CANDERIN

Tablet

:: KOMPOSISI ::
CANDERIN 8 mg
Tiap tablet CANDERIN 8 mg mengandung:
Candesartan cilexetil 8 mg
CANDERIN 16 mg
Tiap tablet CANDERIN 16 mg mengandung:
Candesartan cilexetil 16 mg

:: INDIKASI ::
Hipertensi.
Pengobatan pada pasien dengan gagal jantung dan gangguan fungsi
sistolik ventrikel kiri (LVEF =40%) ketika obat penghambat ACE tidak
ditoleransi.

:: DOSIS DAN CARA PENGGUNAAN ::
Dosis pada hipertensi
Dosis awal candesartan yang direkomendasikan adalah 4 mg per hari dan dapat
ditingkatkan hingga 16 mg satu kali sehari. Efek antihipertensi maksimal akan
dicapai dalam waktu 4 minggu setelah pengobatan.
Dosis pada gagal jantung
Dosis awal candesartan yang direkomendasikan adalah 4 mg per hari.
Candesartan hanya digunakan satu kali sehari dengan atau tanpa makanan.

:: KONTRAINDIKASI ::
Pasien yang hipersensitif terhadap candesartan atau komponen yang
terkandung dalam formulasinya.
Wanita hamil dan menyusui.
Gangguan hati yang berat dan/ ketoasidosis.

:: PERINGATAN DAN PERHATIAN ::
Jika candesartan digunakan pada pasien hipertensi dengan gangguan
ginjal, disarankan dilakukan pemantauan secara berkala kadar kalium dan
kadar kreatinin dalam serum.
Stenosis arteri renalis, intravascular volume depletion, kehamilan dan
menyusui.

:: EFEK SAMPING ::
Infeksi saluran pernafasan bagian atas, nyeri punggung, dan pusing.

:: KEMASAN DAN NOMOR REGISTRASI ::
CANDERIN 8 mg: kotak, 3 blisters@10 tablet;
CANDERIN 16 mg: kotak, 3 blisters@10 tablet;

