Averothiazide 5 mg/12.5 mg/40 mg film-coated tablets
amlodipine (5) / olmesartan medoxomil (40) / Hydrochlorothiazide (12.5)
Treatment of essential hypertension.
Averothiazide is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation.
Averothiazide is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine).
In adult the recommended dose of Averothiazide is 1 tablet per day.
Older people (age 65 years or over) Caution, including more frequent monitoring of blood pressure, is recommended in elderly people, particularly at the maximum dose of Averothiazide 40 mg/10 mg/25 mg per day.
An increase of the dosage should take place with care in elderly people .
Very limited data are available on the use of Averothiazide in patients aged 75 years or older. Extreme
caution, including more frequent monitoring of blood pressure, is recommended.
The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 30 – 60
mL/min) is Averothiazide 20 mg/5 mg/12.5 mg, owing to limited experience of the 40 mg olmesartan
medoxomil dosage in this patient group.
Monitoring of serum concentrations of potassium and creatinine is advised in patients with moderate
renal impairment.
The use of Averothiazide in patients with severe renal impairment (creatinine clearance < 30 mL/min) is
contraindicated.
Averothiazide should be used with caution in patients with mild hepatic impairment (see section Special warnings and precautions for use and Pharmacokinetic properties).
In patients with moderate hepatic impairment the maximum dose should not exceed Averothiazide 20 mg/5 mg/12.5 mg once daily. Close monitoring of blood pressure and renal function is advised in patients with hepatic impairment.
As with all calcium antagonists, amlodipine's half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. Averothiazide should therefore be administered with caution in these patients. The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in
patients with impaired liver function.
Use of Averothiazide is contraindicated in patients with severe hepatic impairment (see sections contraindications and Pharmacokinetic properties), cholestasis or biliary obstruction (see section contraindications).
Averothiazide is not recommended for use in patients aged below 18 years due to a lack of data on
safety and efficacy.
