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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.

Anastrozole is indicated in-

• Treatment of early breast cancer in hormone receptor positive post-menopausal women.
• Adjuvant treatment of early breast cancer in hormone receptor positive
• postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
• Reduction in the incidence of contralateral breast cancers in post menopausal women receiving Anastrozole as adjuvant treatment for early breast cancer.
• Treatment of advanced breast cancer in post-menopausal women.

Hormonal Chemotherapy

Anastrazole exerts its anti-estrogenic effects via selective and competitive inhibition of the aromatase enzyme found predominantly in the adrenal glands, liver, and fatty tissues. Many breast cancers are hormone receptor-positive, meaning their growth is stimulated and/or maintained by the presence of hormones such as estrogen or progesterone. In postmenopausal women, estrogen is primarily derived from the conversion of adrenally-produced androgens into estrogens by the aromatase enzyme- by competitively inhibiting the biosynthesis of estrogen at these enzymes, anastrozole effectively suppresses circulating estrogen levels and, subsequently, the growth of hormone receptor-positive tumours.

Adults Including the Elderly: One tablet (1 mg) to be taken orally once a day.
Children: The use of Anastrozole is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.

Very common side effects: Hot flushes, asthenia, joint stiffness, arthritis, headache, nausea, rash etc. Common side effects: Hair thinning, allergic reactions, diarrhea, vomiting, somnolence etc.

Anastrozole is not recommended for use in children or in pre-menopausal women as safety and efficacy have not been established in these groups of patients.

• Anastrozole has not been investigated in patients with severe hepatic or severe renal impairment. The potential risk/benefit to such patients should be carefully considered before administration of Anastrozole.
• As Anastrozole lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.

Tamoxifen and/or other therapies containing estrogen should not be co-administered with Anastrozole.

Anastrozole must not be administered during pregnancy or lactation.

There is limited clinical experience of overdose of Anastrozole. There are no reports where a patient has taken a dose in excess of 60 mg. No toxicity was observed and no clinically relevant adverse effects have been seen.

Store in a cool & dry place, protected from light and moisture. Keep out of reach of children.

Anti-malarial drugs

Artesunate is metabolized to the active DHA. the endoperoxide bridge of DHA reacts with heme, generating free radicals which inhibit protein and nucleic acid synthesis of the Plasmodium parasites during all erythrocytic stages. Reactions with these free radicals can also lead to alkylation of parasitic proteins such as a calcium adenosine triphosphatase and EXP1, a glutathione S-transferase.

It is to be given by oral route. The oral dose of Artesunate tablet can be defined as follows:

For Artesunate 50 mg tablet:
Adults:

• Two Artesunate 50 tablets twice on the first day, then
• one Artesunate 50 tablet twice daily for the next four days (4, 2, 2, 2, 2)

Children:

• 1-3 years: 3 Artesunate 50 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
• 4-5 years: 6 Artesunate 50 tablets for 5 days (2, 1, 1, 1, 1)
• 6-12 years: 8 Artesunate 50 tablets for 5 days (3, 2, 1, 1, 1)

For Artesunate 100 mg tablet:
Adults: One Artesunate 100 tablet twice on the first day, then half Artesunate 100 tablet twice daily for the next four days (2, 1, 1, 1, 1)

Children:

• 4-5 years: 3 Artesunate 100 tablets for 5 days (1, 1⁄2, 1⁄2, 1⁄2, 1⁄2)
• 6-12 years: 4 Artesunate 100 tablets for 5 days (11⁄2,1,1⁄2,1⁄2,1⁄2)
• Patients aged more than 12 years: should be given same as adult dose.

Dosage for the prevention of malaria: Two Artesunate 50 tablets (or one Artesunate 100 tablet) as a single dose once a week, from one week before entering a malaria-affected area to four weeks after leaving the area.

Artesunate tablet is well tolerated. No adverse effects have been reported from the treatment of artesunate at recommended dose.

Artesunate is contraindicated for patients with known hypersensitivity to Artemisinin and its derivatives or its inactive ingredients.

