Telmidec-40

Telmidec-40

telmisartan

Manufacturer:

Theon Pharmaceuticals

Distributor:

HLM Pharma
Concise Prescribing Info
Contents
Telmisartan
Indications/Uses
HTN, as monotherapy or in combination w/ other antihypertensive agents.
Dosage/Direction for Use
Initially 40 mg once daily. Max: 80 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). 2nd & 3rd trimester of pregnancy.
Special Precautions
Risk of symptomatic hypotension, especially after 1st dose, in patients who are vol &/or Na depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Correct vol &/or Na depletion prior to treatment administration. Acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on renin-angiotensin-aldosterone system (RAAS) activity. Not recommended in patients w/ primary aldosteronism. Hypoglycemia may occur; consider appropriate blood glucose monitoring & dose adjustment of insulin or antidiabetics. May cause hyperkalaemia; closely monitor serum K in at-risk patients. Excessive BP reduction in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. Dual blockade of the RAAS through combined use of ACE inhibitors, ARBs or aliskiren is not recommended. ACE inhibitors & ARBs should not be used concomitantly in patients w/ diabetic nephropathy. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral artery stenosis or stenosis of the artery to a single functioning kidney. Periodically monitor K & creatinine serum levels in patients w/ renal impairment. Patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Caution in patients w/ aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy; mild to moderate hepatic impairment. No experience regarding treatment administration in patients w/ recent kidney transplantation. Should not be initiated during pregnancy. Not recommended during 1st trimester of pregnancy & lactation. Apparently less effective in Black patients.
Adverse Reactions
Uncommon: URTI including pharyngitis & sinusitis, UTI including cystitis; anaemia; hyperkalaemia; depression, insomnia; syncope; vertigo; bradycardia; hypotension, orthostatic hypotension; dyspnoea, cough; abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting; hyperhidrosis, pruritus, rash; myalgia, back pain (eg, sciatica), muscle spasms; renal impairment including acute renal failure; chest pain, asthenia (weakness).
Drug Interactions
Increased peak plasma & trough conc of digoxin. Increased risk of hyperkalaemia w/ other medicinal products that may also provoke hyperkalaemia [salt substitutes containing K, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressives (cyclosporin or tacrolimus), & trimethoprim]. Reversible increases in serum lithium conc & toxicity. Reduced antihypertensive effect w/ NSAIDs. May result in further deterioration of renal function, including possible acute renal failure, w/ COX inhibitors. Risk of vol depletion & hypotension w/ high dose diuretics eg, furosemide & hydrochlorothiazide. Increased BP-lowering effect w/ other antihypertensives. Higher frequency of adverse events w/ ACE inhibitors, ARBs or aliskiren. Potentiated hypotensive effects w/ baclofen or amifostine. Aggravated orthostatic hypotension w/ alcohol, barbiturates, narcotics, or antidepressants. Reduced antihypertensive effect w/ systemic corticosteroids.
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
Telmidec-40 tab 40 mg
Packing/Price
30's