HARTEZE 20MG 28S

What Is HARTEZE 20mg?

Harteze 20mg is the highest and most commonly used dose of Rivaroxaban, a direct Factor Xa inhibitor that prevents blood clots without needing the regular blood test monitoring (INR) required by Warfarin. At 20mg, taken once daily with the evening meal, it provides 24-hour anticoagulant protection.

This dose is the standard maintenance strength for treating established blood clots and for ongoing stroke prevention in patients with atrial fibrillation, making it a cornerstone of modern anticoagulation therapy.

What Is It Used For?

Harteze 20mg is used for three main purposes. First, for the continued treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE) after the initial 21-day treatment phase with 15mg twice daily.

Second, for reducing the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), an irregular heart rhythm that dramatically increases stroke risk.

Third, for secondary prevention in patients with acute coronary syndrome (combined with antiplatelet therapy at a 2.5mg twice-daily dose, note: Harteze 20mg is not used for this indication).

In Kenya, Harteze 20mg is increasingly replacing Warfarin in AF and VTE management due to its simplicity and predictable pharmacokinetics without the need for INR clinic visits.

Usual Dose

20mg ONCE daily, taken with the evening meal (the largest meal of the day). Food is essential for adequate absorption.

With Food

ALWAYS take with food, without food, absorption is significantly reduced. The evening meal timing ensures the highest drug levels during the overnight hours when stroke risk is elevated.

DVT/PE Continuation

Start 20mg once daily after completing the 15mg twice-daily phase (day 22 onwards).

Consistency

Take at the same time every evening. Consistent timing maintains stable blood levels.

Missed Dose

If a dose is missed, take it immediately on the same day. Do not take a double dose the next day.

Do Not Stop Without Medical Advice

Stopping Rivaroxaban suddenly significantly increases the risk of stroke (in AF) or clot recurrence (in DVT/PE).

Common Side Effects

·       Easy bruising

·       Bleeding from cuts or gums taking longer to stop

·       Nausea

·       Dizziness

·       Headache

Uncommon Side Effects

·       Abdominal pain

·       Elevated liver enzymes

·       Hypotension

·       Skin rash

Serious Side Effects, Seek Immediate Medical Attention

·       Life-threatening bleeding, intracranial haemorrhage, GI bleeding, haemoptysis (coughing blood)

·       Anaemia from occult blood loss

·       Severe allergic reactions (very rare)

·       MUST TAKE WITH EVENING MEAL: Food is essential for adequate absorption of the 20mg dose. Never take on an empty stomach.

·       PROSTHETIC HEART VALVES: Rivaroxaban must NOT be used in patients with mechanical heart valves, Warfarin is mandatory in this situation.

·       BLEEDING RISK: Immediately seek emergency care for signs of serious bleeding, black tarry stools, vomiting blood, sudden severe headache, weakness on one side, or sudden vision loss.

·       STOPPING RISK: Stopping Rivaroxaban abruptly in AF patients dramatically increases stroke risk. Always consult your doctor before stopping.

·       SURGICAL PROCEDURES: Stop Rivaroxaban 24–48 hours before elective surgery depending on the procedure and bleeding risk. Your surgeon and anaesthetist must know.

·       SPINAL ANAESTHESIA: The risk of spinal haematoma is elevated, inform your anaesthetist well in advance.

Same critical interactions as all Rivaroxaban doses:

Strong CYP3A4/P-gp inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin): Contraindicated.

Rifampicin / Phenytoin / Carbamazepine: Significantly reduce anticoagulant effect, avoid.

Antiplatelet agents (aspirin, clopidogrel): Substantially increased bleeding risk, use only when clinically necessary.

NSAIDs: Increased GI bleeding risk, avoid or use with gastric protection.

St John's Wort: Reduces anticoagulant effect.

·       Store below 30°C in a cool, dry place.

·       Keep in original blister packaging.

·       Protect from moisture.

·       Keep out of reach of children.

Harteze 20mg is a prescription-only medicine (POM) in Kenya. It must be prescribed by a physician, cardiologist, haematologist, or specialist. Available at Pharmily with a valid prescription.

Harteze 20mg is the standard maintenance anticoagulant dose for AF stroke prevention and continued DVT/PE treatment. The food requirement is non-negotiable and clinically significant, document and counsel explicitly.

Verify the patient does not have a mechanical prosthetic heart valve, Rivaroxaban is absolutely contraindicated in this setting (RE-ALIGN trial showed harm). Screen for rifampicin (TB therapy), this is the most clinically significant interaction in the Kenyan context and renders Rivaroxaban ineffective.

An anticoagulant alert card should be provided at first dispensing. Counsel on the abrupt discontinuation risk in AF patients, stroke risk rises sharply within days of stopping. eGFR monitoring every 6–12 months is recommended, accumulation in declining renal function increases bleeding risk.

Why must I take Harteze 20mg with food?

A: Food dramatically improves how much Rivaroxaban your body absorbs at the 20mg dose. Without food, you may only absorb about 66% of the dose, meaning less protection. Always take with a meal, preferably your largest meal.

Can I take Harteze instead of Warfarin for my irregular heartbeat?

A: For most patients with non-valvular atrial fibrillation, yes, Rivaroxaban offers equivalent stroke prevention without needing regular INR blood tests. However, if you have a mechanical heart valve, Warfarin is still the only appropriate option.

What happens if I accidentally stop taking Harteze?

A: Stopping Rivaroxaban abruptly, especially for AF, significantly increases your stroke risk within days. If you run out or cannot get a refill, contact your doctor or pharmacist urgently.

I am on rifampicin for TB; can I use Harteze?

A: No, rifampicin reduces Rivaroxaban to ineffective levels. A different anticoagulant must be used while on TB treatment. This is very important to discuss with your doctor.