TELMISARTAN TABLETS 20/40/80 mg
Arbitel-20: Each uncoated tablet contains: Telmisartan BP 20 mg
Arbitel-40: Each uncoated tablet contains: Telmisartan BP 40 mg
Arbltel-80: Each uncoated tablet contains: Telmisartan BP 80 mg
Anti hypertensive Agent.
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.
Following oral administration, peak concentrations (Cmax) of telmisartan are reached in 0.5 – 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 40 mg tablet and about 20% after a 160 mg dose. The absolute bioavailability of telmisartan is dose dependent. At 40 and 160 mg, the bioavailability was 42% and 58%, respectively. The pharmacokinetics of orally administered telmisartan are nonlinear over the dose range 20-160 mg, with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses. Telmisartan shows bi-exponential decay kinetics with a terminal half-life of approximately 24 hours. Through plasma concentrations of telmisartan with once daily dosing are about 10-25% of peak plasma concentrations. Telmisartan has an accumulation index in plasma of 1.5 to 2.0 upon repeated once daily dosing.
For the management of mild to moderate hypertension.
Contraindicated in patients who are hypersensitive to any component of the product.
DOSAGE AND ADMINISTRATION
Dosage must be individualized. The usual starting dose of telmisartan is 40 mg once a day. Some patients may derive benefit at a daily dose of 20 mg. Blood pressure response is dose related over the range of 20-80 mg. Most of the antihypertensive effect is apparent within two weeks and maximal reduction is generally attained after four weeks. When additional blood pressure reduction beyond that achieved with 80 mg telmisartan is required, a diuretic may be added.
Patients with depletion of intravascular volume should have the condition corrected or telmisartan should be initiated under close medical supervision. Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.
As limited experience is available in patients with severe renal impairment or haemodialysis, a lower starting dose of 20 mg is recommended in these patients.
In patients with mild to moderate hepatic impairment the dosage should not exceed 40 mg once daily.
The most likely manifestation of overdosage with telmisartan would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by haemodialysis.
No clinically significant drug interactions have yet been observed with telmisartan. Telmisartan can be taken together with diuretics or other medications for high blood pressure.
Telmisartan is usually well tolerated. The side effects have been mild and transient in nature and have only infrequently required discontinuation of therapy. The commonly observed side effects are back pain, diarrhoea, pharyngitis, headache, dizziness, pain, fatigue and nausea.
WARNINGS AND PRECAUTIONS
The usual regimens of therapy with Telmisartan may be followed as long as the patient’s creatinine clearance is >30 mL/min.
Telmisartan should not be used by pregnant women.
Telmisartan may cause birth defects or other problems in the baby if taken during pregnancy.
Telmisartan may pass into breast milk; caution is advised.
Pregnancy and lactation
Drugs that act directly on the rennin-angiotensin system can cause foetal and neonatal morbidity and death when administered to pregnant women. Oligohydramnios has also been reported, presumably resulting from decreased foetal renal function. When pregnancy is detected, telmisartan should be discontinued as soon as possible.
It is not known whether telmisartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in paediatric patients have not been established.
Pack of 10’s.
Store below 30°C. Keep away from the reach of children.
MICRO LABS LIMITED – UNIT III
R.S. No. 63/3&4, Thiruvandar Koil,
PONDICHERRY-605 102. INDIA.
Arbitel-40: NAFDAC Reg. No. A4-5988
Arbitel-80: NAFDAC Reg. No. A4-5989