SANDOZ LOSARTAN HCT DS

 Patients who are hypersensitive to this drug or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.  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 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 ACEIs, ARBs or aliskiren-containing drugs).

WARNINGS AND PRECAUTIONS Serious Warnings and Precautions When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus. When pregnancy is detected, Sandoz Losartan HCT/ Sandoz Losartan HCT DS should be discontinued as soon as possible (see WARNINGS AND PRECAUTIONS, Special Populations).

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.

The risk may be higher with increasing cumulative use (see ADVERSE REACTIONS, Post Market Adverse Drug Reactions). The photosensitizing action of hydrochlorothiazide may be a possible mechanism for NMSC (see 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. ) (see ADVERSE REACTIONS, Post Market Adverse Drug 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.

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. Sandoz Losartan HCT and Sandoz Losartan HCT DS Page 6 of 36 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 DOSAGE AND ADMINISTRATION and DETAILED 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. Ophthalmologic Acute Myopia and […]