Related Information: Abbreviation Index
Manufacturer Dexa Medica
Contents Candesartan cilexetil.
Indications
Treatment of hypertension, heart failure and impaired left
ventricle systolic function (left ventricular ejection fraction
(40%) when ACE-inhibitors are not tolerated.
Dosage
Hypertension: Initially 4 mg once daily. The dose should
be adjusted according to response and with a maximum
dose of 16 mg daily. The maximum effect is achieved
within 4 weeks after initiating therapy.
Elderly: No initial dosage adjustment is necessary.
I mpaired Renal Function: No initial dosage adjustment is
necessary in mild renal impairment. A lower initial dose of
2 mg once daily is suggested for patients with moderate and
severe renal impairment. The dose may be adjusted
according to response.
I mpaired Hepatic Function: An initial dose of 2 mg once
daily is recommended in patients with mild to moderate
hepatic impairment. The dose may be adjusted according to
response. There is no experience in patients with severe
hepatic impairment.
Heart Failure: The usual recommended initial dose 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.
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.
Administration: Candesartan should be taken once daily
with or without food, and can be administered with other
antihypertensive drugs.
Administration May be taken with or without food.
Overdosage
Symptoms: Based on pharmacological considerations, the
main manifestation of an overdose is likely to be
symptomatic hypotension and dizziness.
Treatment: If symptomatic hypotension should occur,
symptomatic treatment should be instituted and vital signs
be monitored. The patient should be placed supine with the
legs elevated. If this is not sufficient, plasma volume
should be increased by infusion of, eg, isotonic saline
solution. Sympathomimetic medicinal products may be
administered if the previously mentioned measures are not
sufficient.
Candesartan is not removed by hemodialysis.
Contraindications
Patients with known hypersensitivity to candesartan or any
ingredient of Canderin. Patient with severe hepatic
impairment and/or cholestasis.
Use in pregnancy & lactation: Canderin tablet is not
recommended in pregnant and lactating women.
Special Precautions
General: In patients whose vascular tone and renal function
depend predominantly on the activity of the renin-
angiotensin-aldosterone system [RAAS (eg, 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, azotemia, oliguria, or
rarely, acute renal failure. The possibility of similar effects
cannot be excluded with angiotensin II receptor
antagonists. As with any antihypertensive 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 glucose-
galactose malabsorption should not take Canderin tablet.
Renal Impairment: As with other agents inhibiting the
RAAS, changes in renal function may be anticipated in
susceptible patients treated with candesartan. When
candesartan is used in hypertensive patients with 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 (CrCl <15 mL/min). In these patients,
candesartan 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, and patients with impaired renal
function. During dose titration of candesartan, monitoring
of serum creatinine and potassium is recommended.
Concomitant Therapy with an ACE Inhibitor in Heart
Failure: The risk of adverse events, especially in renal
function impairment and hyperkalemia, may increase when
candesartan is used in combination with an ACE inhibitor.
Patients with such treatment should be monitored regularly
and carefully.
Haemodialysis: During dialysis, the blood pressure may be
particularly sensitive to AT
1
receptor blockade as a result of
reduced plasma volume and activation of the RAAS.
Therefore, candesartan should be carefully titrated with
thorough monitoring of blood pressure in patients on
haemodialysis.
Renal Artery Stenosis: Other medicinal products that affect
the RAAS, ie, 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.
Hypotension: Symptomatic hypotension may occur.
Patients at particular risk include those with volume- or
salt-depletion secondary to salt restriction, prolonged
diuretic therapy, heart failure or dialysis. In patients with
heart failure, a temporary reduction in the dosage of
candesartan and/or of a diuretic may be needed; blood
pressure should be monitored during dosage escalation and
periodically thereafter.
Surgery/Anesthesia: Hypotension may occur in patients
undergoing major surgery and anesthesia who are receiving
angiotensin II receptor antagonists, including candesartan,
presumably secondry to blockade of the RAAS. Rarely,
hypotension may be severe enough to require volume
expansion 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 RAAS. Therefore, the use of candesartan
is not recommended.
Hyperkalemia: Hyperkalemia may occur in patients with
congestive heart failure receiving candesartan especially in
those receiving concomitant therapy with an ACE inhibitor
and/or a potassium-sparing diuretic eg, spironolactone.
Serum potassium should be monitored during dosage
escalation and periodically thereafter.
Concomitant use of potassium-sparing diuretics, potassium
supplements, salt substitutes-containing potassium, or other
medicinal products that may increase potassium levels (eg,
heparin), may lead to increases of serum potassium in
patients with hypertension.
Sensitivity Reactions: Sensitivity reactions including
various anaphylactoid reaction and/or angioedema have
been reported with use of angiotensin II receptor
antagonists including candesartan. Candesartan is not
recommended in patients with a history of angioedema
associated with or unrelated to ACE or angiotensin II
receptor therapy.
Effects on the Ability to Drive or Operate Machinery:
Caution when driving or doing other things requiring
alertness because of possible dizziness during treatment.
Carcinogenicity: There was no evidence of
carcinogenicity.
Use in pregnancy: When used in pregnancy during the 2nd
and 3rd trimesters, medicinal products that act directly on
the renin-angiotensin system can cause fetal and neonatal
injury (hypotension, renal dysfunction, oliguria and/or
anuria, oligohydramnios, skull hypoplasia, intrauterine
growth retardation) and death. Cases of lung hypoplasia,
facial abnormalities and limb contractures have also been
described.
Candesartan should not be used in pregnancy. If pregnancy
is detected during treatment, candesartan should be
discontinued as soon as possible.
Use in lactation: It is not known whether candesartan is
distributed in breast milk. Discontinue nursing or the use of
Canderin because of the potential risk in nursing infants.
Use in children: The safety and efficacy of candesartan
have not been established in children and adolescents <18
years.
Adverse Drug
Reactions
Adverse effects occurring in 1% of patients receiving
candesartan include back pain, dizziness, upper respiratory
tract infection, pharyngitis and rhinitis. The incidence of
adverse effects was not affected by age, gender or race.
Click to view ADR Monitoring Form
Drug Interactions
Candesartan is eliminated only to a minor extent by hepatic
metabolism (CYP2C9). Available interaction studies
indicate no effect on CYP2C9 and CYP3A4 but the effect
on other cytochrome P-450 isoenzymes is presently
unknown.
The antihypertensive effect of candesartan may be
enhanced by other medicinal products with blood pressure-
lowering properties.
Pharmacokinetic interaction (increased serum lithium
concentrations) when candesartan is used concomitantly
with lithium. Careful monitoring of serum lithium
concentrations is recommended during concomitant use.
When angiotensin II receptor antagonists are administered
simultaneously with nonsteroidal anti-inflammatory drugs
(ie, indometacin), attenuation of the antihypertensive effect
may occur. The bioavailability of candesartan is not
affected by food.
View more drug interactions with Canderin
Pregnancy Category
(US FDA)





Category D: There is positive evidence of human foetal
risk, but the benefits from use in pregnant women may be
acceptable despite the risk (e.g., if the drug is needed in a
life-threatening situation or for a serious disease for which
safer drugs cannot be used or are ineffective).
Storage Store at temperatures below 30C. Protect from light.
Mechanism of Action
Pharmacology: Candesartan is a nonpeptide angiotensin II
antagonist that selectively blocks the binding of angiotensin
II to the AT
1
receptors in tissues eg, vascular smooth
muscle and the adrenal gland. In the renin-angiotensin
system, angiotensin I is converted by angiotensin-
converting enzyme (ACE) to form angiotensin II.
Angiotensin II stimulates the adrenal cortex to synthesize
and secrete aldosterone, which decreases the excretion of
sodium and increases the excretion of potassium.
Angiotensin II also acts as vasoconstrictor in vascular
smooth muscle. By blocking the binding of angiotensin II
to the AT
1
receptors, candesartan causes vasodilation and
decreases the effects of aldosterone. The negative feedback
regulation of angiotensin II on renin secretion is also
inhibited, resulting in a rise in plasma concentrations and
consequent rise in angiotensin II plasma concentrations;
however, these effects do not counteract the blood pressure-
lowering effect that occurs.
Pharmacokinetics: The onset of antihypertensive effect
occurs about 2 hrs after administration and the maximum
effect is achieve within 4 weeks after initiating the therapy.
MIMS Class Angiotensin II Antagonists
ATC Classification
C09CA06 - candesartan ; Belongs to the class of
angiotensin II antagonists. Used in the treatment of
cardiovascular disease.
Drug Classification G
Presentation/Packing Tab 8 mg x 3 x 10's. 16 mg x 3 x 10's.