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Qutipin
Quetiapine Fumarate
Qutipin
Quetiapine Fumarate
Indications
Unipolar and bipolar depression
Indication detailsView
Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.
DosageView
Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Side effectsView
The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
ContraindicationsView
Quetiapine is contra-indicated in patients who are hypersensitive to it.
PrecautionsView
- Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
- Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
- Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
- Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
- Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
- QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
- Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
- Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.
InteractionsView
Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.
Pregnancy & lactationView
The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.
Pediatric usageView
Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Overdose effectsView
In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.
StorageView
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.
Qutipin SR
Quetiapine Fumarate
Qutipin SR
Quetiapine Fumarate
Indications
Unipolar and bipolar depression
Indication detailsView
Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.
DosageView
Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Side effectsView
The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
ContraindicationsView
Quetiapine is contra-indicated in patients who are hypersensitive to it.
PrecautionsView
- Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
- Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
- Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
- Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
- Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
- QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
- Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
- Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.
InteractionsView
Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.
Pregnancy & lactationView
The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.
Pediatric usageView
Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Overdose effectsView
In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.
StorageView
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.
Qutipin SR
Quetiapine Fumarate
Qutipin SR
Quetiapine Fumarate
Indications
Unipolar and bipolar depression
Indication detailsView
Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.
DosageView
Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Side effectsView
The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
ContraindicationsView
Quetiapine is contra-indicated in patients who are hypersensitive to it.
PrecautionsView
- Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
- Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
- Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
- Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
- Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
- QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
- Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
- Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.
InteractionsView
Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.
Pregnancy & lactationView
The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.
Pediatric usageView
Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Overdose effectsView
In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.
StorageView
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.
Qutipin SR
Quetiapine Fumarate
Qutipin SR
Quetiapine Fumarate
Indications
Unipolar and bipolar depression
Indication detailsView
Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.
DosageView
Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.
Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.
Side effectsView
The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
ContraindicationsView
Quetiapine is contra-indicated in patients who are hypersensitive to it.
PrecautionsView
- Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.
- Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period.
- Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
- Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered.
- Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given.
- QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
- Neutropenia: Severe neutropenia (<0.5x109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine.
- Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.
InteractionsView
Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.
Pregnancy & lactationView
The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.
Pediatric usageView
Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Overdose effectsView
In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.
StorageView
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.
R-20
Rabeprazole Sodium
R-20
Rabeprazole Sodium
Indications
Gastric ulcer
Indication detailsView
Rabeprazole Gastro-resistant tablets are indicated for the treatment of:
- Active duodenal ulcer
- Active benign gastric ulcer
- Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
- Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
- Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
- Zollinger-Ellison Syndrome
- In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.
DosageView
Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.
Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.
Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.
Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.
Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.
AdministrationView
For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.
Side effectsView
In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.
ContraindicationsView
Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.
PrecautionsView
- Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
- Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
- Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
- A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
- Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
- There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
- Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
- No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
- Co-administration of atazanavir with Rabeprazole is not recommended.
- Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
InteractionsView
Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.
Pregnancy & lactationView
US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.
Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.
Overdose effectsView
The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
R-Penem
Meropenem Trihydrate
R-Penem
Meropenem Trihydrate
Indications
Uncomplicated pneumococcal pneumonia
Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
- Pneumonia and Nosocomial Pneumonia
- Urinary Tract Infections
- Intra-abdominal Infections
- Gynaecological Infections, such as endometritis and pelvic inflammatory disease
- Skin and Skin Structure Infections
- Meningitis
- Septicaemia
- Pulmonary infections in cystic fibrosis
- Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-
Adults:
Adults:
- The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
- Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
- Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
- Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
- Cystic fibrosis: Upto 2 gm every 8 hours.
- Meningitis: 2 gm IV every 8 hours.
- 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
- Intra-abdominal infections: 20 mg/kg every 8 hours.
- Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
- Meningitis: 40 mg/kg IV every 8 hours.
- Febrile neutropenia: 20 mg/kg every 8 hours.
- Children over 50 kg weight: use adult dosage.
- There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.
