COZAAR Film-coated tablet (2020)

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Merck Sharp & Dohme Corp.

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1. Indications and Usage

1.1 Hypertension COZAAR is indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal ...

2. Dosage and Administration

2.1 Hypertension Adult Hypertension The usual starting dose of COZAAR is 50 mg once daily. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see ...

3. Dosage Forms and Strengths

COZAAR, 25 mg, are white, oval, film-coated tablets with code 951 on one side. COZAAR, 50 mg, are white, oval, film-coated tablets with code 952 on one side and scored on the other. COZAAR, 100 mg, are ...

4. Contraindications

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

5. Warnings and Precautions

5.1 Fetal Toxicity COZAAR 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 additional adverse reactions have been reported in postmarketing experience with COZAAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always ...

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 LIFE study, Black patients with hypertension and left ventricular hypertrophy treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with Black ...

8.1. Pregnancy

Risk Summary COZAAR 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

Risk Summary 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. Because of the potential for ...

8.4. Pediatric Use

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

8.5. Geriatric Use

Of the total number of patients receiving COZAAR in controlled clinical studies for hypertension, 391 patients (19%) were 65 years and over, while 37 patients (2%) were 75 years and over. In a controlled ...

8.7. Renal Impairment

Patients with renal insufficiency have elevated plasma concentrations of losartan and its active metabolite compared to subjects with normal renal function. No dose adjustment is necessary in patients ...

8.8. Hepatic Impairment

The recommended starting dose of COZAAR is 25 mg in patients with mild-to-moderate hepatic impairment. Following oral administration in patients with mild-to-moderate hepatic impairment, plasma concentrations ...

10. Overdosage

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 a mg/m² basis. Limited ...

11. Description

COZAAR (losartan potassium) is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ ...

12.1. Mechanism of Action

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 the renin-angiotensin ...

12.2. Pharmacodynamics

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 persisting for 24 hours. ...

12.3. Pharmacokinetics

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

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Losartan potassium was not carcinogenic when administered at maximally tolerated dosages to rats and mice for 105 and 92 weeks, respectively. Female rats given the highest dose (270 mg/kg/day) had a slightly ...

14. Clinical Studies

14.1 Hypertension Adult Hypertension The antihypertensive effects of COZAAR were demonstrated principally in 4 placebo-controlled, 6- to 12-week trials of dosages from 10 to 150 mg per day in patients ...

16.1. How Supplied

COZAAR is a white film-coated tablet supplied as follows: Losartan Shape Engraving (reverse) NDC 0006-xxxx-xx Bottle/30 Bottle/90 25 mg oval 951 n/a 0951-54 50 mg oval 952 (scored) 0952-31 ...

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 COZAAR during pregnancy. Discuss ...

BOXED WARNING SECTION

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