CANDESARTAN CILEXETIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)

Available from:

Par Pharmaceutical Inc.

INN (International Name):

CANDESARTAN CILEXETIL

Composition:

CANDESARTAN CILEXETIL 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Candesartan cilexetil is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Candesartan cilexetil may be used alone or in combination with other antihypertensive agents. Candesartan cilexetil is indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction ≤ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations [see Clinical Studies (14.2) ] . Candesartan cilexetil also has an added effect on these outcomes when used with an ACE inhibitor [see Drug Interactions (7.4)] . Candesartan cilexetil is contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes [see Drug Interactions (7.4)] . Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue candesartan cilexetil as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue candesartan cilexetil, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to candesartan cilexetil for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4) ] . The effect of candesartan cilexetil on labor and delivery in humans is unknown [see Warnings and Precautions (5.1) ]. It is not known whether candesartan is excreted in human milk, but candesartan has been shown to be present in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue candesartan cilexetil, taking into account the importance of the drug to the mother. Neonates with a history of in utero exposure to candesartan cilexetil : If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. The antihypertensive effects of candesartan cilexetil were evaluated in hypertensive children 1 to < 17 years of age in randomized, double-blind clinical studies [see Clinical Studies (14.1) ] . The pharmacokinetics of candesartan cilexetil have been evaluated in pediatric patients 1 to < 17 years of age [see Clinical Pharmacology (12.3) ] . Children < 1 year of age must not receive candesartan cilexetil for hypertension [see Warnings and Precautions (5.2) ].

Product summary:

No. 3782 — Tablets candesartan cilexetil, 4 mg, are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other. They are supplied as follows: NDC 49884-658-09 unit of use bottles of 90. No. 3780 — Tablets candesartan cilexetil, 8 mg, are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other. They are supplied as follows: NDC 49884-659-09 unit of use bottles of 90. No. 3781 — Tablets candesartan cilexetil, 16 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACH on one side and 016 on the other. They are supplied as follows: NDC 49884-660-09 unit of use bottles of 90 No. 3791 — Tablets candesartan cilexetil, 32 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other. They are supplied as follows: NDC 49884-661-09 unit of use bottles of 90 Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature ]. Keep container tightly closed.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL TABLET
PAR PHARMACEUTICAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CANDESARTAN CILEXETIL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CANDESARTAN
CILEXETIL TABLETS.
CANDESARTAN CILEXETIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
Candesartan cilexetil is an angiotensin II receptor blocker (ARB)
indicated for:
•
•
DOSAGE AND ADMINISTRATION
STARTING DOSE
TARGET DOSE
Adult Hypertension (2.1)
16 mg tablet once daily
8 - 32 mg tablet total daily dose
Pediatric Hypertension (1 to < 6
years) (2.2)
0.20 mg/kg oral suspension once
daily
0.05 - 0.4 mg/kg oral suspension once
daily or consider divided dose
Pediatric Hypertension (6 to <
17 years) (2.2)
< 50 kg 4 – 8 mg tablet once
daily
> 50 kg 8 – 16 mg tablet once
daily
< 50 kg 4 – 16 mg tablet once daily or
consider divided dose
> 50 kg 4 – 32 mg tablet once daily or
consider divided dose
Adult Heart Failure (2.3)
4 mg tablet once daily
32 mg tablet once daily
The target dose is 32 mg once daily, which is achieved by doubling the
dose at approximately 2-week
intervals, as tolerated by patient.
DOSAGE FORMS AND STRENGTHS
Tablets 4 mg, 8 mg, 16 mg, 32 mg (3).
CONTRAINDICATIONS
Known hypersensitivity to product components (4).
Do not co-administer aliskiren with candesartan cilexetil in patients
with diabetes (4).
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL AS SOON
AS
POSSIBLE. (5.1, 8.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS. (5.1, 8.1)
Treatment of hypertension in adults and children 1 to < 17 years of
age, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and non-fatal
cardiovascular events, primarily
strokes and myocardial infa