R-Penem
Meropenem Trihydrate
R-Penem
Meropenem Trihydrate
Indications
Uncomplicated pneumococcal pneumonia
Indication detailsView
Meropenem is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to Meropenem.
- Pneumonia and Nosocomial Pneumonia
- Urinary Tract Infections
- Intra-abdominal Infections
- Gynaecological Infections, such as endometritis and pelvic inflammatory disease
- Skin and Skin Structure Infections
- Meningitis
- Septicaemia
- Pulmonary infections in cystic fibrosis
- Empiric treatment for presumed infections in patients with febrile neutropenia.
Therapeutic classView
Other beta-lactam Antibiotics
PharmacologyView
Meropenem is a carbapenem antibiotic for parenteral use . It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs.). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
DosageView
The dosage and duration of therapy shall be established depending on type, severity of infection and the condition of the patient. The recommended daily dosage is as follows-
Adults:
Adults:
- The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
- Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours.
- Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours.
- Intra-abdominal infections: 500 mg to 1 gm every 8 hours.
- Cystic fibrosis: Upto 2 gm every 8 hours.
- Meningitis: 2 gm IV every 8 hours.
- 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient.
- Intra-abdominal infections: 20 mg/kg every 8 hours.
- Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours.
- Meningitis: 40 mg/kg IV every 8 hours.
- Febrile neutropenia: 20 mg/kg every 8 hours.
- Children over 50 kg weight: use adult dosage.
- There is no experience in children with hepatic or renal impairment.
AdministrationView
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Side effectsView
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhea, headache may occur.
ContraindicationsView
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
PrecautionsView
If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures taken. Use of Meropenem in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
InteractionsView
Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Pregnancy & lactationView
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Pediatric usageView
Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive Meropenem after dialysis has been completed.
Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min.
Use in Children: Efficacy and tolerability in infants under 3 months have not been established.
Overdose effectsView
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove Meropenem and its metabolite.
ReconstitutionView
Preparation of solution:
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain solution which is clear and colorless or pale yellow.
Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.
The use of freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC
StorageView
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.
R-Pil
Ramipril
R-Pil
Ramipril
Indications
Thrombotic cardiovascular (CV) events
Indication detailsView
Ramipril indicated in the following cases:
- Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
- Congestive heart failure; also in combination with diuretics.
- Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
- Treatment of non-diabetic or diabetic overt glomerular or incipient nephropathy.
- Reduction in the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, such as manifest coronary heart disease (with or without a history of myocardial infarction), a history of stroke, a history of peripheral vascular disease, or diabetes mellitus that is accompanied by at least one other cardiovascular risk factor (microalbuminuria, hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, smoking).
Therapeutic classView
Angiotensin-converting enzyme (ACE) inhibitors
PharmacologyView
Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
DosageView
Dosage of Ramipril must be adjusted according to the patient tolerance and response.
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
- For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
- For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.
AdministrationView
Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.
Side effectsView
Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.
ContraindicationsView
Ramipril must not be used
- in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
- in patients with a history of angioedema.
- concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
- in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
- in patients with hypotensive or haemodynamically unstable states.
- with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
- with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
- during pregnancy.
PrecautionsView
Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.
InteractionsView
Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.
Pregnancy & lactationView
Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.
Pediatric usageView
Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Overdose effectsView
Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
StorageView
Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
R-Pil
Ramipril
R-Pil
Ramipril
Indications
Thrombotic cardiovascular (CV) events
Indication detailsView
Ramipril indicated in the following cases:
- Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
- Congestive heart failure; also in combination with diuretics.
- Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
- Treatment of non-diabetic or diabetic overt glomerular or incipient nephropathy.
- Reduction in the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, such as manifest coronary heart disease (with or without a history of myocardial infarction), a history of stroke, a history of peripheral vascular disease, or diabetes mellitus that is accompanied by at least one other cardiovascular risk factor (microalbuminuria, hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, smoking).
