Presenta

tion

Telmipres 40: Each tablet contains Telmisartan BP 40 mg,
Telmipres 80: Each tablet contains Telmisartan BP 80 mg.

Description

Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Indications

Hypertension- Treatment of essential hypertension in adults;

Cardiovascular prevention- Reduction of cardiovascular morbidity in adults with:

1) Atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or

2) Type 2 diabetes mellitus with documented target organ damage.

Dosage & Administration

Dosage must be individualized. The usual starting dose of Telmipres tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmipres is required, may switch to combination. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmipres tablets may be administered with other antihypertensive agents. Telmipres tablets may be administered with or without food. Initial therapy with Telmipres is not recommended in patients ≥75 years old or with hepatic impairment.

Side Effects

In hypertensive patients: The most common side effects of Telmipres tablets include sinus pain and congestion (sinusitis), back pain, diarrhea etc.
For patients of cardiovascular risk reduction: The most common side effects of Telmipres tablets in CV risk reduction include intermittent claudication and skin ulcer.

Precautions

1) Avoid fetal or neonatal exposure
2) Hypotension
3) Monitor carefully in patients with impaired hepatic or renal function
4) Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker

Use in Pregnancy & Lactation

Pregnancy: Pregnancy Category D.
Lactation: It is not known whether Telmisartan is excreted in human milk.

Drug Interaction

1) NSAIDS: Increased risk of renal impairment and loss of antihypertensive effect
2) Co-administration with Aliskiren with Telmipres in patients with diabetes should be avoided

Over Dose

The most likely manifestation of overdosage with Telmipres tablets would be hypotension, dizziness and tachycardia; bradycardia, increase in serum creatinine and acute renal failure could occur from parasympathetic (vagal) stimulation.

Storage

Do not store above 300 C. Protect from light and high humidity. Keep out of the reach of children.

Commercial Pack

Telmipres 40: Each box contains 3 blister strips of 10 tablets.
Telmipres 80: Each box contains 7 blister strips of 4 tablets.

Others

Pediatric use: Safety and effectiveness of Telmisartan in pediatric patients have not been established.
Geriatric use: No overall differences in effectiveness and safety were observed in these patients compared to younger patients.
Hepatic impairment: Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency