Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Merck Sharp and Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
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 4.3, 4.4, 4.5, and 5.1).
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 4.3, 4.4, 4.5, and 5.1) as well as with insulin and other commonly used hypoglycemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
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.
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.
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 4.4).
No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
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 4.3 and 4.4).
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 5.1 and sections 5.2 but no recommendation on posology can be made.
6 years to 18 years: The recommended starting dose in patients >20 to <50 kg is 0.7 mg/kg once daily (up to 25 mg total, in exceptional cases where target doses above 25 mg are required, the maximal dose is 50 mg). 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.
For patients who can swallow tablets, this dosage form is also available.
Losartan is not recommended for use in children below 6 years old due to insufficient data on safety and/or efficacy 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 4.4).
Losartan is also not recommended in children with hepatic impairment (see also section 4.4).
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.
Shake the closed bottle of losartan oral suspension well before use. Push the plunger of the dispenser completely down toward the tip of the dispenser. Insert the dispenser into the adapter on the medication bottle until a tight seal is made between the bottle and the adapter. With the dispenser, adapter, and bottle attached, turn the entire assembly upside down. Pull out the plunger to withdraw the medication medicinal product into the dispenser. Return the entire assembly to the upright position. Remove the dispenser and administer the medication. Replace the original cap onto the bottle.
For reconstitution see section 6.6.
Losartan may be administered with or without food.
Limited data are available with regard to overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation.
If symptomatic hypotension should occur, supportive treatment should be instituted.
Measures are depending on the time of medicinal product intake and kind and severity of symptoms. Stabilisation of the cardiovascular system should be given priority. After oral intake the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.
Neither losartan nor the active metabolite can be removed by haemodialysis.
2 years.
After reconstitution: 4 weeks.
Kit: Do not store above 25°C. Store in the original package.
Store the prepared suspension in a refrigerator (at 2-8°C) for up to 4 weeks.
The following components are packed in a kit:
Losartan suspension is a white to off-white liquid when reconstituted with the supplied solution.
Reconstitution of COZAAR oral suspension [for 200 ml of a 2.5 mg/ml suspension]:
Add 200 ml of solvent to the 240 ml polyethylene terephthalate (PET) bottle provided. Before opening the sachet gently tap on the side of the sachet to facilitate transfer of the material. Carefully add the complete contents of the sachet into the PET container bottle containing the solvent, tapping the side of the sachet and inverting as necessary. It is normal to have a small amount of residual powder adhering to the interior surfaces of the sachet. The sachet should NOT be rinsed. Place the screw cap on the bottle and shake the contents well to disperse. After reconstitution, losartan suspension is an off-white liquid. Remove the screw cap, place the push-in bottle neck adaptor on the bottle, and re-cap the bottle. The suspension should be stored in a refrigerator at 2-8°C for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
Discard the excess solvent not used in the preparation of the suspension.
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