Therapeutic classView
Angiotensin-converting enzyme (ACE) inhibitors
PharmacologyView
Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
DosageView
Dosage of Ramipril must be adjusted according to the patient tolerance and response.
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
- For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
- For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.
AdministrationView
Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.
Side effectsView
Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.
ContraindicationsView
Ramipril must not be used
- in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
- in patients with a history of angioedema.
- concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
- in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
- in patients with hypotensive or haemodynamically unstable states.
- with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
- with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
- during pregnancy.
PrecautionsView
Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.
InteractionsView
Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.
Pregnancy & lactationView
Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.
Pediatric usageView
Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Overdose effectsView
Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
StorageView
Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
R-Pil
Ramipril
R-Pil
Ramipril
Indications
Thrombotic cardiovascular (CV) events
Indication detailsView
Ramipril indicated in the following cases:
- Hypertension; to lower blood pressure, as single-drug therapy or in combination with other antihypertensive agents.
- Congestive heart failure; also in combination with diuretics.
- Treatment of patients who- within the first few days after an acute myocardial infarction- have demonstrated clinical signs of congestive heart failure.
- Treatment of non-diabetic or diabetic overt glomerular or incipient nephropathy.
- Reduction in the risk of myocardial infarction, stroke, or cardiovascular death in patients with an increased cardiovascular risk, such as manifest coronary heart disease (with or without a history of myocardial infarction), a history of stroke, a history of peripheral vascular disease, or diabetes mellitus that is accompanied by at least one other cardiovascular risk factor (microalbuminuria, hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, smoking).
Therapeutic classView
Angiotensin-converting enzyme (ACE) inhibitors
PharmacologyView
Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
DosageView
Dosage of Ramipril must be adjusted according to the patient tolerance and response.
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
Hypertension: For the management of hypertension in adults not receiving a diuretic, the usual initial dose of Ramipril is 1.25-2.5 mg once daily. Dosage generally is adjusted no more rapidly than at 2 week intervals. The usual maintenance dosage in adults is 2.5-20 mg daily given as a single dose or in 2 divided doses daily. If BP is not controlled with Ramipril alone, a diuretic may be added.
Congestive heart failure after myocardial infarction: In this case, Ramipril therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommended, but if hypotension occurs, dose should be reduced to 1.25 mg twice daily. Therapy is then titrated to a target daily dose of 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5 mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment:
- For patients with hypertension and renal impairment: The recommended initial dose is 1.25 mg Ramipril once daily. Subsequent dosage should be titrated according to individual tolerance and BP response, up to a maximum of 5 mg daily.
- For patients with heart failure and renal impairment: The recommended dose is 1.25 mg once daily. The dose may be increased to 1.25 mg twice daily and up to a maximum dose of 2.5 mg twice daily depending upon clinical response and tolerability.
AdministrationView
Ramipril tablets have to be swallowed with sufficient amounts of liquid. The tablets must not be chewed or crushed. Absorption of Ramipril is not significantly affected by food. Ramipril may, therefore, be taken before, during or after a meal.
Side effectsView
Ramipril is generally well tolerated. Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic oedema, anaphylactic reactions and hyperkalaemia have also been reported rarely.
ContraindicationsView
Ramipril must not be used
- in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or any of the excipients of Ramipril.
- in patients with a history of angioedema.
- concomitantly with sacubitril/valsartan therapy. Do not initiate Ramipril until sacubitril/valsartan is eliminated from the body. In case of switch from Ramipril to sacubitril/valsartan, do not start sacubitril/valsartan until Ramipril is eliminated from the body.
- in patients with haemodynamically relevant renal artery stenosis, bilateral or unilateral in the single kidney.
- in patients with hypotensive or haemodynamically unstable states.
- with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance <60 ml/min).
- with angiotensin II receptor antagonists (AIIRAs) in patients with diabetic nephropathy.
- during pregnancy.
PrecautionsView
Ramipril should be used with caution in patients with impaired renal function, hyperkalaemia, hypotension, and impaired hepatic function.
