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Author: Admin | 2025-04-28
One side.Storage And HandlingCOZAAR is a white film-coated tablet supplied as follows: Losartan Shape Engraving (reverse) NDC 78206-xxx-xx Bottle/30 Bottle/90 25 mg oval 951 n/a 121-01 50 mg oval 952(scored) 122-01 122-02 100 mg teardrop 960 123-01 123-02 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.Manufactured for: Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA. Revised: Oct 2021. Side Effects for CozaarClinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to ratesin the clinical trials of another drug and may not reflect the rates observed in practice.HypertensionCOZAAR has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1200 patients weretreated for over 6 months and more than 800 for over one year.Treatment with COZAAR was well-tolerated with an overall incidence of adverse events similar to that of placebo. In controlled clinical trials, discontinuation oftherapy for adverse events occurred in 2.3% of patients treated with COZAAR and 3.7% of patients given placebo. In 4 clinical trials involving over 1000 patients onvarious doses (10-150 mg) of losartan potassium and over 300 patients given placebo, the adverse events that occurred in ≥2% of patients treated with COZAAR andmore commonly than placebo were: dizziness (3% vs. 2%), upper respiratory infection (8% vs. 7%), nasal congestion (2% vs. 1%), and back pain (2% vs. 1%).The following less common adverse reactions have been reported:Blood and lymphatic system disorders: Anemia.Psychiatric disorders: Depression.Nervous system disorders: Somnolence, headache, sleep disorders, paresthesia, migraine.Ear and labyrinth disorders: Vertigo, tinnitus.Cardiac disorders: Palpitations, syncope, atrial fibrillation, CVA.Respiratory, thoracic and mediastinal disorders: Dyspnea.Gastrointestinal disorders: Abdominal pain, constipation, nausea, vomiting.Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash, photosensitivity.Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.Reproductive system and breast disorders: Impotence.General disorders and administration site conditions: Edema.CoughPersistent dry cough (with an incidence of a few percent) has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitortherapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough inhypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged withlisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide(n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below.Table 1 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, issimilar to that associated with hydrochlorothiazide or placebo therapy.Cases of
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