Irvask Caplet

12:58 AM
Composition
Each IRVASK caplet contains: Irbesartan 150 and 300 mg

Pharmacology
Irbesartan is a selective and competitive antagonist of AT1 receptors with a much greater affinity ( › 8500-fold ) for the AT1 receptor than for the AT2 receptor. Irbesartan is expected to block all actions of angiotensin-II mediated by AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. Serum potassium levels are not significantly effected by Irbesartan alone at the recommended doses. Irbesartan does not inhibit ACE (Khinase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites. Irbesartan does not require metabolic activation for its activity.

Pharmacokinotic
After oral administration, Irbesartan is well absorbed, with an absolute bioavailability of 60-80%. Concomitant food intake does not affect the bioavailability of Irbesartan. Plasma protein binding is approximately 96, the average volume of distribution is 53 - 93 liters. Irbesartan is metabolized by the liver via giucuronide conjugation and oxidation. Peak plasma concentrations of Irbesartan are attained at 1.5 - 2 hours after oral administration, total plasma and renal clearances are in the range of 157 -176 and 3.0 - 3.5 ml/min, respectively. The plasma elimination half-life ranges from 11 to 15 hours and steady-state plasma concentrations are achieved wrthin 3 days after initiation dose. Irbesartan and its metabolites are excreted by both biliary and renal routes.

Indication
IRVASK are used for treating hypertension. It may be used alone or in combination with other antihypertansive agents.

Dosage and administration
The usual recommended initial and maintenance dose is 150 mg once daily, can be increased to 300 mg once daily, may be administered with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better blood pressure control than 75 mg. The addition of a diuretic agent such as Hydrochlorothlazide has bean shown to have an additive effect with Irbesartan.

Renal Impairment
No dosage adjustment is necessary in patients with impaired renal function, but a lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.

Hepatic impairment
No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.

Elderly use
No dosage adjustment is necessary.

Pediatric use
Safety and effectiveness in pediatric patients have not been established.

Contraindications
  • Hypersensitivity to Irbesartan.
  • Second and third trimester of pregnancy.
  • Lactation.
Warnings and precautions
Intravascular volume depletion
Volume and/or sodium depletion should be corrected prior to administration of Irbesartan.

Renovascular hypertension
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis are treated with drugs that affect the renin-angiotensin-aldosteron system. While this is not documented with Irbesartan, a similar effect should be anticipated with angiotensin II receptor antagonists.

Renal impairment and kidney transplantation
When Irbesartan 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 Irbesartan in patients with kidney transplantation.

Hyperkalemia
Close monitoring of serum potassium in patients with renal impairment, overt proteinuria due to diabetic renal disease and/or heart failure is recornmended, because hyperkalemia may occur during the treatment with Irbesartan in that patients.

Aortic and mitral vain stenosis
Special caution is indicated in patents suffering from aortic or mitral stenosis.

Primary aldosteronism
Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin-aldosteron system. Therefore, the use of Irbesartan is not recommended.

Hypertensive patients with type-2 diabetes and renal disease
The effect 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 favourable in women and non-white subjects.

Lithium
The combination of Lithium and Irbesartan is not recommended.

General
In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or uderlying renal disease. Including renal artery stenosis), treatment with angiotensin convening enzyme inhibitors or angiotensin-ll receptor antagonist that affect this system has been associated with acute hypotension, azotaemia, digouria, or rarely acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic canjiovascular disease could result in a myocardial infarction or stroke. As observed for angiotensin converting enzyme inhibitors, Irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in Mack people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

Adverse reactions
Respiratory tract infection, headache, myalgia, dizziness, fatigue, diarrhea, cough, nausea, musculoskdetal trauma, chest pain, dyspepsia/heart bum, edema, abdominal pain, rash, tachycardia, anxiety.

Drug Interactions
Diuretics and other antihypertensive agents may increase the hypotensive effects of Irbesartan; however Irbesartan has been safely administered with other antihypertensive agents, such as p-blockers, calcium channel blockers.
The administration of Irbesartan in patients receiving maintenance doses of Warfarin or Digoxin, had no effect on the pharmacodynamics of the Warfarin (prothrombin time) or the onarmacokinetics of Digoxin. Potassium supplements and potassium-sparing diuretics may lead to increases potassium in serum.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effecis have been very rarely reported with Irbesartan so far.
NSAIDs: When angiotensin-II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, Acetosal ( › 3 a/day ) and non selective NSAIDs, attenuation of the antihypertensive effect may occur. As with ACE-inhibitors, concomitant use of angiotensin II antagonist and NSAIDs may lead to an increase risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patiens 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 irritation of concomitant therapy and periodically thereafter.

Overdosage
The most likely manifestations of overdosage are expected to be hypotension and tachycardia, bradycardia, might also occur from overdosage. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored and treatment should be symptomatic and supportive. Suggested measures include induction of omosis and/or gastric lavage. Activated charcoal may be usefull in the treatment of overdosage. Irbesartan Is not remove by haemodialysis.

Presentations
IRVASK 150 mg : Box of 3 strips x 10 caplets Reg. No. DKLOB11638604A1
IRVASK 300 mg : Box of 3 Strips x 10 caplets Reg. No. DKL0811638604B1

Store below 30°C.

ON MEDICAL PRESCRIPTION ONLY.

Manufactured by: PT. DANKOS FARMA, Jakarta - Indonesia
For : PT. KALBE FARMA Tbk., Bekasi - Indonesia

Share this :

Previous
Next Post »
0 Komentar

Penulisan markup di komentar
  • Silakan tinggalkan komentar sesuai topik. Komentar yang menyertakan link aktif, iklan, atau sejenisnya akan dihapus.
  • Untuk menyisipkan kode gunakan <i rel="code"> kode yang akan disisipkan </i>
  • Untuk menyisipkan kode panjang gunakan <i rel="pre"> kode yang akan disisipkan </i>
  • Untuk menyisipkan quote gunakan <i rel="quote"> catatan anda </i>
  • Untuk menyisipkan gambar gunakan <i rel="image"> URL gambar </i>
  • Untuk menyisipkan video gunakan [iframe] URL embed video [/iframe]
  • Kemudian parse kode tersebut pada kotak di bawah ini
  • © 2015 Simple SEO ✔