TELSAT AM 80/10

Indonesia • Ferron Par Pharmaceuticals

TELSAT AM combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, telmisartan, and a dihydropyridine calcium channel blocker, amlodipine. The combination of these subtances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. TELSAT AM once daily produces effective and consistent reductions in blood pressure across the 24-hours therapeutic dose range.

Indication

Treatment of essential hypertension.

Replacement therapy
Patients receiving telmisartan and amlodipine from separate tablets may instead receive TELSAT AM containing the same component doses.

Add on therapy
TELSAT AM is indicated in patients whose blood pressure is not adequately controlled on amlodipine monotherapy.

Composition

Each tablet contains:

  • Telmisartan 80 mg
  • Amlodipine besilate equivalent to amlodipine 10 mg

Package

3 blisters of 10 tablet

Dosage Forms

Tablet

ATC Classification

C09D

Warning

Machinery
Consult Your Doctor
Safety of this item for use while operating heavy machinery has not been established. Please consult your doctor.
Pregnancy
Not Recommended
This item is not safe for use during pregnancy.
Lactation
Caution
This item may not be safe for use during lactation. Use with caution and after consultation with your doctor.

Dosage

0 to 18 Years Old

TELSAT AM is not recommended for use in patients aged below 18 years due to lack of data on safety and efficacy.

18 to 65 Years Old

TELSAT AM should be taken once daily. The maximum recommended dose is one tablet 80 mg telmisartan/10 mg amlodipine per day. TELSAT AM is indicated for long term treatment.

Replacement therapy
Patients receiving telmisartan and amlodipine from separate tablets can instead receive TELSAT AM containing the same component doses in one tablet once daily, e.g. to enhance convenience or compliance.

Add on therapy
TELSAT AM 40/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone. Individual dose titration with the components (i.e. amlodipine and telmisartan) is recommended before changing to the fixed dose combination. When dinically appropriate, direct change from monotherapy to the fixed combination may be considered. Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to TELSAT AM 40/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response. TELSAT AM can be administered with other antihypertensive drugs.

65 Years Old and Above

No dose adjustment is necessary for elderly patients.

How to Use

Tablet for oral administration. TELSAT AM may be taken with or without food.

Patients with Renal Impairment
No posology adjustment is required for patients with renal impairment. Limited experience is available in patients with severe renal impairment or hemodialysis. Caution is advised when using TELSAT AM in such patients as amlodipine and telmisartan are not dialyzable.

Patients with Hepatic Impairment
In patients with mild to moderate hepatic impairment, TELSAT AM should be administered with caution. For telmisartan the posology should not exceed 40 mg once daily. TELSAT AM is contraindicated in patients with severe hepatic impairment.