InteractionsView
Concomitant administration with diuretics may lead to serious hypotension and in addition dangerous hyperkalemia with potassium sparing diuretics. Concomitant therapy with lithium may increase the serum lithium concentration. Reduction in BP may affect the ability to drive and operate machinery and this may be exacerbated by alcohol. NSAIDs may reduce the antihypertensive effect of Ramipril and cause deterioration of renal function.
Pregnancy & lactationView
Ramipril must not be taken during pregnancy. Therefore, pregnancy must be excluded before starting treatment. Pregnancy must be avoided in cases where treatment with ACE inhibitors is indispensable. If the patient intends to become pregnant, treatment with ACE inhibitors must be discontinued, i.e. replaced by another form of treatment. If the patient becomes pregnant during treatment, medication with Ramipril must be replaced as soon as possible by a treatment regimen without ACE inhibitors. Otherwise, there is a risk of harm to the fetus. Ramipril is not recommended during breastfeeding.
Pediatric usageView
Elderly: A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Hepatic impairment: Treatment in these patients must therefore be initiated only under close medical supervision. The maximum permitted daily dose in such cases is 2.5 mg Ramipril.
Renal impairment: With a creatinine clearance between 50 and 20 ml/min per 1.73 m2 body surface area, the initial daily dose is generally 1.25 mg Ramipril. The maximum permitted daily dose, in this case, is 5 mg Ramipril. Patients with incompletely corrected fuid or salt depletion, in patients with severe hypertension, as well as in patients in whom a hypotensive reaction would constitute a particular risk, (e.g., with relevant stenoses of the coronary vessels or those supplying the brain) A reduced initial dose of 1.25 mg Ramipril daily must be considered.
Patients pretreated with a diuretic: Consideration must be given to discontinuing the diuretic for at least 2 to 3 days or- depending on the duration of action of the diuretic- longer before starting treatment with Ramipril, or at least to reducing the diuretic dose. The initial daily dose in patients previously treated with a diuretic is generally 1.25 mg Ramipril.
Overdose effectsView
Sign and symptom: Overdosage may cause excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
Management: Primary detoxifcation by, for example, gastric lavage, administration of adsorbents, sodium sulfate; (if possible during the frst 30 minutes). In the event of hypotension administration of α1-adrenergic agonists (e.g. norepinephrine, dopamine) or angiotensin II (angiotensinamide), which is usually available only in scattered research laboratories, must be considered in addition to volume and salt substitution.
StorageView
Store at 30° or below, protect from light. Keep out of the reach of children. Do not use later than the date of expiry. To be dispensed only on the prescription of a registered physician.
R-Proton
Rabeprazole Sodium
R-Proton
Rabeprazole Sodium
Indications
Gastric ulcer
Indication detailsView
Rabeprazole Gastro-resistant tablets are indicated for the treatment of:
- Active duodenal ulcer
- Active benign gastric ulcer
- Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
- Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
- Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
- Zollinger-Ellison Syndrome
- In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.
DosageView
Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.
Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.
Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.
Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.
Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.
AdministrationView
For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.
Side effectsView
In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.
ContraindicationsView
Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.
PrecautionsView
- Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
- Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
- Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
- A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
- Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
- There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
- Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
- No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
- Co-administration of atazanavir with Rabeprazole is not recommended.
- Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
InteractionsView
Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.
Pregnancy & lactationView
US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.
Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.
Overdose effectsView
The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
R-Saline-N
Oral Rehydration Salt [Powder]
R-Saline-N
Oral Rehydration Salt [Powder]
Indication detailsView
Oral Rehydration Salt replacement of fluid and electrolyte loss due to-
- Acute diarrhea
- Vomiting
- Dehydration
Therapeutic classView
Oral electrolytes preparations
PharmacologyView
This is the preparation of oral rehydration salt. It is composed of anhydrous glucose, sodium chloride, potassium chloride and sodium citrate (as dihydrate). This is a single formulation of glucose based oral rehydration salt to treat or prevent dehydration from diarrhea of any etiology, including cholera and in individuals of any age. This also prevents acidosis due to electrolyte imbalance.
