candesartan

REMS

Alone or with other agents in the management of hypertension.
Treatment of heart failure (New York Heart Association class II-IV) in patients with left ventricular systolic dysfunction (ejection fraction 40%) (can be used with an ACE inhibitor and beta-blocker).

Contraindicated in:

Hypersensitivity
Bilateral renal artery stenosis
Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min)
Severe hepatic impairment
OB: Pregnancy (may cause fetal harm)
Lactation: Lactation.

Use Cautiously in:

Volume- or salt-depleted patients or patients receiving large doses of diuretics (correct deficits before initiating therapy or initiate at lower doses)
Black patients (may not be as effective)
Impaired renal function due to primary renal disease or HF (may worsen renal function)
Rep: Women of reproductive potential
Pedi: Children <1 yr (safety and effectiveness not established).

CNS: dizziness, fatigue, headache.

CV: hypotension, chest pain, edema.

F and E: hyperkalemia.

GI: abdominal pain, diarrhea, nausea.

GU: impaired renal function.

MS: arthralgia, back pain.

Misc: ANGIOEDEMA.

Drug-Drug:

NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal impairment.
Additive hypotension with other antihypertensives.
Excessive hypotension may occur with concurrent use of diuretics.
Concurrent use of potassium-sparing diuretics, potassium-containing salt substitutes, or potassium supplements may ↑ risk of hyperkalemia.
↑risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of ACE inhibitors or aliskiren; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/min
May ↑ lithium risk of toxicity.

(Generic available)

Tablets: 4 mg; 8 mg; 16 mg; 32 mg;
In combination with: hydrochlorothiazide (Atacand HCT). See Appendix [not included in this PDA edition].

Hypertension

PO (Adults): 16 mg once daily; may ↑ up to 32 mg/day in 1–2 divided doses (initiate therapy at a lower dose in patients who are receiving diuretics or are volume depleted).
PO (Children 6–16 yr and >50 kg): 8–16 mg/day (in 1–2 divided doses); may ↑ up to 32 mg/day (in 1–2 divided doses).
PO (Children 6–16 yr and <50 kg): 4–8 mg/day (in 1–2 divided doses); may ↑ up to 16 mg/day (in 1–2 divided doses).
PO (Children 1–5 yr): 0.20 mg/kg/day (in 1–2 divided doses); may ↑ up to 0.4 mg/kg/day (in 1–2 divided doses).

Hepatic Impairment

(Adults): Moderate hepatic impairment — Initiate at 8 mg once daily.

Heart Failure

PO (Adults): 4 mg once daily initially, dose may be doubled at 2-wk intervals up to target dose of 32 mg once daily.

Blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II at various receptor sites, including vascular smooth muscle and the adrenal glands.

Therapeutic Effects:

Lowering of BP in patients with hypertension.
Reduced cardiovascular death and heart-failure-related hospitalizations in patients with heart failure.

Therapeutic Classification: antihypertensives

Pharmacologic Classification: angiotensin II receptor antagonists

Absorption: Candesartan cilexetil is a prodrug that is converted to candesartan (the active component); 15% bioavailability of candesartan.

Distribution: Crosses the placenta and enters breast milk.

Protein Binding: >99%.

Metabolism/Excretion: Minor metabolism by the liver; 33% excreted in urine; 67% in feces (via bile).

Half-life: 9 hr.

(antihypertensive effect)

ROUTE	ONSET	PEAK	DURATION
PO	within 2 wk	4–6 wk	unknown

Emphasize the importance of continuing to take as directed, even if feeling well. Take missed doses as soon as remembered if not almost time for next dose; do not double doses. Instruct patient to take medication at the same time each day. Warn patient not to discontinue therapy unless directed by health care professional. Advise patient to read Patient Information prior to starting and with each Rx refill in case of changes.
Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See Appendix M.
Caution patient to avoid sudden position changes to decrease orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially NSAIDs and cough, cold, or allergy remedies.
Instruct patient to notify health care professional of medication regimen before treatment or surgery.
Instruct patient to notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
Advise women of reproductive potential to use contraception and notify health care professional immediately if pregnancy is planned or suspected or if breastfeeding.
Emphasize the importance of follow-up exams to evaluate effectiveness of medication.
Hypertension: Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, stress management). Medication controls but does not cure hypertension.
- Instruct patient and family on proper technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes.

NDC Code^*

33342- Macleods Pharmaceuticals Limited
33342-114- Candesartan 33342-114-07- 30 TABLET in 1 CONTAINER (33342-114-07)

33342- Macleods Pharmaceuticals Limited
33342-114- Candesartan 33342-114-10- 90 TABLET in 1 CONTAINER (33342-114-10)

33342- Macleods Pharmaceuticals Limited
33342-114- Candesartan 33342-114-12- 10 BLISTER PACK in 1 CARTON (33342-114-12) > 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
33342-114- Candesartan 33342-114-51- 300 TABLET in 1 CONTAINER (33342-114-51)

33342- Macleods Pharmaceuticals Limited
33342-115- Candesartan 33342-115-07- 30 TABLET in 1 CONTAINER (33342-115-07)

33342- Macleods Pharmaceuticals Limited
33342-115- Candesartan 33342-115-10- 90 TABLET in 1 CONTAINER (33342-115-10)

33342- Macleods Pharmaceuticals Limited
33342-115- Candesartan 33342-115-12- 10 BLISTER PACK in 1 CARTON (33342-115-12) > 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
33342-115- Candesartan 33342-115-51- 300 TABLET in 1 CONTAINER (33342-115-51)

33342- Macleods Pharmaceuticals Limited
33342-116- Candesartan 33342-116-07- 30 TABLET in 1 CONTAINER (33342-116-07)

33342- Macleods Pharmaceuticals Limited
33342-116- Candesartan 33342-116-10- 90 TABLET in 1 CONTAINER (33342-116-10)

33342- Macleods Pharmaceuticals Limited
33342-116- Candesartan 33342-116-12- 10 BLISTER PACK in 1 CARTON (33342-116-12) > 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
33342-116- Candesartan 33342-116-51- 300 TABLET in 1 CONTAINER (33342-116-51)

33342- Macleods Pharmaceuticals Limited
33342-117- Candesartan 33342-117-07- 30 TABLET in 1 CONTAINER (33342-117-07)

33342- Macleods Pharmaceuticals Limited
33342-117- Candesartan 33342-117-10- 90 TABLET in 1 CONTAINER (33342-117-10)

33342- Macleods Pharmaceuticals Limited
33342-117- Candesartan 33342-117-12- 10 BLISTER PACK in 1 CARTON (33342-117-12) > 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
33342-117- Candesartan 33342-117-51- 300 TABLET in 1 CONTAINER (33342-117-51)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