Dosing and uses of Atacand HCT (candesartan-hydrochlorothiazide)
Adult dosage forms and strengths
candesartan/hydrochlorothiazide
tablet
- 16mg/12.5mg
- 32mg/12.5mg
- 32mg/25mg
Hypertension
16-32 mg candesartan/12.5-25 mg HCTZ PO qDay; optimum therapeutic effect expected within 4 weeks
Pediatric dosage forms and strengths
Safety & efficacy not established
Atacand HCT (candesartan-hydrochlorothiazide) adverse (side) effects
Adverse reactions with combination products and individual agents
1-10%
Headache (3%)
Dizziness (3%)
Upper respiratory tract infection (4%)
Back pain (3%)
Flu-like syndrome (2%)
Frequency not defined
Candesartan
- Peripheral edema
- Dizziness
- Fatigue
- Abdominal pain
- Diarrhea
- Nausea
- Arthralgia
- Back pain
- Chest pain
- Albuminuria
- Bronchitis
- Coughing
- Pharyngitis
- Rhinitis
- URI
Hydrochlorothiazide
- Anorexia
- Epigastric distress
- Hypotension
- Orthostatic hypotension
- Photosensitivity
- Anaphylaxis
- Anemia
- Confusion
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Dizziness
- Headache
- Hyperuricemia
- Hypokalemia and/or hypomagnesemia
Warnings
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
Contraindications
Hypersensitivity to candesartan, hydrochlorothiazide, or sulfonamides
Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality
Gout
Refractory hypercalcemia
Refractory hypokalemia
Severe hepatic impairment and/or cholestasis
Do not coadminister with aliskiren in patients with diabetes mellitus
As initial therapy
Cautions
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 and lactation
Pregnancy category: C (1st trimester); D (2nd and 3rd trimesters)
Lactation: enters breast milk/contraindicated
Pregnancy categories
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.
