Pacsartan-I Special Precautions

Do not administer to the following patients: Patient with hypersensitivity to the active ingredient or to any of the excipients; Second and third trimesters of pregnancy; This drug contains Lactose, patient with Galactose intolerance, Lapp lactase deficiency, or Glucose-galactose malabsorption should not take this medicinal product.
Carefully give this drug to the following patients: Intravascular volume depletion: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Such conditions should be corrected before the administration of this drug.
Renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. While this is not documented with this drug, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Renal impairment and kidney transplantation: When this drug is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of this drug in patients with a recent kidney transplantation.
Hypertensive patients with Type 2 diabetes and renal disease: The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups. In an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less if favorable in women and non white people.
Hyperkalaemia: As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with this drug, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Primary aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore the use of this drug is not recommended.
General: In patient with vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patient with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists what affect this system has been associated with acute hypotension, azotaemia, oliguria or rarely acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infraction or stroke.
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Driving and using machines: No studies on the effects on the ability to drive and use machines have been performed. Pacsartan-I is unlikely to affect the ability to drive or use machines. However, occasional dizziness or weariness may occur during treatment of high blood pressure. If the patients experience the above, seek counseling from a doctor before attempting to drive or use machines.
Use in children: Pacsartan-I should not be given to children under 18 years of age. If a child swallows tablets, contact to a doctor immediately.