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Renesis
Roxadustat
Renesis
Roxadustat
Indications
Kidney disease
Indication detailsView
Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
PharmacologyView
Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Upon administration, roxadustat binds to and inhibits HIF-PH, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, thereby enhancing erythropoiesis. It also reduces the expression of the peptide hormone hepcidin, improves iron availability, and boosts hemoglobin (Hb) levels. HIF regulates the expression of genes in response to reduced oxygen levels, including genes required for erythropoiesis and iron metabolism.
Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of infammation, and without a need for supplemental intravenous iron.
Roxadustat reversibly binds to and potently inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes, reducing HIF-α breakdown and promoting HIF transcriptional activity. Activation of the HIF pathway in this manner results in the induction of target genes involved in erythropoiesis, such as those for EPO, EPO receptor, proteins promoting iron absorption, iron transport and haem synthesis. Roxadustat dose-dependently increased haemoglobin (Hb) levels, signifcantly reduced hepcidin levels and transiently increased endogenous EPO levels within or near physiological range in patients with anemia of CKD who were not dialysis dependent. Roxadustat reduced the dysregulation of iron metabolism associated with CKD by increasing serum transferrin, intestinal iron absorption and the release of stored iron in a dose-dependent manner in patients with anemia associated with dialysis dependent or dialysis-independent CKD. Cholesterol levels were also signifcantly reduced from baseline with roxadustat, regardless of the use of statins or other lipid-lowering agents.
Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of infammation, and without a need for supplemental intravenous iron.
Roxadustat reversibly binds to and potently inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes, reducing HIF-α breakdown and promoting HIF transcriptional activity. Activation of the HIF pathway in this manner results in the induction of target genes involved in erythropoiesis, such as those for EPO, EPO receptor, proteins promoting iron absorption, iron transport and haem synthesis. Roxadustat dose-dependently increased haemoglobin (Hb) levels, signifcantly reduced hepcidin levels and transiently increased endogenous EPO levels within or near physiological range in patients with anemia of CKD who were not dialysis dependent. Roxadustat reduced the dysregulation of iron metabolism associated with CKD by increasing serum transferrin, intestinal iron absorption and the release of stored iron in a dose-dependent manner in patients with anemia associated with dialysis dependent or dialysis-independent CKD. Cholesterol levels were also signifcantly reduced from baseline with roxadustat, regardless of the use of statins or other lipid-lowering agents.
DosageView
The appropriate dose of roxadustat must be taken orally three times per week and not on consecutive days. The dose should be individualized to achieve and maintain target Hb levels of 10 to 12 g/dL as described below:
Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.
Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.
Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the "Dose increase/decrease table" and "stepwise Dose adjustment sequence" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.
The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).
Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.
Method of administration: Roxadustat tablets are to be taken orally with or without food.
Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.
Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.
Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the "Dose increase/decrease table" and "stepwise Dose adjustment sequence" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.
The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).
Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.
Method of administration: Roxadustat tablets are to be taken orally with or without food.
Side effectsView
The common adverse reactions associated with roxadustat are hypertension, vascular access thrombosis, diarrhoea, peripheral oedema, hyperkalaemia and nausea.
PrecautionsView
Roxadustat tablets should be used in caution. It may initiate few thrombotic vascular events (TVEs) particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs. Roxadustat should be used with caution in patients with a history of seizures. Roxadustat should not be administered if the patient has serious signs and symptoms of an infection. Roxadustat should not be administered if the patient has liver disorder. Roxadustat should not be initiated in pregnant women.
InteractionsView
Roxadustat in combination with other medications may have drug-drug interaction.
Roxadustat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:
Roxadustat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:
- Risk: decreased roxadustat AUC by 67% and 46% and Cmax by 66% and 52%
- Recommendation: Roxadustat should be taken at least 1 hour after administration of phosphate binders or other medicinal products or supplements containing multivalent cations.
- Risk: increased roxadustat AUC by 2.3- fold and Cmax by 1.4-fold
- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
- Risk: AUC and Cmax increased
- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
Pregnancy & lactationView
Do not administered to women that may be pregnant or pregnant. Roxadustat is contraindicated during breast-feeding.
Pediatric usageView
Children: Roxadustat is not indicated in children.
liver dysfunction patients: Roxadustat is not recommended for use in patients with severe hepatic impairment.
liver dysfunction patients: Roxadustat is not recommended for use in patients with severe hepatic impairment.
Overdose effectsView
Symptoms: When this drug was administered 5 mg/kg (510 mg) to a single healthy adult, increased heart rate transient have been reported. Hemoglobin concentration by overdosage of this drug is likely to increase more than necessary.
Treatment: Appropriate measures of dose reduction or interruption, etc. of this drug. This drug is not removed by dialysis.
