Medicines
Find Medicines
Search 21,000+ medicines by brand, generic, indication, or drug class
Eprex
Erythropoietin Alfa
Eprex
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Eprex
Erythropoietin Alfa
Eprex
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Eprex
Erythropoietin Alfa
Eprex
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Eprex
Erythropoietin Alfa
Eprex
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Eprim
Evening primrose oil
Eprim
Evening primrose oil
Indications
Premenstrual syndrome
Indication detailsView
Evening primrose oil is indicated in:
- Premenstrual syndrome symptoms (PMS)
- Benign breast disease & cyclical mastalgia
- Lactation
- Atopic, allergic & neurodermatitis
- Psoriasis
- Hypertension
- Rheumatoid arthritis
- Thrombosis
- Atopic eczema
- Dietary aid
- Promotes healthy skin, nourishes brittle nails & hair.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Improves EFA composition of plasma, erythrocytes, platelet lipids and atocopherol levels in non-diabetic persons and Type 1 diabetic patients; increase total fat and EFA contents of mother's milk; affects fatty acid composition of serum lipids and adipose tissue in men with low dihoma-gamma-linolenic acid (DGLA) levels; helps maintain normal cellular structures and in the precursor of DGLA, which is the parent of the 1-series prostanoids and as a precursor of arachidonic acid, the parent of the 2-series prostanoids.
Evening Primrose Oil supplies gamma-linolenic acid (GLA). The bioactivity of EPO is due primarily to its GLA contents. By supplying GLA, it bypasses the rate-limiting step in the metabolism of LA. After ingestion of EPO, GLA is rapidly absorbed and then converts directly to DGLA and other prostaglandin precurosors. It also acts on the prostanoids pathway.
Evening Primrose Oil supplies gamma-linolenic acid (GLA). The bioactivity of EPO is due primarily to its GLA contents. By supplying GLA, it bypasses the rate-limiting step in the metabolism of LA. After ingestion of EPO, GLA is rapidly absorbed and then converts directly to DGLA and other prostaglandin precurosors. It also acts on the prostanoids pathway.
DosageView
Atopic & Allergic Dermatitis:
Premenstrual Syndrome (PMS): 1 Capsule 2 times daily at morning & night with or after meal.
Rheumatoid arthritis: 1 Capsule daily Or as directed by the registered physician.
- Adult dosage: 1 capsule 2 times daily.
- Children dosage: 1 capsule 1/2 times daily.
Premenstrual Syndrome (PMS): 1 Capsule 2 times daily at morning & night with or after meal.
Rheumatoid arthritis: 1 Capsule daily Or as directed by the registered physician.
Side effectsView
Side effects are rare at recommended dosages. Overdose may cause loose stool and abdominal pain.
ContraindicationsView
Previously it was not recommended for patients diagnosed with schizophrenia. However, a recently published analysis of clinical trials involving polyunsaturated fatty acids in the treatment of schizophrenia did not indicate a clear therapeutic or adverse effect of evening primrose oil supplements on schizophrenic patients.
Pregnancy & lactationView
Linolenic acid, GLA and DGLA are important components of human breast milk, so it is responsible to assure that evening primrose oil may be taken while nursing. According to World Health Organization (WHO), pregnant or lactating women should get 5% of their total daily caloric intake from EFAs.
StorageView
Keep out of reach of children. Keep away from direct sunlight. Store below 25°C in a dry place.
Eprim Plus
Evening primrose oil
Eprim Plus
Evening primrose oil
Indications
Premenstrual syndrome
Indication detailsView
Evening primrose oil is indicated in:
- Premenstrual syndrome symptoms (PMS)
- Benign breast disease & cyclical mastalgia
- Lactation
- Atopic, allergic & neurodermatitis
- Psoriasis
- Hypertension
- Rheumatoid arthritis
- Thrombosis
- Atopic eczema
- Dietary aid
- Promotes healthy skin, nourishes brittle nails & hair.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Improves EFA composition of plasma, erythrocytes, platelet lipids and atocopherol levels in non-diabetic persons and Type 1 diabetic patients; increase total fat and EFA contents of mother's milk; affects fatty acid composition of serum lipids and adipose tissue in men with low dihoma-gamma-linolenic acid (DGLA) levels; helps maintain normal cellular structures and in the precursor of DGLA, which is the parent of the 1-series prostanoids and as a precursor of arachidonic acid, the parent of the 2-series prostanoids.
