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Rutinib
Ruxolitinib
Rutinib
Ruxolitinib
Indications
Polycythaemia vera
Indication detailsView
Myelofibrosis: Ruxolitinib is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.
Polycythemia Vera: Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease: Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus host disease (GVHD) in adult and pediatric patients 12 years and older.
Polycythemia Vera: Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease: Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus host disease (GVHD) in adult and pediatric patients 12 years and older.
Therapeutic classView
Pyrrolopyrimidines
PharmacologyView
Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) known to be associated with dysregulated JAK1 and JAK2 signaling. Oral administration of ruxolitinib prevented splenomegaly, preferentially decreased JAK2V617F mutant cells in the spleen and decreased circulating inflammatory cytokines (eg, TNF-α, IL-6).
Absorption: Ruxolitinib is rapidly absorbed after oral Ruxolitinib administration with maximal plasma concentration (Cmax) achieved within 1 to 2 hours post-dose. Oral absorption of ruxolitinib was estimated to be at least 95%. Distribution: The mean volume of distribution of ruxolitinib at steady-state is 72 L in patient with MF and PV in myelofibrosis patients.
Half-life: the mean half-life of ruxolitinib & metabolites is approximately 5.8 hours. Elimination half-life: The mean elimination half-life of ruxolitinib is approximately 3 hours AUC: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5 to 200 mg.
The plasma protein binding: 97%, mostly to albumin. Metabolism: Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9.
Excretion: Following a single oral dose of radio labeled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. Unchanged drug accounted for less than 1% of the excreted total radioactivity.
Absorption: Ruxolitinib is rapidly absorbed after oral Ruxolitinib administration with maximal plasma concentration (Cmax) achieved within 1 to 2 hours post-dose. Oral absorption of ruxolitinib was estimated to be at least 95%. Distribution: The mean volume of distribution of ruxolitinib at steady-state is 72 L in patient with MF and PV in myelofibrosis patients.
Half-life: the mean half-life of ruxolitinib & metabolites is approximately 5.8 hours. Elimination half-life: The mean elimination half-life of ruxolitinib is approximately 3 hours AUC: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5 to 200 mg.
The plasma protein binding: 97%, mostly to albumin. Metabolism: Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9.
Excretion: Following a single oral dose of radio labeled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. Unchanged drug accounted for less than 1% of the excreted total radioactivity.
DosageView
Myclofibrosis: The recommended starting dose of Ruxolitinib is based on platelet count. A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Doses may be titrated based on safety and efficacy.
Acute Graft-Versus-Host Disease: The recommended dose of Ruxolitinib is 5 mg twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with ruxolitinib. Or as directed by the registered physician.
- Platelet count greater than 200 X 10 9 /L: Starting dose 20 mg orally twice daily.
- Platelet count 100 X 10 9 /L to 200 X 10 9 /L: Starting dose 15 mg orally twice daily.
- Platelet count 50 X 10 9 /L to less than 100 X 10 9 /L: Starting dose 5 mg orally twice daily.
Acute Graft-Versus-Host Disease: The recommended dose of Ruxolitinib is 5 mg twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with ruxolitinib. Or as directed by the registered physician.
AdministrationView
Ruxolitinib is to be taken orally, with or without food. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
Side effectsView
The most common side effects are-
- Thrombocytopenia, Anemia and Neutropenia
- Risk of Infection, bruising, dizziness, headache
- Symptom Exacerbation Following Interruption or Discontinuation of treatment with Ruxolitinib
- Non-Melanoma Skin Cancer
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Ruxolitinib or any other components of this product.
PrecautionsView
Thrombocytopenia, Anemia And Neutropenia: Treatment with Ruxolitinib can cause thrombocytopenia, anemia and neutropenia. Manage thrombocytopenia by reducing the dose or temporarily interrupting Ruxolitinib. Platelet transfusions may be necessary.Patients developing anemia may require blood transfusions and/or dose modifications of Ruxolitinib.Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible by withholding Ruxolitinib until recovery.Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.
Risk of Infection: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly.
Tuberculosis: Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. The decision to continue Ruxolitinib during treatment of active tuberculosis should be based on the overall risk-benefit determination.
Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has occurred with Ruxolitinib treatment. If PML is suspected, stop Ruxolitinib and evaluate.
Herpes Zoster: Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected.
