Cavapro Tablet 75mg10 tablets
Cavapro 75 tablet: White, parallel capsule shaped tablet; each tablet contains Irbesartan USP 5mg.
Cavapro 150 tablet: White, parallel capsule shaped tablet; each tablet contains Irbesartan USP150mg.
Cavapro 300 tablet: White, parallel capsule shaped tablet; each tablet contains Irbesartan USP300mg.
Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part
an antihypertensive drug regimen.
Dosage and administration
The usual recommended initial and maintenance dose is 150 mg (Cavapro 150) once daily, with or without food. Cavapro 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
(Cavapro 75) could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients
insufficiently controlled with 150 mg (Cavapro 150) once daily, the dose of Cavapro can be increased to 300 mg (Cavapro 300), or
other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown
to have an additive effect with Cavapro. In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg (Cavapro
150) once daily and titrated up to 300 mg (Cavapro 300) once daily as the preferred maintenance dose for treatment of renal
disease. The demonstration of renal benefit of Cavapro in hypertensive type 2 diabetic patients is based 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 of 75 mg (Cavapro 75) should be
considered for patients undergoing haemodialysis. Intravascular volume depletion: volume and/or sodium depletion should be
corrected prior to administration of Cavapro. 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 patients:
although consideration should be given to initiating therapy with 75 mg (Cavapro 75) in patients over 75 years of age, dosage
adjustment is not usually necessary for the elderly
Paediatric patients: Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and
Contra-indications, warnings, etc.
Contra-indications: Hypersensitivity to Irbesartan.
Pregnancy and lactation:
Pregnancy: Irbesartan is contraindicated in the second and third trimesters of pregnancy. In the second and third trimesters,
substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia
and even foetal death. As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A
switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed,
irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if,
inadvertently, the treatment was taken for a long period.
Lactation: Irbesartan is contraindicated during lactation. It is not known whether irbesartan is excreted in human milk.
Irbesartan is excreted in the milk of lactating rats. Precautions: 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, diarrhoea or vomiting. Such conditions should be corrected before the administration of
Renovascular hypertension: 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 drugs that affect the
reninangiotensin- aldosterone 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 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 favourable in women and non-white subjects.
Hyperkalaemia: as with other drugs that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the
treatment with Irbesartan, 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 anti-hypertensive drugs acting through
inhibition of the renin-angiotensin system. Therefore, the use of Irbesartan is not recommended.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the
renin-angiotensinaldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including
renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect
this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure. As with any
anti-hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular
disease could result in a myocardial infarction or stroke.
Paediatric patients: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are
insufficient to support an extension of the use in children until further data become available. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Adverse reactions: The frequency of adverse reactions listed below is defined using the following convention: very common, common,
uncommon, rare, and very rare. Within each frequency grouping, undesirable effects are presented in order of decreasing
Hypertension: the incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or
duration of treatment. The following adverse drug reactions were reported: Nervous system disorders: Common: dizziness Cardiac
disorders: Uncommon: tachycardia Vascular disorders: Uncommon: flushing Respiratory, thoracic and mediastinal disorders: Uncommon:
cough Gastrointestinal disorders: Common: nausea/vomiting, Uncommon: diarrhoea, dyspepsia/heartburn Reproductive system and
breast disorders: Uncommon: sexual dysfunction General disorders and administration site conditions: Common: fatigue, Uncommon:
chest pain Investigations: Common: significant increases in plasma creatine kinase were commonly observed in irbesartan treated
subjects. None of these increases were associated with identifiable clinical musculoskeletal events.
Hypertension and type 2 diabetes with renal disease: in addition to the adverse drug reactions mentioned under hypertension, in
diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension
were reported. In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, the following additional
adverse reactions were reported. Nervous system disorders: Common: orthostatic dizziness
Vascular disorders: Common: orthostatic hypotension Musculoskeletal, connective tissue and bone disorders: Common: musculoskeletal
pain. Investigations: Hyperkalaemia occurred more often in diabetic patients treated with irbesartan than with placebo. In
diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (³5.5 mEq/L) occurred in 29.4% (i.e.
very common) of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. In diabetic
hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (³5.5 mEq/L) occurred in 46.3% (i.e.
very common) of the patients in the irbesartan group and 26.3% of the patients in the placebo group. A decrease in haemoglobin,
which was not clinically significant, has been observed in 1.7% (i.e. common) of hypertensive patients with advanced diabetic
renal disease treated with irbesartan.
The following additional adverse reactions have been reported during post-marketing experience: Immune system disorders: as with
other angiotensin II receptor antagonists, rare cases of hypersensitivity reactions such as rash, urticaria, angioedema have been
reported; Metabolism and nutrition disorders: hyperkalaemia Nervous system disorders: headache Ear and labyrinth disorders:
Gastrointestinal disorders: dysgeusia Hepato-biliary disorders: hepatitis, abnormal liver function Musculoskeletal,connective
tissue and bone disorders: Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle
cramps Renal and urinary disorders: Impaired renal function including cases of renal failure in patients at risk. Skin and
subcutaneous tissue disorders: Leukocytoclastic vasculitis
Drug interactions: Diuretics and other antihypertensive agents: prior treatment with high dose diuretics may result in volume
depletion and a risk of hypotension when initiating therapy with Irbesartan.
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other drugs that affect the
renin-angiotensin system, concomitant use of potassiumsparing diuretics, potassium supplements, salt substitutes containing
potassium or other drugs that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is,
therefore, not recommended.
Lithium: reversible increases 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 > 3 g/day and non-selective NSAIDs), attenuation of the
antihypertensive effect may occur. Additional information on irbesartan interactions: In clinical studies, the pharmacokinetic of
irbesartan is not affected by hydrochlorothiazide. Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by
glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered
with warfarin, a drug metabolised 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.
Overdosage: Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely
manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored, and
the treatment should be symptomatic and supportive. Suggested measures include induction of emesis and/or gastric
lavage. Activated charcoal may be useful in the treatment of overdosage. Irbesartan is not removed by haemodialysis.
Store in a cool and dry place, protected from light.
Cavapro 75 tablet: Cartons containing 30 tablets in blister pack.
Cavapro 150 tablet: Cartons containing 30 tablets in blister pack.
Cavapro 300 tablet: Cartons containing 10 tablets in blister pack.