Evening Primrose Oil supplies gamma-linolenic acid (GLA). The bioactivity of EPO is due primarily to its GLA contents. By supplying GLA, it bypasses the rate-limiting step in the metabolism of LA. After ingestion of EPO, GLA is rapidly absorbed and then converts directly to DGLA and other prostaglandin precurosors. It also acts on the prostanoids pathway.
Evening Primrose Oil supplies gamma-linolenic acid (GLA). The bioactivity of EPO is due primarily to its GLA contents. By supplying GLA, it bypasses the rate-limiting step in the metabolism of LA. After ingestion of EPO, GLA is rapidly absorbed and then converts directly to DGLA and other prostaglandin precurosors. It also acts on the prostanoids pathway.
DosageView
Atopic & Allergic Dermatitis:
Premenstrual Syndrome (PMS): 1 Capsule 2 times daily at morning & night with or after meal.
Rheumatoid arthritis: 1 Capsule daily Or as directed by the registered physician.
- Adult dosage: 1 capsule 2 times daily.
- Children dosage: 1 capsule 1/2 times daily.
Premenstrual Syndrome (PMS): 1 Capsule 2 times daily at morning & night with or after meal.
Rheumatoid arthritis: 1 Capsule daily Or as directed by the registered physician.
Side effectsView
Side effects are rare at recommended dosages. Overdose may cause loose stool and abdominal pain.
ContraindicationsView
Previously it was not recommended for patients diagnosed with schizophrenia. However, a recently published analysis of clinical trials involving polyunsaturated fatty acids in the treatment of schizophrenia did not indicate a clear therapeutic or adverse effect of evening primrose oil supplements on schizophrenic patients.
Pregnancy & lactationView
Linolenic acid, GLA and DGLA are important components of human breast milk, so it is responsible to assure that evening primrose oil may be taken while nursing. According to World Health Organization (WHO), pregnant or lactating women should get 5% of their total daily caloric intake from EFAs.
StorageView
Keep out of reach of children. Keep away from direct sunlight. Store below 25°C in a dry place.
Eprox
Naproxen Sodium
Eprox
Naproxen Sodium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
DosageView
Naproxen Tablet-
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
- Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
- Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
- For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
- Is to be applied 2-6 times a day as required and is not recommended for use in children.
Side effectsView
Most frequently reported side effects include following:
- Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
- Central Nervous System: Headache, vertigo, drowsiness.
- Dermatological: Pruritus (itching), purpura.
- Cardiovascular: Edema, palpitation.
- Others: Visual disturbances, hearing disturbances.
ContraindicationsView
Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
InteractionsView
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Pregnancy & lactationView
US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Epson
Clobazam
Epson
Clobazam
Indications
Tension
Indication detailsView
Acute and chronic anxiety states which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and emotional instability.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
Therapeutic classView
Benzodiazepine hypnotics
PharmacologyView
Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.
DosageView
General Dosage: Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
Treatment of anxiety states-
Adults and adolescents over 15 years of age: The initial dose is usually 20 mg clobazam daily. If necessary, the daily dose may be increased. Generally, it is recommended that a total daily dose of 30 mg is not exceeded.Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Treatment of epilepsy in combination with one or more other anticonvulsants-
Adults and adolescents over 15 years of age: It is recommended that administration be started at small doses (5 to 15 mg daily), if necessary, increasing the dose gradually to a maximum daily dose of about 80 mg.Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
AdministrationView
The tablets can be administered whole, or crushed and mixed in applesauce. The 10 mg tablets can be divided into equal halves of 5 mg. Clobazam can be given with or without food.
Side effectsView
Metabolism and nutrition disorders: Common: decreased appetite
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
ContraindicationsView
Clobazam must not be used-
- In patients with hypersensitivity to clobazam or any of the excipients of Clobazam.