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib. The effect of Ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Symptom Exacerbation Following Interruption or Discontinuation Of Treatment With Ruxolitinib: Following discontinuation of Ruxolitinib, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Ruxolitinib: fever, respiratory distress, hypotension, DIC, or multi organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Ruxolitinib, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Ruxolitinib. Instruct patients not to interrupt or discontinue Ruxolitinib therapy without consulting their physician. When discontinuing or interrupting therapy with Ruxolitinib for reasons other than thrombocytopenia or neutropenia, consider tapering the dose of Ruxolitinib gradually rather than discontinuing abruptly.
Non-Melanoma Skin Cancer: Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Ruxolitinib. Perform periodic skin examinations.
Lipid Elevations: Treatment with Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Ruxolitinib. Assess lipid parameters approximately 8-12 weeks following initiation of Ruxolitinib therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia.
Risk of Infection: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly.
Tuberculosis: Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. The decision to continue Ruxolitinib during treatment of active tuberculosis should be based on the overall risk-benefit determination.
Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has occurred with Ruxolitinib treatment. If PML is suspected, stop Ruxolitinib and evaluate.
Herpes Zoster: Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected.
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib. The effect of Ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Symptom Exacerbation Following Interruption or Discontinuation Of Treatment With Ruxolitinib: Following discontinuation of Ruxolitinib, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Ruxolitinib: fever, respiratory distress, hypotension, DIC, or multi organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Ruxolitinib, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Ruxolitinib. Instruct patients not to interrupt or discontinue Ruxolitinib therapy without consulting their physician. When discontinuing or interrupting therapy with Ruxolitinib for reasons other than thrombocytopenia or neutropenia, consider tapering the dose of Ruxolitinib gradually rather than discontinuing abruptly.
Non-Melanoma Skin Cancer: Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Ruxolitinib. Perform periodic skin examinations.
Lipid Elevations: Treatment with Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Ruxolitinib. Assess lipid parameters approximately 8-12 weeks following initiation of Ruxolitinib therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia.
InteractionsView
Fluconazole: Concomitant administration of Ruxolitinib with fluconazole greater than 200 mg daily may increase ruxolitinib exposure due to inhibition of both the CYP3A4 and CYP2C9 metabolic pathways. Increased exposure may increase the risk of exposure-related adverse reactions. Avoid the concomitant use of Ruxolitinib with fluconazole doses of greater than 200 mg daily except in patients with acute GVHD.
Strong CYP3A4 Inhibitors: Concomitant administration of Ruxolitinib with strong CYP3A4 inhibitors increases ruxolitinib exposure. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Ruxolitinib with strong CYP3A4 inhibitors. In patients with acute GVHD, reduce Ruxolitinib dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole.
Strong CYP3A4 Inducers: Concomitant administration of Ruxolitinib with strong CYP3A4 inducers may decrease ruxolitinib exposure. No dose adjustment is recommended; however, monitor patients frequently and adjust the Ruxolitinib dose based on safety and efficacy.
Strong CYP3A4 Inhibitors: Concomitant administration of Ruxolitinib with strong CYP3A4 inhibitors increases ruxolitinib exposure. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Ruxolitinib with strong CYP3A4 inhibitors. In patients with acute GVHD, reduce Ruxolitinib dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole.
Strong CYP3A4 Inducers: Concomitant administration of Ruxolitinib with strong CYP3A4 inducers may decrease ruxolitinib exposure. No dose adjustment is recommended; however, monitor patients frequently and adjust the Ruxolitinib dose based on safety and efficacy.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It is not known whether Ruxolitinib is excreted in human milk. Because many drugs are excreted in human milk, breastfeeding should be discontinued during treatment with Ruxolitinib and for two weeks after the final dose.
Pediatric usageView
Use in children: The safety and effectiveness of Ruxolitinib in pediatric patients have not been established.
Overdose effectsView
There is no known antidote for overdoses with Ruxolitinib. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Ruxolitinib.
StorageView
Store below 30°C in a dry place, away from sunlight. Keep out of reach of children.
Rutinib
Ruxolitinib
Rutinib
Ruxolitinib
Indications
Polycythaemia vera
Indication detailsView
Myelofibrosis: Ruxolitinib is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.
Polycythemia Vera: Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease: Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus host disease (GVHD) in adult and pediatric patients 12 years and older.
Polycythemia Vera: Ruxolitinib is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Acute Graft-Versus-Host Disease: Ruxolitinib is indicated for treatment of steroid-refractory acute graft-versus host disease (GVHD) in adult and pediatric patients 12 years and older.
Therapeutic classView
Pyrrolopyrimidines
PharmacologyView
Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. Myelofibrosis (MF) is a myeloproliferative neoplasm (MPN) known to be associated with dysregulated JAK1 and JAK2 signaling. Oral administration of ruxolitinib prevented splenomegaly, preferentially decreased JAK2V617F mutant cells in the spleen and decreased circulating inflammatory cytokines (eg, TNF-α, IL-6).
