Company: Rowex Ltd.
Legal category: Prescription. GMS. Sport prohibited.
Active ingredient: Telmisartan/hydrochlorothiazide 40/12.5mg, 80/12.5mg, 80/25mg.
Description: Oval, biconvex film-coated tablets. 40/12.5mg, 80/12.5mg, 80/25mg: Red, white, yellow, respectively, marked 40 or 80 on one side and 12.5 or 25 on reverse.
Presentation: 40mg/12.5mg-28, €6.47; 80mg/12.5mg-28, €8.18; 80mg/25mg-28, €8.40.
Indication: Treatment of essential hypertension when blood pressure not adequately controlled on telmisartan alone.
Pharmacology: Telmisartan is an orally effective angiotensin II receptor subtype 1 antagonist. In patients with hypertension it reduces both systolic and diastolic blood pressure without affecting pulse rate. HCTZ is a thiazide diuretic. The mechanism of the antihypertensive effect of thiazide diuretics is not fully known. Thiazides have an effect on the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. The diuretic action of HCTZ reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium. The combination of telmisartan and HCTZ has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Dosage: Adult: Titration of individual components recommended. 40/12.5mg, 80/12.5mg or 80/25mg once daily. Elderly: As per adults. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active substances or to any of the excipients. Hypersensitivity to sulphonamide derivatives. Cholestasis and biliary obstructive disorders, severe hepatic or renal impairment, refractory hypokalaemia, hypercalcaemia. Pregnancy, lactation.
Special precautions: If Renin-angiotensin-aldosterone system (RAAS) dual blockade is considered necessary use only under specialist supervision and closely monitor renal function, electrolytes and BP frequently. Not recommended: Primary aldosteronism. Caution: Hepatic impairment, progressive liver disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Mild to moderate renal impairment (monitor potassium, creatinine, uric acid serum periodically). Renal artery stenosis (renovascular hypertension risk). Recent kidney transplantation (no experience). Correct volume/sodium depletion before starting therapy. RAAS stimulation (severe congestive heart failure, renal disease). Monitor serum electrolytes periodically. Excessive reduction of blood pressure in ischaemic cardiopathy or ischaemic cardiovascular disease may result in myocardial infarction or stroke. History of hypersensitivity or bronchial asthma. May occur: Acute transient myopia and acute angle-closure glaucoma (discontinue immediately), photosensitivity reactions (discontinue, protect from sun/artificial UVA), raised cholesterol and triglyceride levels, hyperuricaemia or frank gout, exacerbation or activation of systemic lupus erythematosus, hypomagnesaemia. Diabetics. Less effective in black patients. Driving/using machines. Contains lactose.
Drug interactions: Contraindicated: Aliskiren (in diabetes or renal impairment). Not recommended: ACE inhibitors (especially in diabetic nephropathy), aliskirin, lithium, drugs affecting serum potassium levels. Caution: NSAIDs (especially in elderly), metformin. Drugs inducing torsades de pointes, digitalis glycosides, other antihypertensives, antidiabetics, cholestyramine and colestipol resins, pressor amines (e.g. noradrenaline), nondepolarizing skeletal muscle relaxants (e.g. tubocurarine), anti-gout drugs (allopurinol, probenecid, sulfinpyrazone), calcium salts, beta blockers, diazoxide, anticholinergics, amantadine, cytotoxic agents (e.g. cyclophosphamide, methotrexate), baclofen, amifostine, alcohol, barbiturates, narcotics, antidepressants.
Adverse drug reactions: Dizziness.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie.
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