TASMI Tablet

For the treatment of essential hypertension. It may be used alone or in combination with other antihypertensive agents.

Dosage and administration

Dosage of TASMI tablets must be individualized; the usual starting dose of TASMI tablets is 40mg once a day. Blood pressure response is dose related over the range of 20-80mg. TASMI tablets may be taken with or without food.

Adults

The usual effective dose of TASMI tablets is 40mg once daily. Some patients may already benefit at a daily dose of 20mg, In case where the target blood pressure is not achieved, telmisartan dose can be increased to a maximum of 80mg once daily. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained 4-8 weeks after the start of treatment.

Renal impaired patients

No dose adjustment is required in patients with mild to moderate renal impairment. Limited experience is available in patients with severe renal impairment or hemodialysis. A lower starting dose of 20mg is recommended in these patients.

Hepatic impaired patients

In patients with mild to moderate hepatic impairment the dosage should not exceed 40mg once daily.

- In patients who are hypersensitive to this drug or any component of this product.

- During second and third trimesters of pregnancy and lactation.

- In patients with biliary obstructive disorders.

- In patients with severe hepatic impairment.

- In patients with severe renal impairment.

- In patient with hereditary fructose intolerance.

Adverse effects reported from telmisartan have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The incidence of adverse events were not dose related.

Common: Symptoms of infection (e.g., urinary tract infections including cystitis), upper respiratory tract infections including pharyngitis and sinusitis, abdominal pain, diarrhea, dyspepsia, eczema, arthralgia, back pain (e.g., sciatica), muscle spasms or pain in extremity myalgia, chest pain and influenza-like illness.

Uncommon: Anxiety, visual disturbance, vertigo, dry mouth, flatulence, hyperhidrosis and tendonitis.

Rare: Stomach discomfort.

Clinical Laboratory Findings:

Infrequently, a hemoglobin decrease or a blood uric acid increase has been observed which occur more often during treatment with telmisartan than with placebo. Increase in creatinine or hepatic enzyme increase has been observed during treatment with telmisartan but these changes in laboratory findings occurred with a frequency similar to or lower than placebo.

In addition, cases with blood creatinine phosphokinase increase (CPK) have been reported.

Liver Enzymes: Occasional elevations of liver enzymes occurred in patients treated with telmisartan; all marked elevations occurred at a higher frequency with placebo. No telmisartan-treated patients discontinued therapy due to abnormal hepatic function.

- Digoxin

- potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products, heparin, immunosuppresor (cyclosporine or tacrolimus), trimethoprim, ACE inhibitors, angiotensinⅡreceptors antagonist, NSAIDs.

- lithium

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, telmisartan tablets should be discontinued as soon as possible.

- Symptomatic hypotension, especially after the first dose. may occur in patients who are volume or sodium depleted by vigorous diuretic therapy, dietary salt restriction, and diarrhea or vomiting. Such conditions especially volume or sodium depletion, should be corrected before administration of telmisartan.

- Patients on dialysis may develop orthostatic hypotension so their blood pressure should be closely monitored. The majority of telmisartan is eliminated in the bile. Patients with biliary obstructive disorders or severe hepatic insufficiency can be expected to have reduced clearance. Telmisartan tablets should be used only with caution in these patients.

- There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.

- During treatment with medicinal products that affect the renin-angiotensin-aldosterone system hyperkalemia may occur, especially in the presence of renal impairment and/or heart failure. Monitoring of serum potassium in patients at risk is recommended.

- In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotemia, oliguria, or rarely acute renal failure.

- As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

- Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore the use of telmisartan is not recommended.

- When telmisartan is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.

- The safety and efficacy of telmisartan has not been established for the children under the age of 18 years.

- When driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy.

AngiotensinⅡis formed from angiotensinⅠin a reaction catalyzed by angiotensin-converting enzyme (ACE, kininaseⅡ). AngiotensinⅡis the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensinⅡto the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensinⅡsynthesis. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Blockade of renin-angiotensin system with ACE inhibitors, inhibits the biosynthesis of angiotensinⅡfrom angiotensinⅠand is widely used in the treatment of hypertension.