Absorption: Ruxolitinib is rapidly absorbed after oral Ruxolitinib administration with maximal plasma concentration (Cmax) achieved within 1 to 2 hours post-dose. Oral absorption of ruxolitinib was estimated to be at least 95%. Distribution: The mean volume of distribution of ruxolitinib at steady-state is 72 L in patient with MF and PV in myelofibrosis patients.
Half-life: the mean half-life of ruxolitinib & metabolites is approximately 5.8 hours. Elimination half-life: The mean elimination half-life of ruxolitinib is approximately 3 hours AUC: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5 to 200 mg.
The plasma protein binding: 97%, mostly to albumin. Metabolism: Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9.
Excretion: Following a single oral dose of radio labeled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. Unchanged drug accounted for less than 1% of the excreted total radioactivity.
Absorption: Ruxolitinib is rapidly absorbed after oral Ruxolitinib administration with maximal plasma concentration (Cmax) achieved within 1 to 2 hours post-dose. Oral absorption of ruxolitinib was estimated to be at least 95%. Distribution: The mean volume of distribution of ruxolitinib at steady-state is 72 L in patient with MF and PV in myelofibrosis patients.
Half-life: the mean half-life of ruxolitinib & metabolites is approximately 5.8 hours. Elimination half-life: The mean elimination half-life of ruxolitinib is approximately 3 hours AUC: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5 to 200 mg.
The plasma protein binding: 97%, mostly to albumin. Metabolism: Ruxolitinib is metabolized by CYP3A4 and to a lesser extent by CYP2C9.
Excretion: Following a single oral dose of radio labeled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism with 74% of radioactivity excreted in urine and 22% excretion via feces. Unchanged drug accounted for less than 1% of the excreted total radioactivity.
DosageView
Myclofibrosis: The recommended starting dose of Ruxolitinib is based on platelet count. A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Doses may be titrated based on safety and efficacy.
Acute Graft-Versus-Host Disease: The recommended dose of Ruxolitinib is 5 mg twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with ruxolitinib. Or as directed by the registered physician.
- Platelet count greater than 200 X 10 9 /L: Starting dose 20 mg orally twice daily.
- Platelet count 100 X 10 9 /L to 200 X 10 9 /L: Starting dose 15 mg orally twice daily.
- Platelet count 50 X 10 9 /L to less than 100 X 10 9 /L: Starting dose 5 mg orally twice daily.
Acute Graft-Versus-Host Disease: The recommended dose of Ruxolitinib is 5 mg twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with ruxolitinib. Or as directed by the registered physician.
AdministrationView
Ruxolitinib is to be taken orally, with or without food. If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
Side effectsView
The most common side effects are-
- Thrombocytopenia, Anemia and Neutropenia
- Risk of Infection, bruising, dizziness, headache
- Symptom Exacerbation Following Interruption or Discontinuation of treatment with Ruxolitinib
- Non-Melanoma Skin Cancer
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Ruxolitinib or any other components of this product.
PrecautionsView
Thrombocytopenia, Anemia And Neutropenia: Treatment with Ruxolitinib can cause thrombocytopenia, anemia and neutropenia. Manage thrombocytopenia by reducing the dose or temporarily interrupting Ruxolitinib. Platelet transfusions may be necessary.Patients developing anemia may require blood transfusions and/or dose modifications of Ruxolitinib.Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible by withholding Ruxolitinib until recovery.Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.
Risk of Infection: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly.
Tuberculosis: Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. The decision to continue Ruxolitinib during treatment of active tuberculosis should be based on the overall risk-benefit determination.
Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has occurred with Ruxolitinib treatment. If PML is suspected, stop Ruxolitinib and evaluate.
Herpes Zoster: Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected.
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib. The effect of Ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Symptom Exacerbation Following Interruption or Discontinuation Of Treatment With Ruxolitinib: Following discontinuation of Ruxolitinib, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Ruxolitinib: fever, respiratory distress, hypotension, DIC, or multi organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Ruxolitinib, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Ruxolitinib. Instruct patients not to interrupt or discontinue Ruxolitinib therapy without consulting their physician. When discontinuing or interrupting therapy with Ruxolitinib for reasons other than thrombocytopenia or neutropenia, consider tapering the dose of Ruxolitinib gradually rather than discontinuing abruptly.
Non-Melanoma Skin Cancer: Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Ruxolitinib. Perform periodic skin examinations.