Treatment: Appropriate measures of dose reduction or interruption, etc. of this drug. This drug is not removed by dialysis.
StorageView
Store in a cool (below 30°C), dry place, away from light and moisture. Keep out of the reach of children.
Renesis
Roxadustat
Renesis
Roxadustat
Indications
Kidney disease
Indication detailsView
Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
PharmacologyView
Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Upon administration, roxadustat binds to and inhibits HIF-PH, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, thereby enhancing erythropoiesis. It also reduces the expression of the peptide hormone hepcidin, improves iron availability, and boosts hemoglobin (Hb) levels. HIF regulates the expression of genes in response to reduced oxygen levels, including genes required for erythropoiesis and iron metabolism.
Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of infammation, and without a need for supplemental intravenous iron.
Roxadustat reversibly binds to and potently inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes, reducing HIF-α breakdown and promoting HIF transcriptional activity. Activation of the HIF pathway in this manner results in the induction of target genes involved in erythropoiesis, such as those for EPO, EPO receptor, proteins promoting iron absorption, iron transport and haem synthesis. Roxadustat dose-dependently increased haemoglobin (Hb) levels, signifcantly reduced hepcidin levels and transiently increased endogenous EPO levels within or near physiological range in patients with anemia of CKD who were not dialysis dependent. Roxadustat reduced the dysregulation of iron metabolism associated with CKD by increasing serum transferrin, intestinal iron absorption and the release of stored iron in a dose-dependent manner in patients with anemia associated with dialysis dependent or dialysis-independent CKD. Cholesterol levels were also signifcantly reduced from baseline with roxadustat, regardless of the use of statins or other lipid-lowering agents.
Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of infammation, and without a need for supplemental intravenous iron.
Roxadustat reversibly binds to and potently inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes, reducing HIF-α breakdown and promoting HIF transcriptional activity. Activation of the HIF pathway in this manner results in the induction of target genes involved in erythropoiesis, such as those for EPO, EPO receptor, proteins promoting iron absorption, iron transport and haem synthesis. Roxadustat dose-dependently increased haemoglobin (Hb) levels, signifcantly reduced hepcidin levels and transiently increased endogenous EPO levels within or near physiological range in patients with anemia of CKD who were not dialysis dependent. Roxadustat reduced the dysregulation of iron metabolism associated with CKD by increasing serum transferrin, intestinal iron absorption and the release of stored iron in a dose-dependent manner in patients with anemia associated with dialysis dependent or dialysis-independent CKD. Cholesterol levels were also signifcantly reduced from baseline with roxadustat, regardless of the use of statins or other lipid-lowering agents.
DosageView
The appropriate dose of roxadustat must be taken orally three times per week and not on consecutive days. The dose should be individualized to achieve and maintain target Hb levels of 10 to 12 g/dL as described below:
Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.
Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.
Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the "Dose increase/decrease table" and "stepwise Dose adjustment sequence" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.
The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).
Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.
Method of administration: Roxadustat tablets are to be taken orally with or without food.
Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.
Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.
Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the "Dose increase/decrease table" and "stepwise Dose adjustment sequence" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.
The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).
Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.
Method of administration: Roxadustat tablets are to be taken orally with or without food.
Side effectsView
The common adverse reactions associated with roxadustat are hypertension, vascular access thrombosis, diarrhoea, peripheral oedema, hyperkalaemia and nausea.
PrecautionsView
Roxadustat tablets should be used in caution. It may initiate few thrombotic vascular events (TVEs) particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs. Roxadustat should be used with caution in patients with a history of seizures. Roxadustat should not be administered if the patient has serious signs and symptoms of an infection. Roxadustat should not be administered if the patient has liver disorder. Roxadustat should not be initiated in pregnant women.
InteractionsView
Roxadustat in combination with other medications may have drug-drug interaction.
Roxadustat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:
Roxadustat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:
- Risk: decreased roxadustat AUC by 67% and 46% and Cmax by 66% and 52%
- Recommendation: Roxadustat should be taken at least 1 hour after administration of phosphate binders or other medicinal products or supplements containing multivalent cations.
- Risk: increased roxadustat AUC by 2.3- fold and Cmax by 1.4-fold
- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
- Risk: AUC and Cmax increased
- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
Pregnancy & lactationView
Do not administered to women that may be pregnant or pregnant. Roxadustat is contraindicated during breast-feeding.
Pediatric usageView
Children: Roxadustat is not indicated in children.
liver dysfunction patients: Roxadustat is not recommended for use in patients with severe hepatic impairment.
liver dysfunction patients: Roxadustat is not recommended for use in patients with severe hepatic impairment.
Overdose effectsView
Symptoms: When this drug was administered 5 mg/kg (510 mg) to a single healthy adult, increased heart rate transient have been reported. Hemoglobin concentration by overdosage of this drug is likely to increase more than necessary.
