国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Solco Healthcare LLC
LISINOPRIL
LISINOPRIL 10 mg
ORAL
PRESCRIPTION DRUG
Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a vari
Lisinopril and hydrochlorothiazide 10-12.5 Tablets, USP, White to off-white, round tablets, imprinted with ‘H150’ on one side and plain on the other side. NDC 43547-420-10 Bottle of 100 tablets NDC 43547-420-50 Bottle of 500 tablets NDC 43547-420-11 Bottle of 1000 tablets Lisinopril and hydrochlorothiazide 20-12.5 Tablets, USP, Yellow, round tablets, imprinted with ‘H151’ on one side and plain on the other side. NDC 43547-421-10 Bottle of 100 tablets NDC 43547-421-50 Bottle of 500 tablets NDC 43547-421-11 Bottle of 1000 tablets Lisinopril and hydrochlorothiazide 20-25 Tablets, USP, Pink mottled, round tablets, imprinted with ‘H152’ on one side and plain on the other side. NDC 43547-422-10 Bottle of 100 tablets NDC 43547-422-50 Bottle of 500 tablets NDC 43547-422-11 Bottle of 1000 tablets Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. Dispense in a well-closed container, if product package is subdivided. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 04/2020 17727-02
Abbreviated New Drug Application
LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS TABLET SOLCO HEALTHCARE LLC ---------- LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, FOR ORAL USE RX ONLY WARNING: FETAL TOXICITY • • YOU MAY REPORT SIDE EFFECTS TO SOLCO HEALTHCARE US, LLC AT 1-866-257-2597 OR FDA AT 1-800- FDA-1088. DESCRIPTION Lisinopril and hydrochlorothiazide tablets combine an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C H N O . 2H O and its structural formula is: Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C H ClN O S and its structural formula is: Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP, are available for oral use in three tablet combinations WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 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_. 21 31 3 5 2 7 8 3 4 2 of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10-12.5 containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets 20-12.5 containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and, lisinopril and hydrochlorothiazide tablets 20-25 containing 20 mg lisinopril and 25 mg hydrochlorothiazide. INACT 完全なドキュメントを読む