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PENDO-TELMISARTAN-HCTZ is a brand name for Telmisartan, 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.
73m2) is contraindicated (see WARNINGS and PRECAUTIONS, Cardiovascular, 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 who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph Pregnant women (see WARNINGS AND PRECAUTIONS, Special Populations – Pregnant Women) Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations – Nursing Women) Patients with anuria due to the presence of hydrochlorothiazide WARNINGS AND PRECAUTIONS General A case of rare but fatal angioedema occurred in a patient who had been medicated for about 6 months with telmisartan, one of the active components of telmisartan/hydrochlorothiazide.
The Autopsy Report described evidence of edema of the laryngeal mucosa, with terminal respiratory and circulatory failure. 2 million patient-years exposure to telmisartan annually. If laryngeal stridor or angioedema of the face, extremities, lips, tongue, or glottis occurs, pendo-TELMISARTAN-HCTZ should be discontinued immediately, the patient treated appropriately in accordance with accepted medical care, and carefully observed until the swelling disappears.
In instances where swelling is confined to the face and lips, the condition generally resolves without treatment, although antihistamines may be useful in relieving symptoms. Where there is involvement of tongue, glottis, or larynx, likely to cause airway 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, pendo-TELMISARTAN-HCTZ should be discontinued as soon as possible (see WARNINGS AND PRECAUTIONS, Special Populations). 5 mL of subcutaneous epinephrine solution 1:1000) should be administered promptly (see ADVERSE REACTIONS - Post Marketing Adverse Drug Reactions).
Patients with a known hypersensitivity (anaphylaxis) or angioedema to ARBs should not be treated with pendo-TELMISARTAN-HCTZ (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions -All Clinical Trials, Immune System, Not known: angioedema and ADVERSE REACTIONS - Post Market Adverse Drug Reactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Telmisartan 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.
Carcinogenesis and Mutagenesis See TOXICOLOGY, Carcinogenicity and Mutagenicity. Cardiovascular Hypotension In patients who are volume-depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting, symptomatic hypotension may occur after initiation of therapy with telmisartan.
Such conditions, especially volume and/or sodium depletion, should be corrected prior to administration of telmisartan. In these patients, because of the potential fall in blood pressure, therapy with telmisartan should be initiated 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. Aortic and Mitral Valve Stenosis, Obstructive Hypertrophic Cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
These patients are at risk of decreased coronary perfusion resulting from a cardiac output that is limited by a fixed cardiac vascular obstruction. 73m2). Therefore, the use of pendo-TELMISARTAN-HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see CONTRAINDICATIONS).
Further, co-administration of ARBs, including the telmisartan component of pendo-TELMISARTAN-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, renal failure, and hyperkalemia.
5 mg) in combination, there were no reports of hyperkalemia. 4% of patients treated with the combination. No discontinuations due to hypokalemia occurred during treatment. The absence of significant changes in serum potassium levels may be due to the opposing mechanisms of action of telmisartan and hydrochlorothiazide on potassium excretion by the kidney.
The use of a dual renin-angiotensin-aldosterone system (RAAS) blockade may lead to increased occurrence of hyperkalemia when given as add-on therapy in patients with controlled blood pressure. Hydrochlorothiazide During thiazide diuretic therapy, periodic determinations of serum electrolytes to […]