Lipid Elevations: Treatment with Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Ruxolitinib. Assess lipid parameters approximately 8-12 weeks following initiation of Ruxolitinib therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia.
Risk of Infection: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Ruxolitinib until active serious infections have resolved. Observe patients receiving Ruxolitinib for signs and symptoms of infection and manage promptly.
Tuberculosis: Tuberculosis infection has been reported in patients receiving Ruxolitinib. Observe patients receiving Ruxolitinib for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Ruxolitinib, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Ruxolitinib. The decision to continue Ruxolitinib during treatment of active tuberculosis should be based on the overall risk-benefit determination.
Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has occurred with Ruxolitinib treatment. If PML is suspected, stop Ruxolitinib and evaluate.
Herpes Zoster: Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected.
Hepatitis B: Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib. The effect of Ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Symptom Exacerbation Following Interruption or Discontinuation Of Treatment With Ruxolitinib: Following discontinuation of Ruxolitinib, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Ruxolitinib: fever, respiratory distress, hypotension, DIC, or multi organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Ruxolitinib, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Ruxolitinib. Instruct patients not to interrupt or discontinue Ruxolitinib therapy without consulting their physician. When discontinuing or interrupting therapy with Ruxolitinib for reasons other than thrombocytopenia or neutropenia, consider tapering the dose of Ruxolitinib gradually rather than discontinuing abruptly.
Non-Melanoma Skin Cancer: Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Ruxolitinib. Perform periodic skin examinations.
Lipid Elevations: Treatment with Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Ruxolitinib. Assess lipid parameters approximately 8-12 weeks following initiation of Ruxolitinib therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia.
InteractionsView
Fluconazole: Concomitant administration of Ruxolitinib with fluconazole greater than 200 mg daily may increase ruxolitinib exposure due to inhibition of both the CYP3A4 and CYP2C9 metabolic pathways. Increased exposure may increase the risk of exposure-related adverse reactions. Avoid the concomitant use of Ruxolitinib with fluconazole doses of greater than 200 mg daily except in patients with acute GVHD.
Strong CYP3A4 Inhibitors: Concomitant administration of Ruxolitinib with strong CYP3A4 inhibitors increases ruxolitinib exposure. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Ruxolitinib with strong CYP3A4 inhibitors. In patients with acute GVHD, reduce Ruxolitinib dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole.
Strong CYP3A4 Inducers: Concomitant administration of Ruxolitinib with strong CYP3A4 inducers may decrease ruxolitinib exposure. No dose adjustment is recommended; however, monitor patients frequently and adjust the Ruxolitinib dose based on safety and efficacy.
Strong CYP3A4 Inhibitors: Concomitant administration of Ruxolitinib with strong CYP3A4 inhibitors increases ruxolitinib exposure. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Ruxolitinib with strong CYP3A4 inhibitors. In patients with acute GVHD, reduce Ruxolitinib dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole.
Strong CYP3A4 Inducers: Concomitant administration of Ruxolitinib with strong CYP3A4 inducers may decrease ruxolitinib exposure. No dose adjustment is recommended; however, monitor patients frequently and adjust the Ruxolitinib dose based on safety and efficacy.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It is not known whether Ruxolitinib is excreted in human milk. Because many drugs are excreted in human milk, breastfeeding should be discontinued during treatment with Ruxolitinib and for two weeks after the final dose.
Pediatric usageView
Use in children: The safety and effectiveness of Ruxolitinib in pediatric patients have not been established.
Overdose effectsView
There is no known antidote for overdoses with Ruxolitinib. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Ruxolitinib.
StorageView
Store below 30°C in a dry place, away from sunlight. Keep out of reach of children.
Rutix
Ofloxacin (Oral & Injection)
Rutix
Ofloxacin (Oral & Injection)
Indications
Uncomplicated cystitis
Indication detailsView
Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.
- Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
- Gastrointestinal Tract: Enteric fever, shigellosis.
- Multi-drug-resistant Tuberculosis.
- Skin and skin structures: Uncomplicated skin and skin structure infections.
- Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
- Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.
Therapeutic classView
4-Quinolone preparations, Aural Anti-bacterial preparations
PharmacologyView
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
DosageView
Intravenous (Adult):
- Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
- Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
- Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Oral (Adult):
General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.- Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
- Shigellosis: 400 mg single dose.
- Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
- Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
- Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
- Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
- Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
- Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.
Elderly: No adjustment of dosage is required in the elderly.
AdministrationView
May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.
Side effectsView
Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.
ContraindicationsView
Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.
PrecautionsView
Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.
InteractionsView
Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.
