NIKP-Losartan

NIKP-Losartan Adverse Reactions

losartan

Manufacturer:

Nichi-Iko

Distributor:

DKSH
Full Prescribing Info
Adverse Reactions
Surveys or studies that demonstrate frequency of adverse reaction have not been conducted.
Clinically significant adverse reactions (Frequency unknown): Adverse reactions such as the following may occur, so if these symptoms develop, discontinue administration and take appropriate therapeutic measures.
Anaphylaxis: Symptoms including discomfort, oral cavity discomfort, sweating, hives, breathing difficulty, generalized flushing, and edema may develop, so careful observation is required.
Angioedema: Swelling of the face, lips, pharynx, tongue, and elsewhere may manifest as symptoms, so careful observation is required.
Acute hepatitis or fulminant hepatitis.
Renal failure.
Shock, fainting, loss of consciousness: Shock, fainting followed with blood pressure reduction, and loss of consciousness may occur, so observe the patient carefully, and take appropriate therapeutic measures immediately if chills, vomiting, loss of consciousness, etc. occur. Especially for patients undergoing hemodialysis, under severe limitation of salt intake, or being administered with antihypertensive diuretic, administration should start at a low dose, and if dose is increased, it should be done gradually while observing the patient's condition.
Rhabdomyolysis: Rhabdomyolysis, characterized by myalgia, torpor, increased CK (CPK), and increased myoglobin in blood and urine, may occur, so if these symptoms develop, discontinue administration and take appropriate therapeutic measures. Also pay attention for the onset of acute renal failure due to rhabdomyolysis.
Hyperkalemia: Severe hyperkalemia may occur, so observe the patient carefully, and take appropriate therapeutic measures immediately if any abnormality is observed.
Arrhythmia: Arrhythmias such as premature ventricular contraction and atrial fibrillation may occur, so observe the patient carefully, and take appropriate therapeutic measures immediately if any abnormality is observed.
Pancytopenia, leucopenia, and thrombopenia: Pancytopenia, leucopenia, and thrombopenia may occur, so observe the patient carefully, and take appropriate therapeutic measures immediately if any abnormality is observed.
Hypoglycemia: Hypoglycemia may occur (this symptom is common in patients being treated for diabetes), so observe the patient carefully, and discontinue administration and take appropriate therapeutic measures if any of the following symptoms developed: torpor, hunger sensation, cold sweat, hand tremors, reduced concentration, twitching, disturbance of consciousness, etc.
Hyponatremia: Hyponatremia followed with malaise, loss of appetite, nausea, vomiting, twitching, disturbance of consciousness, etc. may occur, so observe the patient carefully, and discontinue administration and take appropriate therapeutic measures immediately if any abnormality is observed.
Other adverse reactions: If any of the following symptoms or abnormalities occur, take appropriate therapeutic measures, such as discontinuing administration. (See Table 4.)

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