COZAAR-COMP

Posology Hypertension Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone. Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended.

When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. 5 mg) once daily. 5 mg, the dosage may be increased to one tablet of Cozaar Comp 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once daily.

The maximum dose is one tablet of Cozaar Comp 100 mg/25 mg once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. 5 mg) is available for those patients titrated to 100 mg of Cozaar who require additional blood pressure control.

e. creatinine clearance 30-50 ml/min). Losartan and hydrochlorothiazide tablets are not recommended for haemodialysis patients. e. 3). Use in patients with intravascular volume depletion Volume and/or sodium depletion should be corrected prior to administration of losartan/HCTZ tablets.

3). Use in the elderly Dosage adjustment is not usually necessary for the elderly. Paediatric population Use in children and adolescents (< 18 years) There is no experience in children and adolescents. Therefore, losartan/hydrochlorothiazide should not be administered to children and adolescents.

1). Cozaar Comp tablets should be swallowed whole with a glass of water. Cozaar Comp may be administered with or without food.

The adverse reactions below are classified where appropriate by system organ class and frequency according to the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

In clinical trials with losartan potassium salt and hydrochlorothiazide, no adverse reactions peculiar to this combination of substances were observed. The adverse reactions were restricted to those which were formerly observed with losartan potassium salt and/or hydrochlorothiazide.

In controlled clinical trials for essential hypertension, dizziness was the only adverse reaction reported as substance-related that occurred with an incidence greater than placebo in 1% or more of patients treated with losartan and hydrochlorothiazide.

4) very rare Gastrointestinal disorders sialoadenitis, spasms, stomach irritation, nausea, vomiting, diarrhoea, constipation uncommon Hepato-biliary disorders icterus (intrahepatic cholestasis), pancreatitis uncommon photosensitivity, urticaria, toxic epidermal necrolysis uncommonSkin and subcutaneous tissue disorders cutaneous lupus erythematosus not known Musculoskeletal and connective tissue disorders muscle cramps uncommon Neoplasms benign, malignant and unspecified (incl.

cysts and polyps) Non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) not known […]

8). 8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, losartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.

Hypotension and Intravascular volume depletion Symptomatic hypotension, especially after the first dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.

3). Electrolyte imbalances Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. Therefore, the plasma concentrations of potassium and creatinine clearance values should be closely monitored; especially patients with heart failure and a creatinine clearance between 30-50 ml/min should be closely monitored.

5). Liver function impairment Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, Cozaar Comp should be used with caution in patients with a history of mild to moderate hepatic impairment.

There is no therapeutic experience with losartan in patients with severe hepatic impairment. 2). Renal function impairment As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function, including renal failure, have been reported (in particular, in patients whose renal function is dependent on the renin- angiotensin-aldosterone system, such as those with severe cardiac insufficiency or pre-existing renal dysfunction).

As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.

e. 1).