DosageView
Daily dose should be equivalent to patients' fluid requirement for maintenance and replenishment of losses. During this therapy, mother should not stop breastfeeding to their child and normal food should be continued in case of adults.
Children less than 2 years: After each loose stool or vomiting 50-100 mL (10 to 20 teaspoonful) of prepared this.
Children 2 to 10 years: After each loose stool or vomiting 100-200 mL (1/2 to 1 glass) of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 mL (1 to 2 glass) of prepared this.
Children less than 2 years: After each loose stool or vomiting 50-100 mL (10 to 20 teaspoonful) of prepared this.
Children 2 to 10 years: After each loose stool or vomiting 100-200 mL (1/2 to 1 glass) of prepared oral saline.
Adult and children above 10 years: After each loose stool or vomiting 200-400 mL (1 to 2 glass) of prepared this.
AdministrationView
- Disperse the full contents of the sachet in 500 mL (1/2 liter) of pure drinking water.
- Do not mix the oral saline with hot water or heat the prepared solution.
- Discard the unused prepared oral saline after 12 hours of preparation.
PrecautionsView
Depressed renal function, severe continuing diarrhea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline.
InteractionsView
There are no known drug interactions and none well documented.
StorageView
Do not store above 30°C temperature. Keep away from light and wet places. Keep out of reach of children.
R-Vit
Vitamin C, Vitamin E, Lutein, Copper & Zinc
R-Vit
Vitamin C, Vitamin E, Lutein, Copper & Zinc
Indications
Vitamin or mineral deficiency
Indication detailsView
This preparation is indicated for Age-related Eye Disease. This is an advanced new antioxidant supplement formulated to provide nutritional support for the eye. The formulation contains essential antioxidant vitamins, minerals, and Lutein.
Therapeutic classView
Anti-oxidant Multivitamin Multimineral preparations, Antioxidant vitamins & minerals for eye
PharmacologyView
Vitamin C is highly concentrated in the lens compared to blood. A long term Vitamin C supplement use (10+ years) has been associated with reduced risk of cataract. Vitamin C has an important role in harmful free radicals scavenging activity.
In study, it is found that high serum Vitamin E concentrations have been associated with reduced risk of cataract (exact mechanism of action is not still established). As an antioxidant vitamin, it also plays an important role in harmful free radicals scavenging activity.
Lutein is a carotenoid, specially concentrated in the macula. Clinical and animaldata indicates that this caretenoid could protect the macula from oxidative or light damage.
Although exact mechanism of action is not clear but onelarge study has found that high levels of dietary Lutein is associated with relatively lower risk of AMD (Age-Related Macular Degeneration). Zinc is an essential trace element involved in many enzymes system.
Symptoms of less severe deficiency include distorted or absent perception of taste, smell and poor wound healing. Severe deficiency causes skin lesion, alopecia, diarrhea, increased susceptibility to infection and failure to thrive in children.
Copper plays important role in growth, skeletal integrity, and development of nervous system. As a part of various enzymes, it takes part in numerous metabolic conversions.
In study, it is found that high serum Vitamin E concentrations have been associated with reduced risk of cataract (exact mechanism of action is not still established). As an antioxidant vitamin, it also plays an important role in harmful free radicals scavenging activity.
Lutein is a carotenoid, specially concentrated in the macula. Clinical and animaldata indicates that this caretenoid could protect the macula from oxidative or light damage.
Although exact mechanism of action is not clear but onelarge study has found that high levels of dietary Lutein is associated with relatively lower risk of AMD (Age-Related Macular Degeneration). Zinc is an essential trace element involved in many enzymes system.
Symptoms of less severe deficiency include distorted or absent perception of taste, smell and poor wound healing. Severe deficiency causes skin lesion, alopecia, diarrhea, increased susceptibility to infection and failure to thrive in children.
