ZESTORETIC Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Almatica Pharma Inc.

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BOXED WARNING SECTION

WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ZESTORETIC as soon as possible. Drugs that ...

1. Description

ZESTORETIC (Lisinopril and Hydrochlorothiazide) combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral ...

2. Clinical Pharmacology

Lisinopril and Hydrochlorothiazide As a result of its diuretic effects, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, and decreases serum potassium. Administration ...

3. Indications and Usage

ZESTORETIC is 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 ...

4. Contraindications

ZESTORETIC is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor ...

5. Warnings

Lisinopril Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, ...

6.1. General

Lisinopril Aortic Stenosis/Hypertrophic Cardiomyopathy As with all vasodilators, lisinopril should be given with caution to patients with obstruction in the outflow tract of the left ventricle. Impaired ...

6.2. Information for Patients

Angioedema Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including ZESTORETIC. Patients should be so advised and told to report ...

6.4. Drug Interactions

Lisinopril Hypotension Patients on Diuretic Therapy Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Lisinopril and Hydrochlorothiazide Lisinopril in combination with hydrochlorothiazide was not mutagenic in a microbial mutagen test using Salmonella typhimurium (Ames test) or Escherichia ...

6.9. Nursing Mothers

It is not known whether lisinopril is excreted in human milk. However, milk of lactating rats contains radioactivity following administration of 14C lisinopril. In another study, lisinopril ...

6.10. Pediatric Use

Neonates with a history of in utero exposure to ZESTORETIC If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may ...

6.11. Geriatric Use

Clinical studies of ZESTORETIC did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

ZESTORETIC has been evaluated for safety in 930 patients including 100 patients treated for 50 weeks or more. In clinical trials with ZESTORETIC no adverse experiences peculiar to this combination drug ...

9. Overdosage

No specific information is available on the treatment of overdosage with ZESTORETIC. Treatment is symptomatic and supportive. Therapy with ZESTORETIC should be discontinued and the patient observed closely. ...

10. Dosage and Administration

Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 mg to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 mg per day to 50 mg per day. ...

11. How Supplied

ZESTORETIC 10-12.5 Tablets: Peach, round, biconvex, uncoated tablets identified with 141 debossed on one side and ZESTORETIC on the other side are supplied in bottles of 90 tablets (NDC 52427-435-90). ...

12. Storage and Handling

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [see USP]. Protect from excessive light and humidity.