Telmisartan IP 20 mg / 40 mg Tablets
Each uncoated tablets contains:
(Telmisartan IP 20 mg / 40 mg )
Tablet for Oral Use
Telmisartan interferes with the binding of angiotensin II to the angiotensin II AT1-receptor by binding reversibly and selectively to the receptors in vascular smooth muscle and the adrenal gland. As angiotensin II is a vasoconstrictor, which also stimulates the synthesis and release of aldosterone, blockage of its effects results in decreases in systemic vascular resistance.
Telmisartan can improve carbohydrate and lipid metabolism, as well as control insulin resistance without causing the side effects that are associated with full PPARγ activators.
Absorption: Absolute bioavailability depends on dosage. Food slightly decreases the bioavailability (a decrease of about 6% is seen when the 40-mg dose is administered with food).
Distribution: The volume of distribution of Telmisartan is 500L. Highly bound to plasma proteins (>99.5%), mainly albumin and a1-acid glycoprotein. Binding is not dose-dependent
Metabolism: Minimally metabolized by conjugation to form a pharmacologically inactive acylglucuronide; the glucuronide of the parent compound is the only metabolite that has been identified in human plasma and urine. Following either intravenous or oral administration of Telmisartan, most of the administered dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found in the urine (0.91% and 0.49% of total radioactivity, respectively
Half Life: Has Elimination half-life of approximately 24 hours.
- Used alone or in combination with other classes of antihypertensive for the treatment of hypertension.
- Also used in the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes mellitus, as well as the treatment of congestive heart failure
ADVERSE REACTION: Upper respiratory tract infection, Back pain, Sinusitis, Diarrhea, Cough, Pharyngitis, muscle cramps or stiffness, numbness or tingling in the hands, feet, or lips
DOSAGE AND ADMINISTRATION:
Hypertension: 40 mg/day PO initially; titrated to 20-80 mg/day PO, depending on response; patients with volume depletion should receive the lower dosage initially, under close supervision. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction is required after the 80-mg dose, a diuretic may be added.
Cardiovascular risk reduction
Indicated for cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors, 80 mg PO OD
- Hypersensitivity to Telmisartan or any other component of this product
- Coadministration with Aliskiren in patients with diabetes
WARNINGS AND PRECAUTIONS:
- When pregnancy is detected, discontinue Telmisartan as soon as possible
- Using alcohol with this drug can increase your risk for low blood pressure. This may cause faintness or dizziness.
- Should not be used in patient with severe kidney problem and heart failure
Pregnancy Category: D
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
- Increased risk of hyperkalemia with concurrent use of potassium supplements or potassium sparing diuretics
- May increase serum Digoxin Level
- Antihypertensive effect may be blunted by NSAIDs.