Copper plays important role in growth, skeletal integrity, and development of nervous system. As a part of various enzymes, it takes part in numerous metabolic conversions.
DosageView
One capsule, one or two times daily or as directed by the physician
Side effectsView
Large doses of Vitamin C are reported to cause diarrhoea and other gastrointestinal disturbances. Large doses of Vitamin E may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances; fatigue and weakness have also been reported. Side effects of Zinc salt are abdominal pain and dyspepsia.
ContraindicationsView
It is contraindicated in persons with a history of hypersensitivity to any of its ingredients.
PrecautionsView
Vitamin C should be given with care to patients with hyperoxaluria. In patients taking oral anticoagulants or oestrogen, Vitamin E should be given carefully because it has been found to antagonise the effects of vitamin K leading to an increase in blood clotting time in these patient
InteractionsView
No drug interaction has been reported.
Pregnancy & lactationView
Recommended in Pregnancy & Lactation.
StorageView
Store in a dry place below 25° C. Protect from light.
R-Y Jelly
Glycerol
R-Y Jelly
Glycerol
Indications
Skin irritations
Indication detailsView
This Jelly is indicated to enhance the comfort and ease of intimate activity with or without latex condoms. This personal lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourses.
Therapeutic classView
Miscellaneous topical agents
DosageView
Apply the desired amount of lubricant to your intimate areas. Reapply as needed. This Jelly is not applicable for pediatric Use.
Side effectsView
No common side effects have been reported with this preparation. Few allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation may occur.
ContraindicationsView
This Jelly is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.
PrecautionsView
Discontinue if irritation or discomfort occurs. Do not eat and keep the gel away from nose, eye and open wounds.
This Jelly is not a contraceptive and does not contain a spermicide. Keep out of reach of children and away from eyes and ears. Do not use if quality seal on the opening of the tube or bottle is broken or missing. Avoid use if pregnant or breast feeding unless prescribed by your doctor. Glycerol-based lubricants may slow sperm down, so if you're trying to have a baby, talk to your doctor before use.
This Jelly is not a contraceptive and does not contain a spermicide. Keep out of reach of children and away from eyes and ears. Do not use if quality seal on the opening of the tube or bottle is broken or missing. Avoid use if pregnant or breast feeding unless prescribed by your doctor. Glycerol-based lubricants may slow sperm down, so if you're trying to have a baby, talk to your doctor before use.
InteractionsView
Drug interaction-related data not found. If any abnormality consults with the doctor.
Pregnancy & lactationView
It may feel strange to have sex as the baby grows within, but so long as you're having a normal, healthy pregnancy, intercourse is generally considered safe but be sure to consult with doctor if you have any questions about safety. Avoid use if pregnant unless prescribed by physician. No known risk found during the lactation period.
StorageView
Store at room temperature below 30°C. Do not freeze.
R-Zol
Albendazole
R-Zol
Albendazole
Indications
Worm infections
Indication detailsView
Albendazole is indicated in single and mixed infestations of-
- Hookworm (Ancylostoma, Necator)
- Roundworm (Ascaris)
- Threadworm (Enterobius)
- Whipworm (Trichuris)
- Strongyloides
- Tapeworm
- Opisthorchi
- Hydatid.
Therapeutic classView
Anthelmintic
PharmacologyView
Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.
DosageView
Adults & children over 2 years:
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
- In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated.
Children under 1 year: Not recommended.
In Hydatid disease (Echinococcosis):
- Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
- A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
- For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
- For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
- In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.
Side effectsView
Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.
ContraindicationsView
Neonates: Albendazole is not normally used in neonates.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.
Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.
Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.
PrecautionsView
Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts
InteractionsView
No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.
