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Telmisartan is indicated in-

Hypertension: Treatment of essential hypertension in adults.
Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with:

• Atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
• Type 2 diabetes mellitus with documented target organ damage.

Angiotensin-ll receptor blocker

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. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Dosage must be individualized. The usual starting dose of Telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan is required, may switch to the combination. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. Initial therapy with Telmisartan is not recommended in patients ≥75 years old or with hepatic impairment.

In hypertensive patients: The most common side effects of Telmisartan tablets include sinus pain and congestion (sinusitis), back pain, diarrhea etc.

For patients of cardiovascular risk reduction: The most common side effects of Telmisartan tablets in CV risk reduction include intermittent claudication and skin ulcer.

Known hypersensitivity to this product or any of its components.

Pregnancy Category C (first trimester) and D (second and third trimester). Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Telmisartan in pediatric patients have not been established.

Geriatric use: No overall differences in effectiveness and safety were observed in these patients compared to younger patients.

Hepatic impairment: Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.

The most likely manifestation of overdosage with Telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia, increase in serum creatinine and acute renal failure could occur from parasympathetic (vagal) stimulation.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Combined antihypertensive preparations

This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is 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, which leads to an increase in blood pressure (hypertension). 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. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.

Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.

Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.

Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.

Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.

Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Combined antihypertensive preparations

This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is 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, which leads to an increase in blood pressure (hypertension). 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. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.

Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.

Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.

Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.

Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.

Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Combined antihypertensive preparations

This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is 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, which leads to an increase in blood pressure (hypertension). 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. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.

Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.

Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.

Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.

Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.

Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Combined antihypertensive preparations

This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is 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, which leads to an increase in blood pressure (hypertension). 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. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.

Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.

Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.

Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.

Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.

Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

Telmisartan and Hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. This combination can be used alone or with other antihypertensive agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Combined antihypertensive preparations

Telmisartan: Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is 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 aldosteronesecreting 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.

There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000-fold) for the AT1 receptor than for the AT2 receptor.

Telmisartan does not inhibit ACE (kininase II) nor does it bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.

Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium salt and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an ARB tends to reverse the potassium loss associated with these diuretics. The mechanism of the antihypertensive effect of thiazides is not fully understood.

Initiate a patient whose blood pressure is not adequately controlled with-

• Telmisartan monotherapy 80 mg: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
• Hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Telmisartan and Hydrochlorothiazide may be administered with other antihypertensive drugs.

Common side effects include dizziness, drowsiness, tired feeling, flushing (warmth, redness, or tingly feeling), back pain, nausea, diarrhea, stomach pain. Other adverse events include allergy, fever, leg pain, chest pain, insomnia, somnolence, and dry mouth, elevations of liver enzymes or serum bilirubin, leg cramps, myalgia, dermatitis. Other adverse events that have been reported includes weakness, gastric irritation, photosensitivity, urticaria, muscle spasm, restlessness.

This is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to Telmisartan, Hydrochlorothiazide or any other component of this product. Do not co-administer Aliskiren with this tablet in patients with Diabetes.

Before using this medication, tell your doctor about your medical history, especially of kidney disease, liver disease, bile duct blockage, loss of too much body water and/or minerals (dehydration), untreated mineral imbalance (such as low or high potassium), gout, lupus. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. This product may affect your body potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor. This drug may make you dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

Caution should be exercised before taking this drug if you are taking aliskiren, digoxin, lithium, other medicines for high blood pressure, NSAIDs (such as aspirin, ibuprofen, naproxen, others), corticosteroids (such as prednisone, hydrocortisone, others), angiotensin-converting enzyme (ACE) blockers (such as benazepril, enalapril, lisinopril) angiotensin II receptor blockers (such as losartan, olmesartan, valsartan). This product may interfere with certain laboratory tests (including parathyroid test, protein-bound iodide test), possibly causing false test results.

Pregnancy Category D. 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmisartan and hydrochlorothiazide as soon as possible.

