LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE

Posology Hypertension Losartan potassium 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 Losartan potassium / Hydrochlorothiazide 100 mg /25 mg once daily.

The maximum dose is one tablet of Losartan potassium / Hydrochlorothiazide 100 mg /25 mg once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. e. creatinine clearance 30-50 ml/min).

Losartan potassium / hydrochlorothiazide tablets are not recommended for haemodialysis patients. e. 3). Useinpatientswithintravascularvolumedepletion Volume and /or sodium depletion should be corrected prior to administration of losartan potassium / hydrochlorothiazide tablets.

Useinpatientswithhepaticimpairment Losartan potassium / hydrochlorothiazide tablets is contraindicated in patients with severe hepatic impairment. 3). Useintheelderly Dosage adjustment is not usually necessary for the elderly. Paediatric population Use in childrenand adolescents(<18years) There is no experience in children and adolescents.

Therefore, losartan potassium / hydrochlorothiazide should not be administered to children and adolescents. 1). Losartan potassium / Hydrochlorothiazide should be swallowed whole with a glass of water. Losartan potassium / Hydrochlorothiazide 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 events peculiar to this combination of substances were observed.

The adverse events 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 experience reported as substance-related that occurred with an incidence greater than placebo in 1% or more of patients treated with losartan and hydrochlorothiazide.

4) Gastrointestinal disorders Uncommon: Sialoadenitis, spasms, stomach irritation, nausea, vomiting, diarrhoea, constipation Hepatobiliary disorders Uncommon: Icterus (intrahepatic cholestatis), pancreatitis Skin and subcutaneous tissue disorders Uncommon: Photosensitivity, urticaria, toxic epidermal necrolysis Not Unknown: Cutaneous lupus erythematosus Musculoskeletal and connective tissue disorders Uncommon: Muscle cramps Renal and urinary disorders Uncommon: Glycosuria, interstitial nephritis, renal dysfunction, renal failure General disorders and […]

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. 2. ). 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, Losartan potassium / Hydrochlorothiazide 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).