国: シンガポール
言語: 英語
ソース: HSA (Health Sciences Authority)
HYDROCHLOROTHIAZIDE; IRBESARTAN
SANOFI-AVENTIS SINGAPORE PTE. LTD.
C09DA04
12.50 mg
TABLET, FILM COATED
HYDROCHLOROTHIAZIDE 12.50 mg; IRBESARTAN 300.00 mg
ORAL
Prescription Only
SANOFI WINTHROP INDUSTRIE
ACTIVE
2001-08-28
COAPROVEL ® irbesartan/hydrochlorothiazide [sanofi logo] COMPOSITION COAPROVEL 150/12.5 MG FILM-COATED TABLETS Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide. Excipient: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate). For a full list of excipients, see _List of excipients_. COAPROVEL 300/12.5 MG FILM-COATED TABLETS Each film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide. Excipient: Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate). For a full list of excipients, see _List of excipients_. COAPROVEL 300/25 MG FILM-COATED TABLETS Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. Excipient: Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate). For a full list of excipients, see _List of excipients_. PREGNANCY AND LACTATION USE IN PREGNANCY: Should exposure to angiotensin-II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin-II receptor antagonists should be closely observed for hypotension (see also _Contraindications_ and _Special warnings and special _ _precautions for use_ ). Although there is no experience with CoAprovel in pregnant women, _in utero_ exposure to angiotensin converting enzyme inhibitors given to pregnant women during the second and third trimesters has been reported to cause injury and death to the developing foetus. As for any drug that also acts directly on the renin-angiotensin-aldosterone system, CoAprovel should not be used during pregnancy. Thiazides cross the placental barrier and appear in cord blood. They may cause foetal electrolyte disturbances and possibly other reactions that have occurred in the adults. Cases o 完全なドキュメントを読む
SG/COA/0822/SmPC0222 COAPROVEL ® irbesartan/hydrochlorothiazide [sanofi logo] QUALITATIVE AND QUANTITATIVE COMPOSITION COAPROVEL 150/12.5 MG FILM-COATED TABLETS Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate). For a full list of excipients, see _List of excipients_. COAPROVEL 300/12.5 MG FILM-COATED TABLETS Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate). For a full list of excipients, see _List of excipients_. COAPROVEL 300/25 MG FILM-COATED TABLETS Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. Excipient with known effect: Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate). For a full list of excipients, see _List of excipients_. PHARMACEUTICAL FORM COAPROVEL 150 MG/12.5 MG FILM-COATED TABLET Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side. COAPROVEL 300 MG/12.5 MG FILM-COATED TABLET Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side. COAPROVEL 300 MG/25 MG FILM-COATED TABLET Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. This fixed dose combination is also indicated as initial therapy in patients with moderate to severe essential hypertension for whom the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy in these patients (see _Pharmacodynamic properties_). POSOLOGY AND METHOD OF ADMINISTRATION 完全なドキュメントを読む