If this combination proves essential, serum lithium level monitoring is recommended during concomitant use.When angiotensin II antagonists are administered simultaneously with NSAIDs (i.e. Should exposure to losartan have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. It allows continued monitoring of the benefit/risk balance of the medicinal product. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. • In a controlled clinical trial in 177 hypertensive paediatric patients 6 to 16 years of age • in controlled clinical trials in >3,000 adult patients 18 years of age and older for essential hypertension Data in the paediatric population are limited. CV death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.Following oral administration, losartan is well absorbed and undergoes first pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites. The use of losartan is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. The pharmacokinetic parameters for the metabolite differed to a greater extent between the age groups. Cozaar (Losartan Potassium) - 100mg (30 Tablets) ハイザール（ロサルタンカリウム／ヒドロクロロチアジド）50mg／12.5mg　 (30錠) 3950 円 Hyzaar (Losartan Potassium/Hydrochlorothiazide) - 50mg/12.5mg (30 Tablets) ロスタール（ロサルタンカリウム）12.5mg　 (90錠) 1280 円 During once daily dosing with 100 mg, neither losartan nor its active metabolite accumulates significantly in plasma.Both biliary and urinary excretions contribute to the elimination of losartan and its metabolites. Amlodipine was given at doses of 0.05 mg/kg to 0.2 mg/kg (up to a maximum dose of 5 mg per day).Overall, after 12 weeks of treatment, patients receiving losartan experienced a statistically significant reduction from baseline in proteinuria of 36% versus 1% increase in placebo/amlodipine group (p≤0.001). As with other medicinal products that affect the rennin-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. For the following individual and combined components of the primary endpoint, the results showed a significant risk reduction in the group treated with losartan: 25.3 % risk reduction for doubling of the serum creatinine (p = 0.006); 28.6 % risk reduction for end stage renal failure (p = 0.002); 19.9 % risk reduction for end stage renal failure or death (p = 0.009); 21.0 % risk reduction for doubling of serum creatinine or end stage renal failure (p = 0.01).

Therefore, the plasma concentrations of potassium as well as 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.The concomitant use of potassium-sparing diuretics, potassium supplements and potassium-containing salt substitutes with losartan is not recommended (see section 4.5).Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment. Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in particular during initiation of treatment or when the dose is increased.Losartan has been evaluated in clinical studies as follows: This site uses cookies. There is no therapeutic experience in patients with severe hepatic impairment. The systemic bioavailability of losartan tablets is approximately 33%. • Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age.

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