Pregnancy & lactationView
The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.
Pediatric usageView
Renal Impairment:
- CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
- CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.
Overdose effectsView
Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
StorageView
Store between 15-30° C. Protect from light.
Rutix
Ofloxacin (Oral & Injection)
Rutix
Ofloxacin (Oral & Injection)
Indications
Uncomplicated cystitis
Indication detailsView
Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.
- Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
- Gastrointestinal Tract: Enteric fever, shigellosis.
- Multi-drug-resistant Tuberculosis.
- Skin and skin structures: Uncomplicated skin and skin structure infections.
- Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
- Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.
Therapeutic classView
4-Quinolone preparations, Aural Anti-bacterial preparations
PharmacologyView
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.
DosageView
Intravenous (Adult):
- Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
- Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
- Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Oral (Adult):
General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.- Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
- Shigellosis: 400 mg single dose.
- Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
- Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
- Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
- Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
- Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
- Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.
Elderly: No adjustment of dosage is required in the elderly.
AdministrationView
May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.
Side effectsView
Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.
ContraindicationsView
Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.
PrecautionsView
Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.
InteractionsView
Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.
Pregnancy & lactationView
The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.
Pediatric usageView
Renal Impairment:
- CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
- CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.
Overdose effectsView
Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.
StorageView
Store between 15-30° C. Protect from light.
Ruvastin
Rosuvastatin
Ruvastin
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
Ruvastin
Rosuvastatin
Ruvastin
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
Ruvastin
Rosuvastatin
Ruvastin
Rosuvastatin
Indications
Stroke
Indication detailsView
Rosuvastatin is indicated in-
- Heterozygous Hypercholesterolemia (Familial and Non familial)
- Homozygous Hypercholesterolemia (Familial)
- Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
- Primary prevention of cardiovascular disease
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
DosageView
Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
HoFH: Starting dose 20 mg/day.
Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.
Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.
AdministrationView
Rosuvastatin can be taken with or without food, at any time of day.
Side effectsView
Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.
ContraindicationsView
Rosuvastatin is contraindicated if-
- Known hypersensitivity to product components
- Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
- Pregnant women and women who may become pregnant
- Nursing mothers
PrecautionsView
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.
Liver enzymes should be monitored before and during treatment
InteractionsView
Remarkable drug interactions of Rosuvastatin are-
- Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
- Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
- Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
- Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
- Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.
Pregnancy & lactationView
The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.
Pediatric usageView
Use in children: The safety and effectiveness in pediatric patients have not been established.
StorageView
Keep below 30oC temperature, protected from light & moisture. Keep out of the reach of children.
Ruzmet
Metformin Hydrochloride
Ruzmet
Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
- In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
- In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
- Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
- Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
- Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
- Children: Metformin extended release tablet has not been studied in children.
- Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
- Severe renal failure (GFR <30 mL/min).
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
- Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.
Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.
Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
- At least annually in patients with normal renal function,
- At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Rymin
Diphenhydramine Hydrochloride
Rymin
Diphenhydramine Hydrochloride
Indications
Wheezing
Indication detailsView
Diphenhydramine is indicated for the treatment of followings:
- Seasonal, perennial, vasomotor rhinitis
- Urticaria, angioneurotic oedema, anaphylaxis
- Pruiritic conditions
- Premedication for emesis and motion sickness
- Miscellaneous like meniere's disease and parkinsonism
Therapeutic classView
Sedating Anti-histamine
PharmacologyView
Diphenhydramine is an antihistamine with anticholinergic and sedative effects. It competes with histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and respiratory tract.
DosageView
Adult-
- Most allergic conditions: 25-50 mg three times a day with a further 50 mg at night.
- 1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day
- More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a day
Side effectsView
Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.
ContraindicationsView
Known hypersensitivity to Diphenhydramine Hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.
PrecautionsView
Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.
InteractionsView
Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.
Pregnancy & lactationView
Category B: There are no adequate and well controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.
Overdose effectsView
Symptoms: Impaired consciousness; psychosis, seizures, antimuscarinic symptoms (e.g. mydriasis, tachycardia, tachyarrhythmias), resp failure, rhabdomyolysis; acute delirium with visual and auditory hallucination (topical).
Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.
Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.
StorageView
Store between 15-30° C. Protect from moisture.
Rynex
Oxymetazoline Hydrochloride (Nasal Preparation)
Rynex
Oxymetazoline Hydrochloride (Nasal Preparation)
Indications
Sinusitis
Indication detailsView
Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.
Therapeutic classView
Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations
PharmacologyView
Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.
DosageView
Oxymetazoline nasal spray-
- Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
- Elderly: There is no need for dosage reduction in the elderly for nasal administration.
