Oratel-40/Oratel-80

Oratel-40/Oratel-80

telmisartan

Manufacturer:

Theon Pharma

Distributor:

Orange Biotec
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
HTN as monotherapy or in combination w/ other antihypertensives.
Dosage/Direction for Use
Initially 40 mg once daily. Max: 80 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders. Concomitant use of aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment. Pregnancy (2nd & 3rd trimester).
Special Precautions
Hyperkalaemia may occur especially in elderly, patients w/ renal insufficiency & diabetic. Concomitant use w/ K-sparing diuretics, salt substitutes containing K or other medical products that may increase K level (eg, ACE inhibitors, AIIAs, NSAIDs, heparin, immunosuppressives, trimethoprim). Renovascular HTN. Symptomatic hypotension in vol &/or Na-depleted patients. Dual blockade of renin-angiotensin-aldosterone system (eg, adding ACE inhibitor or direct renin-inhibitor aliskiren to ARBs) is not recommended. Other conditions w/ stimulation of the renin-angiotensin-aldosterone system (eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis). Not recommended in patients w/ primary aldosteronism. Patients suffering from aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy, diabetic patients treated w/ insulin or antidiabetics. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Possible MI or stroke in patients w/ ischaemic cardiopathy or CV disease due to excessive reduction of BP. Not to be given in patients w/ cholestasis, biliary obstructive disorders & severe hepatic impairment. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. Mild to moderate hepatic impairment. Not recommended during pregnancy (1st trimester) & lactation. Less effective in lowering BP in black people.
Adverse Reactions
Anaphylactic reaction, angioedema & acute renal failure.
Drug Interactions
Increase in peak plasma conc of digoxin. May provoke hyperkalaemia w/ salt substitute containing K, K-sparing diuretics, ACE inhibitors, AIIAs, NSAID (including COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), trimethoprim. Reversible increase in serum lithium conc. May reduce the antihypertensive effect w/ NSAIDs. Vol depletion & increased risk of hypotension w/ high dose diuretics (eg, furosemide & HCTZ). May potentiate hypotensive effects w/ baclofen, amifostine & other antihypertensive medicinal products. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants. Reduced antihypertensive effect w/ corticosteroids.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA07 - telmisartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Oratel-40 tab 40 mg
Packing/Price
30's
Form
Oratel-80 tab 80 mg
Packing/Price
30's
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