Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
quinapril hydrochloride (UNII: 33067B3N2M) (quinapril - UNII:RJ84Y44811)
Dr.Reddy's Laboratories Limited
quinapril hydrochloride
quinapril 5 mg
ORAL
PRESCRIPTION DRUG
Quinapril hydrochloride is indicated for the treatment of hypertension. It may be used alone or incombination with thiazide diuretics. In using quinapril hydrochloride, consideration should be given to the fact that another angiotensinconvertingenzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renalimpairment or collagen vascular disease. Available data are insufficient to show that quinaprilhydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitor monotherapy have beenreported to have a higher incidence of angioedema compared to non-blacks. It should also be notedthat in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in blackpatients than in non-blacks. Quinapril hydrochloride is contraindicated in patients who are hypersensitive to this product and inpatients with a history of angioedema related to previous treatment with an ACE inhibitor.
Quinapril Tablets USP are supplied as follows: 5-mg tablets: brown, round biconvex tablets de-bossed with I on the left side of bisect and G on theright side of bisect and 267 on other. NDC 55111-621-90 bottles of 90 tablets NDC 55111-621 -1 a bottles of 1000 tablets 10-mg tablets: brown, round biconvex tablets de-bossed with IG on one side and 268 on other. NDC 55111-622-90 bottles of 90 tablets NDC 55111-622-1 a bottles of 1000 tablets 20-mg tablets: brown, round biconvex tablets de-bossed with IG on one side and 269 on other. NDC 55111-623-90 bottles of 90 tablets NDC 55111-623-1 a bottles of 1000 tablets 40-mg tablets: brown, oval biconvex tablets de-bossed with IG on one side and 270 on other. NDC 55111-624-90 bottles of 90 tablets NDC 55111-624-10 bottles of 1000 tablets Dispense in well-closed containers as defined in the USP. Store at controlled room temperature, 20° to 25°C (68° to 7JOF) with excursions permitted betweenPlacebo 15° to 30°C (59° to 86°F). [See USP]. Protect from light. Manufactured by: InvaGen Pharmaceuticals, Inc Hauppauge, NY 11788 Distributed by: Dr. Reddy's Laboratories Inc., Bridgewater, NJ 08807 USA Rev: 05/09
Abbreviated New Drug Application
QUINAPRIL- QUINAPRIL TABLET DR.REDDY'S LABORATORIES LIMITED ---------- QUINAPRIL TABLETS USE IN PREGNANCY WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, quinapril tablets should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality DESCRIPTION Quinapril hydrochloride USP is the hydrochloride salt of quinapril, the ethyl ester of a non- sulfhydryl,angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2- [[1(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1 ,2,3,4-tetrahydro-3- isoquinolinecarboxylicacid, monohydrochloride. Its empirical formula is C SH N s -HCI and its structural formula is: Quinapril hydrochloride USP is a white to off-white amorphous powder that is freely soluble inaqueous solvents. Quinapril Tablets USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mgof quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate,crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, ironoxide and macrogol). CLINICAL PHARMACOLOGY MECHANISM OF ACTION Quinapril is deesterified to the principal metabolite, quinaprilat, which is aninhibitor of ACE activity in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzesthe conversion of angiotensin I to the vasoconstrictor, angiotensin II. The effect of quinapril inhypertension appears to result primarily from the inhibition of circulating and tissue ACE activity,thereby reducing angiotensin II formation. Quinapril inhibits the elevation in blood pressure causedby intravenously administered angiotensin I, but has no effect on the pressor response toangiotensin II, norepinephrine or epinephrine. Angiotensin II also stimulates the secretion ofaldosterone from the adrenal cortex, thereby facilitating renal sodium and সম্পূর্ণ নথি পড়ুন