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Telmizart

Telmizart

telmisartan

Manufacturer:

Lloyd

Distributor:

Medhaus
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
Essential HTN. Prevention of CV morbidity & mortality in patients ≥55 yr at high risk of CV disease.
Dosage/Direction for Use
Adult Essential HTN 40 mg once daily, can be increased to max of 80 mg once daily when the target BP is not achieved. Alternatively, may be used in combination w/ thiazide-type diuretics eg, hydrochlorothiazide. Doses up to 160 mg alone & in combination w/ hydrochlorothiazide 12.5-25 mg daily were well tolerated & effective in patient w/ severe HTN. Prevention of CV morbidity & mortality 80 mg once daily. Patient w/ 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 in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Fructose intolerance. Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy. Lactation.
Special Precautions
Not recommended in patients w/ primary aldosteronism. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of artery to a single functioning kidney. Risk of acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on activity of the renin-angiotensin-aldosterone system (RAAS) eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis. Hyperkalaemia may occur, especially in the presence of renal impairment &/or heart failure. Risk of fatal MI & unexpected CV death may be increased in diabetic patients w/ an additional CV risk ie, coexistent CAD. Excessive reduction of BP in patients w/ ischaemic cardiopathy or CV disease could result in MI or stroke. Patients w/ aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy; biliary obstructive disorders or hepatic insufficiency. Less effective in lowering BP in black than non-black patients. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. Correct vol- &/or Na-depletion (eg, in patients on vigorous diuretics therapy, dietary salt restriction, diarrhea or vomiting) prior to administration. Limit dual blockade of the RAAS (eg, by adding ACE inhibitor or aliskiren) to individually defined cases w/ close monitoring of renal function. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medicinal products that may increase K level (eg, heparin). Not to be taken by patients w/ fructose intolerance. No experience in patients w/ recent kidney transplant. Not recommended during 1st trimester of pregnancy & not to be initiated during pregnancy; discontinue use immediately when pregnancy is diagnosed. Ultrasound check of renal function & skull of infant is recommended should exposure to AIIA have occurred from 2nd trimester of pregnancy. Closely observe for hypotension in infants whose mothers have taken AIIA. Safety & efficacy have not been established in childn <18 yr.
Adverse Reactions
UTI (including cystitis), URTI, sepsis included fatal outcome; anaemia, eosinophilia, thrombocytopenia; anaphylactic reaction, hypersensitivity; hyperkalaemia, hypoglycaemia (in diabetic patients); anxiety, insomnia, depression; syncope; visual disturbance; vertigo; bradycardia, tachycardia; hypotension, orthostatic hypotension; dyspnoea; abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence, stomach discomfort, vomiting; abnormal hepatic function/liver disorder; pruritus, hyperhidrosis, rash, angioedema (w/ fatal outcome), eczema, erythema, urticaria, drug & toxic skin eruption; back pain, muscle spasms (leg cramps), myalgia, arthralgia, pain in extremity (leg pain), tendon pain (tendinitis-like symptoms); renal impairment including acute renal failure; chest pain, flu-like illness, asthenia; increased blood creatinine, blood uric acid, hepatic enzymes & creatine phosphokinase, decreased Hb.
Drug Interactions
May lead to an increase in serum K w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medicinal products increasing K level (eg, heparin). May increase hypotensive effect of other antihypertensive agents. Increased media plasma trough conc of digoxin. Increased AUC0-30h & Cmax of ramipril & ramiprilat. Reversible increases in serum lithium conc & toxicity. Reduced antihypertensive effect w/ NSAIDs.
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
Telmizart tab 40 mg
Packing/Price
30's
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