Indications
Ihybes 150 is indicated for the treatment of:
- Idiopathic arterial hypertension, especially in case of cough caused by using angiotensin-converting-enzyme inhibitor, and for reducing the risk of stroke in patients with left ventricular hypertrophy.
- Renal disease in patients with hypertension and type 2 diabetes mellitus.
Dosage and Administration
- The usual initial and maintenance dose is 150 mg (1 tablet) once daily, with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
- Initiation of therapy with 75 mg may be indicated, particularly in haemodialysed patients and in the elderly over 75 years.
- In patients insufficiently controlled with 150 mg once daily, Irbesartan dose can be increased to 300 mg, or can be combined with other antihypertensive agents. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan.
- In hypertensive type 2 diabetic patients, therapeutic dose of 150 mg irbesartan once daily should be started and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The detection of renal benefit of irbesartan in hypertensive type 2 diabetic patients is based on studies where irbesartan is used in combination with other antihypertensive agents, as needed, to achieve desired blood pressure.
- Renal impairment: Dosage adjustment is not necessary in patients with impaired renal function. A lower initial dose of irbesartan (75 mg daily) is recommended in patients undergoing haemodialysis.
- Hypovolemia: If hypovolemia or loss of body water and salt was observed this condition should be corrected before taking Ihybes.
- Hepatic impairment: Dosage adjustment is not necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.
- Children: The safety and efficacy of irbesartan in children have not been established.
- Dose adjustmentis required after 1 to 2 months if blood pressure has not been well controlled. It may take several months to attain well control of blood pressure.
Contraindications
- Hypersensitivity to one of ingredients of Ihybes.
- Pregnant women.
- Breastfeeding mothers.
Precautions
- Hypovolemia: Symptomatic hypotension may occur, especially after the first dose, in volume and/or sodium depleted patients, caused by strong diuretics, dietary salt restriction, diarrhea or vomiting. Correct these conditions before the administration of Irbesartan.
- Renal artery stenosis: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
- Renal impairmentandkidneytransplantation: WhenIrbesartan is usedinpatientswith impaired renal function, potassium and creatinine serum levels should be monitored frequently.
- Hyperkalemia: Hyperkalaemia may occur during the treatment with Irbesartan, particularly in patients with impaired cardiac or renal function. Serum potassium levels in these patients should be frequently controlled. Avoid coadministration of irbesartan and potassium-sparing diuretics.
- Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: Irbesartan should be used with specialcaution inpatients withmitraloraortic valvestenosis, or obstructive hypertrophic cardiomyopathy.
- Primary aldosteronism: Administration of irbesartan is not recommended.
Interactions
- Other antihypertensive agents: Other antihypertensive agents may increase the hypotensive effects of irbesartan; however, irbesartan may be indicated concurrently with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. Previous treatment with high dose diuretics may lead to decreased blood volume and a risk of hypotension when starting irbesartan therapy.
- Potassium supplements and potassium-sparing diuretics: Concomitant use of irbesartan with potassium-sparing diuretics, potassium supplements may increase serum potassium levels.
- Lithium: The reversible increases in serum lithium concentrations and toxicity have been reported when it is concomitantly taken with ACE inhibitors. If the combination is necessary, serum lithium levels should be monitored carefully.
- Other information on interactions: Thepharmacokinetic of digoxin was not altered by co-administration of a 150 mg dose of irbesartan in healthy
- The pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Pregnancy and Lactation
- Pregnancy: Ihybes 150 is contraindicated in pregnant women. During the first trimester of pregnancy, the contraindication is due to the prudence. The use of Ihybes 150 during the second and third trimesters can affect the growth and development of the fetus or induce human fetotoxicity.
- Lactation: Ihybes 150 is contraindicated in breastfeeding mothers.
Effects on ability to drive and use machines
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment.
Undesirable effects
In general, undesirable effects of irbesartan are mild and transient.
- Common, ADR > 1/100: Dizziness, headache and orthostatic hypotension related to dose, hypotension particularly in volume depleted patients (e.g. patients taking high doses of diuretics), renal failure and severe hypotension associated with bilateral renal artery stenosis.
- Uncommon, 1/1000 < ADR < 1/100: Rash, urticaria, pruritus, angioedema, elevated liver enzymes, hyperkalemia, muscle pain, joint pain.
- Rare: ADR < 1/1000: Cough, respiratory disturbance, back pain, digestive disorder, fatigue, neutropenia.
Pharmacodynamic properties
- Irbesartanisatetrazolederivative, an angiotensin II type 1 (AT1) receptor blocker.
- Irbesartan is a nonpeptide tetrazole derivative, an angiotensin II antagonist that selectively blocks the binding of angiotensin II to the AT1 receptor. Irbesartan blocks physiological effectsofangiotensin-II, even vasoconstrictor and aldosterone-secreting effects, by selectively binding to the AT1 angiotensin II receptor inmanytissues, includingthe adrenal glandandvascularsmooth muscle.
- When irbesartan is administered at recommended doses serum potassium levels are not significantly affected, except in the case of renal failure and/ or heart failure.
- Irbesartan lowers blood pressure with minimal change in heart rate. Antihypertensive effect of irbesartan is dose-dependent for once daily with a tendency that there is no further reduction of blood pressure at doses above 300 mg. Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours. The blood pressure lowering effect of irbesartan is evident within 1-2 weeks. Maximal effect is attained within 4-6 weeks after starting the treatment and is maintained during long-term therapy. After withdrawal of therapy, blood pressure gradually returns toward baseline. Rebound hypertension has not been observed.
Pharmacokinetic properties
- Absorption: After oral administration, irbesartan is rapidly absorbed from the gastrointestinal tract with bioavailability of 60-80%. Food does not alter the bioavailability of Ihybes 150. Peak plasma concentrations are reached approximately 1-2 hours after one oral dose. Steady-state concentrations are achieved after starting the therapy for 3 days.
- Distribution: Irbesartanis about 96% bound to plasma proteins. The volume of distribution is 53 – 93 liters.
- Metabolism: Irbesartan is metabolized by the liver primarily by the cytochrome P450 isoenzyme CYP2C9 and possibly by glucuronide conjugation. The metabolic products are inactive.
- Elimination: Irbesartan and its metabolites are excreted by both biliary and renal routes. About 20% of theadministered dose is excreted in the urine as metabolites and less than 2% as unchanged. Elimination half life is 11-15 hours.
Overdose and management
- Overdose symptoms: In adults, doses of up to 900 mg irbesartan daily for 8 weeks do not cause any signs of acute toxicity. In case of overdose, clinical symptoms commonly seen are hypotension and tachycardia; bradycardia may also occur.
- Management: No specific measure is available on the treatment of overdose with irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive including emesis and/or gastric lavage, ingestion of activated charcoal. Irbesartan is not removed from the body by haemodialysis.
KEEP OUT OF REACH OF CHILDREN
READ CAREFULLY THE INSTRUCTIONS BEFORE USE
FOR FURTHER INFORMATION, CONSULT YOUR PHYSICIAN
USE ONLY UNDER A PHYSICIAN’S PRESCRIPTION
Storage: Protect from humidity and light, below 300C.
Shelf – life: 36 months from the manufacturing date.
Do not use after the expiry date printed on the label.
A1202034803