Treatment: Appropriate measures of dose reduction or interruption, etc. of this drug. This drug is not removed by dialysis.
Treatment: Appropriate measures of dose reduction or interruption, etc. of this drug. This drug is not removed by dialysis.
StorageView
Store in a cool (below 30°C), dry place, away from light and moisture. Keep out of the reach of children.
Renesis
Roxadustat
Renesis
Roxadustat
Indications
Kidney disease
Indication detailsView
Roxadustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
PharmacologyView
Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Upon administration, roxadustat binds to and inhibits HIF-PH, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, thereby enhancing erythropoiesis. It also reduces the expression of the peptide hormone hepcidin, improves iron availability, and boosts hemoglobin (Hb) levels. HIF regulates the expression of genes in response to reduced oxygen levels, including genes required for erythropoiesis and iron metabolism.
Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of infammation, and without a need for supplemental intravenous iron.
Roxadustat reversibly binds to and potently inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes, reducing HIF-α breakdown and promoting HIF transcriptional activity. Activation of the HIF pathway in this manner results in the induction of target genes involved in erythropoiesis, such as those for EPO, EPO receptor, proteins promoting iron absorption, iron transport and haem synthesis. Roxadustat dose-dependently increased haemoglobin (Hb) levels, signifcantly reduced hepcidin levels and transiently increased endogenous EPO levels within or near physiological range in patients with anemia of CKD who were not dialysis dependent. Roxadustat reduced the dysregulation of iron metabolism associated with CKD by increasing serum transferrin, intestinal iron absorption and the release of stored iron in a dose-dependent manner in patients with anemia associated with dialysis dependent or dialysis-independent CKD. Cholesterol levels were also signifcantly reduced from baseline with roxadustat, regardless of the use of statins or other lipid-lowering agents.
Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of infammation, and without a need for supplemental intravenous iron.
Roxadustat reversibly binds to and potently inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase enzymes, reducing HIF-α breakdown and promoting HIF transcriptional activity. Activation of the HIF pathway in this manner results in the induction of target genes involved in erythropoiesis, such as those for EPO, EPO receptor, proteins promoting iron absorption, iron transport and haem synthesis. Roxadustat dose-dependently increased haemoglobin (Hb) levels, signifcantly reduced hepcidin levels and transiently increased endogenous EPO levels within or near physiological range in patients with anemia of CKD who were not dialysis dependent. Roxadustat reduced the dysregulation of iron metabolism associated with CKD by increasing serum transferrin, intestinal iron absorption and the release of stored iron in a dose-dependent manner in patients with anemia associated with dialysis dependent or dialysis-independent CKD. Cholesterol levels were also signifcantly reduced from baseline with roxadustat, regardless of the use of statins or other lipid-lowering agents.
DosageView
The appropriate dose of roxadustat must be taken orally three times per week and not on consecutive days. The dose should be individualized to achieve and maintain target Hb levels of 10 to 12 g/dL as described below:
Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.
Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.
Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the "Dose increase/decrease table" and "stepwise Dose adjustment sequence" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.
The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).
Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.
Method of administration: Roxadustat tablets are to be taken orally with or without food.
Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.
Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.
Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the "Dose increase/decrease table" and "stepwise Dose adjustment sequence" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.
The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).
Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.
Method of administration: Roxadustat tablets are to be taken orally with or without food.
Side effectsView
The common adverse reactions associated with roxadustat are hypertension, vascular access thrombosis, diarrhoea, peripheral oedema, hyperkalaemia and nausea.
PrecautionsView
Roxadustat tablets should be used in caution. It may initiate few thrombotic vascular events (TVEs) particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs. Roxadustat should be used with caution in patients with a history of seizures. Roxadustat should not be administered if the patient has serious signs and symptoms of an infection. Roxadustat should not be administered if the patient has liver disorder. Roxadustat should not be initiated in pregnant women.
InteractionsView
Roxadustat in combination with other medications may have drug-drug interaction.
Roxadustat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:
Roxadustat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:
- Risk: decreased roxadustat AUC by 67% and 46% and Cmax by 66% and 52%
- Recommendation: Roxadustat should be taken at least 1 hour after administration of phosphate binders or other medicinal products or supplements containing multivalent cations.
- Risk: increased roxadustat AUC by 2.3- fold and Cmax by 1.4-fold
- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
- Risk: AUC and Cmax increased
- Recommendation: Adjust the dose of roxadustat following dose adjustment rules based on Hb monitoring.
Pregnancy & lactationView
Do not administered to women that may be pregnant or pregnant. Roxadustat is contraindicated during breast-feeding.
