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TEVA-CANDESARTAN/HCTZ is a brand name for Hydrochlorothiazide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEVA-CANDESARTAN/HCTZ (candesartan cilexetil/hydrochlorothiazide) is indicated for: • the treatment of essential hypertension in patients for whom combination therapy is appropriate. TEVA-CANDESARTAN/HCTZ is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). The dosage of TEVA-CANDESARTAN/HCTZ must…
Verbatim from this product's HC label. Tap a section to expand.
). The dosage of TEVA-CANDESARTAN/HCTZ must be individualized. The dose of TEVA- CANDESARTAN/HCTZ should be determined by titration of the individual components. 3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS Candesartan cilexetil/hydrochlorothiazide is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
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Valvular Stenosis:
There is concern on theoretical grounds that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction. Driving and Operating Machinery The effect of candesartan cilexetil/hydrochlorothiazide on the ability to drive and use machines has not been studied, but based on its pharmacodynamic properties candesartan cilexetil/hydrochlorothiazide is unlikely to affect this ability.
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur TEVA-CANDESARTAN/HCTZ Page 10 of 47 during treatment of hypertension. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
Endocrine and Metabolism Metabolism:
Patients receiving thiazides, including hydrochlorothiazide (HCTZ), should be carefully observed for clinical signs of fluid and electrolyte imbalance (hyponatremia, hypochloremic alkalosis and hypokalemia). Periodic determinations of serum electrolytes, to detect possible electrolyte disturbance, should be performed at appropriate intervals.
Warning signs or symptoms of fluid and electrolyte imbalance include dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. g. increased ventricular irritability).
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
Carcinogenesis and Mutagenesis Non-melanoma skin cancer:
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of the skin] after hydrochlorothiazide therapy was reported in some epidemiological studies. 5 Post-Market Adverse Reactions).
The photosensitizing action of hydrochlorothiazide may be a possible mechanism for NMSC (see Hydrochlorothiazide). Patients taking hydrochlorothiazide should be informed of the potential risk of NMSC. They should be advised to regularly check their skin for new lesions as well as changes to existing ones, and to promptly report any suspicious skin lesions.
g. a broad spectrum sunscreen with a SPF of 30 or higher, clothing, and a hat) when exposed to sunlight or UV light to minimize the risk of skin cancer. 5 Post-Market Adverse Reactions). 73m2). Therefore, the use of TEVA-CANDESARTAN/HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see 2 CONTRAINDICATIONS).
Further, co-administration of ARBs, including the candesartan cilexetil component of TEVA-CANDESARTAN/HCTZ, with other agents blocking the RAS, such as ACEIs or aliskiren- containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, decreased renal function (including acute renal failure), and hyperkalemia.
Avoid the concomitant use of ACE inhibitors and ARBs in patients with diabetic nephropathy. If dual blockade therapy is considered necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Hypotension:
Candesartan cilexetil/hydrochlorothiazide is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
5 Post-Market Adverse Reactions). 1 Pregnant Women). 2 Breast-feeding). • Children aged < 1 year. 4 Drug-Drug Interactions). • Patients with severe hepatic impairment and/or cholestasis. 73 m2 BSA). • Patients with gout. • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydrochlorothiazide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Any chloride deficit during thiazide therapy is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather.
Appropriate therapy is water restriction rather than administration of salt, except in rare instances, when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice. Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy.
Thiazides may decrease serum PBI (protein bound iodine) levels without signs of thyroid disturbance. Thiazides have been shown to increase excretion of magnesium; this may result in hypomagnesemia. Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function. 4 Drug-Drug Interactions). Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
However, at the doses contained in candesartan cilexetil/hydrochlorothiazide tablets, minimal effects were observed.
Hepatic/Biliary/Pancreatic Hepatic Impairment:
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid or electrolyte balance may precipitate hepatic coma. Dose titration is recommended in patients with mild to moderate chronic liver disease (see Hepatic Impairment).
candesartan cilexetil/hydrochlorothiazide is contraindicated in patients with severe hepatic failure and/or cholestasis (see 2 CONTRAINDICATIONS). No studies were carried out with candesartan cilexetil/hydrochlorothiazide fixed combination in patients with impaired hepatic function.
Immune Hypersensitivity Reactions:
Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma.
Systemic Lupus Erythematosus:
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported in patients treated with hydrochlorothiazide. Ophthalmologic Choroidal Effusion, Acute Myopia and Secondary Angle-Closure Glaucoma related to Hydrochlorothiazide: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion, acute transient myopia and/or acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity, blurred vision or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue TEVA-CANDESARTAN/HCTZ as rapidly as possible.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Peri-Operative Considerations Thiazides may increase the responsiveness to tubocurarine.
TEVA-CANDESARTAN/HCTZ Page 12 of 47 Renal Renal Impairment:
As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), changes in renal function have been seen in susceptible individuals. In patients whose renal function may depend on the activity of the RAAS, such as patients with bilateral renal artery stenosis, unilateral renal artery stenosis to a solitary kidney, or severe congestive heart failure, treatment with agents that inhibit this system has been associated with oliguria, progressive azotemia, and rarely, acute renal failure and/or death.
In susceptible patients, concomitant diuretic use may further increase risk. The use of ARBs, including the candesartan cilexetil component of TEVA-CANDESARTAN/HCTZ, or ACEIs with aliskiren-containing drugs is contraindicated in patients with moderate to […]
Occasionally, symptomatic hypotension has occurred after administration of candesartan cilexetil. It is more likely to occur in patients who are volume-depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting, or undergoing surgery with anesthesia.
In these patients, because of the potential fall in blood pressure, therapy should be started under close medical supervision. Similar considerations apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in myocardial infarction or cerebrovascular accident (see
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