Pacsartan-I

Pacsartan-I

irbesartan

Manufacturer:

Pacific Pharma

Distributor:

AA Medical
Full Prescribing Info
Contents
Irbesartan.
Description
Each tablet contains Irbesartan 150 mg.
Excipients/Inactive Ingredients: Animal Origin: Lactose Hydrate (from Cow milk).
Indications/Uses
This drug is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Dosage/Direction for Use
Essential Hypertension: The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan can be increased to 300 mg or other antihypertensive agents can be added.
Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with this drug.
Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus: In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg Irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan in hypertensive type 2 diabetic patients in base on studies where Irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure.
Renal impairment: No dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.
Elderly patients: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
If Pacsartan-I was taken more than a patient should, accidently, contact a doctor immediately.
If missed to take a daily dose of Pacsartan-I accidently, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
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.
Use In Pregnancy & Lactation
Pregnancy: A patient must tell a doctor if the patient thinks she is (or might become) pregnant.
If noticed to be pregnant, the doctor will advise the patient to take another medicine instead of Pacsartan-I.
Pacsartan-I is not recommended in early pregnancy. And must not be taken when more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding: A patient must tell a doctor if she is breast-feeding or about to start breast-feeding.
Pacsartan-I is not recommended for mothers who are breast-feeding and the doctor may choose another treatment for the patient if she wishes to breast-feed, especially if the baby is a newborn or was born prematurely.
Side Effects
Like all medicines, Pacsartan-I can cause side effects, although not everybody gets them.
Some of the side effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (rash, urticarial), as well as localized swelling of the face, lips, and/or tongue have been reported in patients taking irbesartan. If the patient gets any of these symptoms or gets short of breath, stop taking Pacsartan-I and contact a doctor immediately.
The frequency of the side effects listed as follows is defined using the following convention: See table.

Click on icon to see table/diagram/image

Some undesirable effects have been reported since marketing of Pacsartan-I.
Undesirable effects where the frequency is not known are: feeling of spinning, Headache, Taste Disturbance, Ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
If any side effect becomes serious, or if the patient notices any side effect not listed, please seek counseling from a doctor or pharmacist.
Drug Interactions
Diuretic and other antihypertensive agents: Other antihypertensive agents may increase the hypotensive effects of Irbesartan; however this drug has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with this drug.
Potassium supplements and potassium-sparing diuretics: Based on experience with the use of potassium-sparing diuretics potassium supplements, salt substitutes containing potassium or other medicinal products what may increase serum potassium levels (e.g. heparin) may lead to increase in serum potassium and is therefore, not recommended.
Lithium: Reversible increase in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effects have been very rarely reported with irbesartan so far. Therefore, this combination is not recommended. If the combination proves necessary careful, monitoring of serum lithium levels is recommended.
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
As with ACE inhibitors concomitant use of angiotensin II antagonists and NSAIDs may lead to in increased risk of worsening of renal function, including possible acute renal failure, and an increase serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolized by CYP2C9 and to a lesser extent by glucuronidation. No significant pharmacokinetics or pharmacodynamics interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolized by CYP2C9. The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Storage
The product should be kept in a tight container in a dry place below 30°C.
Shelf-Life: 36 months.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Tab 150 mg x 10 x 10's.
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