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Diltiazem Hydrochloride sustained release tablet is indicated in the prophylaxis and treatment of angina pectoris. It is used in the management of classical and vasospastic angina pectoris. It has also been used in the treatment of essential hypertension. It is used for prophylaxis of some selected supraventricular tachyarrhythmias.

Calcium-channel blockers

Diltiazem hydrochloride is a calcium channel antagonist. It is a peripheral and coronary vasodilator with some negative inotropic activity. Diltiazem inhibits cardiac conduction particularly at the sino-atrial and atrioventricular nodes. Diltiazem has the following actions:

Antianginal: A direct dilatation of coronary arteries and arterioles proved oxygen supply to myocardial tissues. In addition dilatation of the peripheral vasculature reduces systemic pressure of cardiac "after load" which results in lessened stress and reduced oxygen requirements of the myocardial tissues.

Antiarrhythmic: The inhibited influx of calcium ions in cardiac tissues result in slowed electrophysiological activity through the S-A and A-V nodes without affecting accessory bypass conduction or altering normal atrial action potential or intraventricular conduction.

Antihypertensive: Reduces peripheral vascular resistance as a result of vasodilatation. More than 90% of an oral dose is rapidly absorbed. Protein binding is very high. Peak plasma concentration reaches within 30-60 minutes. It is metabolised in the liver and excreted (60%) through bile.

Mild to moderate hypertension: initially 90 mg or 120 mg twice daily (elderly once daily); up to 360 mg daily may be required (elderly upto 240 mg) daily.

Angina: initially 90 mg or 120 mg twice daily in divided doses may be required (elderly up to 240 mg daily).

Bradycardia, sino-atrial block, atrioventricular block, hypertension, malaise, headache, hot flushes, GIT disturbances, oedema, hepatitis and depression reported.

Diltiazem Hydrochloride sustained release tablet is contraindicated in patients with known hypersensitivity to the drug, sick sinus syndrome, second or third degree AV block, severe hypertension or acute myocardial infarction and rediographically documented pulmonary congestion.

Concomitant prophylactic therapy with short-or long-acting nitrates may be administered safely during diltiazem therapy. Diltiazem recommended caution and careful dosage titration when diltiazem is administered concomitantly with other drugs that can affect cardiac contractility and/ or conduction.

There are no adequate and controlled studies to date with diltiazem in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Because diltiazem is distributed into milk, women receiving the drug should not breastfeed their infants; an alternative method of infant feeding should be used if diltiazem therapy is considered necessary in nursing women.

Keep medicine out of the reach of children. Store in a cool and dry place.

Diltiazem Hydrochloride sustained release tablet is indicated in the prophylaxis and treatment of angina pectoris. It is used in the management of classical and vasospastic angina pectoris. It has also been used in the treatment of essential hypertension. It is used for prophylaxis of some selected supraventricular tachyarrhythmias.

Calcium-channel blockers

Diltiazem hydrochloride is a calcium channel antagonist. It is a peripheral and coronary vasodilator with some negative inotropic activity. Diltiazem inhibits cardiac conduction particularly at the sino-atrial and atrioventricular nodes. Diltiazem has the following actions:

Antianginal: A direct dilatation of coronary arteries and arterioles proved oxygen supply to myocardial tissues. In addition dilatation of the peripheral vasculature reduces systemic pressure of cardiac "after load" which results in lessened stress and reduced oxygen requirements of the myocardial tissues.

Antiarrhythmic: The inhibited influx of calcium ions in cardiac tissues result in slowed electrophysiological activity through the S-A and A-V nodes without affecting accessory bypass conduction or altering normal atrial action potential or intraventricular conduction.

Antihypertensive: Reduces peripheral vascular resistance as a result of vasodilatation. More than 90% of an oral dose is rapidly absorbed. Protein binding is very high. Peak plasma concentration reaches within 30-60 minutes. It is metabolised in the liver and excreted (60%) through bile.

Mild to moderate hypertension: initially 90 mg or 120 mg twice daily (elderly once daily); up to 360 mg daily may be required (elderly upto 240 mg) daily.

Angina: initially 90 mg or 120 mg twice daily in divided doses may be required (elderly up to 240 mg daily).

Bradycardia, sino-atrial block, atrioventricular block, hypertension, malaise, headache, hot flushes, GIT disturbances, oedema, hepatitis and depression reported.

