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CoAprovel
irbesrtan/hydrochlorothiazide
QUALITATIVE AND QUANTITATIVE FORMULA
CoAprovel 150 mg/12.5 mg tablets
Each tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
CoAprovel 300 mg/12.5 mg tablets
Each tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
PHARMACEUTICAL FORM
150 mg/12,5 mg Tablets
Peach biconvex, oval-shaped, with a heart debossed on one side and the number 2875
engraved on the other side.
300 mg/12.5 mg Tablets
Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876
engraved on the other side.
CLINICAL PARTICULARS
- Therapeutic indications
- Treatment of essential hypertension.
- This fixed dose combination is indicated in patients whose blood pressure is not
adequately controlled on irbesartan or hydrochlorothiazide alone.
Posology and method of administration
CoAprovel can be used once daily, with or without food in-patients whose blood
pressure is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide)
can be recommended.
When clinically appropriate direct change from monotherapy to the fixed combinations
may be considered:
• CoAprovel 150/12.5 mg may be administered in patients whose blood pressure is not
adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
• CoAprovel 300/12.5 mg may be administered in patients insufficiently controlled by
irbesartan 300 mg or by CoAprovel 150/12.5 mg.
• CoAprovel 300/25mg may be administered in patients insufficiently controlled by
CoAprovel 300/12.5mg
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not
recommended. When necessary, CoAprovel may be administered with another
antihypertensive drug (see interactions with other medicinal products and other forms of
interaction).
Renal impairment: due to the hydrochlorothiazide component, CoAprovel is not
recommended for patients with severe renal dysfunction (creatinine clearance < 30
ml/min). Loop diuretics are preferred to thiazides in this population. No dosage
adjustment is necessary in patients with renal impairment whose renal creatinine
clearance is > 30 ml/min (see Contra-indications and Special warnings and special
precautions for use).
Intravascular volume depletion: volume and/or sodium depletion should be corrected
prior to administration of CoAprovel.
Hepatic impairment: CoAprovel is not indicated in-patients with severe hepatic
impairment. Thiazides should be used with caution in patients with impaired hepatic
function. No dosage adjustment of CoAprovel is necessary in patients with mild to
moderate hepatic impairment (see Contra-indications).
Elderly patients: no dosage adjustment of CoAprovel is necessary in elderly patients.
Children: safety and efficacy of CoAprovel have not been established in children (< 18
years).
Contraindications
Second and third trimester pregnancy
(see Pregnancy and lactation)
Lactation (see Pregnancy and lactation)
Hypersensitivity to the active substances, to any of the excipients, or to other
sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived
substance).
The following contraindications are associated with hydrochlorothiazide:
• severe renal impairment (creatinine clearance < 30 ml/min),
• refractory hypokalemia, hypercalcaemia,
• severe hepatic impairment, biliary cirrhosis and cholestasis.
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