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Telmez

Telmez

telmisartan

Manufacturer:

Ajanta Pharma Phil

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
Essential HTN in adults. Reduction of CV morbidity in adults w/ manifest atherothrombotic CV disease (history of CHD, stroke, or peripheral arterial disease) or type 2 DM w/ documented target organ damage.
Dosage/Direction for Use
Essential HTN 40 mg once daily. May already benefit at a daily dose of 20 mg. Max: 80 mg once daily in cases where target BP is not achieved. CV prevention 80 mg once daily. Renal impairment Start at a lower dose of 20 mg. Mild to moderate hepatic impairment Max: 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders. Severe hepatic impairment. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimesters).
Special Precautions
Not to be given to patients w/ cholestasis. Risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of artery to a single functioning kidney. Patients w/ recent kidney transplantation. Periodic monitoring of K & creatinine serum levels in patients w/ impaired renal function. Intravascular hypovolemia; correct vol &/or Na depletion prior to administration. Concomitant use of ACE inhibitors, ARBs or aliskiren is not recommended; close monitoring of renal function, electrolytes & BP if dual blockade therapy is absolutely necessary. Do not use ACE inhibitors & ARBs concomitantly in patients w/ diabetic nephropathy. May cause acute hypotension, hyperazotemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend on activity 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. Aortic & mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Hypoglycemia. Diabetic patients treated w/ insulin or antidiabetics; consider appropriate blood glucose monitoring. Hyperkalemia w/ increased risk in patients w/ DM, renal impairment, on combination treatment w/ other medicinal products that affect renin-angiotensin-aldosterone system &/or K supplements; salt substitutes containing K, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressives (cyclosporin or tacrolimus), & trimethoprim; intercurrent events in particular dehydration, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of renal condition (eg, infectious diseases), cellular lysis (eg, acute limb ischemia, rhabdomyolysis, extend trauma). Not to be taken by patients w/ rare hereditary problems of fructose intolerance. Black people. Excessive reduction of BP in patients w/ ischemic cardiopathy or ischemic CV disease may result to MI or stroke. May affect ability to drive & use machine due to dizziness or drowsiness. Mild to moderate hepatic impairment. Not recommended during pregnancy & lactation. Not recommended in childn & adolescent <18 yr.
Adverse Reactions
UTI including cystitis, URTI including pharyngitis & sinusitis; anaemia; hyperkalemia; insomnia, depression; syncope; vertigo; bradycardia; hypotension, orthostatic hypotension; dyspnoea, cough; abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting; pruritus, hyperhidrosis, rash; back pain (eg, sciatica), muscle spasms, myalgia; renal impairment including acute renal failure; chest pain, asthenia (weakness); increased blood creatinine.
Drug Interactions
Increased peak plasma conc & trough conc of digoxin. Increased risk of hyperkalemia w/ salt substitutes containing K, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressives (cyclosporin or tacrolimus), & trimethoprim. Increased serum K w/ K-sparing diuretics eg, spironolactone, eplerenone, triamterene, or amiloride, K supplements, or K-containing salt substitutes. Increased serum conc & toxicity of lithium. Reduced antihypertensive effect w/ NSAIDs (ie, ASA at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs); corticosteroids (systemic route). Increased AUC0-24 & Cmax of ramipril & ramiprilat. May result in vol depletion & risk of hypotension w/ high dose diuretics eg, furosemide & hydrochlorothiazide. Increased BP lowering effect w/ ACE inhibitors, ARBs or aliskiren. May potentiate hypotensive effects w/ baclofen, amifostine. May aggravate orthostatic hypotension w/ alcohol, barbiturates, narcotics or antidepressants.
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
Telmez tab 40 mg
Packing/Price
30's
Form
Telmez tab 80 mg
Packing/Price
30's
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