Dosing & Uses
Dosage Forms & Strengths
16-32 mg candesartan/12.5-25 mg HCTZ PO qDay; optimum therapeutic effect expected within 4 weeks
Safety & efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Adverse reactions with combination products and individual agents
Upper respiratory tract infection (4%)
Back pain (3%)
Flu-like syndrome (2%)
Frequency Not Defined
- Peripheral edema
- Abdominal pain
- Back pain
- Chest pain
- Epigastric distress
- Orthostatic hypotension
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Hypokalemia and/or hypomagnesemia
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death
Hypersensitivity to candesartan, hydrochlorothiazide, or sulfonamides
Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality
Severe hepatic impairment and/or cholestasis
Do not coadminister with aliskiren in patients with diabetes mellitus
As initial therapy
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without history of allergy or bronchial asthma, but are more likely in patients with such a history
Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Photosensitivity may occur
Monitor serum electrolytes periodically; drugs that inhibit the renin-angiotensin system can cause hyperkalemia; hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesema can result in hypokalemia which appears difficult to treat despite potassium repletion
Thiazides decrease urinary calcium excretion and may cause mild elevation of serum calcium; avoid therapy in patients with hypercalcemia
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for renal function changes (including acute renal failure) compared to monotherapy
Caution in aortic mitral stenosis, hepatic impairment, hypercholesterolemia, hypercalcemia, parathyroid disease, pre-existing renal insufficiency, systemic lupus erythematosus, bilateral renal artery stenosis or anuria
Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides
Thiazides may decrease urinary calcium excretion
Symptomatic hypotension most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting’ may require temporarily reducing dose or volume repletion; volume and/or salt depletion should be corrected before initiating therapy
In patients with heart failure, therapy may cause excessive hypotension, which may lead to oliguria, azotemia, and (rarely) with acute renal failure and death; in such patients therapy should be started under close medical supervision; monitor closely for first 2 weeks of treatment and whenever dose of candesartan or diuretic is increased
Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function
Hydrochlorothiazide may raise serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients
Thiazide diuretics reported to cause exacerbation or activation of systemic lupus erythematosus
Pregnancy & Lactation
Pregnancy Category: C (1st trimester); D (2nd and 3rd trimesters)
Lactation: enters breast milk/contraindicated
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.