NIKP-Losartan HCTZ

NIKP-Losartan HCTZ Adverse Reactions

losartan + hydrochlorothiazide

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, perspiration, 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.
Acute renal failure: Acute renal failure may occur, so observe the patient carefully, and take appropriate therapeutic measures immediately if any abnormality is observed.
Shock, fainting, loss of consciousness: Shock, fainting accompanying 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. Patient condition should be observed with particular care in patients under severe limitation of salt intake and patients being administered with diuretic antihypertensive drugs.
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.
Hypokalemia, hyperkalemia: Severe hypokalemia and hyperkalemia may occur, and symptoms such as malaise, torpor, and arrhythmia may manifest with abnormal variations in serum potassium level, so observe the patient carefully, and take appropriate therapeutic measures immediately, such as discontinuing administration, 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.
Aplastic anemia, hemolytic anemia: Severe blood disorders may occur, so observe the patient carefully, and take appropriate therapeutic measures immediately if any abnormality is observed.
Necrotizing vasculitis.
Interstitial lung disease, pulmonary edema.
Aggravation of systemic lupus erythematosus.
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 develop: torpor, hunger sensation, cold sweat, hand tremors, reduced concentration, twitching, disturbance of consciousness, etc.
Hyponatremia: Hyponatremia accompanied by malaise, loss of appetite, nausea, vomiting, disturbance of consciousness, etc. may occur (this symptom is common in the elderly), so observe the patient carefully, and discontinue administration and take appropriate therapeutic measures immediately if any abnormality is observed.
Acute myopia, angle-closure glaucoma: Acute myopia (including blurring, decreased visual acuity, etc.) and angle-closure glaucoma may occur, so if sudden decrease in vision, eye pain or similar abnormalities is observed, discontinue administration and instruct the patient to immediately seek treatment from an ophthalmologist.
Other adverse reactions: Symptoms and abnormalities such as the following may occur, so if these conditions appear, take appropriate therapeutic measures such as discontinuing administration. (See Table 3.)

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