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MAR-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: AND CLINICAL USE .................................................................................................. 3 CONTRAINDICATIONS ....................................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions When used in pregnancy, angiotensin receptor (AT1) blockers (ARBs) can cause injury or even death of the developing fetus. When pregnancy is detected, MAR-CANDESARTAN / HCTZ should be discontinued as soon as possible (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
73m2). Therefore, the use of MAR-CANDESARTAN / HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see CONTRAINDICATIONS). Further, co-administration of ARBs, including the candesartan cilexetil component of MAR- 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 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 anaesthesia.
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.
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.
Page 6 of 46 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.
MAR-CANDESARTAN / HCTZ (candesartan cilexetil/hydrochlorothiazide) is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. Patients with anuria and patients who are hypersensitive to other sulfonamide-derived drugs, because of the hydrochlorothiazide component (see WARNINGS AND PRECAUTIONS, Immune and ADVERSE REACTIONS, Post-Market Adverse Drug Reactions).
Pregnant women (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women). Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations, Nursing Women). Children aged < 1 year. 73m2) (see WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and DRUG INTERACTIONS, Dual Blockade of the Renin- Angiotensin-System (RAS) with ARBs, ACEIs or aliskiren-containing drugs).
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. Page 5 of 46 WARNINGS AND PRECAUTIONS Serious Warnings and Precautions When used in pregnancy, angiotensin receptor (AT1) blockers (ARBs) can cause injury or even death of the developing fetus.
When pregnancy is detected, MAR-CANDESARTAN / HCTZ should be discontinued as soon as possible (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women). 73m2). Therefore, the use of MAR-CANDESARTAN / HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see CONTRAINDICATIONS).
Further, co-administration of ARBs, including the candesartan cilexetil component of MAR- 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.
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.
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).
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. Treatment with a thiazide diuretic may impair glucose tolerance. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
However, at the doses contained in MAR-CANDESARTAN / HCTZ, minimal effects were observed. General Page 7 of 46 Driving and Operating Machinery The effect of MAR-CANDESARTAN / HCTZ on the ability to drive and use machines has not been studied, but based on its pharmacodynamic properties MAR-CANDESARTAN / HCTZ 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 during treatment of hypertension. 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 DOSAGE AND ADMINISTRATION, Hepatic Impairment).
MAR-CANDESARTAN / HCTZ is contraindicated in patients with severe hepatic failure and/or cholestasis (see CONTRAINDICATIONS). No studies were carried out with candesartan cilexetil/hydrochlorothiazide fixed combination in patients […]
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 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 anaesthesia.
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.
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.
Page 6 of 46 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).
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 […]
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