HYZAAR Film-coated tablet (2020)

Βιβλιογραφική αναφορά

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Merck Sharp & Dohme Corp.

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BOXED WARNING SECTION

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue HYZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing ...

1. Indications and Usage

1.1 Hypertension HYZAAR is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes ...

2. Dosage and Administration

2.1 Hypertension The usual starting dose of HYZAAR is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan ...

3. Dosage Forms and Strengths

HYZAAR 50/12.5 are yellow, oval, film-coated tablets, with code 717 on one side. HYZAAR 100/12.5 are white, oval, film-coated tablets, with code 745 on one side. HYZAAR 100/25 are light yellow, oval, film-coated ...

4. Contraindications

HYZAAR is contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria. For coadministration with aliskiren in patients with diabetes.

5. Warnings and Precautions

5.1 Fetal Toxicity HYZAAR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of HYZAAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium ...

8. Use in Specific Populations

8.6 Race In the Losartan Intervention For Endpoint reduction in hypertension (LIFE) study, Black patients with hypertension and left ventricular hypertrophy treated with atenolol had a lower risk of stroke, ...

8.1. Pregnancy

Risk Summary HYZAAR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal ...

8.2. Lactation

It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. Thiazides appear in human milk. Because of ...

8.4. Pediatric Use

Safety and effectiveness of HYZAAR in pediatric patients have not been established. Neonates with a history of in utero exposure to HYZAAR: If oliguria or hypotension occurs, direct attention ...

8.5. Geriatric Use

In a controlled clinical study for the reduction in the combined risk of cardiovascular death, stroke and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 2857 patients ...

8.7. Hepatic Impairment

Initiation of HYZAAR is not recommended for patients with hepatic impairment because the appropriate starting dose of losartan, 25 mg, is not available.

8.8. Renal Impairment

Changes in renal function have been reported in susceptible individuals [see Dosage and Administration (2.1), Warnings and Precautions (5.4), and Clinical Pharmacology (12.3)]. Safety and effectiveness ...

10. Overdosage

Losartan Potassium Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on ...

11. Description

HYZAAR 50/12.5 (losartan potassium-hydrochlorothiazide), HYZAAR 100/12.5 (losartan potassium-hydrochlorothiazide) and HYZAAR 100/25 (losartan potassium-hydrochlorothiazide) tablets combine an angiotensin ...

12.1. Mechanism of Action

Losartan Potassium Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of ...

12.2. Pharmacodynamics

Losartan Potassium Losartan inhibits the pressor effect of angiotensin II (as well as angiotensin I) infusions. A dose of 100 mg inhibits the pressor effect by about 85% at peak with 25-40% inhibition ...

12.3. Pharmacokinetics

Losartan Potassium Absorption Following oral administration, losartan is well absorbed and undergoes substantial first-pass metabolism. The systemic bioavailability of losartan is approximately 33%. Mean ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Losartan Potassium-Hydrochlorothiazide No carcinogenicity studies have been conducted with the losartan potassium-hydrochlorothiazide combination. Losartan potassium-hydrochlorothiazide when tested at ...

14. Clinical Studies

14.1 Losartan Monotherapy Reduction in the Risk of Stroke The LIFE study was a multinational, double-blind study comparing losartan and atenolol in 9193 hypertensive patients with ECG-documented left ventricular ...

16.1. How Supplied

HYZAAR is supplied as a film-coated tablet. Losartan/Hydrochlorothiazide Color Shape Engraving NDC 0006-xxxx-xx Bottle/ 30 Bottle/ 90 Bottle/ 1000 50/12.5 mg yellow oval 717 0717-31 0717-54 ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy Advise female patients of childbearing age about the consequences of exposure to HYZAAR during pregnancy. Discuss ...