Pediatric usageView
Children: Roxadustat is not indicated in children.
liver dysfunction patients: Roxadustat is not recommended for use in patients with severe hepatic impairment.
liver dysfunction patients: Roxadustat is not recommended for use in patients with severe hepatic impairment.
Overdose effectsView
Symptoms: When this drug was administered 5 mg/kg (510 mg) to a single healthy adult, increased heart rate transient have been reported. Hemoglobin concentration by overdosage of this drug is likely to increase more than necessary.
Treatment: Appropriate measures of dose reduction or interruption, etc. of this drug. This drug is not removed by dialysis.
Treatment: Appropriate measures of dose reduction or interruption, etc. of this drug. This drug is not removed by dialysis.
StorageView
Store in a cool (below 30°C), dry place, away from light and moisture. Keep out of the reach of children.
Renete
Ranitidine Hydrochloride
Renete
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.
Renib
Regorafenib
Renib
Regorafenib
Indications
Hepatocellular Carcinoma
Indication detailsView
Regorafenib is a kinase inhibitor that is indicated:
- For the treatment of metastatic colorectal cancer (CRC) after disease progression on or intolerance to fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy.
- For the treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST) after disease progression on or intolerance to prior treatment with imatinib and sunitinib.
- For the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib
Therapeutic classView
Targeted Cancer Therapy
PharmacologyView
Regorafenib is a kinase inhibitor and it inhibits multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. Regorafenib or its major human active metabolites M-2 and M-5 inhibits the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, Trk2A, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, and Abl. Due to its inhibitory functions, regorafenib can inhibit the progression of certain solid tumors.
DosageView
Metastatic colorectal cancer (CRC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Gastrointestinal stromal tumours (GIST): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Hepatocellular carcinoma (HCC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Gastrointestinal stromal tumours (GIST): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Hepatocellular carcinoma (HCC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Side effectsView
The most common side effects (≥30%) are asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)], diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia.
PrecautionsView
- Hemorrhage: Permanently discontinue regorafenib for severe or life-threatening hemorrhage.
- Dermatological toxicity: Interrupt and then reduce or discontinue regorafenib depending on severity and persistence of dermatologic toxicity.
- Hypertension: Temporarily or permanently discontinue regorafenib for severe or uncontrolled hypertension.
- Cardiac ischemia and infarction: Withhold regorafenib for new or acute cardiac ischemia/infarction and resume only after resolution of acute ischemic events.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue regorafenib.
- Gastrointestinal perforation or fistulae: Discontinue regorafenib.
- Wound healing complications: Stop regorafenib before surgery. Discontinue in patients with wound dehiscence.
- Embryofetal toxicity: Can cause fetal harm. Advise women of potential risk to a fetus.
InteractionsView
CYP3A4 Inhibitors: Avoid concomitant use of strong CYP3A4 inhibitors with Regorafenib.
CYP3A4 Inducers: Avoid concomitant use of strong CYP3A4 inducers with Regorafenib.
CYP3A4 Inducers: Avoid concomitant use of strong CYP3A4 inducers with Regorafenib.
Pregnancy & lactationView
Regorafenib is Pregnancy Category D. Based on its mechanism of action, Regorafenib can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies with Regorafenib in pregnant women. Based on animal reproduction studies Regorafenib was seen to cause embryo lethal and teratogenic defects and also increased the incidences of cardiovascular, genitourinary, and skeletal malformations in animals. Advice pregnant women or women with reproductive potential of the potential hazards of Regorafenib to the fetus. There is no information regarding the presence of regorafenib or its metabolites being excreted in human milk. Regorafenib and its metabolites were excreted in rat milk and because of the potential for serious adverse reactions in nursing infants from Regorafenib, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and effectiveness of Regorafenib in pediatric patients less than 18 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed between adult subjects and younger subjects.
Hepatic Impairment: No clinically important differences in the mean exposure of regorafenib or the active metabolites M-2 and M-5 were observed in patients with hepatocellular carcinoma and mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to patients with normal hepatic function. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. Regorafenib is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) as it has not been studied in this population.
Renal Impairment: No dose adjustment is recommended for patients with mild renal impairment. Limited pharmacokinetic data are available from patients with moderate renal impairment (CLcr 30-59 mL/min/1.73m2). Regorafenib has not been studied in patients with severe renal impairment or end-stage renal disease.
Females and Males of Reproductive Potential: Contraception: Use effective contraception during treatment and up to 2 months after completion of therapy.
Infertility: There are no data on the effect of regorafenib on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility
Geriatric Use: No overall differences in safety or effectiveness were observed between adult subjects and younger subjects.
Hepatic Impairment: No clinically important differences in the mean exposure of regorafenib or the active metabolites M-2 and M-5 were observed in patients with hepatocellular carcinoma and mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to patients with normal hepatic function. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. Regorafenib is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) as it has not been studied in this population.
