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Ortacta 10mg Tablets

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Ortacta 10mg Tablets

Ortacta is a branded formulation of rivaroxaban, a direct oral anticoagulant (DOAC) that inhibits factor Xa. The 10 mg dose is often used for prevention of venous thromboembolism (VTE) postoperatively (e.g. after hip or knee replacement) or for extended prophylaxis in selected patients. 

Price: 23.00 /Tablet

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Description:Ortacta is a branded formulation of rivaroxaban, a direct oral anticoagulant (DOAC) that inhibits factor Xa. The 10 mg dose is often used for prevention of venous thromboembolism (VTE) postoperatively (e.g. after hip or knee replacement) or for extended prophylaxis in selected patients. 

 

Prescription:Prescription-only (Rx). It must be prescribed by a qualified clinician due to bleeding risks. 

 

Therapeutic Category:Anticoagulant / Direct Factor Xa inhibitor 

 

    Active    Ingredients Rivaroxaban 10 mg per tablet (active ingredient). 

Excipients and the full composition vary by manufacturer (film coating, tablet core, etc.), as typical.

 

  Variant(s) Other strengths / variants of Ortacta include 15 mg and 20 mg tablets. 

 

Consume Type Oral tablet (film-coated) to be swallowed with water.

 

Directions / Usage
  • 10 mg once daily is a common dose for VTE prophylaxis after hip or knee replacement (usually for 2–5 weeks) 
  •  10 mg once daily may also be used in extended prevention of recurrent DVT/PE in some patients after ≥ 6 months of treatment. 
  •  Food requirements: Ortacta 10 mg can be taken with or without food (in contrast, the higher doses require food). 
  •  If a dose is missed (in daily dosing period), take it as soon as possible on the same day; do not double the dose in the same day. 

 

Common Side Effects
  • Bleeding (most common) ─ e.g. nosebleeds, gum bleeding, gastrointestinal bleeding 
  •  Bruising easily
  •  Anemia from bleeding
  •  Headache, dizziness
  •  Elevated liver enzymes (rare)
  •  Rare: serious bleeding events (e.g. intracranial hemorrhage)

 

Package Type Commonly sold in blister packs (e.g. 30 tablets) for Ortacta 10 mg. 

 

Storage Advice Store below 30 °C (room temperature), protected from moisture and light. Keep in the original package to protect from light and humidity.

 

Safety Advice / Precautions
  • Bleeding risk: avoid in patients at high bleeding risk
  •  Contraindications: active pathological bleeding, severe hepatic disease associated with coagulopathy, and some others per local guidance
  •  Use caution in patients with impaired renal function; in severe renal impairment (CrCl < 15 mL/min) it is not recommended. 
  •  When switching from or to other anticoagulants, certain protocols must be followed
  •  Before surgeries or invasive procedures, Ortacta should generally be stopped at least 24 hours prior, depending on bleeding risk
  •  Use caution in spinal/epidural anesthesia because of risk of epidural hematoma
  •  Avoid concomitant use of strong inhibitors of both CYP3A4 and P-gp which increase rivaroxaban levels
  •  In pregnancy and breastfeeding, use only if benefit outweighs risk
  •  Patients should carry a “patient alert card” indicating they are on Ortacta (for bleeding risk & medical procedures) 
  •  No routine anticoagulation monitoring (INR not useful)
  •  Monitor renal and hepatic function periodically

 

              Product Substitutes Other rivaroxaban brands / generics (e.g. Xarelto)

Other oral anticoagulants (depending on indication) such as apixaban, dabigatran, edoxaban, warfarin (if appropriate)

 

Manufacturer / Marketer Ortacta is marketed by Acino (or associated licensing company) in certain markets. 

 

Country of Origin While rivaroxaban is originally developed by Bayer (Germany), the “Ortacta” variant is registered in Ghana (FDA registration: FDA/SD.223-030362)

 

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