Diltiazem Hydrochloride sustained release tablet is contraindicated in patients with known hypersensitivity to the drug, sick sinus syndrome, second or third degree AV block, severe hypertension or acute myocardial infarction and rediographically documented pulmonary congestion.

Concomitant prophylactic therapy with short-or long-acting nitrates may be administered safely during diltiazem therapy. Diltiazem recommended caution and careful dosage titration when diltiazem is administered concomitantly with other drugs that can affect cardiac contractility and/ or conduction.

There are no adequate and controlled studies to date with diltiazem in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Because diltiazem is distributed into milk, women receiving the drug should not breastfeed their infants; an alternative method of infant feeding should be used if diltiazem therapy is considered necessary in nursing women.

Keep medicine out of the reach of children. Store in a cool and dry place.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Bronchodilator

Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.

The recommended dosage of Glycopyrronium is the inhalation of the contents of one capsule once daily with the ConviHaler device at the same time of day.

Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation, dizziness, insomnia, skin and subcutaneous tissue disorders, immune system disorders.

Hypersensitivity to the active substance or to any of the excipients.

Glycopyrronium, as a once-daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Glycopyrronium inhalation powder. As with other anticholinergic drugs, Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.

Although no formal drug interaction studies have been performed, Glycopyrronium inhalation powder has been used concomitantly with other drugs, commonly used in the treatment of COPD, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids without clinical evidence of drug interactions.

There is a limited amount of data from the use of Glycopyrronium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. Glycopyrronium should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.

High doses of Glycopyrronium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 150 micrograms Glycopyrronium in healthy volunteers.

Should be stored at temperature not exceeding 25ºC but do not freeze. Should be stored in cool and dry place, protected from light.

Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Long-acting selective β-adrenoceptor stimulants

Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.

The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.

Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.

No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.

The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis and dizziness.

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.

Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.

Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.

Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. Indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.

The expected signs and symptoms associated with over dosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an over dose of Indacaterol powder.

Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.

Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Long-acting selective β-adrenoceptor stimulants

Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.

The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.

Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.

No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.

The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis and dizziness.

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.

Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.

Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.

Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. Indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.

The expected signs and symptoms associated with over dosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an over dose of Indacaterol powder.

Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia and
• Chronic Musculoskeletal Pain.

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.

Major Depressive Disorder (MDD)-

• Starting Dose: 40 mg/day to 60 mg/day
• Target Dose: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day
• Maximum Dose: 120 mg/day

Generalized Anxiety Disorder (GAD)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 120 mg/day

Diabetic Peripheral Neuropathic Pain (DPNP)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Fibromyalgia-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Chronic Musculoskeletal Pain-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.

The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.

Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended

Use in the pediatric population: Safety and efficacy in pediatric patients have not been established

There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting the absorption of Duloxetine from the gastrointestinal tract.

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

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia and
• Chronic Musculoskeletal Pain.

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.

Major Depressive Disorder (MDD)-

• Starting Dose: 40 mg/day to 60 mg/day
• Target Dose: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day
• Maximum Dose: 120 mg/day

Generalized Anxiety Disorder (GAD)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 120 mg/day

Diabetic Peripheral Neuropathic Pain (DPNP)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Fibromyalgia-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Chronic Musculoskeletal Pain-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.

The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.

Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended

Use in the pediatric population: Safety and efficacy in pediatric patients have not been established

There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting the absorption of Duloxetine from the gastrointestinal tract.

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

Alpha-Glucosidase inhibitor

Alpha-glucosidase inhibitors are saccharides that act as competitive inhibitors of enzymes needed to digest carbohydrates: specifically alpha-glucosidase enzymes in the brush border of the small intestines. The membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the small intestine. Acarbose also blocks pancreatic alpha-amylase in addition to inhibiting membrane-bound alpha-glucosidases. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine. Inhibition of these enzyme systems reduces the rate of digestion of complex carbohydrates. Less glucose is absorbed because the carbohydrates are not broken down into glucose molecules. In diabetic patients, the short-term effect of these drugs therapies is to decrease current blood glucose levels: the long term effect is a small reduction in hemoglobin-A1c level.

Normal Adult Dose: Usually, Voglibose tablets are orally administered in a single dose of 0.2 mg, 3 times a day, before each meal. If the effect is not sufficient, the quantity of a single dose may be increased up to 0.3 mg.

Pediatrics: The safety and effectiveness of Voglibose in children has not been established.