- Children below 6 years of age: It is not suitable for children below 6 years of age.
- Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
- Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.
ContraindicationsView
It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.
PrecautionsView
Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.
InteractionsView
Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.
Pregnancy & lactationView
The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.
Overdose effectsView
Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
StorageView
Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.
Rynex
Oxymetazoline Hydrochloride (Nasal Preparation)
Rynex
Oxymetazoline Hydrochloride (Nasal Preparation)
Indications
Sinusitis
Indication detailsView
Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.
Therapeutic classView
Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations
PharmacologyView
Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.
DosageView
Oxymetazoline nasal spray-
- Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
- Elderly: There is no need for dosage reduction in the elderly for nasal administration.
- Children below 6 years of age: It is not suitable for children below 6 years of age.
- Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
- Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.
ContraindicationsView
It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.
PrecautionsView
Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.
InteractionsView
Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.
Pregnancy & lactationView
The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.
Overdose effectsView
Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
StorageView
Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.
Rynex
Oxymetazoline Hydrochloride (Nasal Preparation)
Rynex
Oxymetazoline Hydrochloride (Nasal Preparation)
Indications
Sinusitis
Indication detailsView
Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.
Therapeutic classView
Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations
PharmacologyView
Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.
DosageView
Oxymetazoline nasal spray-
- Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
- Elderly: There is no need for dosage reduction in the elderly for nasal administration.
- Children below 6 years of age: It is not suitable for children below 6 years of age.
- Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
- Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening
AdministrationView
How to use the Nasal Spray-
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/ other nostril for consecutive doses.
- Remove the dust cover.
- Gently pull off the nasal applicator.
- Wash the applicator and dust cover in warm water.
- Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
- Gently push the applicator back on the top of the bottle and re-fix the dust cover.
Side effectsView
Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.
ContraindicationsView
It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.
PrecautionsView
Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.
InteractionsView
Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.
Pregnancy & lactationView
The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.
Overdose effectsView
Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.
StorageView
Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.
Rynofex
Fexofenadine Hydrochloride
Rynofex
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Rynofex
Fexofenadine Hydrochloride
Rynofex
Fexofenadine Hydrochloride
Indications
Urticaria
Indication detailsView
Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.
DosageView
Seasonal Allergic Rhinitis-
Adults and children 12 years and older:
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 30 mg or 5 ml twice daily
- In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
- Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
- In case of impaired renal function: 60 mg once daily
- Tablet: 30 mg twice daily or 60 mg once daily
- In case of impaired renal function: 30 mg once daily
- Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
- In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
- Suspension: 30 mg or 5 ml (1 tsp) twice daily
- In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily
Side effectsView
Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.
ContraindicationsView
Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.
PrecautionsView
Caution should be exercised in elderly patient and patient with decreased renal function.
InteractionsView
Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.
Pregnancy & lactationView
US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Overdose effectsView
In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Ryth
Roxithromycin
Ryth
Roxithromycin
Indications
Urethritis
Indication detailsView
Roxithromycin is indicated in the treatment of infections caused by susceptible microorganisms-
- Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia
- ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.
- Skin infections like folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo and infected dermatitis.
- Genital infections like urethritis, prostatitis, cervicitis and salpingitis especially if produced by Chlamydia trachomatis.
Therapeutic classView
Macrolides
PharmacologyView
Roxithromycin inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.
DosageView
Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.
Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed
Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed
- 6 to 11 Kg: 25 mg Roxithromycin 12 hourly.
- 12 to 23 Kg: 50 mg Roxithromycin 12 hourly.
- 24 to 40 Kg: 100 mg Roxithromycin 12 hourly.
Side effectsView
Roxithromycin is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.
ContraindicationsView
Roxithromycin should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.
PrecautionsView
Roxithromycin should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycin should not exceed 150 mg twice a day.
InteractionsView
Roxithromycin does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycin shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycin.
Pregnancy & lactationView
The safety of Roxithromycin in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.
Ryth
Roxithromycin
Ryth
Roxithromycin
Indications
Urethritis
Indication detailsView
Roxithromycin is indicated in the treatment of infections caused by susceptible microorganisms-
- Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia
- ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.
- Skin infections like folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo and infected dermatitis.
- Genital infections like urethritis, prostatitis, cervicitis and salpingitis especially if produced by Chlamydia trachomatis.
Therapeutic classView
Macrolides
PharmacologyView
Roxithromycin inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.
DosageView
Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.
Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed
Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed
- 6 to 11 Kg: 25 mg Roxithromycin 12 hourly.
- 12 to 23 Kg: 50 mg Roxithromycin 12 hourly.
