Kirbex 75 Mg/150 Mg/300 Mg Tablets

KIRBEX TABLETS is indicated for the treatment of essential hypertension. It may be used either alone or in combination with other antihypertensive medicines. KIRBEX TABLETS is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (> 300 mg/day) in patients with Type 2 diabetes and 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 KIRBEX TABLETS can be increased to 300 mg, or other anti-hypertensive agents can be added.

In patients with hypertension and type 2 diabetic renal disease, 300 mg of KIRBEX TABLETS once daily is the preferred maintenance dose.

Elderly Patients and Patients with Renal or Hepatic Impairment: No dosage reduction is generally necessary in the elderly or in patients with mild to moderate impaired renal function or hepatic function. Patients with Intravascular Volume Depletion: See WARNINGS AND SPECIAL PRECAUTIONS u2013 Hypotension u2013 Volume-depleted patients.

KIRBEX TABLETS is contra-indicated in patients who are hypersensitive to irbesartan or to any other component of the KIRBEX TABLETS formulation. A history of angioedema related to previous therapy with ACE inhibitors or angiotensin receptor blockers (ARBs): These patients must never again be given these medicines. Hereditary or idiopathic angioedema. Hypertrophic obstructive cardiomyopathy (HOCM). Severe renal function impairment (creatinine clearance less than 30 ml/min). Bilateral renal artery stenosis. Renal artery stenosis in patients with a single kidney. Aortic stenosis. Concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene, amiloride (see INTERACTIONS). Porphyria. Lithium therapy: Concomitant administration with KIRBEX TABLETS may lead to toxic blood concentrations of lithium (see INTERACTIONS). Use of KIRBEX TABLETS with renin inhibitors such as aliskiren. Paediatric Use: Safety and effectiveness in paediatric patients have not been established.

Should a woman become pregnant while receiving KIRBEX TABLETS, the treatment should be stopped promptly and switched to a different class of antihypertensive medicine (See CONTRA-INDICATIONS and PREGNANCY AND LACTATION).

Hypotension u2013 Volume-Depleted Patients: KIRBEX TABLETS has been associated with hypotension in hypertensive patients without other co-morbid conditions. Symptomatic hypotension may be expected to occur in sodium/volume-depleted patients such as those treated vigorously with diuretics and/or salt restriction, or on haemodialysis. Volume and/or sodium-depletion should be corrected before initiating therapy with irbesartan or a lower starting dose (KIRBEX 75 mg TABLETS) should be considered.

Hyperkalaemia: May occur during the treatment with KIRBEX TABLETS, and especially frequent 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.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS): Dual blockade of the RAAS with angiotensin-receptor blockers, ACE-inhibitors, or renin inhibitors such as aliskiren increases the risk of hypotension, hyperkalaemia and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function, and electrolytes in patients taking KIRBEX TABLETS and other medicines that affect the RAAS. ACE inhibitors and angiotensin-receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

General: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system (e.g. hypertensive patients with renal artery stenosis in one or both kidneys, or patients with severe congestive heart failure), treatment with other medicines that affect this system has been associated with oliguria and/or progressive uraemia and with acute renal failure and/or death. The possibility of a similar effect occurring with the use of an angiotensin II receptor antagonist cannot be excluded.

Use in the elderly: In clinical studies there was no age-related difference in efficacy or safety profile of KIRBEX TABLETS.

Effects on the ability to drive or use machinery: KIRBEX TABLETS may cause side effects such as dizziness, headaches and nervousness which may impair concentration, therefore caution is advised until the effect of KIRBEX TABLETS on the individual is established.

Based on in vitro data, no interactions would be expected to occur with medicines whose metabolism is dependent upon cytochrome P450, isoenzymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1 or 3A4. KIRBEX TABLETS is primarily metabolised by 2C9, however, during clinical interactions studies, no significant pharmacodynamic interactions were observed when KIRBEX TABLETS was co-administered with warfarin (a medicine metabolised by 2C9).

NSAIDs should be used with caution in patients taking KIRBEX TABLETS as the risk of renal impairment may be increased, particularly in those who are inadequately hydrated; use of NSAIDs may also attenuate the hypotensive effect of KIRBEX TABLETS.

Giving lithium with ACE inhibitors has been reported to increase serum-lithium concentrations, resulting in some cases, in lithium toxicity (see CONTRA-INDICATIONS).

Dual blockade of the RAAS with angiotensin-receptor blockers, ACE-inhibitors, or renin inhibitors such as aliskiren increases the risk of hypotension, hyperkalaemia and changes in renal function (including acute renal failure) compared to monotherapy. In most patients no benefit has been associated with using two RAAS inhibitors concomitantly. KIRBEX TABLETS does not affect the pharmacokinetics of digoxin or simvastatin. The pharmacokinetics of irbesartan is not affected by co-administration with nifedipine or hydrochlorothiazide. Based on experience with the use of other medicines that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium (see CONTRA-INDICATIONS).

Safety in pregnancy and lactation has not been established (see CONTRA-INDICATIONS). When pregnancy is planned or confirmed KIRBEX TABLETS should be discontinued. Medicines affecting the renin-angiotensin system, such as KIRBEX TABLETS, can cause embryonal toxicity, foetal and neonatal morbidity and mortality when administered to pregnant women. Women of childbearing age should ensure effective contraception.

The following side effects have been reported:

• Immune system disorders
• Less frequent: Angioedema
• Metabolism and nutrition disorders
• Less frequent: Hyperkalaemia.
• Psychiatric disorders
• Less frequent: Anxiety and/or nervousness.
• Nervous system disorders
• Frequent: Dizziness.
• Less frequent: Headache.
• Ear and labyrinth disorders
• Less frequent: Tinnitus, vertigo.
• Cardiac disorders
• Less frequent: Tachycardia.
• Vascular disorders
• Frequent: Orthostatic hypotension, flushing.
• Less frequent: Hypotension usually seen in volume-or salt-depleted patients receiving high doses of a diuretic.
• Respiratory, thoracic and mediastinal disorders
• Less frequent: Upper respiratory infection (cold symptoms), cough.
• Gastrointestinal disorders
• Frequent: Nausea, vomiting.
• Less frequent: Diarrhoea, dyspepsia, dysgeusia.
• Hepato-biliary disorders
• Less frequent: Jaundice, increased liver function tests, hepatitis.
• Skin and subcutaneous tissue disorders
• Less frequent: Urticaria.
• Musculoskeletal, connective tissue and bone disorders
• Less frequent: Musculoskeletal pain, arthralgia, myalgia, muscle cramps.
• Reproductive system and breast disorders
• Less frequent: Sexual dysfunction.
• General disorders and administrative site conditions
• Frequent: Fatigue.
• Less frequent: Chest pain.

The patients should be closely monitored and treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric lavage. KIRBEX TABLETS is not removed from the body by haemodialysis.