Vicardis

Vicardis

telmisartan

Manufacturer:

Centurion Lab

Distributor:

Philgen
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
HTN Usual starting dose: 40 mg once daily. CV risk reduction 80 mg once daily.
Administration
May be taken with or without food.
Contraindications
Biliary obstructive disorders. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Symptomatic hypotension, especially after 1st dose, in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting; correct such conditions before telmisartan administration. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. Hyperkalemia may occur, especially in presence of renal impairment, overt proteinuria due to diabetic renal disease, &/or heart failure; closely monitor serum K in patients at risk. Caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Not recommended in patients w/ primary aldosteronism. Associated w/ acute hypotension, azotemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of renin-angiotensin-aldosterone system (RAAS) (eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis). Excessive BP decrease in patients w/ ischemic cardiopathy or ischemic CV disease could result in MI or stroke. Dual blockade of RAAS through combined use of ACE inhibitors, ARBs or aliskiren is not recommended. Should not be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. No experience in patients w/ recent kidney transplantation. Discontinue immediately when pregnancy is diagnosed. Not recommended during pregnancy (1st trimester) & lactation.
Adverse Reactions
Uncommon: UTI including cystitis, URTI including pharyngitis & sinusitis; anemia; hyperkalemia; insomnia, depression; syncope; vertigo; bradycardia; hypotension, orthostatic hypotension; dyspnea, cough; abdominal pain, diarrhea, dyspepsia, flatulence, vomiting; abnormal hepatic function/liver disorder; 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 & trough conc of digoxin. May lead to significant increase in serum K w/ K-sparing diuretics eg, spironolactone, eplerenone, triamterene, or amiloride, K supplements, or K-containing salt substitutes. Reversible increases in serum conc & toxicity of lithium. Antihypertensive effect may be reduced w/ NSAIDs (ie, aspirin at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs). Prior treatment w/ high dose diuretics eg, furosemide (loop diuretic) & hydrochlorothiazide (thiazide diuretic) may result in vol depletion, & in risk of hypotension when initiating therapy w/ telmisartan. Increased BP-lowering effect w/ other antihypertensive medicinal products. Higher frequency of adverse events eg, hypotension, hyperkalemia & decreased renal function (including acute renal failure) w/ combined use of ACE inhibitors, ARBs or aliskiren. Hypotensive effects may be potentiated w/ baclofen, amifostine. Orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants. Reduction of antihypertensive effect w/ corticosteroids (systemic route).
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
Vicardis tab 40 mg
Packing/Price
30's
Form
Vicardis tab 80 mg
Packing/Price
30's