Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Ranbaxy Pharmaceuticals Inc.
FOSINOPRIL SODIUM
FOSINOPRIL SODIUM 10 mg
ORAL
PRESCRIPTION DRUG
Fosinopril sodium and hydrochlorothiazide tablets, USP is indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION .) In using fosinopril sodium and hydrochlorothiazide tablets, USP, 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: Neutropenia/Agranulocytosis ). 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 ). Fosinopril sodium and hydrochlorothiazide is contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide is also contraindicated in patients who are hypersensitive to fosinopril, to any othe
Fosinopril sodium and hydrochlorothiazide tablets, USP is available in two different strengths. Dosage strengths of both components, tablet characteristics, and available quantities/packaging are identified below. Storage Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . You may report side effects to FDA at 1-800-FDA-1088 . Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ranbaxy Laboratories Ltd. New Delhi – 110 019, India November 2013
Abbreviated New Drug Application
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE - FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET RANBAXY PHARMACEUTICALS INC. ---------- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP RX ONLY WARNING: FETAL TOXICITY When pregnancy is detected, discontinue fosinopril and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity DESCRIPTION Fosinopril sodium, USP is a white to off-white powder, freely soluble in methanol; soluble in chloroform and water. Fosinopril sodium, USP is designated chemically as L-proline, 4- cyclohexyl-1- [[[2-methyl-1-(1-oxopropoxy)- propoxy]-(4 phenylbutyl)- phosphinyl]acetyl]-, sodium salt, _trans-_; its structural formula is: Its molecular formula is C H NNaO P, and its molecular weight is 585.65. Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Fosinopril is converted to fosinoprilat by hepatic cleavage of the ester group. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide, USP is designated chemically as 6-chloro-3,4-dihydro-2_H_-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is: 30 45 7 Its molecular formula is C H ClN O S , and its molecular weight is 297.73. Hydrochlorothiazide, USP is a thiazide diuretic. Fosinopril sodium and hydrochlorothiazide tablets, USP is a combination of fosinopril sodium, USP and hydrochlorothiazide, USP. It is available for oral use in two tablet strengths: Fosinopril sodium hydrochlorothiazide tablets, USP 10/12.5, containing 10 mg of fosinopril sodium, USP and 12.5 mg of hydrochlorothiazide, USP; and fosinopril sodium and hydrochlorothiazide tablets, USP 2 Lees het volledige document