Artesunate may have interaction with other artemisinin drugs i.e. artemether, arteether which have the same effect in prolonging the PQ and QT interval. It has interaction when it is given with other antimalarial drugs (eg. Quinine, quinidine, mafloquine and halofantrine) which have cardiac action. It also has interaction with other drugs which prolong QT interval (such as erythromycin, terfenadine, astemizole, probucol, procainamide, disopyramide, amiodarone, bretylium, bepridil, sotalol, tricyclic antidepressants and neuroleptics).

A WHO report assessing the safety of artemisinin derivatives in pregnancy concluded that these drugs should continue to be available for the treatment of malaria in pregnancy, irrespective of the trimester. WHO also stressed that further study was needed. Therefore Artesunate tablet should be given to pregnant women especially, in first trimester if recommended by Registered Physician. Like many other drugs there is possibility for presence of artesunate in breast milk. Because of potential of adverse effect of artesunate in nursing baby, breast-feeding should be stopped during the treatment of malaria by Artesunate tablet.

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

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Aripiprazole is indicated for-

• Schizophrenia
• Schizoaffective disorder
• Acute manic and mixed episodes associated with Bipolar I Disorder
• Maintaining efficacy in patients with Bipolar I Disorder who are stabilized

Atypical neuroleptic drugs

Aripiprazole is an atypical antipsychotic that has both dopamine and serotonin receptors activity. It is a partial agonist of dopamine D2 receptors that relieves the symptoms of schizophrenia. It is characterized as a dopamine system stabilizer. It is a potent partial agonist at serotonin 5-HT1A receptors and antagonist at 5-HT2A receptors. This is associated with improvement of depressive, cognitive and negative symptoms.

For Schizophrenia: 10 to 15 mg, once daily, without regard to food. Dose increment should not be made before 2 weeks, the time needed to achieve steady state.

For Bipolar mania: 30 mg, once daily, without regard to food.

Headache, constipation, asthenia, nausea, dyspepsia, vomiting, coughing, abdominal pain.

Aripiprazole is contraindicated in patients who are hypersensitive to it or to any component of this product.

Aripiprazole may be associated with orthostatic hypotension (orthostatic lightheadedness).

Aripiprazole should be used with caution in patients with known cardiovascular disease (myocardial infarction or ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

Seizures occurred in aripiprazole-treated patients. As with other antipsychotic drugs, aripiprazole should be used cautiously in patients with Alzheimer's dementia.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Caution should be exercised when aripipazole is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in aripiprazole clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit aripiprazole elimination and cause increased blood levels.

Aripiprazole should not be used in pregnancy as no human trial is performed. Patients should be advised not to breast feed an infant if they are taking aripiprazole.

Aripiprazole at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with aripiprazole overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

This is indicated for-

• Internal and external hemorrhoids
• Post-partum hemorrhoidal condition
• Anal pruritus, peri-anal eczema, anal fissures and proctitis 
• Post-hemorrhoidectomy application to relieve pain and discomfort

Compound steroidal preparations, Drugs used in Ano-rectal region

Cinchocaine is a local anesthetic which relieves severe pain and relaxes sphincteric spasm. Hydrocortisone acts as an anti-inflammatory and anti-pruritic agent and thereby eliminates itching and inflammation. Neomycin is a broad-spectrum antibiotic which eradicates most infections which may already be present or arise in lesions of the anorectal area. Esculin improves skin vasculature and is effective in management of cellulitis.

Ointment: A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and should be squeezed gently from the lower end while withdrawing.

Suppository: One suppository in the morning and one in the evening, and one after each stool.

Use in children: Not recommended for children.

Side effects which have been reported for individual constituents may occur and appropriate precautions should be taken when using this preparation.

Contraindicated in patients hypersensitive to any component of the product.

Like most of the steroids under certain circumstances hydrocortisone may be absorbed in sufficient amount to produce systemic effects. So, long term use should be avoided. Adrenal suppression may occur even without occlusion. When used for prolonged period striae may occur. Skin sensitisation may occur due to Neomycin. Absorption of the antibiotic from wound or inflamed skin may occur and this may affect the hearing irreversibly. Hence this preparation should not be given to extensively damaged skin.

Use in pregnancy: The safe use of topical corticosteroids during pregnancy has not been fully established.

Keep in a cool dry place protected from light. Keep out of reach of children.

