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SANDOZ LOSARTAN HCT 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: Hypertension: Sandoz Losartan HCT / Sandoz Losartan HCT DS (losartan potassium and hydrochlorothiazide) is indicated for: • the treatment of essential hypertension in patients for whom combination therapy is appropriate Sandoz Losartan HCT / Sandoz Losartan HCT DS is not indicated as the initial therapy for essential…
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS). 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): No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see 4 DOSAGE AND ADMINISTRATION).
2 CONTRAINDICATIONS • Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see
5 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.
5 Post Market Adverse Reactions).
Cardiovascular Hypotension:
Occasionally, symptomatic hypotension has occurred after administration of losartan, in some cases after the first dose. It is more likely to occur in patients who are volume- depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
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. 73m2). Therefore, the use of losartan potassium and hydrochlorothiazide tablets in combination with aliskiren-containing drugs is contraindicated in these patients.
Co-administration of ARBs, including losartan potassium and hydrochlorothiazide tablets, with other agents blocking the RAS, such as ACEIs or aliskiren- containing drugs, is not recommended in any patients, as adverse outcomes cannot be excluded.
, Respiratory 03/2023 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.............................................................................................................
• Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Because of the hydrochlorothiazide component, Sandoz Losartan HCT/ Sandoz Losartan HCT DS is also contraindicated in patients with anuria, and in patients who are hypersensitive to other sulfonamide-derived drugs.
73 m2) is contraindicated (see 7 WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ACEIs, ARBs or aliskiren-containing drugs).
Sandoz Losartan HCT and Sandoz Losartan HCT DS Page 5 of 51
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 Metabolism:
Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy. Thiazides may decrease serum PBI 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. 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. Increases in cholesterol, triglyceride and glucose levels may be associated with thiazide diuretic therapy.
Hepatic/Biliary/Pancreatic Patients with Liver Impairment:
Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan and its active metabolite in cirrhotic patients after administration of losartan potassium, a lower dose should be considered for patients with hepatic impairment, or a history of hepatic impairment (see 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY).
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Immune Sandoz Losartan HCT and Sandoz Losartan HCT DS Page 11 of 51 Hypersensitivity: Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma.
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported in patients treated with hydrochlorothiazide. Anaphylactic reactions, angioedema (involving swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, and/or tongue and pharynx, requiring intubation/tracheotomy in some cases) have been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with ACE inhibitors.
Vasculitis, including Henoch-Schoenlein purpura, has been reported rarely. Ophthalmologic Choroidal Effusion, Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulphonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion, acute transient myopia and 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 hydrochlorothiazide 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 sulphonamide or penicillin allergy.
Renal Renal Impairment:
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal functions have been reported in susceptible […]
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 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.................................................................................... 17 9 DRUG INTERACTIONS ...............................................................................................
1 Serious Drug Interactions ............................................................................................. 4 Drug-Drug Interactions .................................................................................................
5 Drug-Food Interactions ................................................................................................. 6 Drug-Herb Interactions .................................................................................................
7 Drug-Laboratory Test Interactions................................................................................ 24 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ....................................................................................................
2 Pharmacodynamics ....................................................................................................... 3 Pharmacokinetics ..........................................................................................................
25 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 27 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 28 PART II: SCIENTIFIC INFORMATION ......................................................................................
28 13 PHARMACEUTICAL INFORMATION ........................................................................... 28 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ........................................................................................... 2 Comparative Bioavailability Studies ......................................................................
31 15 MICROBIOLOGY ....................................................................................................... 33 16 NON-CLINICAL TOXICOLOGY .....................................................................................
33 17 SUPPORTING PRODUCT […]
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