Renal Impairment: No dose adjustment is recommended for patients with mild renal impairment. Limited pharmacokinetic data are available from patients with moderate renal impairment (CLcr 30-59 mL/min/1.73m2). Regorafenib has not been studied in patients with severe renal impairment or end-stage renal disease.
Females and Males of Reproductive Potential: Contraception: Use effective contraception during treatment and up to 2 months after completion of therapy.
Infertility: There are no data on the effect of regorafenib on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Renicon
Ranitidine Hydrochloride
Renicon
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.
Renisol
Prednisolone Acetate
Renisol
Prednisolone Acetate
Indications
Surgical aid in the anterior segment
Indication detailsView
Prednisolone eye drops is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Therapeutic classView
Glucocorticoids
PharmacologyView
Prednisolone decreases inflammation by inhibition of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It suppresses the immune system by reducing the activity and production of the lymphocytes and eosinophils.
DosageView
Adult: Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue the therapy before completing the course.
Paediatric: Safety and effectiveness in pediatric patients have not been established.
Paediatric: Safety and effectiveness in pediatric patients have not been established.
Side effectsView
Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing. Fungal and viral infections of the cornea are particularly may develop coincidentally with long-term applications of steroid.
ContraindicationsView
Prednisolone Acetate is contraindicated in viral diseases of the cornea, conjunctiva and known hypersensitivity to any of the ingredients of this preparation or other corticosteroids.
PrecautionsView
Shake the bottle well before use. Prolonged use of corticosteroids may result in damage to the optic nerve and defects in vision. If this product is used for longer period of time, intraocular pressure should be routinely monitored.
InteractionsView
No significant drug interactions have been reported.
Pregnancy & lactationView
Prednisolone Acetate is pregnancy category C. So, this drug should be used during pregnancy only if clearly needed. It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prednisolone Acetate is administered to a nursing woman.
Overdose effectsView
A one-time accidental overdose of Prednisolone Ophthalmic Suspension generally will not cause acute problems. Long time overdose may show general side-effects. In accidental overdose sufficient water should be taken to dilute the medication.
StorageView
Store in a cool, dry place and protect from light. Keep out of the reach of children. Protect from freezing. Shake well before using.
Reno
Ranitidine Hydrochloride
Reno
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.
Renocid
Aluminium Hydroxide + Magnesium Hydroxide
Renocid
Aluminium Hydroxide + Magnesium Hydroxide
Indications
Upper Gl bloating
Indication detailsView
Aluminium Hydroxide and Magnesium Hydroxide is indicated for Hyperacidity, peptic ulcer, gastritis, heartburn, sour stomach & dyspepsia.
Therapeutic classView
Antacids
PharmacologyView
This drug is well-balanced combination of essential non-systemic antacids which excel in efficacy and palatability. These are dependable antacid preparations without acid rebound, constipating or cathertic effects. Both the preparations provide symptomatic relief of hyperacidity associated with heartburn, acid ingestion or sour stomach.
Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.
Aluminium hydroxide gel, a slow acting antacid and an adsorbent with prolonged effect, has high neutralizing power. Magnesium Hydroxide possesses a slow but sustained acid neutralizing property. Antacids of both tablet and suspension possess adsorbent property. They form a protecting coating over the ulcer surface facilitating its healing; thus protecting the sensitive mucosa of stomach and duodenum from further irritation.
DosageView
Tablet: Two tablets 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.
Suspension: 2 tea spoonful 1-3 hours after meal and at bed time or as directed by the physician.
Side effectsView
Long term use of any antacid results in alkaluria, which may predispose to nephrolithiasis by forming precipitation of calcium phosphate.
ContraindicationsView
This is contraindicated in hypophosphataemia. It is also contraindicated in alkalosis and hypermagnesaemia where abdominal distention may be due to partial or complete intestinal obstruction.
PrecautionsView
Antacids reduce the absorption of tetracycline when given concomitantly. These should not be used concomitantly
InteractionsView
This drug inhibits the absorption of following drugs: Azithromycin, cefpodoxime, ciprofloxacin, isoniazid, rifampicin, norfloxacin, ofloxacin, pivampicillin, tetracyclines, Gabapentin and phenytoin, Itraconazole, ketoconazole, Chloroquine, hydroxychloroquine and Phenothiazines.
Pregnancy & lactationView
It is advised to avoid antacid preparations in the first trimester of pregnancy.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Renorma
Tibolone
Renorma
Tibolone
Indications
Vaginal dryness
Indication detailsView
Treatment of symptoms resulting from the natural or surgical menopause in post menopausal women. Prevention of osteoporosis in women who have gone through the menopause and are at high risk of fractures, but cannot take other medicines used to prevent osteoporosis.
