Teva Losartan 100mg

Each tablet contains 100 mg losartan potassium, equivalent to 91.6 mg losartan.

Excipients with known effect: Each tablet contains 18.0 mg lactose monohydrate.

Tablet core:

Lactose monohydrate

Microcrystalline cellulose (E460a)

Pregelatinized starch (corn)

Magnesium stearate (E572)

Covering – white Opadry:

Polyvinyl alcohol (partially hydrolyzed)

Titanium dioxide (E171)

Macrogol 3350

Active ingredients

Losartan potassium

Application

Treatment of essential hypertension in adults and children and adolescents aged 6 to 18 years.

Treatment of renal disease in adult hypertensive patients with type 2 diabetes mellitus with proteinuria ? 0.5 g/day as part of antihypertensive therapy.

Treatment of chronic heart failure in adult patients, when treatment with angiotensin converting enzyme (ACE) inhibitors is not considered appropriate due to incompatibility, especially cough, or contraindication. Patients with heart failure stabilized with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction? 40% to have and be clinically stable and under-treated chronic heart failure.

Reduction of the risk of stroke in adult hypertensive patients with ECG-detected left ventricular hypertrophy

Usage

Dosage

Hypertension

The usual starting and maintenance dose for most patients is 50 mg once daily. The maximum blood pressure lowering effect is achieved 3 to 6 weeks after the start of therapy. Some patients may benefit from increasing the dose to 100 mg once daily. in the morning. Losartan Teva can be administered with other antihypertensive agents, especially diuretics (e.g. hydrochlorothiazide).

Hypertensive patients with type 2 diabetes mellitus with proteinuria? 0.5 g/day

The usual starting dose is 50 mg once daily. From one month after initiation of therapy, the dose can be increased to 100 mg once daily, depending on the blood pressure response. Losartan Teva may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha or beta blockers, and centrally acting agents) and with insulin and other commonly used hypoglycemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

Heart failure

The usual starting dose of losartan in patients with heart failure is 12.5 mg once daily. The dose should generally be titrated at weekly intervals (i.e. 12.5 mg/day, 25 mg/day, 50 mg/day, 100 mg/day, up to a maximum dose of 150 mg once daily), as tolerated by the patient. .

Losartan Teva is not available in Belgium in oral form of 12.5 mg or 25 mg. However, the 50 mg can be divided into two equal halves of 25 mg.

Reduction of the risk of stroke in hypertensive patients with ECG-detected left ventricular hypertrophy

The usual starting dose is 50 mg losartan once daily. Depending on the blood pressure response, a low dose of hydrochlorothiazide should be added and/or the dose of losartan should be increased to 100 mg once daily.

Special populations

Use in patients with intravascular volume depletion :

For patients with intravascular volume depletion (e.g. those treated with high doses of diuretics), an initial dose of 25 mg once daily should be considered. Use in patients with renal impairment and patients on dialysis: No initial dose adjustment is necessary in patients with renal impairment and patients on dialysis.

Use by patients with hepatic impairment:

A lower dose should be considered for patients with a history of hepatic impairment. There is no therapeutic experience in patients with severe hepatic impairment. Therefore, losartan is contraindicated in patients with severe hepatic impairment.

Pediatric patients

6 months – younger than 6 years

Safety and efficacy in children aged 6 months to less than 6 years have not been established. Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.

6 to 18 years

For patients weighing between 20 and 50 kg and who can swallow tablets, the recommended dose is 25 mg once daily. In exceptional cases the dosage can be increased to a maximum of 50 mg once daily. The dosage should be adjusted according to the blood pressure response.

In patients weighing more than 50 kg, the usual dose is 50 mg once daily. In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily. Daily doses above 1.4 mg/kg (or above 100 mg) have not been studied in children. Losartan is not recommended for use in children under 6 years of age as data are limited. Losartan is not recommended in children with a glomerular filtration rate < 30 ml/min/1.73 m2 as data are lacking.

Losartan is also not recommended in children with hepatic impairment.

Elderly patients

Although caution is required when initiating treatment with 25 mg in patients aged 75 years or older, dosage adjustment is generally not necessary in the elderly.

Method of administration

Losartan Teva tablets should be taken with a glass of water.

Losartan Teva can be taken with or without food.