- In patients with myasthenia gravis (risk of aggravation of muscle weakness).
- In patients with severe respiratory insufciency (risk of deterioration).
- In patients with sleep apnoea syndrome (risk of deterioration).
- In patients with severe impairment of liver function (risk of precipitating encephalopathy).
- In breast-feeding women Benzodiazepines must not be given to children without careful assessment of the need for their use.
- Clobazam must not be used in children between the ages of 6 months and 3 years, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication.
PrecautionsView
Serious Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions. SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
InteractionsView
Alcohol: Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% and therefore lead to increased clobazam effects.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Pregnancy & lactationView
Pregnancy: Clobazam is not recommended during the first trimester of pregnancy and in women of childbearing potential not using contraception. Clobazam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have demonstrated reproductive toxicity. Clobazam crosses the placenta. In the post-marketing safety database, limited data on exposed pregnancies are available with clobazam. A large amount of data collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines during the first trimester of pregnancy. However, in certain epidemiological case-control studies, an increased incidence of cleft lip and palate was observed with benzodiazepines. Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines during the second and/or third trimester of pregnancy. Administration of clobazam during the late phase of pregnancy or during childbirth can result in the occurrence of neonatal respiratory depression (including respiratory distress and apnea), which may be associated with other disorders such as sedation signs, hypothermia, hypotonia, and feeding difficulties (which may result in poor weight gain) in the newborn (signs and symptoms of the so-called "floppy infant syndrome"). Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. Women of childbearing potential should be informed of the risks and benefits of the use of Clobazam during pregnancy. If a woman plans a pregnancy or becomes pregnant, carefully evaluate the risks and benefits and whether treatment with Clobazam should be discontinued. If Clobazam treatment is to be continued, use Clobazam at the lowest effective dose.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
StorageView
Do not use the medicine later than the date of expiry. Store below 30° and protect from light. Keep out of the reach of children.
Eptase
Streptokinase
Eptase
Streptokinase
Indications
Pulmonary thromboembolism
Indication detailsView
Streptokinase is indicated for use in the management of acute myocardial infarction, for the lysis of intracoronary thrombi, for the improvement of ventricular function, and reduction of mortality when administered by either the intravenous or intracoronary route. Earlier administration of streptokinase is correlated with greater clinical benefit, the greatest benefit (in terms of mortality reduction) being seen when Streptase is administered within the first 4 hours after onset of symptoms. The treatment should always commence within 6 hours of the onset of pain.
Therapeutic classView
Fibrinolytics (Thrombolytics)
PharmacologyView
Streptokinase forms a complex with plasminogen which then converts plasminogen to plasmin. Plasmin breaks down clots as well as fibrinogen and other plasma proteins.
DosageView
Streptokinase can be reconstituted using 5 ml sodium chloride injection or 5% Dextrose Injection directing the diluent at the side of the vacuum packed vial rather than into drug powder
Acute Myocardial Infarction:
IV infusion:- Vial size (IU): 15,00,000
- Total solution volume: 45 ml
- Infusion rate: Infuse 45 ml within 60 mins
- Vial size (IU): 2,50,000
- Total solution volume: 125 ml
- 20,000 IU bolus, Infusion rate: Loading dose of 10 ml
- 2,000 IU/min. for 60 minutes, Infusion rate: 60 ml/hour
Pulmonary Embolism, Deep Vein Thrombosis, Arterial Thrombosis or Embolism:
- 2,50,000 IU loading dose over 30 min, Vial size (IU): 15,00,000, Total solution volume 90 ml, Infusion rate: Infuse 30 ml/hour for 30 min
- 1,00,000 IU/hour for maintenance dose, Infusion rate: Infuse 6 ml/hour
Side effectsView
The following adverse reactions are based on experience from clinical trials and on post marketing experience of Streptokinase.
General disorders:
General disorders:
- Common: Headache and back pain, muscle pain (including myalgia), chills and/or fever as well as asthenia/malaise.
