Averothiazide 40 mg/5 mg/12.5 mg 30 tablets

Averothiazide 40 mg/5 mg/12.5 mg 30 tablets

Composition:
Each tablet contains:
Olmesartan medoxomil (micronized) — 40 mg
Amlodipine (as besilate) — 5 mg
Hydrochlorothiazide — 12.5 mg.
Description:
A triple-combination antihypertensive medication that includes an angiotensin II receptor blocker (olmesartan), a calcium channel blocker (amlodipine), and a thiazide diuretic (hydrochlorothiazide). Used in adult patients whose blood pressure is inadequately controlled by dual therapy.
Indications for Use:
Treatment of essential hypertension in adults
As add-on therapy in patients not adequately controlled on olmesartan and amlodipine
As substitution therapy in patients already controlled on olmesartan, amlodipine, and hydrochlorothiazide taken separately or in two-component combinations.
Directions for Use:
The usual dose is one tablet once daily. The tablet should be swallowed whole with a glass of water, at the same time each day, with or without food.
Do not chew or split the tablet.
Dose escalation should be gradual.
Maximum daily dose: 40 mg/5 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. Protect from moisture.
Packaging:
Carton box containing 3 strips, each with 10 film-coated tablets.