Nursing Mothers: It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in pediatric patients have not been established.

Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Use in Patients with Hepatic Impairment: Patients with biliary obstructive disorders or hepatic insufficiency should initiate treatment under close medical supervision.

Use in Patients with Renal Impairment: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in patients with severe renal impairment (Cr.Cl. <30 ml/min) have not been established. In patients with severe renal impairment, Telmisartan and Hydrochlorothiazide tablets are not recommended. No dose adjustment is required in patients with mild (Cr.Cl. 60 to 90 ml/min) or moderate (Cr.Cl. 30 to 60 ml/min) renal impairment.

The most likely manifestations of overdosage are hypertension, dizziness, tachycardia, bradycardia, hypokalemia, hypochloremia, hyponatremia and dehydration etc. Telmisartan is not removed by hemodialysis and the degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

Keep out of the reach of children. Keep in a cool and dry place. Protect from light.

Telmisartan and Hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. This combination can be used alone or with other antihypertensive agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Combined antihypertensive preparations

Telmisartan: Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is 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 aldosteronesecreting 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.

There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000-fold) for the AT1 receptor than for the AT2 receptor.

Telmisartan does not inhibit ACE (kininase II) nor does it bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.

Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium salt and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an ARB tends to reverse the potassium loss associated with these diuretics. The mechanism of the antihypertensive effect of thiazides is not fully understood.

Initiate a patient whose blood pressure is not adequately controlled with-

• Telmisartan monotherapy 80 mg: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
• Hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Telmisartan and Hydrochlorothiazide may be administered with other antihypertensive drugs.

Common side effects include dizziness, drowsiness, tired feeling, flushing (warmth, redness, or tingly feeling), back pain, nausea, diarrhea, stomach pain. Other adverse events include allergy, fever, leg pain, chest pain, insomnia, somnolence, and dry mouth, elevations of liver enzymes or serum bilirubin, leg cramps, myalgia, dermatitis. Other adverse events that have been reported includes weakness, gastric irritation, photosensitivity, urticaria, muscle spasm, restlessness.

This is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to Telmisartan, Hydrochlorothiazide or any other component of this product. Do not co-administer Aliskiren with this tablet in patients with Diabetes.

Before using this medication, tell your doctor about your medical history, especially of kidney disease, liver disease, bile duct blockage, loss of too much body water and/or minerals (dehydration), untreated mineral imbalance (such as low or high potassium), gout, lupus. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. This product may affect your body potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor. This drug may make you dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

Caution should be exercised before taking this drug if you are taking aliskiren, digoxin, lithium, other medicines for high blood pressure, NSAIDs (such as aspirin, ibuprofen, naproxen, others), corticosteroids (such as prednisone, hydrocortisone, others), angiotensin-converting enzyme (ACE) blockers (such as benazepril, enalapril, lisinopril) angiotensin II receptor blockers (such as losartan, olmesartan, valsartan). This product may interfere with certain laboratory tests (including parathyroid test, protein-bound iodide test), possibly causing false test results.

Pregnancy Category D. 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmisartan and hydrochlorothiazide as soon as possible.

Nursing Mothers: It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in pediatric patients have not been established.

Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Use in Patients with Hepatic Impairment: Patients with biliary obstructive disorders or hepatic insufficiency should initiate treatment under close medical supervision.

Use in Patients with Renal Impairment: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in patients with severe renal impairment (Cr.Cl. <30 ml/min) have not been established. In patients with severe renal impairment, Telmisartan and Hydrochlorothiazide tablets are not recommended. No dose adjustment is required in patients with mild (Cr.Cl. 60 to 90 ml/min) or moderate (Cr.Cl. 30 to 60 ml/min) renal impairment.

The most likely manifestations of overdosage are hypertension, dizziness, tachycardia, bradycardia, hypokalemia, hypochloremia, hyponatremia and dehydration etc. Telmisartan is not removed by hemodialysis and the degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

Keep out of the reach of children. Keep in a cool and dry place. Protect from light.

