APROVASC Film-coated tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aprovasc film coated tablet.
Qualitative and quantitative composition
<u>Aprovasc film coated tablet 150 mg/5 mg:</u> Each tablet contains 150 mg irbesartan and 5 mg of amlodipine (7 mg of amlodipine besilate). <u>Aprovasc film coated tablet 300 mg/10 mg:</u> Each tablet ...
Pharmaceutical form
<u>Film coated tablet 150 mg/5 mg:</u> White, oval shaped film coated tablets with 150/5 debossed on one side and plain on other side. <u>Film coated tablet 300 mg/5 mg:</u> Yellow, oval shaped film coated ...
Therapeutic indications
Treatment of essential hypertension. Aprovasc is indicated in the treatment of hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy. ...
Posology and method of administration
The usual initial and maintenance dose of Aprovasc is one tablet per day. Aprovasc can be administered with or without food. Aprovasc should be administered in patients whose blood pressure is not adequately ...
Contraindications
Due to the presence of both irbesartan and amlodipine, Aprovasc is contraindicated in: Hypersensitivity to irbesartan, amlodipine, dihydropyridines or to any formulation component. Shock (including cardiogenic ...
Special warnings and precautions for use
Special warnings Hypotension – Patients with volume depletion Symptomatic hypotension may occur in patients with sodium/volume depletion and in those under intensive treatment with diuretics and/or salt ...
Interaction with other medicinal products and other forms of interaction
For irbesartan and amlodipine combination: Based on a pharmacokinetic study where irbesartan and amlodipine were administered alone or in combination, there is no pharmacokinetic interaction between irbesartan ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant women. Aprovasc is contraindicated during pregnancy. Aprovasc should not be used in women of childbearing potential unless effective ...
Effects on ability to drive and use machines
For irbesartan The effect of irbesartan on the ability to drive and use machines has not been investigated. Based on its pharmacodynamic properties, it is unlikely that irbesartan will have an effect on ...
Undesirable effects
Adverse events Since clinical studies are conducted under broadly variable conditions, the incidence of adverse reactions observed in drug clinical studies cannot be directly compared to clinical studies ...
Overdose
Experience in adults exposed to Irbesartan doses up to 900 mg/day for 8 weeks revealed no toxicity. No specific information is available on the treatment of overdosage with irbesartan. The information ...
Pharmacodynamic properties
The pharmacodynamic properties of each drug, irbesartan and amlodipine, provide an additive antihypertensive effect when administered in combination compared to the effect of each drug administered separately. ...
Pharmacokinetic properties
Irbesartan Irbesartan is an orally active agent and does not require biotransformation for its activity. After oral administration, irbesartan is rapidly and completely absorbed. Peak plasma concentrations ...
List of excipients
<u>Aprovasc film coated tablet 150 mg/5 mg:</u> Cellulose microcrystalline PH 101, Cellulose microcrystalline PH 112, Croscarmellose sodium, Hypromellose, silicon dioxide, magnesium stearate, macrogol ...
Shelf life
Please refer to outer box packaging for more information.
Special precautions for storage
Store below 30°C.
Marketing authorization holder
Sanofi-aventis de México, S.A. de C.V., Acueducto del Alto Lerma No. 2, Zona Industrial de Ocoyoacac, C. P. 52740 Ocoyoacac, Edo. de México
Date of revision of the text
May 2023
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