- 24 to 40 Kg: 100 mg Roxithromycin 12 hourly.
Side effectsView
Roxithromycin is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.
ContraindicationsView
Roxithromycin should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.
PrecautionsView
Roxithromycin should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycin should not exceed 150 mg twice a day.
InteractionsView
Roxithromycin does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycin shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycin.
Pregnancy & lactationView
The safety of Roxithromycin in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.
Ryth
Roxithromycin
Ryth
Roxithromycin
Indications
Urethritis
Indication detailsView
Roxithromycin is indicated in the treatment of infections caused by susceptible microorganisms-
- Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia
- ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.
- Skin infections like folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo and infected dermatitis.
- Genital infections like urethritis, prostatitis, cervicitis and salpingitis especially if produced by Chlamydia trachomatis.
Therapeutic classView
Macrolides
PharmacologyView
Roxithromycin inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.
DosageView
Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycin is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.
Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed
Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed
- 6 to 11 Kg: 25 mg Roxithromycin 12 hourly.
- 12 to 23 Kg: 50 mg Roxithromycin 12 hourly.
- 24 to 40 Kg: 100 mg Roxithromycin 12 hourly.
Side effectsView
Roxithromycin is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.
ContraindicationsView
Roxithromycin should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.
PrecautionsView
Roxithromycin should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycin should not exceed 150 mg twice a day.
InteractionsView
Roxithromycin does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycin shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycin.
Pregnancy & lactationView
The safety of Roxithromycin in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.
Rythmosin
Propafenone Hydrochloride
Rythmosin
Propafenone Hydrochloride
Indications
Supraventricular and ventricular arrhythmias
Indication detailsView
Propafenone is indicated for the treatment of paroxysmal atrial fibrillation/flutter (PAF), paroxysmal supraventricular tachycardia (PSVT). Propafenone is also indicated for the treatment of documented ventricular arrhythmias.
Therapeutic classView
Membrane stabilizing agent (Sodium channel blockers)
PharmacologyView
Propafenone works by slowing the influx of sodium ions into the cardiac muscle cells, causing a decrease in excitability of the cells. Propafenone is more selective for cells with a high rate, but also blocks normal cells more than class Ia or Ib. Propafenone differs from the prototypical class Ic antiarrhythmic in that it has additional activity as a beta-adrenergic blocker which can cause bradycardia and bronchospasm.
DosageView
The dose of Propafenone must be individually titrated on the basis of response and tolerance. It is recommended that therapy be initiated with Propafenone 150 mg given every eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day) and if necessary, to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established.
Side effectsView
Adverse reactions associated with propafenone occur most frequently in the gastrointestinal, cardiovascular and central nervous systems. Change in taste, constipation, diarrhea, dizziness, drowsiness, dry mouth, gas, headache, light-headedness, nausea, tiredness etc. may happen. Severe allergic reactions also reported with propafenone.
ContraindicationsView
Propafenone is contraindicated in the presence of uncontrolled congestive heart failure, cardiogenic shock, sinoatrial, atrioventricular and intraventricular disorders of impulse generation and/or conduction (e.g. sick sinus node syndrome, atrioventricular block) in the absence of an artificial pacemaker, bradycardia, marked hypotension, bronchospastic disorders, manifest electrolyte imbalance and known hypersensitivity to the drug.
PrecautionsView
Hepatic Dysfunction: Propafenone is highly metabolized by the liver and should therefore, be administered cautiously to patients with impaired hepatic function. As a result, the dose of propafenone given to patients with impaired hepatic function should be approximately 20 to 30% of the dose given to patients with normal hepatic function.
Renal Dysfunction: A considerable percentage of propafenone metabolites (18.5% to 38% of the dose/48 hours) are excreted in the urine. Until further data are available, propafenone should be administered cautiously to patients with impaired renal function.
Neuromuscular Dysfunction: Exacerbation of myasthenia gravis has been reported during propafenone therapy.
Renal Dysfunction: A considerable percentage of propafenone metabolites (18.5% to 38% of the dose/48 hours) are excreted in the urine. Until further data are available, propafenone should be administered cautiously to patients with impaired renal function.
Neuromuscular Dysfunction: Exacerbation of myasthenia gravis has been reported during propafenone therapy.
InteractionsView
Propafenone is metabolized by CYP2D6 (major pathway) and CYP1A2 and CYP3A4. Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline), CYP1A2 (such as amiodarone) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin and grapefruit juice) can be expected to cause increased plasma levels of propafenone. In addition, propafenone is an inhibitor of CYP2D6. Coadministration of propafenone with drugs metabolized by CYP2D6 (such as desipramine, imipramine, haloperidol, venlafaxine) might lead to increase plasma concentrations of these drugs.
