Telcardis Tablet 40mg

Product Information

TELCARDIS

Telcardis ®Telmisartan

Presentation

Telcardis 40mg tablet: White, shieldshaped tablet; each tablet contains Telmisartan USP 40mg.

Telcardis 80mg tablet: White, diamondshaped tablet; each tablet contains Telmisartan USP 80mg.

Description

Telmisartan is a nonpeptideangiotensin II receptor antagonist which is used in the treatment of hypertension.

Indication

Telcardis is an angiotensin II receptor blocker (ARB) indicated for treatment of hypertension and Cardiovascular (CV) risk

reduction in patients who are indicated for ACE inhibitors.

Dosage & Administration

In case of hypertension usually 40mg once daily. Increased if necessary after at least 4 weeks to maximum 80mg once daily.

Prevention of cardiovascular events 80mg once daily.

Side effect

Most people tolerate telmisartan well.Side effects are usually minor and either require no treatment or can easily be treated by

physician. The most common telmisartan side effects include-Upper respiratory infection such as the common cold or flu up to 7

percent of people, Back pain up to 3 percent of people, Diarrhea up to 3 percent of people, Inflammation of the sinuses up to 3

percent of people.

Contraindications

Telmisartan is contraindicated in conditions like Pregnancy, Adjunct in treatment of opioid dependence, Dry or painful cough.

Telmisartan is also contraindicated in patients with known hypersensitivity to telmisartan.

Pharmacokinetics

Following oral administration, peak concentrations (Cmax) of telmisartan are reached in 0.5 to 1 hour after dosing. Food slightly

reduces the bioavailability of telmisartan, with a reduction in the area under the plasma concentration-time curve (AUC) of about

6% with the 40mg tablet and about 20% after a 160mg dose. The absolute bioavailability of telmisartan is dose dependent. At 40mg

and 160mg the bioavailability was 42% and 58% respectively.

Drug Interactions

When certain medicines are taken together, there is a possibility of developing drug interactions. With Telmisartan, drugs such as

potassium supplements or potassium-sparing diuretics may cause an interaction. When Telmisartan was co-administered with digoxin,

median increases in digoxin peak plasma concentration (49%) and in through concentration (20%) where observed. Therefore, monitor

digoxin levels when initiating, adjusting and discontinuing Telmisartan for the purpose of keeping the digoxin level within the

therapeutic range. NSAID use may lead to increase risk of renal impairment and loss of antihypertensive effect. Monitor renal

function periodically in patients receiving Telmisartan and NSAID therapy.

Warnings

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal

function and increases fetal and neonatal morbidity and death. Telmisartan may potentially cause extreme low blood pressure or

a decrease in kidney function. Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal

impairment, heart failure, on renal replacement therapy or on potassium supplements, potassium-sparing diuretics, potassium

containing salt substitutes or other drugs that increase potassium levels.

Pregnancy and Lactation

Telmisartan has been assigned to pregnancy categories C (use during first trimester) by the FDA. When pregnancy is detected

or expected, Telmisartan should be discontinued as soon as possible. The use of drugs that act directly on the RAA system during

the second and third trimesters has been associated with fetal and neonatal injury, including hypotension, neonatal skull

hypoplasia, anuria, reversible or irreversible renal failure and death. There are no data on the excretion of Telmisartan into

human milk, due to the potential for serious adverse effects in the nursing infant, a decision should be made to discontinue

nursing or discontinue the drug.

Pharmaceutical Precautions

Store in a cool and dry place, protected from light. Keep out of children’s reach .

Packaging Quantities

Telcardis 40mg tablet: Each pack contains 14 tablets. Telcardis 80mg tablet: Each pack contains 14 tablets.