- Common: Haemorrhages at invaded or disturbed sites, including the injection site, and ecchymoses. Gastrointestinal or genitourinary bleedings (including aggravation of menstrual bleeding), epistaxis.
- Uncommon: Intracranial haemorrhages with their complications and possible fatal outcome, retinal haemorrhages, severe haemorrhages (also with fatal outcome) including liver haemorrhages, retroperitoneal bleedings, splenic rupture. Blood transfusions are rarely required.
- Very common: Development of antistreptokinase antibodies
- Common: Allergic-anaphylactic reactions such as rash, flushing, itching, urticaria, angioneurotic oedema, minor breathing difficulty, periorbital swelling, bronchospasm or hypotension.
- Rare: Neurologic symptoms (e.g., dizziness, confusion, paralysis, hemiparesis, agitation or convulsion) in the context of cerebral haemorrhages or cardiovascular disorders with hypoperfusion of the brain.
- Very common: Hypotension, heart rate and rhythm disorders, angina pectoris.
- Common: Recurrent ischaemia, heart failure, reinfarction, cardiogenic shock, pericarditis, pulmonary oedema.
- Uncommon: Cardiac arrest (leading to respiratory arrest), mitral insufficiency, pericardial effusion, cardiac tamponade, myocardial rupture, pulmonary or distal embolism.
- Very rare: Non-cardiogenic pulmonary oedema after intracoronary thrombolytic therapy in patients with extensive myocardial infarction.
- Common: Nausea, diarrhoea, epigastric pain and vomiting.
ContraindicationsView
As thrombolytic therapy increases the risk of bleeding, Streptokinase, administered either systemically or locally, is contraindicated in the following situations:
Existing or recent haemorrhage and haemorrhagic diathesis (with the exception of consumption coagulopathy) Potential for internal bleeding (e.g., peptic ulcer, ulcerative colitis, diverticulitis or visceral tumours) All forms of reduced blood coagulability, in particular spontaneous fibrinolysis and extensive clotting disorders.
Recent (within 2 months) cerebrovascular accident, recent (within 10 days) facial or head trauma, intracranial or intraspinal surgery, known intracranial neoplasm and all known neoplasms with risk of haemorrhage
Invasive operations, e.g., recent organ biopsy, invasive diagnostic procedure, recent implantation of a vessel prosthesis, long-term traumatic closed-chest massage or other recent surgery (until the 6th to 10th post operative day, depending on the severity of surgical intervention)
Arteriovenous malformation or aneurysm: Haemorrhagic diathesis including thrombocytopenia or pronounced hepatic or renal dysfunction
Severe uncontrolled hypertension (systolic BP > 200 mm Hg, diastolic BP > 100 mm Hg), or hypertensive retinal changes grades III/IV), hypertonic fundus
Severe liver or kidney damage: Simultaneous treatment with oral anticoagulants (International Normalized Ratio (INR) >1.3)
Endocarditis or pericarditis (Immediately after streptococcal infections which have produced a high antiStreptokinase titre (acute rheumatic fever, acute glomerulo-nephritis, etc.). More than 5 days and less than 12 months since previous Streptokinase therapy.
Existing or recent haemorrhage and haemorrhagic diathesis (with the exception of consumption coagulopathy) Potential for internal bleeding (e.g., peptic ulcer, ulcerative colitis, diverticulitis or visceral tumours) All forms of reduced blood coagulability, in particular spontaneous fibrinolysis and extensive clotting disorders.
Recent (within 2 months) cerebrovascular accident, recent (within 10 days) facial or head trauma, intracranial or intraspinal surgery, known intracranial neoplasm and all known neoplasms with risk of haemorrhage
Invasive operations, e.g., recent organ biopsy, invasive diagnostic procedure, recent implantation of a vessel prosthesis, long-term traumatic closed-chest massage or other recent surgery (until the 6th to 10th post operative day, depending on the severity of surgical intervention)
Arteriovenous malformation or aneurysm: Haemorrhagic diathesis including thrombocytopenia or pronounced hepatic or renal dysfunction
Severe uncontrolled hypertension (systolic BP > 200 mm Hg, diastolic BP > 100 mm Hg), or hypertensive retinal changes grades III/IV), hypertonic fundus
Severe liver or kidney damage: Simultaneous treatment with oral anticoagulants (International Normalized Ratio (INR) >1.3)
Endocarditis or pericarditis (Immediately after streptococcal infections which have produced a high antiStreptokinase titre (acute rheumatic fever, acute glomerulo-nephritis, etc.). More than 5 days and less than 12 months since previous Streptokinase therapy.