Telmisartan and Hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. This combination can be used alone or with other antihypertensive agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Combined antihypertensive preparations

Telmisartan: Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is 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 aldosteronesecreting 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.

There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000-fold) for the AT1 receptor than for the AT2 receptor.

Telmisartan does not inhibit ACE (kininase II) nor does it bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.

Hydrochlorothiazide: Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium salt and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an ARB tends to reverse the potassium loss associated with these diuretics. The mechanism of the antihypertensive effect of thiazides is not fully understood.

Initiate a patient whose blood pressure is not adequately controlled with-

• Telmisartan monotherapy 80 mg: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
• Hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen: Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Telmisartan and Hydrochlorothiazide may be administered with other antihypertensive drugs.

Common side effects include dizziness, drowsiness, tired feeling, flushing (warmth, redness, or tingly feeling), back pain, nausea, diarrhea, stomach pain. Other adverse events include allergy, fever, leg pain, chest pain, insomnia, somnolence, and dry mouth, elevations of liver enzymes or serum bilirubin, leg cramps, myalgia, dermatitis. Other adverse events that have been reported includes weakness, gastric irritation, photosensitivity, urticaria, muscle spasm, restlessness.

This is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to Telmisartan, Hydrochlorothiazide or any other component of this product. Do not co-administer Aliskiren with this tablet in patients with Diabetes.

Before using this medication, tell your doctor about your medical history, especially of kidney disease, liver disease, bile duct blockage, loss of too much body water and/or minerals (dehydration), untreated mineral imbalance (such as low or high potassium), gout, lupus. If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. This product may affect your body potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor. This drug may make you dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

Caution should be exercised before taking this drug if you are taking aliskiren, digoxin, lithium, other medicines for high blood pressure, NSAIDs (such as aspirin, ibuprofen, naproxen, others), corticosteroids (such as prednisone, hydrocortisone, others), angiotensin-converting enzyme (ACE) blockers (such as benazepril, enalapril, lisinopril) angiotensin II receptor blockers (such as losartan, olmesartan, valsartan). This product may interfere with certain laboratory tests (including parathyroid test, protein-bound iodide test), possibly causing false test results.

Pregnancy Category D. 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmisartan and hydrochlorothiazide as soon as possible.

Nursing Mothers: It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in pediatric patients have not been established.

Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Use in Patients with Hepatic Impairment: Patients with biliary obstructive disorders or hepatic insufficiency should initiate treatment under close medical supervision.

Use in Patients with Renal Impairment: Safety and effectiveness of Telmisartan and Hydrochlorothiazide in patients with severe renal impairment (Cr.Cl. <30 ml/min) have not been established. In patients with severe renal impairment, Telmisartan and Hydrochlorothiazide tablets are not recommended. No dose adjustment is required in patients with mild (Cr.Cl. 60 to 90 ml/min) or moderate (Cr.Cl. 30 to 60 ml/min) renal impairment.

The most likely manifestations of overdosage are hypertension, dizziness, tachycardia, bradycardia, hypokalemia, hypochloremia, hyponatremia and dehydration etc. Telmisartan is not removed by hemodialysis and the degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

Keep out of the reach of children. Keep in a cool and dry place. Protect from light.

Telmisartan is indicated in-

Hypertension: Treatment of essential hypertension in adults.
Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with:

• Atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
• Type 2 diabetes mellitus with documented target organ damage.

Angiotensin-ll receptor blocker

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. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Dosage must be individualized. The usual starting dose of Telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan is required, may switch to the combination. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. Initial therapy with Telmisartan is not recommended in patients ≥75 years old or with hepatic impairment.

In hypertensive patients: The most common side effects of Telmisartan tablets include sinus pain and congestion (sinusitis), back pain, diarrhea etc.

