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PMS-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: pms-CANDESARTAN-HCTZ (candesartan cilexetil/hydrochlorothiazide) is indicated for: • the treatment of essential hypertension in patients for whom combination therapy is appropriate. pms-CANDESARTAN-HCTZ is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). The dosage of pms-CANDESARTAN-HCTZ must be…
Verbatim from this product's HC label. Tap a section to expand.
). The dosage of pms-CANDESARTAN-HCTZ must be individualized. The dose of pms-CANDESARTAN-HCTZ should be determined by titration of the individual components. 3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS pms-CANDESARTAN-HCTZ (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, pms-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. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
pms-CANDESARTAN-HCTZ (candesartan cilexetil / hydrochlorothiazide) Page 10 of 51 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. , 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.
, Respiratory 10/2023 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 03/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics .....................................................................................................................
2 Geriatrics ..................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
7 5 OVERDOSAGE .................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING........................................ 8 7 WARNINGS AND PRECAUTIONS .........................................................................................
pms-CANDESARTAN-HCTZ (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. pms-CANDESARTAN-HCTZ (candesartan cilexetil / hydrochlorothiazide) Page 5 of 51 • 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.
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 pms-CANDESARTAN-HCTZ (candesartan cilexetil / hydrochlorothiazide) Page 11 of 51 diuretic therapy.
However, at the doses contained in candesartan cilexetil/hydrochlorothiazide, 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).
pms-CANDESARTAN-HCTZ 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 pms-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.
pms-CANDESARTAN-HCTZ (candesartan cilexetil / hydrochlorothiazide) Page 12 of 51 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 pms-CANDESARTAN-HCTZ, or […]
1 Special Populations ................................................................................................... 1 Pregnant Women ......................................................................................................
2 Breast-feeding ........................................................................................................... 3 Pediatrics ...................................................................................................................
4 Geriatrics ................................................................................................................... 14 8 ADVERSE REACTIONS .......................................................................................................
1 Adverse Reaction Overview ....................................................................................... 2 Clinical Trial Adverse Reactions .................................................................................
3 Less Common Clinical Trial Adverse Reactions .......................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions ................................................................................ 19 9 DRUG INTERACTIONS .......................................................................................................
1 Serious Drug Interactions .......................................................................................... 2 Drug Interactions Overview .......................................................................................
3 Drug-Behavioural Interactions................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions.............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 27 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action................................................................................................. 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 28 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
31 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 31 13 PHARMACEUTICAL INFORMATION................................................................................... 32 14 CLINICAL TRIALS ...............................................................................................................
1 Clinical Trials by Indication ........................................................................................ 2 Comparative Bioavailability Studies ..........................................................................
36 15 MICROBIOLOGY […]
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