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NRA-OLMESARTAN 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.
Verbatim from this product's HC label. Tap a section to expand.
). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥65 years of age): Reported clinical experience has not identified differences in responses between elderly and younger patients, however, greater sensitivity of some older individuals cannot be ruled out (see 4 DOSAGE AND ADMINISTRATION).
2. CONTRAINDICATIONS • NRA-Olmesartan HCTZ 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 Post Market Adverse Reactions). The photosensitizing action of hydrochlorothiazide may be a possible mechanism for NMSC (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity – 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.
6 Post Market Adverse Reactions). , those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with NRA-Olmesartan HCTZ. Treatment should start 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.
If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline (see 4 DOSAGE AND ADMINISTRATION). When electrolyte and fluid imbalances have been corrected, therapy usually can be continued without difficulty.
A transient hypotensive response is not a contraindication to further treatment. • Valvular Stenosis: there is concern on theoretical grounds that patients with aortic stenosis might be at a particular risk of decreased coronary perfusion, because they do not develop as much afterload reduction.
73m2). Therefore, the use of NRA-Olmesartan HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see 2 CONTRAINDICATIONS). Further, co- administration of ARBs, including the “olmesartan medoxomil” component of NRA- Olmesartan HCTZ, with other agents blocking the RAS, such as ACE inhibitors or aliskiren-containing drugs, is generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure and hyperkalemia.
1 Pregnant Women 11/2025 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis, Non-Melanoma Skin Cancer 11/2020 7 WARNINGS and PRECAUTIONS, Sensitivity/Resistance, Photosensitivity 11/2020 TABLE OF CONTENTS 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 ........................................ 3 Reconstitution...........................................................................................
4 Administration....................................................... .................................... 5 Missed Dose............................................................................................. 7 5 OVERDOSAGE ..................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING............ 8 7 WARNINGS AND PRECAUTIONS .................................................................... 1 Special Populations ................................................................................
1 Pregnant Women ................................................................................... 2 Breast-feeding ........................................................................................ 3 Pediatrics (<18 years of age) .................................................................
1 Pregnant Women 11/2025 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis, Non-Melanoma Skin Cancer 11/2020 7 WARNINGS and PRECAUTIONS, Sensitivity/Resistance, Photosensitivity 11/2020 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...................................................
4 1 INDICATIONS ..................................................................................................... 1 Pediatrics ................................................................................................. 2 Geriatrics ..................................................................................................
4 2 CONTRAINDICATIONS ..................................................................................... 4
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.
Endocrine and Metabolism Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals. All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis and hypokalemia.
Serum and urine electrolyte determinations are important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular 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. NRA-Olmesartan HCTZ contains olmesartan, a drug that inhibits the renin-angiotensin NRA-Olmesartan HCTZ Product Monograph Page 11 of 43 system (RAS).
Drugs that inhibit the RAS can cause hyperkalaemia. Monitor serum electrolytes periodically. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. , increased ventricular irritability). Although 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), chloride replacement may be required in the treatment of metabolic alkalosis.
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.
Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Thiazides may decrease urinary calcium excretion. Thiazides 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. Thiazides may decrease PBI levels without signs of thyroid […]
4 Geriatrics (≥65 years of age) .................................................................. 14 8 ADVERSE REACTIONS................................................................................... 1 Adverse Reaction Overview ...................................................................
2 Clinical Trial Adverse Reactions ............................................................. 3 Less Common Clinical Trial Adverse Reactions (<1%) .......................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .........................................................................
5 Clinical Trial Adverse Reactions (Pediatrics) .......................................... 6 Post-Market Adverse Reactions ............................................................. 18 9 DRUG INTERACTIONS....................................................................................
1 Serious Drug Interactions Box ................................................................ 2 Overview ................................................................................................ 3 Drug-Drug Interactions ...........................................................................
4 Drug-Food Interactions........................................................................... 5 Drug-Herb Interactions ........................................................................... 6 Drug-Laboratory Test Interactions ..........................................................
7 Drug-Lifestyle Interactions ...................................................................... 24 10 ACTION AND CLINICAL PHARMACOLOGY .................................................. 1 Mechanism of Action ..............................................................................
2 Pharmacodynamics ................................................................................ 3 Pharmacokinetics ................................................................................... 26 11 STORAGE, STABILITY AND DISPOSAL ........................................................
27 12 SPECIAL HANDLING INSTRUCTIONS ........................................................... 27 PART II: SCIENTIFIC INFORMATION ........................................................................ 28 13 PHARMACEUTICAL INFORMATION ..............................................................
28 14 CLINICAL TRIALS ........................................................................................... 1 Trial Design and Study Demographics ................................................... 2 Study Results .........................................................................................
3 Comparative Bioavailability Studies ....................................................... 32 15 MICROBIOLOGY.............................................................................................. 33 16 NON-CLINICAL TOXICOLOGY .......................................................................
33 17 SUPPORTING PRODUCT MONOGRAPHS .................................................... 36 PATIENT MEDICATION INFORMATION .................................................................... 37 NRA-Olmesartan HCTZ Product Monograph Page 4 of 43 PART I: HEALTH PROFESSIONAL INFORMATION 1.
INDICATIONS NRA-Olmesartan HCTZ (Olmesartan Medoxomil and Hydrochlorothiazide) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. NRA-Olmesartan HCTZ is not indicated for initial therapy (see 4 DOSAGE AND […]
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