Therapeutic classView
Drugs for menopausal symptoms: Hormone replacement therapy
PharmacologyView
Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 3α−OH and 3β−OH metabolite) have predominantly estrogenic activity; a third metabolite (δ4-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.
DosageView
The dose is one Tibolone tablet per day (2.5 mg daily). The tablet should be swallowed with some water or other drink, preferably at the same time in each day. Improvement of symptoms generally occurs within a few weeks, but optimal results are obtained when therapy is continued for at least 3 months.
Starting Tibolone Tablet: Women experiencing a natural menopause should commence treatment with Tibolone tablet at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone tablet may commence immediately.
Switching from a sequential or continuous combined HRT (Hormone Replacement Therapy) preparation: If changing from a sequential HRT preparation, treatment with Tibolone should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.
Missed dose: A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the later case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting
Starting Tibolone Tablet: Women experiencing a natural menopause should commence treatment with Tibolone tablet at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Tibolone tablet may commence immediately.
Switching from a sequential or continuous combined HRT (Hormone Replacement Therapy) preparation: If changing from a sequential HRT preparation, treatment with Tibolone should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.
Missed dose: A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the later case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting
Side effectsView
Occasionally, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other adverse effects are headache and migraine, oedema, dizziness, pruritus, increase in body weight, nausea, abdominal pain, rash, and depression.
ContraindicationsView
Contraindicated in pregnancy and lactation, known or suspected hormone-dependent tumours, cardiovascular or cerebrovascular disorders, active deep vein thrombosis, thromboembolic disorders, vaginal bleeding of unknown etiology and severe liver disorders.
PrecautionsView
In patients with renal dysfunction, history of liver disease, epilepsy, migraine, hypercholesterolemia, impaired carbohydrate metabolism, diabetes mellitus and cholestatic jaundice.
InteractionsView
No examples of interactions between Tibolone and other medicines have been reported in clinical practice. However, the following potential interactions should be considered on a theoretical basis: Enzyme-inducing compounds such as barbiturates, carbamazepine, hydantoins, and rifampicin may enhance the metabolism of Tibolone and thus decrease its therapeutic effect. Since Tibolone may increase blood or fibrinolytic activity (lower fibrinogen levels; higher AT III, plasminogen, and fibrinolytic activity values), it may enhance the effect of anticoagulants.
Pregnancy & lactationView
Tibolone tablet is contraindicated during pregnancy. If pregnancy occurs during medication with this tablet, treatment should be withdrawn immediately. For this tablet no clinical data on exposed pregnancies are available. Tibolone tablet is contraindicated in lactating women.
Overdose effectsView
The acute toxicity of Tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose - nausea, vomiting, and withdrawal bleeding in females may develop. Symptomatic treatment can be given if necessary.
StorageView
Keep in a cool & dry place. Protect from light. Keep out of the reach of children.
Renosart
Losartan Potassium
Renosart
Losartan Potassium
Indications
Stroke
Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Renosart Plus
Losartan Potassium + Hydrochlorothiazide
Renosart Plus
Losartan Potassium + Hydrochlorothiazide
Indications
Stroke
Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
- The usual starting dose of 50/12.5 is one tablet once daily.
- For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
- A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
- In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
- In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
- No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
- The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
- For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
- Hypersensitivity: Angiooedema
- Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
- Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
- Impaired renal function and
- Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.
Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs: additive effect or potentiation.
Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.
Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.
Renosev
Sevelamer Carbonate
Renosev
Sevelamer Carbonate
Indications
Hyperphosphataemia
Indication detailsView
Sevelamer Carbonate is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer Carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 mmol/l. Sevelamer Carbonate should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Therapeutic classView
Drugs for reduction of serum phosphorus in patients with ESRD
PharmacologyView
Sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).
DosageView
Starting dose: The recommended starting dose of Sevelamer Carbonate is 2.4 g (Three Sevelamer 800 mg tablets or Three Sevelamer 800 mg sachets of powder for oral suspension) or 4.8 g (Six Sevelamer 800 mg tablets or Six Sevelamer 800 mg sachets of powder for oral suspension) per day based on clinical needs and serum phosphorus level. Sevelamer Carbonate tablet or suspension must be taken three times per day with meals.
For patients previously on phosphate binders (Sevelamer Hydrochloride or calcium based), Sevelamer Carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer Carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Sevelamer Carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Paediatric population: The safety and efficacy of Sevelamer Carbonate has not been established in children below the age of 18 years. Sevelamer Carbonate is not recommended in children below the age of 18 years.
For patients previously on phosphate binders (Sevelamer Hydrochloride or calcium based), Sevelamer Carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer Carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Sevelamer Carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Paediatric population: The safety and efficacy of Sevelamer Carbonate has not been established in children below the age of 18 years. Sevelamer Carbonate is not recommended in children below the age of 18 years.
