Generic Name: Telmisartan + Hydrochlorothiazide

Regulatory Class: Rx

Formulations: Per 40 mg/12.5 mg tab Telmisartan 40 mg, hydrochlorothiazide 12.5 mg. Per 80 mg/12.5 mg tab Telmisartan 80 mg, hydrochlorothiazide 12.5 mg. Per 80 mg/25 mg tab Telmisartan 80 mg, hydrochlorothiazide 25 mg

Indications or Uses: Treatment of essential hypertension in patients with blood pressure inadequately controlled on telmisartan alone.

Dosage or Directions for use: Patient w/ BP inadequately controlled by telmisartan 40 mg or hydrochlorothiazide, administer40 mg/12.5 mg once daily. Patient w/ BP inadequately controlled by telmisartan 80 mg or by 40 mg/12.5 mg tab, administer 80 mg/12.5 mg once daily. Patient w/ BP inadequately controlled by 80 mg/12.5 mg tab administer 80 mg/25 mg once daily. Patient w/ mild to moderate hepatic impairment Not to exceed 40 mg/12.5 mg once daily.

Administration: Telmisartan and hydrochlorothiazide may be taken with or without food. 

Contraindications: Hypersensitivity. Cholestasis and biliary obstructive disorders. Severe hepatic and renal (CrCl <30 mL/min) impairment. Refractory hypokalemia, hypercalcemia. Concomitant use with aliskiren in patients with DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd and 3rd trimester) and lactation.

Special Precautions:  Patients with cholestasis, biliary obstructive disorder or severe hepatic insufficiency, bilateral renal artery stenosis or stenosis of the artery to single functioning kidney, severe renal impairment (CrCl <30 mL/min), volume and/or sodium depletion. Dual blockade of RAAS. Primary aldosteronism, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Metabolic and endocrine effects. Electrolyte imbalance. Galactose intolerance. DM. Acute myopia and secondary angle-closure glaucoma. Non-melanoma skin cancer. Childn. Pregnancy (1st trimester).

Adverse Reaction: Bronchitis, pharyngitis, sinusitis; exacerbation or activation of SLE; hypokalaemia, hyponatraemia, hyperuricaemia; anxiety, depression; dizziness, syncope/faint, paraesthesia, sleep disturbances, insomnia; abnormal & transient blurred vision; vertigo; cardiac arrhythmias, tachycardia; hypotension (including orthostatic hypotension); dyspnoea, resp distress (including pneumonitis & pulmonary oedema); diarrhoea, dry mouth, flatulence, abdominal pain, constipation, dyspepsia vomiting, gastritis; abnormal hepatic function/liver disorder; angiooedema, erythema, pruritus, rash, increased sweating, urticaria; back pain, muscle spasm, myalgia, arthralgia, leg pain & cramps; impotence; chest pain, flu-like symptoms, pain; increased uric acid, creatinine, liver enzymes, blood creatine phosphokinase.

Interactions: Lithium, kaliuretic diuretics, laxatives, corticosteroids, ACTH, ampothericin, carbenoxolone, penicillin G sodium, salicylic acid, and derivatives. ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitute containing potassium, ciclosporin, and heparin. HCTZ: Digitalis glycosides, digoxin, and other antihypertensive agents, antidiabetic products, cholestyramine and colestipol resins, NSAIDs, norepinephrine, calcium salts, beta-blockers and diazoxide, atropine, biperiden, amantidine, antiarrhythmics, antipsychotic, narcotics, alcohol.

Presentation or Packaging: Tablet 40 mg/12.5 mg x 30's, 80 mg/12.5 mg x 30's, 80 mg/25 mg x 30's

For more information on this product, please see the product insert.