NIKP-Losartan

NIKP-Losartan Special Precautions

losartan

Manufacturer:

Nichi-Iko

Distributor:

DKSH
Full Prescribing Info
Special Precautions
Careful administration (NIKP-Losartan tablet 50mg and 100mg should be administered with care in the following patients): (1) Patients with unilateral or bilateral renal artery stenosis (see Important Precautions).
(2) Patients with hyperkalemia (see Important Precautions).
(3) Patients with severe renal function disorder [Hyperkalemia may occur more easily. As there is also a risk of worsening renal function, if serum creatinine is 2.5 mg/dL or greater, administration should be done carefully, e.g., at a lower dose, etc. (See Important Precautions.)
(4) Patients with hepatic function disorder or a history of hepatic function disorder [It has been reported overseas that, compared to healthy adults, patients with mild to moderate alcoholic cirrhosis had a delay in elimination of losartan, and plasma concentrations of losartan and carboxylic acid bodies increased five-fold and two-fold, respectively.]
(5) Patients with cerebrovascular disorders [Excessive decrease in pressure may lead to incomplete cerebral blood flow, possibly making the patient's condition worse.]
(6) Patients with decreased bodily fluids (being administered with antihypertensive diuretic, under severe limitation of salt intake, undergoing hemodialysis) (see Important Precautions).
(7) Elderly patients (see Elderly).
Important Precautions: (1) For patients with unilateral or bilateral renal artery stenosis, there is a risk of sudden worsening of renal function due to decreased renal blood flow and decreased glomerular filtration pressure, and therefore use should be avoided unless it is judged to be therapeutically unavoidable.
(2) For patients with hyperkalemia, there is a risk that hyperkalemia may become worse, and therefore use should be avoided unless it is judged to be therapeutically unavoidable. Furthermore, for patients for whom elevated serum potassium levels occur more readily due to renal function disorder, poorly controlled diabetes, etc., there is a risk of hyperkalemia, and therefore attention should be paid to serum potassium levels.
(3) Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
(4) The administration of NIKP-Losartan tablet 50mg or 100mg risks causing transient blood pressure to drop (accompanied by shock symptoms, loss of consciousness, breathing difficulty, etc.). If these symptoms develop, administration should be discontinued and appropriate therapeutic measures should be taken. Blood pressure should be monitored regularly (at the start of administration: every 2 weeks, after stabilization: monthly) during administration of NIKP-Losartan tablet 50mg or 100mg. For the following patients especially, administration should start at a low dose, and if dose is increased, it should be done gradually while carefully observing the patient's condition.
(i) Patients being administered with antihypertensive diuretic.
(ii) Patients under severe limitation of salt intake.
(iii)Patients undergoing hemodialysis.
(5) Since NIKP-Losartan tablet 50mg and 100mg may induce dizziness or lightheadedness due to its hypotensive effects, patients should be instructed to use with caution when operating hazardous machinery such as working at heights or driving a car.
(6) Administration within the 24 hours before surgery is undesirable.
(7) There have been reports of rare cases of development of hepatitis and other severe hepatic disorders during administration of angiotensin II receptor antagonist, which includes the losartan potassium preparation. Observe the patient carefully, with measures such as hepatic function testing, and take appropriate therapeutic measures, such as discontinuing administration if any abnormality is observed.
(8) Because anemia may occur more easily in patients with diabetic nephropathy in type 2 diabetes, patients should be observed carefully, such as by performing regularly (at the start of administration: every 2 weeks, after stabilization: monthly) blood tests, during administration of NIKP-Losartan tablet 50mg, or NIKP-Losartan tablet 100mg, and if an abnormality is observed, consideration should be paid to a cause of anemia, and appropriate therapeutic measures should be taken.
(9) Because increased serum potassium and serum creatinine may occur more easily in patients with diabetic nephropathy in type 2 diabetes, patients should undergo regular monitoring (at the start of administration: every 2 weeks, after stabilization: monthly) of serum potassium and serum creatinine levels during administration of NIKP-Losartan tablet 50mg, or NIKP-Losartan tablet 100mg, and careful observation should be given. If an abnormality is observed in serum potassium or serum creatinine levels, appropriate therapeutic measures should be taken.
Elderly: (1) Since physiological functions generally decline with age, attention should be paid to the patient's condition.
(2) Excessive decrease in blood pressure is generally regarded as undesirable in the elderly. (Cerebral infarction, etc. may occur.)
Therefore, administration should be done carefully, such as by starting at a low dose, while observing the patient's condition.
(3) Internal pharmacokinetics testing in the elderly has observed higher plasma concentrations of losartan and carboxylate forms than in non-elderly subjects (compared to non-elderly subjects, plasma concentrations of losartan and carboxylate forms were elevated to approximately 2 times and approximately 1.3 times, respectively).
(4) No difference has been observed regarding occurrence of hypotensive effect and adverse reactions between elderly and non-elderly.
Children: The safety of NIKP-Losartan tablet 50mg or 100mg in children has not been established (No clinical experience).
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