Cosmos Pharmaceutical Limited | Telmicos® Tablets
Cosmos Limited is one of the leading manufacturers of pharmaceutical products in Kenya and East Africa. Through our specialized Human Health and Animal Health.
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Telmicos® Tablets

PRESENTATION: Telmicos® 40 Tablets: White to off-white, circular biconvex tablet embossed ‘C’ on one side and a breakline on the other side. Each tablet contains: Telmisartan USP 40mg. Telmicos® 80 Tablets: White to off-white, circular biconvex tablet embossed ‘COSMOS’ on one side and plain on the other side. Each tablet contains: Telmisartan USP 80mg.
CLINICAL PHARMACOLOGY:

Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in a number of tissues. It does not cause persistent dry cough that normally complicates ACE inhibitors therapy. This is due to the fact that it does not inhibit the breakdown of Kinins. Pharmacokinetics: Telmisartan is rapidly absorbed from the gastrointestinal tract; the absolute oral bio availability is dose dependent and is about 42%f ollowing a 40mg dose and 58% following a 160mg dose. Peak plasma concentrations of Telmisartan are reached about 0.5 to 1 hour after oral dose. Telmisartan is over 99 % bound to plasma proteins. It is excreted almost entirely in faeces via bile, mainly as unchanged drug. The terminal elimination half-life of Telmisartan is about 24 hours.

USES:

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage.

DOSAGE AND ADMINISTRATION:

The usual starting dose of Telmisartan is 40mg once a day;blood pressure response is dose related over the range of 20-80 mg. Patients with depletion of intravascular volume should have the condition corrected or Telmisartan tablets should be initiated under close medical supervision.
Posology and Method of Administration Treatment of essential hypertension The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan. Cardiovascular prevention The recommended dose is 80 mg once daily. Elderly patients No dose adjustment is necessary for elderly patients. Paediatric population The safety and efficacy of Telmisartan in children and adolescents aged below 18 years have not been established.

Method of administration

Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food. Precautions to be taken before handling or administering the medicinal product. Tablets should be taken out of the blister shortly before administration.

CONTRA-INDICATIONS AND WARNINGS:

Telmisartan is contra-indicated in; Second and third trimesters of pregnancy; Biliary obstructive disorders and Severe hepatic impairment. The concomitant use of Telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment(GFR<60mL/min/1.73 m2) Adverse

Effects:

Adverse Effect Soccurringin 1% or more of patients receiving Telmisartan include upper respiratory tract infection, sinusitis, pharyngitis, back pain and diarrhoea.

WARNING TELMICOS®

Tablets should not be taken during pregnancy Drug Interactions: Drugs Affecting Hepatic Microsomal inhibitors or inducers of the cytochrome P-450 (CYP) isoenzyme system; pharmacokinetic interactions unlikely. Digoxin pharmacokinetic interactions (increased plasma digoxin concentrations).It is recommended that serum digoxin concentration be monitored when Telmisartan therapy is initiated, adjusted, or discontinued in patients stabilized on digoxin. Warfarin Pharmacokinetic interactions (decreased plasma warfarin concentrations; international normalized ratio (INR) not affected) Acetaminophen, amlodipine, glyburide, Ibuprofen, simvastatin pharmacological interactions unlikely.

PHARMACEUTICAL PRECAUTIONS:

Store in a dry place below 30°C. Protect from light. Keep all medicines out of the reach of children.
LEGAL CATEGORY: Prescription Only Medicine (POM)

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