Concise Prescribing Info
Contents
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/Uses
HTN, alone or in combination w/ other antihypertensive agents.
Dosage/Direction for Use
Patient whose BP is not adequately controlled w/ telmisartan monotherapy 80 mg, or patient whose BP is not adequately controlled w/ hydrochlorothiazide 25 mg once daily or is controlled but who experiences hypokalemia w/ this regimen Initially 80 mg/12.5 mg once daily, can be titrated up to 160 mg/25 mg after 2-4 wk if necessary. Patient w/ biliary obstructive disorders or hepatic insufficiency Initially 40 mg/12.5 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ anuria. Co-administration w/ aliskiren in patients w/ diabetes.
Special Precautions
Symptomatic hypotension may occur after initiation of treatment in patients w/ activated renin-angiotensin system eg, vol- or salt-depleted patients (eg, those being treated w/ high doses of diuretics). Correct vol or salt depletion prior to administration. Not recommended for patients w/ severe hepatic impairment. Monitor renal function periodically in patients whose renal function may depend in part on the activity of the renin-angiotensin system (eg, patients w/ renal artery stenosis, CKD, severe CHF, or vol depletion) due to risk of developing oliguria, progressive azotemia, or acute renal failure. Consider w/holding or discontinuing therapy in patients who develop clinically significant decrease in renal function. Discontinue treatment as soon as possible when pregnancy is detected. Discontinue nursing or discontinue the drug, considering importance of the drug to the mother. Telmisartan: Hyperkalemia, particularly in patients w/ renal insufficiency, diabetes, or combination use w/ other ARBs or ACE inhibitors & concomitant use of other drugs that raise serum K levels. Hydrochlorothiazide: Hypersensitivity reactions may occur in patients w/ or w/o history of allergy or bronchial asthma. Risk of hypokalemia & hyponatremia; hypomagnesemia. Monitor serum electrolytes periodically. May alter glucose tolerance & raise serum levels of cholesterol & triglycerides. Hyperuricemia may occur or frank gout may be precipitated. Attenuated diuretic-induced hyperuricemia. Discontinue treatment as rapidly as possible in case of acute transient myopia & acute angle-closure glaucoma. Reports of exacerbation or activation of SLE. Enhanced antihypertensive effects in post sympathectomy patient. Increased risk of non-melanoma skin cancer (basal cell carcinoma & squamous cell carcinoma) w/ increasing cumulative dose. Limit exposure to sunlight & UV rays.
Adverse Reactions
Hypotension, renal impairment, electrolytes & metabolic disorders, pain (including back & abdominal), dyspepsia, erythema, vomiting, bronchitis, pharyngitis, fetal toxicity. Telmisartan: Impotence, increased sweating, flushing; allergy, fever, leg pain, malaise, chest pain; palpitation, dependent edema, angina pectoris, leg edema, abnormal ECG, HTN, peripheral edema; insomnia, somnolence, migraine, paresthesia, involuntary muscle contractions, hypoaesthesia; flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroesophageal reflux, toothache; gout, hypercholesterolemia, DM; arthritis, arthralgia, leg cramps, myalgia; anxiety, depression, nervousness; infection, fungal infection, abscess, otitis media; asthma, rhinitis, dyspnea, epistaxis; dermatitis, eczema, pruritus; micturition frequency, cystitis; abnormal vision, conjunctivitis, tinnitus, earache. Hydrochlorothiazide: Weakness; pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation; aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis & cutaneous vasculitis), fever, resp distress including pneumonitis & pulmonary edema, anaphylactic reactions; hyperglycemia, glycosuria, hyperuricemia; muscle spasm; restlessness; renal failure, renal dysfunction, interstitial nephritis; erythema multiforme including SJS, exfoliative dermatitis including TEN; transient blurred vision, xanthopsia.
Drug Interactions
Hyperkalemia w/ other ARBs or ACE inhibitors; other drugs that raise serum K levels.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA07 - telmisartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Telarb Plus 40 mg/12.5 mg tab
Packing/Price
30's (P472.5/box)
Form
Telarb Plus 80 mg/12.5 mg tab
Packing/Price
30's (P555/box)
Form
Telarb Plus 80 mg/25 mg tab
Packing/Price
30's (P750/box)