Angitel

Angitel

telmisartan

Manufacturer:

Sanbe
Concise Prescribing Info
Contents
Telmisartan
Dosage/Direction for Use
Adult 40 mg once daily. May be increased to a max of 80 mg once daily in cases where the target BP is not achieved. May be used in combination w/ thiazide-type diuretics eg, hydrochlorothiazide. Mild to moderate hepatic impairment Max: 40 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Biliary obstructive disorders; rare hereditary conditions. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy. Lactation.
Special Precautions
Increased risk of severe hypotension & renal insufficiency when patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated w/ medical products that affect the renin-angiotensin-aldosterone system (RAAS). Periodic monitoring of serum K & creatinine levels in patients w/ impaired renal function. Symptomatic hypotension especially after the 1st dose, may occur in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Dual blockade of the RAAS. Patients whose vascular tone & renal function depend predominantly on the activity of the RAAS (eg, patients w/ severe CHF or underlying renal disease). Not recommended in patients w/ primary aldosteronism. Patients suffering from aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy; w/ biliary obstructive disorder or hepatic insufficiency. Possible hyperkalaemia especially in the presence of renal impairment &/or heart failure; monitor serum K. Concomitant use w/ K-sparing diuretics, K supplements, K-containing salt substitutes or other medical products that may increase K level (eg, heparin). Increased risk of fatal MI & unexpected CV death when treated w/ BP lowering agents (eg, ARBs or ACE-inhibitors) in diabetics w/ additional CV risk (ie, patients w/ DM & coexistent CAD). Excessive reduction of BP in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. May affect ability to drive & use machines due to occasional dizziness or drowsiness. Not recommended during the 1st trimester of pregnancy & not to be initiated during pregnancy. Not recommended for use in childn <18 yr.
Adverse Reactions
UTI (eg, cystitis), URTIs, sepsis including fatal outcome; anaemia, eosinophilia, thrombocytopenia; anaphylactic reaction, hypersensitivity; hyperkalaemia, hypoglycaemia (in diabetic patients); insomnia, depression, anxiety; syncope (faint); visual disturbance; vertigo; bradycardia, tachycardia; hypotension, orthostatic hypotension; dyspnoea; abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dry mouth, stomach discomfort; abnormal hepatic function/liver disorder; pruritus, hyperhidrosis, rash, angioedema (w/ fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption; back pain, muscle spasms (cramps in legs), myalgia, arthralgia, pain in extremity (leg pain), tendon pain (tendinitis like symptoms); renal impairment including acute renal failure; chest pain, asthenia (weakness), flu-like illness; increased blood creatinine, blood uric acid, hepatic enzymes, blood creatine phosphokinase (CPK), decreased haemoglobin.
Drug Interactions
May increase hypotensive effects of other antihypertensive agents. Increase in digoxin median plasma. Reversible increases in serum lithium conc & toxicity during concomitant use w/ lithium. Potential for acute renal insufficiency in dehydrated patients in concomitant use w/ NSAIDs. May promote hypokalemia w/ salt substitutes containing K, K-sparing diuretics, ACE inhibitors, other AIIA, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressives (cyclosporin or tacrolimus) & trimethoprim. Vol depletion & risk of hypotension w/ high dose diuretics eg, furosemide & hydrochlorothiazide. Reduce antihypertensive effect w/ corticosteroids in systemic route, 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
Angitel caplet 40 mg
Packing/Price
2 × 10's (Rp356,000/boks)
Form
Angitel caplet 80 mg
Packing/Price
2 × 10's (Rp439,000/boks)
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