CARVALTAS 50
CARVALTAS 50
Active ingredient: Losartan potassium 50 mg.
Dosage form: Film-coated tablet.
Packaging: Box of 3 blisters x 10 tablets.
Expiry date: 36 months.
Posology
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning).
Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide) (see sections Contraindications, Special warnings and precautions for use, Interactions, and Pharmacodynamic properties).
Hypertensive type II diabetic patients with proteinuria ≥ 0.5 g/day
The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on blood pressure response from one month onwards after initiation of therapy. Losartan may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) (see sections Contraindications, Special warnings and precautions for use, Interactions and Pharmacodynamic properties) as well as with insulin and other commonly used hypoglycaemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Heart Failure
The usual initial 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 daily, 25 mg daily, 50 mg daily, 100 mg daily, up to a maximum dose of 150 mg once daily) as tolerated by the patient.
Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG
The usual starting dose is 50 mg of losartan once daily. A low dose of hydrochlorothiazide should be added and/or the dose of losartan should be increased to 100 mg once daily based on blood pressure response.
Special populations
Use in patients with intravascular volume depletion
For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered (see section Special warnings and precautions for use).
Use in patients with renal impairment and haemodialysis patients
No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
Use in 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 (see sections Contraindications and Special warnings and precautions for use).
Paediatric population
6 months – less than 6 years
The safety and efficacy of children aged 6 months to less than 6 years has not been established. Currently available data are described in sections Pharmacodynamic properties and Pharmacokinetic properties but no recommendation on posology can be made.
6 years to 18 years
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients > 20 to < 50 kg. (In exceptional cases the dose can be increased to a maximum of 50 mg once daily). Dosage should be adjusted according to blood pressure response.
In patients >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. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in paediatric patients.
Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups.
It is not recommended in children with glomerular filtration rate < 30 ml/min/1.73 m2, as no data are available (see also section Special warnings and precautions for use).
Losartan is also not recommended in children with hepatic impairment (see also section Special warnings and precautions for use).
Use in Elderly
Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Administration
Losartan tablets should be swallowed whole with a glass of water.
Losartan tablets may be administered with or without food.
INDICATIONS
- Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age.
- Treatment of renal disease in adult patients with hypertension and type II diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment (see sections Contraindications, Special warnings and precautions for use, Interactions andPharmacodynamic properties).
- Treatment of chronic heart failure in adult patients when treatment with Angiotensin-converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure.
- Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG (see section Pharmacodynamic properties – Life study, Race).
CONTRAINDICATIONS
- Hypersensitivityto the active substance or to any of the excipients.
- 2ndand 3rd trimester of pregnancy (see sections Special warnings and precautions for use, Pregnant and breast-feeding women).
- Severehepatic impairment.
- The concomitant use of losartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections Interactions and Pharmacodynamic properties).
