)
  • treatment of deep vein thrombosis (DVT)
  • treatment of pulmonary embolism (PE)
  • prevention of blood clots after certain surgeries

How it works

Rivaroxaban works by blocking specific proteins in your blood that are necessary for clotting, which helps keep your blood flowing smoothly.

Who it's for

This medication is for adults who need help preventing or treating blood clots.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: rivaroxiban

Rivaroxaban is an oral anticoagulant that belongs to the class of direct factor Xa inhibitors. It is primarily used for the prevention and treatment of thromboembolic disorders, including deep vein thrombosis (DVT), pulmonary embolism (PE), and for stroke prevention in patients with non-valvular atrial fibrillation. Rivaroxaban works by inhibiting factor Xa, an essential component in the coagulation cascade, thereby reducing the ability of blood to clot.

Indications

  • Prevention of venous thromboembolism (VTE) in patients undergoing hip or knee replacement surgery
  • Treatment of DVT and PE
  • Prevention of recurrent DVT and PE
  • Stroke prevention in patients with non-valvular atrial fibrillation
  • Prevention of thromboembolic events in patients with coronary artery disease

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for paediatric patients.

Adults: Refer to the BNF for specific dosing recommendations based on the indication and patient factors.

Mechanism of action

Rivaroxaban selectively inhibits factor Xa, which is crucial in the conversion of prothrombin to thrombin, leading to a reduction in thrombin generation and a consequent decrease in fibrin formation.

Pharmacodynamics

Rivaroxaban has a rapid onset of action and provides predictable anticoagulation with a dose-dependent effect. Its anticoagulant effect can be monitored through standard coagulation tests like prothrombin time, although routine monitoring is not required in most cases. The anticoagulation effects are maintained as long as the drug is present in the system.

Pharmacokinetics

Rivaroxaban is well absorbed after oral administration, with peak plasma concentrations occurring within 2 to 4 hours. It has a bioavailability of approximately 66% to 100%. The drug is extensively metabolized in the liver, with a half-life of about 5 to 9 hours in healthy individuals. Rivaroxaban is primarily excreted in urine, with a proportion being eliminated unchanged.

Contra-indications

  • Active bleeding
  • Severe renal impairment (creatinine clearance < 15 mL/min)
  • Hepatic impairment with coagulopathy
  • Pregnancy
  • Hypersensitivity to rivaroxaban or any excipients

Adverse effects

  • Bleeding complications
  • Anemia
  • Nausea
  • Vomiting
  • Diarrhea
  • Elevated liver enzymes
  • Skin rash
  • Thrombocytopenia

Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) increase rivaroxaban exposure
  • Strong CYP3A4 inducers (e.g., rifampicin, St. John's wort) decrease rivaroxaban exposure
  • Anticoagulants (e.g., warfarin, dabigatran) may increase bleeding risk
  • NSAIDs may increase the risk of gastrointestinal bleeding
  • Antiplatelet agents may enhance the risk of bleeding

Precautions

  • Use with caution in patients with a history of bleeding disorders
  • Monitor renal function regularly
  • Avoid abrupt discontinuation in patients at high risk for thromboembolic events
  • Patients should be monitored for signs of bleeding

Pregnancy

Rivaroxaban is contraindicated in pregnancy due to potential risks to the fetus.

Breast-feeding

It is not known if rivaroxaban is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets (10 mg, 15 mg, 20 mg)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.