Cozaar - Side Effects & Drug Interactions

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COZAAR ® (Losartan Potassium Tablets) 9573524

Study 1 * HCTZ Losartan Lisinopril

Cough 25% 17% 69%

Study 2 ** Placebo Losartan Lisinopril

Cough 35% 29% 62%

* Demographics = (89% caucasian, 64% female)

** Demographics = (90% caucasian, 51% female)

These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy. Cases of cough, including positive re-challenges, have been reported with the use of losartan in post-marketing experience. Hypertensive Patients with Left Ventricular Hypertrophy In the LIFE study, adverse events with COZAAR were similar to those reported previously for patients with hypertension.

Nephropathy in Type 2 Diabetic Patients

In the RENAAL study involving 1513 patients treated with COZAAR or placebo, the overall incidences of reported adverse experiences were similar for the two groups. COZAAR was generally well tolerated as evidenced by a similar incidence of discontinuations due to side effects compared to placebo (19% for COZAAR, 24% for placebo). The adverse experiences, regardless of drug relationship, reported with an incidence of 4% of patients treated with COZAAR and occurring more commonly than placebo, on a background of conventional antihypertensive therapy, are shown in the table below.

COZAAR ® (Losartan Potassium Tablets) 9573524

Losartan

and Conventional

Antihypertensive

Therapy

Incidence

%

(n= 751)

Placebo

and Conventional

Antihypertensive

Therapy

Incidence

%

(n= 762)

Body as a Whole

Asthenia/ Fatigue

Chest Pain

Fever

Infection

Influenza-like disease

Trauma

14

12

4

5

10

4

10

8

3

4

9

3 Cardiovascular

Hypotension

Orthostatic hypotension 7 4 3 1

Digestive

Diarrhea

Dyspepsia

Gastritis

15

4

5

10

3

4 Endocrine

Diabetic neuropathy

Diabetic vascular disease 4 10 3 9

Eyes, Ears, Nose and Throat

Cataract

Sinusitis 7 6 5 5

Hemic

Anemia 14 11

Metabolic and Nutrition

Hyperkalemia

Hypoglycemia

Weight gain

7

14

4

3

10

3 Musculoskeletal

Back pain

Leg pain