Tolura

Tolura

telmisartan

Manufacturer:

KRKA

Distributor:

Pahang Pharmacy
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
Essential HTN. Reduce risk of MI, stroke or death 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 max: 80 mg once daily. Severe HTN Up to 160 mg alone or in combination w/ hydrochlorothiazide 12.5-25 mg daily. CV risk reduction 80 mg once daily. Mild to moderate hepatic impairment Not to exceed 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders. Concomitant use w/ aliskiren-containing products. Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Patients w/ bilateral renal artery stenosis or artery stenosis to single functioning kidney, 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. Dual blockade of renin-angiotensin-aldosterone system. Dehydration, acute cardiac decompensation, metabolic acidosis, infectious diseases, cellular lysis eg, acute limb ischemia, rhabdomyolysis, extend trauma. Monitor K & serum creatinine levels periodically. Correct vol &/or Na depletion prior to administration. 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, Lapp lactase deficiency or glucose-galactose malabsorption. Black patients. May affect the ability to drive & use machines. Renal impairment; kidney transplantation. Not to be given in patients w/ cholestasis, biliary obstructive disorders or severe hepatic impairment. Mild to moderate hepatic impairment. Not recommended during 1st trimerster of pregnancy & lactation. Elderly >70 yr.
Adverse Reactions
Uncommonly, UTI, upper resp tract infection; anaemia; hyperkalaemia; insomnia, depression; syncope; vertigo; bradycardia; hypotension; dyspnoea; cough; GI disorders; pruritus, hyperhidrosis, rash; back pain, muscle spasms, myalgia; renal impairment; chest pain, asthenia; increased blood creatinine.
Drug Interactions
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/ diuretics eg, hydrochlorothiazide or furosemide. 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/ systemic corticosteroids. Monitor digoxin levels.
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
Tolura tab 40 mg
Packing/Price
3 × 10's;4 × 7's
Form
Tolura tab 80 mg
Packing/Price
3 × 10's;4 × 7's
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