Pregnancy & lactationView
US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
RN-D
Calcium Carbonate [Elemental source] + Vitamin D3
RN-D
Calcium Carbonate [Elemental source] + Vitamin D3
Indications
Rickets
Indication detailsView
This combination is used for treatment of osteoporosis, osteomalacia, rickets, tetany and in parathyroid disease. Calcium supplements are often used to ensure adequate dietary intake in conditions such as pregnancy & lactation, osteogenesis and tooth formation (adjunct with definite treatment) and therapy with anti-seizure medications. It is also used as routine supplement and phosphate binder in chronic renal failure.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
This is the preparation of Calcium Carbonate and Vitamin D3 (Cholecalciferol). Calcium is necessary for many normal functions of our body, especially bone formation and maintenance. Vitamin D3 helps for the absorption & reabsorption of Calcium. Vitamin D3 also stimulates bone formation. Clinical studies showed that Calcium and Vitamin D3 all together helps in bone growth, and in prevention of osteoporosis & bone fracture.
DosageView
Calcium 500 mg and Vitamin D3 200 IU Tablet: 2 tablets daily or 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Calcium 500 mg and Vitamin D3 400 IU Tablet: 1 tablet twice daily. It is best taken with or just after a meal to improve absorption.
Side effectsView
It is generally well tolerated. If there is experience like nausea, vomiting, stomach cramps, dry mouth, increased thirst, increased urination while taking, noticed to physicians. Constipation may occur.
ContraindicationsView
It is contraindicated in case of hypercalcaemia, hyperthyroidism, renal calculi & nephrolithiasis and Zollinger-Ellison Syndrome.
PrecautionsView
If there is any pre-existing heart disease or kidney disease, precautions should be taken.
InteractionsView
It has possible interaction with calcium, aluminium or magnesium containing antacids & other calcium supplements, calcitriol & other vitamin D3 supplements; digoxin, tetracycline, doxycycline, minocycline or oxytetracycline.
Pregnancy & lactationView
This combination should be used as directed by physician during pregnancy or while breast-feeding.
Overdose effectsView
Symptoms of overdosage may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, diarrhea, headache, constipation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
RP 20
Rabeprazole Sodium
RP 20
Rabeprazole Sodium
Indications
Gastric ulcer
Indication detailsView
Rabeprazole Gastro-resistant tablets are indicated for the treatment of:
- Active duodenal ulcer
- Active benign gastric ulcer
- Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).
- Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)
- Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)
- Zollinger-Ellison Syndrome
- In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.
DosageView
Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.
Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.
Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.
Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.
Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.
Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.
AdministrationView
For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.
Side effectsView
In general, Rabeprazole is well-tolerated in both short-term and long-term studies. Rabeprazole may sometimes cause headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness, dizziness.
ContraindicationsView
Hypersensitivity to the active substance or to any of the excipients. Rabeprazole is contra-indicated in pregnancy and during breastfeeding.
PrecautionsView
- Symptomatic response to therapy with Rabeprazole does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole 20 mg Gastro-resistant Tablets.
- Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
- Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care and they should have an adequate intake of vitamin D and calcium.
- A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.
- Patients should be cautioned that Rabeprazole gastro-resistant tablets should not be chewed or crushed, but should be swallowed whole.
- There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
- Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.
- No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However because there are no clinical data on the use of rabeprazole in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole 20mg Gastro-resistant. Tablets is first initiated in such patients.
- Co-administration of atazanavir with Rabeprazole is not recommended.
- Treatment with proton pump inhibitors, including rabeprazole, may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
Influence on vitamin B12 absorption: Rabeprazole sodium, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or a- chlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Rabeprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Rabeprazole 20mg Gastro-resistant Tablets treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
InteractionsView
Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.
Pregnancy & lactationView
US FDA pregnancy category 'C'. Studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Rabeprazole. There are however, no adequate and well-controlled studies in pregnant women. Rabeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Renal and hepatic impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.
Pediatric populations: Rabeprazole is not recommended for use in children due to a lack of data on safety and efficacy.
Overdose effectsView
The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
RT 150
Ranitidine Hydrochloride
RT 150
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
RTV
Rosuvastatin
RTV
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
RTV
Rosuvastatin
RTV
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.