For patients of cardiovascular risk reduction: The most common side effects of Telmisartan tablets in CV risk reduction include intermittent claudication and skin ulcer.

Known hypersensitivity to this product or any of its components.

Pregnancy Category C (first trimester) and D (second and third trimester). Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Telmisartan in pediatric patients have not been established.

Geriatric use: No overall differences in effectiveness and safety were observed in these patients compared to younger patients.

Hepatic impairment: Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.

The most likely manifestation of overdosage with Telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia, increase in serum creatinine and acute renal failure could occur from parasympathetic (vagal) stimulation.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Combined antihypertensive preparations

This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is 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, which leads to an increase in blood pressure (hypertension). 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. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.

Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.

Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.

Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.

Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.

Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

Telmisartan is indicated in-

Hypertension: Treatment of essential hypertension in adults.
Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with:

• Atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
• Type 2 diabetes mellitus with documented target organ damage.

Angiotensin-ll receptor blocker

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. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Dosage must be individualized. The usual starting dose of Telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan is required, may switch to the combination. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. Initial therapy with Telmisartan is not recommended in patients ≥75 years old or with hepatic impairment.

In hypertensive patients: The most common side effects of Telmisartan tablets include sinus pain and congestion (sinusitis), back pain, diarrhea etc.

For patients of cardiovascular risk reduction: The most common side effects of Telmisartan tablets in CV risk reduction include intermittent claudication and skin ulcer.

Known hypersensitivity to this product or any of its components.

Pregnancy Category C (first trimester) and D (second and third trimester). Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Telmisartan in pediatric patients have not been established.

Geriatric use: No overall differences in effectiveness and safety were observed in these patients compared to younger patients.

Hepatic impairment: Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.

The most likely manifestation of overdosage with Telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia, increase in serum creatinine and acute renal failure could occur from parasympathetic (vagal) stimulation.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

Telmisartan is indicated in-

Hypertension: Treatment of essential hypertension in adults.
Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with:

• Atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
• Type 2 diabetes mellitus with documented target organ damage.

Angiotensin-ll receptor blocker

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. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Dosage must be individualized. The usual starting dose of Telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan is required, may switch to the combination. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. Initial therapy with Telmisartan is not recommended in patients ≥75 years old or with hepatic impairment.

In hypertensive patients: The most common side effects of Telmisartan tablets include sinus pain and congestion (sinusitis), back pain, diarrhea etc.

For patients of cardiovascular risk reduction: The most common side effects of Telmisartan tablets in CV risk reduction include intermittent claudication and skin ulcer.

Known hypersensitivity to this product or any of its components.

Pregnancy Category C (first trimester) and D (second and third trimester). Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Telmisartan in pediatric patients have not been established.

Geriatric use: No overall differences in effectiveness and safety were observed in these patients compared to younger patients.

Hepatic impairment: Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.

The most likely manifestation of overdosage with Telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia, increase in serum creatinine and acute renal failure could occur from parasympathetic (vagal) stimulation.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Combined antihypertensive preparations

This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is 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, which leads to an increase in blood pressure (hypertension). 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. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.

Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.

Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.

Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.

Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.

Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

This is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Combined antihypertensive preparations

This is a fixed dose combination of Telmisartan and Amiodipine. Telmisartan, a non-peptide angiotensin receptor blocker (ARB), is specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin II is 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, which leads to an increase in blood pressure (hypertension). 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. Therefore, Telmisartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Amiodipine, a dihydropyridine calcium-channel blocker (CCB), inhibits the transmembrane influx of calcium ion into vascular smooth muscle and cardiac muscle. Amiodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Initial Therapy: Patient may be initiated on this tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started with 80/5 mg once daily. Initial therapy with this is not recommended in patients 575 years old or with hepatic impairment.

Add-on Therapy: Patients not adequately controlled with amiodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. Patients treated with 10 mg amiodipine who experience adverse reactions such as edema, may be switched to this 40/5 mg tablets once daily, reducing the dose of amiodipine without reducing the overall expected antihypertensive response.