This is indicated for-

• Internal and external hemorrhoids
• Post-partum hemorrhoidal condition
• Anal pruritus, peri-anal eczema, anal fissures and proctitis 
• Post-hemorrhoidectomy application to relieve pain and discomfort

Compound steroidal preparations, Drugs used in Ano-rectal region

Cinchocaine is a local anesthetic which relieves severe pain and relaxes sphincteric spasm. Hydrocortisone acts as an anti-inflammatory and anti-pruritic agent and thereby eliminates itching and inflammation. Neomycin is a broad-spectrum antibiotic which eradicates most infections which may already be present or arise in lesions of the anorectal area. Esculin improves skin vasculature and is effective in management of cellulitis.

Ointment: A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and should be squeezed gently from the lower end while withdrawing.

Suppository: One suppository in the morning and one in the evening, and one after each stool.

Use in children: Not recommended for children.

Side effects which have been reported for individual constituents may occur and appropriate precautions should be taken when using this preparation.

Contraindicated in patients hypersensitive to any component of the product.

Like most of the steroids under certain circumstances hydrocortisone may be absorbed in sufficient amount to produce systemic effects. So, long term use should be avoided. Adrenal suppression may occur even without occlusion. When used for prolonged period striae may occur. Skin sensitisation may occur due to Neomycin. Absorption of the antibiotic from wound or inflamed skin may occur and this may affect the hearing irreversibly. Hence this preparation should not be given to extensively damaged skin.

Use in pregnancy: The safe use of topical corticosteroids during pregnancy has not been fully established.

Keep in a cool dry place protected from light. Keep out of reach of children.

This preparation is indicated in Gastric reflux, Heartburn, Flatulence associated with gastric reflux, Heartburn of pregnancy, All cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

Antacids

The mode of action of the product is physical and does not depend on absorption into the systemic circulation. On ingestion, the product reacts rapidly with gastric acid to form a raft of Alginic acid gel having a near-neutral pH and which floats on the stomach contents quickly and effectively impeding gastro-esophageal reflux, for up to 4 hours. In severe cases, the raft itself may be refluxed into the esophagus in preference to the stomach contents and exert a demulcent effect.

For oral administration:

Adult and children over 12 years:10-20 mL after meals and at bedtime, up to four times a day.

Children 6 to 12 years: 5-10 mL after meals and at bedtime, up to four times a day.

Children under 6 years: Not recommended.

Elderly: No dosage modification is required for this age group.

In addition to the desired effect of the drug, some side effects may appear such as: constipation, flatulence, stomach cramp or belching. In these cases consult a physician. If too big dose has been taken, there might appear a sensation of swelling. In this case, it is advisable to consult a physician.

This product is contraindicated in patients with known or suspected hypersensitivity to the active ingredients or to any of the excipients.

If symptoms do not improve after 7 days, the clinical situation should be reviewed. Each 10 mL dose has a Sodium content of 141 mg (6.2 mmoL). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment. Each 10 mL dose contains 160 mg (1.6 mmoL) of Calcium Carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

A time-interval of 2 hours should be considered between this drug intake and the administration of other medicinal products, especially Tetracyclines, Digoxine, Fluoroquinolone, Iron salt, Ketoconazole, Neuroleptics, Thyroid Hormones, Penicillamine, beta-blockers (Atenolol, Metoprolol, Propranolol), Glucocorticoid, Chloroquine and Biphosphonates (diphosphonates) and Estramustine.

Pregnancy: Clinical studies in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, indicate no malformative nor feto/neonatal toxicity of the active ingredients. This drug can be used during pregnancy, if clinically needed.

Breastfeeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This drug can be used during breastfeeding.

Fertility: Pre-clinical investigations have revealed Alginate has no negative effect on parental or offspring fertility or reproduction. Clinical data do not suggest that this drug has an effect on human fertility.

In the event of over dosage symptomatic treatment should be given. The patient may notice abdominal distension.

Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children. Do not refrigerate or freeze.

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi. Clotrimazole causes inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is either completely or partially inhibited, the cell is no longer able to construct an intact and functional cell membrane. Because ergosterol directly promotes the growth of fungal cells in a hormone‐like fashion, rapid onset of the above events leads to dose-dependent inhibition of fungal growth.

