Fosinopril 10 mg
INDICATIONS AND USAGE Fosinopril Na tablets (fosinopril sodium tablets) are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril Na tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION ). In using fosinopril Na tablets consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS ). In considering use of fosinopril Na tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS , Head and Neck Angioedema and Intestinal Angioedema ).
Apotex Corp.
OVAL WHITE APO FOS 10
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HOW SUPPLIED Fosinopril Na Tablets, USP (Fosinopril Sodium Tablets) 10 mg tablets white, capsule shaped, biconvex, partially scored tablets, engraved "APO" on one side and "FOS-10" on the other side. They are supplied in bottles of 90 (NDC 60505-2510-2), 100 (NDC 60505-2510-3) and 1000 (NDC 60505-2510-4). Bottles contain a desiccant canister. 20 mg tablets white, oval, biconvex tablets, engraved "APO" on one side and "FOS-20" on the other side. They are supplied in bottles of 90 (NDC 60505-2511-2), 100 (NDC 60505-2511-3) and 1000 (NDC 60505-2511-4). Bottles contain a desiccant canister. 40 mg tablets white, round, biconvex tablets, engraved "APO" on one side and "FOS-40" on the other side. They are supplied in bottles of 90 (NDC 60505-2512-2), 100 (NDC 60505-2512-3) and 1000 (NDC 60505-2512-8). Bottles contain a desiccant canister. STORAGE Store at 25° C (77° F): excursions permitted to 15° C to 30° C (59° F to 86° F). [see USP Controlled Room temperature]. Keep tightly closed (protect from moisture). APOTEX INC. FOSINOPRIL Na TABLETS , USP 10 mg, 20 mg and 40 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 November 2013 Rev.6
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