Averothiazide 40 mg/10 mg/12.5 mg 30 tablets

Averothiazide 40 mg/10 mg/12.5 mg 30 tablets

Composition:

Each film-coated tablet contains:

Olmesartan medoxomil (micronized) – 40 mg

Amlodipine (as amlodipine besilate) – 10 mg

Hydrochlorothiazide – 12.5 mg.

Description:

Averothiazide is a fixed-dose triple-combination antihypertensive medication containing an angiotensin II receptor antagonist (olmesartan), a calcium channel blocker (amlodipine), and a thiazide diuretic (hydrochlorothiazide). It is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled by a dual-combination therapy.

Indications for Use:

Treatment of essential hypertension.

Add-on therapy in adults whose blood pressure is not adequately controlled on dual combination of olmesartan medoxomil and amlodipine.

Substitution therapy in patients already controlled on olmesartan, amlodipine, and hydrochlorothiazide in separate formulations.

Dosage and Method of Administration:

One tablet once daily, with or without food.

The tablet should be swallowed whole with water, without chewing or crushing.

Titration from individual components is recommended before switching.

Maximum recommended daily dose is 40 mg/10 mg/25 mg.

Contraindications:

Hypersensitivity to active substances or excipients

Severe renal impairment (creatinine clearance < 30 mL/min)

Severe hepatic impairment, cholestasis or biliary obstruction

Refractory hypokalaemia, hypercalcaemia, hyponatraemia, symptomatic hyperuricaemia

Pregnancy (2nd and 3rd trimesters)

Concomitant use with aliskiren in diabetic or renal-impaired patients (GFR < 60 mL/min/1.73 m²)

Cardiogenic shock, high-grade aortic stenosis, unstable heart failure after myocardial infarction.

Precautions:

Caution in elderly patients, especially at maximum doses

Monitor renal function and electrolytes, particularly in renal impairment

Use with caution in hepatic impairment

Risk of hypotension in volume/salt-depleted patients

Risk of photosensitivity and non-melanoma skin cancer with hydrochlorothiazide

May unmask latent diabetes or alter lipid/glucose metabolism

Not recommended in patients under 18 years.

Side Effects:

Most common adverse effects:

Peripheral oedema

Headache

Dizziness.

Other possible effects:

Hypotension

Hyperuricaemia

Electrolyte imbalances

Skin reactions (including photosensitivity)

Increased risk of skin cancer with long-term hydrochlorothiazide use.

Pregnancy and Lactation:

Contraindicated during pregnancy due to risk of fetal toxicity and death.

Not recommended during breastfeeding. Amlodipine and hydrochlorothiazide are excreted in human milk; olmesartan is excreted in rat milk (human data unknown). Use alternatives with established safety profiles during lactation.

Storage Conditions:

Store below 30°C in a dry place.

Packaging:

Carton box containing 3 strips each with 10 film-coated tablets + package leaflet.