Pregnancy & lactationView
Pregnancy: Propafenone has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Limited data indicate that propafenone has been administered during the third trimester of pregnancy without adverse maternal or fetal effects. Propafenone should be given during pregnancy only when benefit outweighs risk.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from propafenone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from propafenone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and effectiveness of propafenone in pediatric patients have not been established.
Geriatric Use: Clinical studies of propafenone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Geriatric Use: Clinical studies of propafenone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
StorageView
Store at 25° C. Store in a cool and dry place, protected from light. Keep out of children’s reach.
Ryzodeg
Insulin Degludec + Insulin Aspart Premixed
Ryzodeg
Insulin Degludec + Insulin Aspart Premixed
Indications
Type 1 DM
Indication detailsView
Insulin degludec (a long-acting human insulin analog) and insulin aspart (a rapid-acting human insulin analog) indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus
Therapeutic classView
Combination Insulin
PharmacologyView
Insulin degludec and insulin aspart binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
DosageView
This is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart.
This is to be dosed in accordance with the individual patient's needs. Dose-adjustments are recommended to be primarily based on fasting plasma glucose measurements.
Patients with type 2 diabetes mellitus: The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments.
Patients with type 1 diabetes mellitus: The recommended starting dose is 60-70% of the total daily insulin requirements. This is to be used once-daily at meal-time in combination.
This is to be dosed in accordance with the individual patient's needs. Dose-adjustments are recommended to be primarily based on fasting plasma glucose measurements.
Patients with type 2 diabetes mellitus: The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments.
Patients with type 1 diabetes mellitus: The recommended starting dose is 60-70% of the total daily insulin requirements. This is to be used once-daily at meal-time in combination.
AdministrationView
This can be administered once- or twice-daily with the main meal(s). When needed, the patient can change the time of administration as long as this insulin is dosed with the largest meal when taken once daily.
In patients with type 2 diabetes mellitus this insulin can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin.
In type 1 diabetes mellitus, this insulin is combined with short-/rapid-acting insulin at the remaining meals.
In patients with type 2 diabetes mellitus this insulin can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin.
In type 1 diabetes mellitus, this insulin is combined with short-/rapid-acting insulin at the remaining meals.
Side effectsView
Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain
ContraindicationsView
Hypersensitivity to the active substances or to any of the excipients.
PrecautionsView
Hypoglycaemia: Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Concomitant illness, especially infections and fever, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.
Hyperglycaemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement.
Eye disorder: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Avoidance of accidental mix-ups: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between this and other insulin products.
Older patients (> 65 years old): Insulin Degludec & Insulin Aspart Premixed can be used in older patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.
Paediatric population: This Insulin has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties. Safety and efficacy have not been investigated in children and adolescents.
Hyperglycaemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement.
Eye disorder: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Avoidance of accidental mix-ups: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between this and other insulin products.
Older patients (> 65 years old): Insulin Degludec & Insulin Aspart Premixed can be used in older patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.
Paediatric population: This Insulin has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties. Safety and efficacy have not been investigated in children and adolescents.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effect on milk production. Insulin degludec is present in rat milk. One small published study reported that exogenous nsulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant and no available information on the effects of insulin aspart on milk production.
There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effect on milk production. Insulin degludec is present in rat milk. One small published study reported that exogenous nsulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant and no available information on the effects of insulin aspart on milk production.
Pediatric usageView
Renal and hepatic impairment: This insulin can be used in renal and hepatic impaired patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.
S-32 Gold
Multivitamin & Multimineral [A-Z gold preparation]
S-32 Gold
Multivitamin & Multimineral [A-Z gold preparation]
Indications
Vitamin deficiency
Indication detailsView
This is indicated for the prevention and treatment of vitamins & minerals deficiencies. As a complete daily nutritional supplement, it is also indicated to meet the increased demand for vitamins and minerals in the conditions like physical and emotional stress, chronic diseases, infection illness, osteoporosis, injuries or wound, surgery, poor digestion, old age, pregnancy and lactation, poor appetite, excess dieting, exposure to environmental pollution, heavy exercise etc.
Therapeutic classView
Multi-vitamin & Multi-mineral combined preparations
PharmacologyView
This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.
DosageView
One tablet daily or as recommended by the physician.
Side effectsView
Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.
ContraindicationsView
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
PrecautionsView
Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Recommended by the consultation with physician.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.