Geriatrics: Since elderly patients generally have a physiological hypofunction, it is desirable that such caution be taken as starting the administration at a lower dose (eg, 0.1 mg at a time). Furthermore, this drug should be carefully administered under close observation, through the course of the disease condition, with careful attention to the blood sugar level and the onset of gastrointestinal symptoms.

Diarrhoea, loose stools, abdominal pain, constipation, loss of appetite, urge to vomit (nausea), vomiting, heartburn, increased gas, and intestinal obstruction like symptoms due to increased intestinal gas. OHAs plus voglibose may cause hypoglycaemia (0.1% to <5%), delay in digestion and absorption of disaccharides, fulminant hepatitis, serious liver dysfunction with increased liver enzymes, jaundice, anaemia, numbness, edema, blurred vision, hot flushes, malaise, weakness, hyperkalemia, increased pancreatic enzyme (serum amylase).

Contraindicated in patients with Hypersensitivity to Voglibose or to any of the excipients; Diabetic ketoacidosis, diabetic pre-coma; Severe infection, before and after operation or with serious trauma; Gastrointestinal obstruction or predisposed to it.

Careful Administration (should be administered with care in following patients):

• Patients who are receiving other antidiabetic drugs as hypoglycaemia may occur
• Patients with a history of laparotomy or ileus (intestinal obstruction-like symptoms are liable to develop due to an increase in intestinal gas, etc.)
• Patients with chronic intestinal disease accompanied by a disturbance in digestion and absorption (the action of this drug may aggravate the pathologic conditions)
• Patients with Roemheld’s Syndrome, severe hernia, Stenosis or ulceration of the large intestine, etc. (Symptoms may worsen due to an increase in the intestinal gas, etc.)
• Patients with serious hepatic dysfunction (Because of possible changes in metabolic condition, the status of plasma glucose control may greatly vary. In patients with severe liver cirrhosis, hyperammonemia may worsen, followed by disturbance of consciousness.)
• Patients with serious renal dysfunction (Because of possible changes in metabolic conditions, the status of plasma glucose control may greatly vary.)
• Elderly patients

Voglibose should be administered with care when co-administered with the following drugs:

Antidiabetic drugs: Derivative(s) of sulfonylamide and sulfonylurea, biguanide derivatives, insulin preparations and improving agents for insulin resistance.

For the concomitant use of antldlabetlc drugs and the drugs which enhance or diminish the hypoglycaemic action of antldlabetlc drugs:

• Drugs enhancing the hypoglycaemic action of antidiabetic drugs: β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate derivatives for the treatment of hyperlipemia, warfarin, etc.
• Drugs diminishing the hypoglycemic actton of antidiabetic drugs: Adrenaline, adrenocortical hormone, thyroid hormone, etc.

Pregnancy: The safety of Voglibose in pregnancy has not been established. However, no adequate and well controlled studies have been done on pregnant women.

Lactatlng and Nursing Mothers: Although the levels of Voglibose reached in human milk are exceedingly low, it is recommended that Voglibose may not be administered to such women.

Dosage in Renal Failure: Voglibose is poorly absorbed after oral doses and renal excretion is negligible, suggesting that no dose adjustment is required. However, pharmacokinetic studies in patients with renal insufficiency are not available.

Unlike sulfonylureas or insulin, an overdose of Voglibose tablets will not result in hypoglycaemia. An overdose may result is transient increase in flatulence, diarrhoea and abdominal discomfort. Because of lack of extra-intestinal effects soon with Voglibose, no serious systemic reactions are expected in the event of an overdose.

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

Alpha-Glucosidase inhibitor

Alpha-glucosidase inhibitors are saccharides that act as competitive inhibitors of enzymes needed to digest carbohydrates: specifically alpha-glucosidase enzymes in the brush border of the small intestines. The membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the small intestine. Acarbose also blocks pancreatic alpha-amylase in addition to inhibiting membrane-bound alpha-glucosidases. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine. Inhibition of these enzyme systems reduces the rate of digestion of complex carbohydrates. Less glucose is absorbed because the carbohydrates are not broken down into glucose molecules. In diabetic patients, the short-term effect of these drugs therapies is to decrease current blood glucose levels: the long term effect is a small reduction in hemoglobin-A1c level.

Normal Adult Dose: Usually, Voglibose tablets are orally administered in a single dose of 0.2 mg, 3 times a day, before each meal. If the effect is not sufficient, the quantity of a single dose may be increased up to 0.3 mg.