Replacement Therapy: Patients receiving amiodipine and telmisartan from separate tablets may instead receive this tablets containing the same component doses once daily. Dosage must be individualized and may be increased after at least 2 weeks. The maximum recommended dose of this tablet is 80/10 mg once daily.

Dizziness, peripheral edema, migraine, headache, paraesthesia, vertigo, bradycardia, palpitations, hypotension, cough, abdominal pain, diarrhea, nausea, pruritus, myalgia, spasm, erectile dysfunction,chest pain, fatigue, edema etc.

Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amiodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19.

Telmisartan is not expected to interact with drugs that inhibit or are metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

In clinical trials, amiodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti inflammatory drugs, antibiotics, and oral hypoglycemic drugs.

The following have no clinically relevant effects on the pharmacokinetics of amiodipine: cimetidine, grapefruit juice, sildenafil. Amiodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin.

Pregnancy Categories C (first trimester) and D (second and third trimesters). It is not known whether telmisartan and amiodipine is excreted in human milk. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue the drug after taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness of Telmisartan & Amiodipine combination in pediatric patients have not been established.

Geriatric use: Initial therapy with Telmisartan & Amiodipine combination is not recommended in patients ≥75 years old.

Hepatic impairment: Initial therapy with Telmisartan & Amiodipine combination is not recommended in hepatically impaired patients.

Telmisartan: Limited data are available with regard to overdosage in humans. The most likely manifestations of over dosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amiodipine: Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly reflex tachycardia. If massive overdose occur, active cardiac and respiratory monitoring should be instituted. Frequent bipod pressure measurements are essential. If hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Amiodipine is not removed by hemodialysis.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

Telmisartan is indicated in-

Hypertension: Treatment of essential hypertension in adults.
Cardiovascular prevention: Reduction of cardiovascular morbidity in adults with:

• Atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
• Type 2 diabetes mellitus with documented target organ damage.

Angiotensin-ll receptor blocker

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. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Dosage must be individualized. The usual starting dose of Telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan is required, may switch to the combination. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. Initial therapy with Telmisartan is not recommended in patients ≥75 years old or with hepatic impairment.

In hypertensive patients: The most common side effects of Telmisartan tablets include sinus pain and congestion (sinusitis), back pain, diarrhea etc.

For patients of cardiovascular risk reduction: The most common side effects of Telmisartan tablets in CV risk reduction include intermittent claudication and skin ulcer.

Known hypersensitivity to this product or any of its components.

Pregnancy Category C (first trimester) and D (second and third trimester). Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: The safety and effectiveness of Telmisartan in pediatric patients have not been established.

Geriatric use: No overall differences in effectiveness and safety were observed in these patients compared to younger patients.

Hepatic impairment: Monitor carefully and up titrate slowly in patients with biliary obstructive disorders or hepatic insufficiency.

The most likely manifestation of overdosage with Telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia, increase in serum creatinine and acute renal failure could occur from parasympathetic (vagal) stimulation.

Do not store above 30°C. Protect from light and high humidity. Keep out of the reach of children.

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Leukotriene receptor antagonists

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

Adults & adolescents (15 years & older)-

• Asthma & Allergic Rhinitis: 10 mg/day 
• Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

• Asthma & Allergic Rhinitis: 5 mg/day 
• Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

• Asthma & Allergic Rhinitis: 4 mg/day 
• Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Cough expectorants & mucolytics

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

Average daily dose (preferably after meal):

Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

Specific mineral & vitamin combined preparations

This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.

Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.

It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.

It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.

If there is any pre-existing heart disease or kidney disease, precautions should be taken.

It has possible interaction with calcium, aluminium or magnesium containing antacids &  other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.

This combination should be used as directed by physician during pregnancy or while breast-feeding.

Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.

Keep in a dry place away from light and heat. Keep out of the reach of children.