Though decreased ergosterol, due to the inhibition of lanosterol 14-demethylase (also known as CYP51) is accepted to be primarily responsible for the antimycotic properties of clotrimazole, this drug also shows other pharmacological effects. These include the inhibition of sarcoplasmic reticulum Ca²⁺ ATPase, depletion of intracellular calcium, and blocking of calcium‐dependent potassium channels and voltage‐dependent calcium channels. The action of clotrimazole on these targets accounts for other effects of this drug that are separate from its antimycotic activities.

Clotrimazole Cream: This should be thinly applied 2-3 times daily to the infected sites and rubbed in. On account of the excellent efficacy, a small amount of cream is usually sufficient for an area about the size of the palm. For the treatment to become a complete success, reliable and sufficiently long-time application of Clotrimazole Cream is important. The duration of treatment varies; it depends among other factors on the extent and localization of the disease.

Recommended duration of treatment-

• Dermatomycoses: 3-4 weeks
• Candida vulvitis and Candida balanitis: 1-2 weeks
• Erythrasma and Pityriasis Versicolor: 3 weeks (approximately)

In fungal infection of the feet, to prevent relapse, treatment should be continued for about 2 weeks beyond the disappearance of all signs of disease. After washing, the feet should be thoroughly dried (particularly spaces between the toes). Clotrimazole Cream is odorless, can be washed off and does not stain clothing.

Clotrimazole topical solution: Apply this sparingly to the affected areas and rub in gently, two or three times daily.

When applied topically, Clotrimazole is well tolerated.With external application, systemic effects are not observed. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful.

Hypersensitivity to Clotrimazole.

No information is available.

It is recommended that Clotrimazole should be used in pregnancy only when considered necessary by the physician.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Vitamin in bone formation, Vitamin-D preparations

Colecalciferol (Vitamin D3) helps for the absorption & reabsorption of Calcium & Phosphorous. Vitamin D3 is essential for normal bone growth & to maintain bone density. It also reduces the severity of bacterial infection, improves lung function, prevents the risk of cancer (breast, colorectal) & helps to maintain adequate insulin levels for type 2 diabetes patients.

For capsule: Adults:

• Treatment of Vitamin D3 deficiency: 40000 IU once weekly for 7 weeks. Doses for maintenance therapy is 1400-2000 IU/day. To confirm the target level of 25 hydroxyvitamin D, measurement of it should be determined 3-4 months after initiating the maintenance therapy.
• Prevention of Vitamin D3 deficiency: 20000 IU every 4 weeks. Higher doses may be required in certain situations.
• Addition to specific therapy for osteoporosis: 20000 IU once a month.

For capsule: Children (12-18 years):

• Treatment of Vitamin D3 deficiency: 20000 IU once every 2 weeks for 6 weeks.
• Prevention of Vitamin D3 deficiency: 20000 IU every 6 weeks.

For film-coated tablet: 1000 IU (1-2 tablets) daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal.

For oroflash or chewable tablets: 1000 IU to 2000 IU daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. Place the tablet in mouth swallow after chewing.

For Syrup:
For patients with risk of Cholecalciferol deficiency:

• 0-1 yr: 400 IU/ day (2 ml)
• >1 Yr: 600 lU/ day (3 ml)

For Cholecalciferol deficient patients:

• 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
• 1 -18 yrs: 2000 IU/ day for 6 weeks.

Injection: Prevention: 

• Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 6 months.
• Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months.
• Adolescents: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months during winter.
• Pregnancy: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. from the 6th or 7th month of pregnancy.
• Elderly: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 3 months. Digestive disorders, concomitant treatment with antiepileptics & other particular condition not described above; 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. or 1 ampoule (1ml) i.e. 2,00000 I.U. every 3 or 6 months.

Injection: Vitamin D deficiency:

• 1 ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.

The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.

It is contraindicated in patients with known hypersensitivity to Vitamin D3.

It should be used with caution in patients with impaired renal function.

It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.

Studies have shown safe use of doses up to 4000 IU during pregnancy. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment

Vitamin D3 and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.

The safety & efficacy of Vitamin D3 in children under 12 years have not been established.

It can lead to hypervitaminosis D.

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