Tolura

Tolura

telmisartan

Manufacturer:

KRKA

Distributor:

Uni Drug
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
Essential HTN. Reduction of the risk of non-fatal stroke or MI in patients ≥55 yr at high risk of developing major CV events who cannot tolerate ACE inhibitors.
Dosage/Direction for Use
Essential HTN 40 mg once daily, may be increased to a max: 80 mg once daily. Reduction of CV morbidity 80 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders, fructose & galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ aliskiren-containing products. Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy. Lactation.
Special Precautions
Patients w/ bilateral renal artery stenosis, diabetic nephropathy, severe CHF or underlying renal disease (including renal artery stenosis), primary aldosteronism, aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy, DM, ischaemic cardiopathy or CV disease. Monitor K & creatinine serum levels periodically. Correct vol &/or Na depletion prior to administration. Dehydration, acute cardiac decompensation, metabolic acidosis, infectious diseases, cellular lysis eg, acute limb ischemia, rhabdomyolysis, extend trauma. Concomitant use w/ K supplements, K-containing salt substitutes, K-sparing diuretics, ACE inhibitor, angiotensin II receptor antagonists, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressants, trimethoprim. Fructose & galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Black patients. May affect the ability to drive & use machines. Renal impairment & kidney transplantation. Mild to moderate hepatic impairment. Not to be given in patients w/ cholestasis, biliary obstructive disorders or severe hepatic impairment. Not recommended during 1st trimester of pregnancy & lactation. Elderly >70 yr.
Adverse Reactions
Acute renal failure. Rarely, anaphylactic reaction & angioedema.
Drug Interactions
Increased median plasma trough conc. Increased risk of hyperkalaemia w/ K-containing salt substitutes, K-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (including selective COX-2 inihibitors), heparin, immunosuppressives (eg, cyclosporin or tacrolimus) & trimethoprim. Increased serum K w/ K-sparing diuretics (eg, spirinolactone, eplerenone, triamterene, or amiloride), K supplements or K-containing salt substitutes. Increased lithium conc & toxicity. Reduced antihypertensive effect by NSAIDs. Increased risk of vol depletion & hypotension w/ thiazide (eg, hydrochlorothiazide) or loop (eg, furosemide) diuretics. Increased BP-lowering effects w/ other antihypertensive agents. Higher frequency of adverse events w/ ACE inhibitors, angiotensin II receptor blockers or aliskiren. Potentiated hypotensive effects w/ baclofen, amifostine. Aggravated orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants. Reduced antihypetensive effect w/ corticosteroids.
ATC Classification
C09CA07 - telmisartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Tolura tab 40 mg
Packing/Price
28's
Form
Tolura tab 80 mg
Packing/Price
28's
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