Favotan Special Precautions

Administration with Special Precautions: Patients with intravascular volume depletion (e.g. patients who are taking diuretic drug); Patients under stringent salt-restriction; Mild to severe renal impairment patients (e.g. creatinine clearance <20 mL/min) or dialysis patients; Hyperkalemia patients.
General Precautions: Slight blood pressure lowering effect remains after the discontinuation of amlodipine because the half-life of its blood concentration is long. Therefore, use caution to determine dose and dosing interval, and monitor patients' condition when administering other blood pressure depressant after discontinuing amlodipine.
Hypersensitivity: angioedema (refer to Adverse Reactions).
Patients with Impaired Hepatic Function: Because significantly increased plasma concentrations of losartan in cirrhotic patients has been reported, this drug is not recommended for patients with impaired liver function if a lower dose should be considered in these patients.
Patients with Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function have been reported. These changes in renal function were reversible upon the discontinuation of the therapy. For patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar outcomes have been reported with losartan. Some studies have reported that ACE inhibitors have increased blood urea and serum creatinine in patients with bilateral or unilateral renal artery stenosis. Similar symptoms have been reported with losartan, but these symptoms were reversible upon the discontinuation of the drug.
Hyperkalemia (serum potassium >5.5 mmol/L) has occurred among 1.5% of patients with losartan monotherapy, but the discontinuation of losartan was not necessary. Concomitant use of potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium, or other agents which may lead to increase in potassium level (e.g. heparin, food or beverages containing high potassium amount such as 100% orange juice) should be carefully considered (especially for elderly patients or patients with impaired renal function) for administration. Serum potassium level should also be monitored with caution.
Losartan may lead to transient hypotension accompanying shock, apsychia, and dyspnea. In that case, therefore, discontinue administration and provide the patient with appropriate treatment. In particular, doctors need to fully monitor the condition of patients as follows: Patients required 25 mg losartan per day should not receive the drug because this drug does not contain 25 mg of losartan; Patients with intravascular volume depletion (e.g. patients getting diuretic treatment); Patients under stringent salt-restriction; Mild to severe renal impairment patients (e.g. creatinine clearance: <20 mL/min) or patients undergoing dialysis.
Effects on the Ability to Drive and Use Machines: Dizziness may occur due to blood pressure lowering effect. So, patients should not operate machines, which may cause risk while taking this drug (e.g., driving or activities in high altitude).