|
Atacand®
candesartan cilexetil
Composition
Each tablet contains 8 mg or 16 mg candesartan cilexetil.
Pharmaceutical form
Atacand 8 mg are round (diameter 7 mm), light pink tablets with a score and
marked A/CG on one side and marked 008 on the other side.
Atacand 16 mg are round (diameter 7 mm), pink tablets with a score and
marked A/CH on one side and marked 016 on the other side.
Therapeutic indication
Treatment of hypertension.
Treatment of patients with heart failure and impaired left ventricle
systolic function (left ventricular ejection fraction ≤40%) as add-on
therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Posology and method of administration
Dosage in Hypertension
The recommended initial dose and usual maintenance dose is 8 mg once daily.
The dose may be increased to 16 mg once daily. If blood pressure is not
sufficiently controlled after 4 weeks of treatment with 16 mg once daily,
the dose may be further increased to a maximum of 32 mg once daily (see
Pharmacodynamic properties). If blood pressure control is not achieved with
this dose, alternative strategies should be considered.
Therapy should be adjusted according to blood pressure response. Most of the
antihypertensive effect is attained within 4 weeks of initiation of
treatment.
Use in the elderly
No initial dosage adjustment is necessary in elderly patients.
Use in patients with intravascular volume depletion
An initial dose of 4 mg may be considered in patients at risk for
hypotension, such as patients with possible volume depletion (see Special
warnings and special precautions for use).
Use in impaired renal function
No initial dosage adjustment is necessary in patients with mild to moderate
renal impairment
(i.e. creatinine clearance ≥30 ml/min/1.73 m2 BSA). In
patients with severe renal impairment
(i.e. creatinine clearance <30 ml/ min/1.73 m2 BSA), the clinical
experience is limited and a lower initial dose of 4 mg should be considered.
Use in impaired hepatic function
No initial dosage adjustment is necessary in patients with mild to moderate
chronic liver disease.
There is only limited experience available in patients with severe hepatic
impairment and/or cholestasis. A lower initial dose of 4 mg should therefore
be considered in these patients.
Concomitant therapy
Addition of a thiazide-type diuretic such as hydrochlorothiazide has been
shown to have an additive antihypertensive effect with Atacand.
Use in black patients
The antihypertensive effect of candesartan is less in black than non-black
patients. Consequently, uptitration of Atacand and concomitant therapy may
be more frequently needed for blood pressure control in black than non-black
patients (see also Pharmacodynamic properties).
Dosage in Heart Failure
The usual recommended initial dose of Atacand is 4 mg once daily.
Up-titration to the target dose of 32 mg once daily or the highest tolerated
dose is done by doubling the dose at intervals of at least 2 weeks (see
section Special warnings and special precautions for use).
Special patient populations
No initial dose adjustment is necessary for elderly patients or in patients
with intravascular volume depletion, renal impairment or mild to moderate
hepatic impairment.
Concomitant therapy
Atacand can be administered with other heart failure treatment, including
ACE inhibitors, beta-blockers, diuretics and digitalis or a combination of
these medicinal products (see also section Special warnings and special
precautions for use and Pharmacodynamic properties).
Administration
Atacand should be taken once daily with or without food.
Use in children and adolescents
The safety and efficacy of Atacand have not been established in children and
adolescents (under 18 years).
Contraindications
Hypersensitivity to candesartan cilexetil or to any of the excipients.
Pregnancy and lactation (see
Pregnancy and lactation).
Special warnings and special
precautions for use
Renal impairment
As with other agents inhibiting the renin-angiotensin-aldosterone system,
changes in renal function may be anticipated in susceptible patients treated
with Atacand.
When Atacand is used in hypertensive patients with severe renal impairment,
periodic monitoring of serum potassium and creatinine levels is recommended.
There is limited experience in patients with very severe or end-stage renal
impairment (CIcreatinine <15 ml/min). In these patients Atacand
should be carefully titrated with thorough monitoring of blood pressure.
Evaluation of patients with heart failure should include periodic
assessments of renal function, especially in elderly patients 75 years or
older, and patients with impaired renal function. During dose titration of
Atacand, monitoring of serum creatinine and potassium is recommended.
Clinical trials in heart failure did not include patients with serum
creatinine >265 µmol/L (>3 mg/dL).
Concomitant therapy with an ACE inhibitor in heart failure
The risk of adverse events, especially renal function impairment and
hyperkalaemia, may increase when candesartan is used in combination with an
ACE inhibitor (see Undesirable effects). Patients with such treatment should
be monitored regularly and carefully.
Haemodialysis
During dialysis the blood pressure may be particularly sensitive to AT1-receptor
blockade as a result of reduced plasma volume and activation of the
renin-angiotensin-aldosterone system. Therefore, Atacand should be carefully
titrated with thorough monitoring of blood pressure in patients on
haemodialysis.
Renal artery stenosis
Other medicinal products that affect the renin-angiotensin-aldosterone
system, i.e. angiotensin converting enzyme (ACE) inhibitors, may increase
blood urea and serum creatinine in patients with bilateral renal artery
stenosis or stenosis of the artery to a solitary kidney. A similar effect
may be anticipated with angiotensin II receptor antagonists.
Kidney transplantation
There is no experience regarding the administration of Atacand in patients
with a recent kidney transplantation.
Hypotension
Hypotension may occur during treatment with Atacand in heart failure
patients. As described for other agents acting on the
renin-angiotensin-aldosterone system, it may also occur in hypertensive
patients with intravascular volume depletion such as those receiving high
dose diuretics. Caution should be observed when initiating therapy and
correction of hypovolemia should be attempted.
Anaesthesia and surgery
Hypotension may occur during anaesthesia and surgery in patients treated
with angiotensin II antagonists due to blockade of the renin-angiotensin
system. Very rarely, hypotension may be severe such that it may warrant the
use of intravenous fluids and/or vasopressors.
Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy)
As with other vasodilators, special caution is indicated in patients
suffering from haemodynamically relevant aortic or mitral valve stenosis, or
obstructive hypertrophic cardiomyopathy.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism will not generally respond to
antihypertensive medicinal products acting through inhibition of the
renin-angitensin-aldosterone system. Therefore, the use of Atacand is not
recommended.
Hyperkalaemia
Based on experience with the use of other medicinal products that affect the
renin-angiotensinaldosterone system, concomitant use of Atacand with
potassium-sparing diuretics, potassium supplements, salt substitutes
containing potassium, or other medicinal products that may increase
potassium levels (e.g. heparin) may lead to increases in serum potassium in
hypertensive patients.
In heart failure patients treated with Atacand, hyperkalaemia may occur.
During treatment with Atacand in patients with heart failure, periodic
monitoring of serum potassium is recommended, especially when taken
concomitantly with ACE inhibitors and potassium-sparing diuretics such as
spironolactone.
General
In patients whose vascular tone and renal function depend predominantly on
the activity of the reninangiotensin-aldosterone system (e.g. patients with
severe congestive heart failure or underlying renal disease, including renal
artery stenosis), treatment with other medicinal products that affect this
system has been associated with acute hypotension, azotaemia, oliguria or,
rarely, acute renal failure. The possibility of similar effects cannot be
excluded with angiotensin II receptor antagonists. As with any anti
hypertensive agent, excessive blood pressure decrease in patients with
ischaemic cardiopathy or ischaemic cerebrovascular disease could result in a
myocardial infarction or stroke.
Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucosegalactose malabsorption should not take this
medicinal product.
1
2
3 |