Pediatrics: The safety and effectiveness of Voglibose in children has not been established.

Geriatrics: Since elderly patients generally have a physiological hypofunction, it is desirable that such caution be taken as starting the administration at a lower dose (eg, 0.1 mg at a time). Furthermore, this drug should be carefully administered under close observation, through the course of the disease condition, with careful attention to the blood sugar level and the onset of gastrointestinal symptoms.

Diarrhoea, loose stools, abdominal pain, constipation, loss of appetite, urge to vomit (nausea), vomiting, heartburn, increased gas, and intestinal obstruction like symptoms due to increased intestinal gas. OHAs plus voglibose may cause hypoglycaemia (0.1% to <5%), delay in digestion and absorption of disaccharides, fulminant hepatitis, serious liver dysfunction with increased liver enzymes, jaundice, anaemia, numbness, edema, blurred vision, hot flushes, malaise, weakness, hyperkalemia, increased pancreatic enzyme (serum amylase).

Contraindicated in patients with Hypersensitivity to Voglibose or to any of the excipients; Diabetic ketoacidosis, diabetic pre-coma; Severe infection, before and after operation or with serious trauma; Gastrointestinal obstruction or predisposed to it.

Careful Administration (should be administered with care in following patients):

• Patients who are receiving other antidiabetic drugs as hypoglycaemia may occur
• Patients with a history of laparotomy or ileus (intestinal obstruction-like symptoms are liable to develop due to an increase in intestinal gas, etc.)
• Patients with chronic intestinal disease accompanied by a disturbance in digestion and absorption (the action of this drug may aggravate the pathologic conditions)
• Patients with Roemheld’s Syndrome, severe hernia, Stenosis or ulceration of the large intestine, etc. (Symptoms may worsen due to an increase in the intestinal gas, etc.)
• Patients with serious hepatic dysfunction (Because of possible changes in metabolic condition, the status of plasma glucose control may greatly vary. In patients with severe liver cirrhosis, hyperammonemia may worsen, followed by disturbance of consciousness.)
• Patients with serious renal dysfunction (Because of possible changes in metabolic conditions, the status of plasma glucose control may greatly vary.)
• Elderly patients

Voglibose should be administered with care when co-administered with the following drugs:

Antidiabetic drugs: Derivative(s) of sulfonylamide and sulfonylurea, biguanide derivatives, insulin preparations and improving agents for insulin resistance.

For the concomitant use of antldlabetlc drugs and the drugs which enhance or diminish the hypoglycaemic action of antldlabetlc drugs:

• Drugs enhancing the hypoglycaemic action of antidiabetic drugs: β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate derivatives for the treatment of hyperlipemia, warfarin, etc.
• Drugs diminishing the hypoglycemic actton of antidiabetic drugs: Adrenaline, adrenocortical hormone, thyroid hormone, etc.

Pregnancy: The safety of Voglibose in pregnancy has not been established. However, no adequate and well controlled studies have been done on pregnant women.

Lactatlng and Nursing Mothers: Although the levels of Voglibose reached in human milk are exceedingly low, it is recommended that Voglibose may not be administered to such women.

Dosage in Renal Failure: Voglibose is poorly absorbed after oral doses and renal excretion is negligible, suggesting that no dose adjustment is required. However, pharmacokinetic studies in patients with renal insufficiency are not available.

Unlike sulfonylureas or insulin, an overdose of Voglibose tablets will not result in hypoglycaemia. An overdose may result is transient increase in flatulence, diarrhoea and abdominal discomfort. Because of lack of extra-intestinal effects soon with Voglibose, no serious systemic reactions are expected in the event of an overdose.

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

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Diloxanide is indicated for intestinal amoebiasis

Amoebicides

Diloxanide is a luminal amoebicide which is hydrolysed in the gut, thus releasing the free diloxanide which acts as an amoebicide. It is given alone in asymptomatic cyst passers. For patients with active amoebic infections, it can be administered with a 5-nitroimidazole e.g. metronidazole or tinidazole.

Adult: The recommended dose is 500 mg 3 times/day for 10 days. May repeat course if needed.

Child: >25 kg: 20 mg/kg daily in 3 divided doses for 10 days, repeated if necessary.

The frequency of these side-effects is unknown flatulence, itching, urticaria, vomiting

Hypersensitivity.

Caution should be exercised in pregnant and breastfeeding women. Avoid excess dosage.

There are no known drug interactions and none well documented.

Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.