AdministrationView
Method of administration for Sevelamer Carbonate tablet: Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.
Method of administration for Sevelamer Carbonate powder for oral suspension: Each sachet of 800 mg of powder is to be dispersed in 30 ml or 6 teaspoons of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.
Method of administration for Sevelamer Carbonate powder for oral suspension: Each sachet of 800 mg of powder is to be dispersed in 30 ml or 6 teaspoons of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.
ContraindicationsView
Sevelamer Carbonate is contraindicated in patients with bowel obstruction. Sevelamer Carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
InteractionsView
Drug interactions: Interaction studies have not been conducted in patients on dialysis. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Sevelamer Hydrochloride in a single dose study. Consequently, Sevelamer Carbonate should not be taken simultaneously with ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with Sevelamer Hydrochloride without any clinical consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal. Very rare cases of hypothyroidism have been reported in patients co-administered Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving Sevelamer Carbonate and levothyroxine. Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Sevelamer Carbonate to patients also taking these medicinal products. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Sevelamer Carbonate is not absorbed and may affect the bioavailability of other medicinal products. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Sevelamer Carbonate, or the physician should consider monitoring blood levels.
Pregnancy & lactationView
Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
Pediatric usageView
Pediatric Use: The safety and efficacy of Sevelamer Carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with CKD. In this study, Sevelamer Carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children < 13 years of age and children not on dialysis. Given its mechanism of action, Sevelamer Carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with CKD. Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. No new risks or safety signals were identified with the use of sevelamer carbonate in the trial. Sevelamer Carbonate has not been studied in pediatric patients below 6 years of age.
Geriatric Use: Clinical studies of Sevelamer Carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Geriatric Use: Clinical studies of Sevelamer Carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Overdose effectsView
In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
StorageView
Store in a cool and dry place, protected from light.
Renosev
Sevelamer Carbonate
Renosev
Sevelamer Carbonate
Indications
Hyperphosphataemia
Indication detailsView
Sevelamer Carbonate is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer Carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1.78 mmol/l. Sevelamer Carbonate should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Therapeutic classView
Drugs for reduction of serum phosphorus in patients with ESRD
PharmacologyView
Sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).
DosageView
Starting dose: The recommended starting dose of Sevelamer Carbonate is 2.4 g (Three Sevelamer 800 mg tablets or Three Sevelamer 800 mg sachets of powder for oral suspension) or 4.8 g (Six Sevelamer 800 mg tablets or Six Sevelamer 800 mg sachets of powder for oral suspension) per day based on clinical needs and serum phosphorus level. Sevelamer Carbonate tablet or suspension must be taken three times per day with meals.
For patients previously on phosphate binders (Sevelamer Hydrochloride or calcium based), Sevelamer Carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer Carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Sevelamer Carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Paediatric population: The safety and efficacy of Sevelamer Carbonate has not been established in children below the age of 18 years. Sevelamer Carbonate is not recommended in children below the age of 18 years.
For patients previously on phosphate binders (Sevelamer Hydrochloride or calcium based), Sevelamer Carbonate should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Titration and Maintenance: Serum phosphorus levels must be monitored and the dose of Sevelamer Carbonate titrated every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Sevelamer Carbonate should adhere to their prescribed diets. In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Paediatric population: The safety and efficacy of Sevelamer Carbonate has not been established in children below the age of 18 years. Sevelamer Carbonate is not recommended in children below the age of 18 years.
AdministrationView
Method of administration for Sevelamer Carbonate tablet: Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.
Method of administration for Sevelamer Carbonate powder for oral suspension: Each sachet of 800 mg of powder is to be dispersed in 30 ml or 6 teaspoons of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.
Method of administration for Sevelamer Carbonate powder for oral suspension: Each sachet of 800 mg of powder is to be dispersed in 30 ml or 6 teaspoons of water prior to administration. The suspension should be ingested within 30 minutes after being prepared.
ContraindicationsView
Sevelamer Carbonate is contraindicated in patients with bowel obstruction. Sevelamer Carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
InteractionsView
Drug interactions: Interaction studies have not been conducted in patients on dialysis. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with Sevelamer Hydrochloride in a single dose study. Consequently, Sevelamer Carbonate should not be taken simultaneously with ciprofloxacin. Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with Sevelamer Hydrochloride without any clinical consequences (i.e graft rejection). The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal. Very rare cases of hypothyroidism have been reported in patients co-administered Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, and levothyroxine. Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving Sevelamer Carbonate and levothyroxine. Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials. Caution should be exercised when prescribing Sevelamer Carbonate to patients also taking these medicinal products. In interaction studies in healthy volunteers, Sevelamer Hydrochloride, which contains the same active moiety as Sevelamer Carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol. Sevelamer Carbonate is not absorbed and may affect the bioavailability of other medicinal products. When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Sevelamer Carbonate, or the physician should consider monitoring blood levels.
Pregnancy & lactationView
Sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
Sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to Sevelamer carbonate. Clinical Considerations Sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women.
Pediatric usageView
Pediatric Use: The safety and efficacy of Sevelamer Carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with CKD. In this study, Sevelamer Carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children < 13 years of age and children not on dialysis. Given its mechanism of action, Sevelamer Carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with CKD. Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. No new risks or safety signals were identified with the use of sevelamer carbonate in the trial. Sevelamer Carbonate has not been studied in pediatric patients below 6 years of age.
Geriatric Use: Clinical studies of Sevelamer Carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Geriatric Use: Clinical studies of Sevelamer Carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Overdose effectsView
In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
StorageView
Store in a cool and dry place, protected from light.
Renova
Paracetamol
Renova
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Renova
Paracetamol
Renova
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Renova
Paracetamol
Renova
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Renova
Paracetamol
Renova
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Renova
Paracetamol
Renova
Paracetamol
Indications
Toothache
Indication detailsView
Paracetamol is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.
Therapeutic classView
Non opioid analgesics
PharmacologyView
Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.
DosageView
Tablet:
- Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
- Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.
- Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.
- Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
- 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
- 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
- 6-12 years: 2-A teaspoonful 3 to 4 times daily.
- Adults: 4-8 teaspoonful 3 to 4 times daily.
- Children 3-12 months: 60-120 mg,4 times daily.
- Children 1-5 years: 125-250 mg 4 times daily.
- Children 6-12 years: 250-500 mg 4 times daily.
- Adults & children over 12 years: 0.5-1 gm 4 times daily.
- Children Upto 3 months: 0.5 ml (40 mg)
- 4 to 11 months: 1.0 ml (80 mg)
- 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.
- Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
- Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.
Side effectsView
Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
ContraindicationsView
It is contraindicated in known hypersensitivity to Paracetamol.
PrecautionsView
Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.
InteractionsView
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Paracetamol. Alcohol can increase the hepatotoxicity of Paracetamol overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Paracetamol levels by increasing first-pass metabolism or clearance.
Pregnancy & lactationView
Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed
Overdose effectsView
Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Renova
Paracetamol (IV Infusion)
Renova
Paracetamol (IV Infusion)
Indication detailsView
Paracetamol IV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, the reduction of fever.
PharmacologyView
Paracetamol exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Its weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS.
Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.
Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.
DosageView
Adults and adolescents weighing 50 kg and over: the recommended dosage of Paracetamol IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Paracetamol IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 4000 mg per day.
Adults and adolescents weighing under 50 kg: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
Children >2 to 12 years of age: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
Adults and adolescents weighing under 50 kg: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
Children >2 to 12 years of age: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
Side effectsView
As all paracetamol products, adverse drug reactions are rare (>1/10000, <1/1000) or very rare (<1/10000). Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation). Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment. Cases of erythema, flushing, pruritus and tachycardia have been reported.
ContraindicationsView
Paracetamol is contraindicated in patients with known hypersensitivity to its active ingredient or to any of the excipients in the intravenous formulation. Also contraindicated in patients with severe hepatic impairment or severe active liver disease
PrecautionsView
Administration of Paracetamol in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Paracetamol. Use caution when administering Paracetamol in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance < 30 ml/min). There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Paracetamol IV immediately if symptoms associated with allergy or hypersensitivity occurs. Do not use Paracetamol IV in patients with Paracetamol allergy.
Pregnancy & lactationView
Pregnancy Category C. There are no studies of intravenous Paracetamol in pregnant women; however, epidemiological data on oral Paracetamol use in pregnant women show no increased risk of major congenital malformations. Animal reproduction studies have not been conducted with IV Paracetamol and it is not known whether Paracetamol IV can cause fetal harm when administered to a pregnant woman. Paracetamol IV should be given to a pregnant woman only if clearly needed. There are no adequate and well-controlled studies with Paracetamol IV during labor and delivery; therefore, it should be used in such settings only after a careful benefit-risk assessment. While studies with Paracetamol IV have not been conducted, Paracetamol is secreted in human milk in small quantities after oral administration.
Pediatric usageView
Pediatric Use: The safety and effectiveness of Paracetamol IV for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Paracetamol IV in adults.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Patients with Hepatic Impairment: Paracetamol is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Paracetamol may be warranted.
Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Paracetamol may be warranted.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Patients with Hepatic Impairment: Paracetamol is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Paracetamol may be warranted.
Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Paracetamol may be warranted.
StorageView
Store in a cool & dry place & away from children. For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.