PrecautionsView
Because of the increased likelihood of resistance, due to antistreptokinase antibodies, retreatment with Streptokinase or Streptokinase-containing products may not be effective if administered between five days and twelve months of prior Streptokinase administration or Streptococcal infections, such as Streptococcal pharyngitis, acute rheumatic fever or acute glomerulonephritis secondary to a Streptococcal infection.
In principle, no thrombolytic treatment should be commenced before the 10th postoperative day. However, in cases of pulmonary embolism, the indication for earlier treatment may be very strong and after careful consideration of all the risks, Streptokinase may be given before the tenth postoperative day. The danger of bleeding from the operative area must, of course, be taken into account.
The danger of haemorrhage is increased by simultaneous or previous treatment with anticoagulants (e.g., Heparin) or substances which inhibit platelet formation or function. If the patient is under active heparinisation, it should be neutralised by the administration of protamine sulphate before the start of thrombolytic therapy.
Repeated Administration: After administration of Streptokinase, the titre of antistreptokinase antibodies begins to rise after approximately one week, reaching a peak at 2 to 3 weeks and remains elevated for 8 to 12 months. Because of the increased likelihood of resistance, Streptokinase may not be effective if given during this period.
In principle, no thrombolytic treatment should be commenced before the 10th postoperative day. However, in cases of pulmonary embolism, the indication for earlier treatment may be very strong and after careful consideration of all the risks, Streptokinase may be given before the tenth postoperative day. The danger of bleeding from the operative area must, of course, be taken into account.
The danger of haemorrhage is increased by simultaneous or previous treatment with anticoagulants (e.g., Heparin) or substances which inhibit platelet formation or function. If the patient is under active heparinisation, it should be neutralised by the administration of protamine sulphate before the start of thrombolytic therapy.
Repeated Administration: After administration of Streptokinase, the titre of antistreptokinase antibodies begins to rise after approximately one week, reaching a peak at 2 to 3 weeks and remains elevated for 8 to 12 months. Because of the increased likelihood of resistance, Streptokinase may not be effective if given during this period.
InteractionsView
There is an increased risk of haemorrhage in patients simultaneously or previously receiving anticoagulants (such as Heparin or Coumarin derivatives) or drugs which inhibit platelet formation or function (e.g., Platelet aggregation inhibitors, Dextrans, Phenylbutazone, Dipyridamole, Non-steroidal anti-inflammatory drugs). The effect of Heparin can be neutralized rapidly by administration of Protamine Sulphate. The Thrombin time (TT) should not be more than twice the normal control value before thrombolytic therapy is started. In the case of prior treatment with coumarin derivatives, the International Normalized Ratio (INR) must be less than 1.3 before starting Streptokinase infusion.
Combination of Streptokinase with Aspirin for treatment of Myocardial infarction: Study showed a significant benefit to patients treated with these two agents after acute myocardial infarction. Mortality (both short and longer term) was reduced in these patients to a greater extent than in those treated with either agent alone.
Unless contraindicated, the concomitant use of Acetylsalicylic acid (ASA, Aspirin), starting prior to Streptokinase infusion and continued for one month thereafter may be instituted at the discretion of the physician. The benefit of combination therapy should therefore be weighed against the risk of increased haemorrhage.
Anticoagulation treatment following Streptokinase: Following high dose (1.5 million IU), short term treatment with Streptokinase, for acute myocardial infarction, the use of subsequent anticoagulant treatment has not yet been shown to be of unequivocal benefit. Therefore, in this situation, the use of anticoagulants should be decided by the physician.
Combination of Streptokinase with Aspirin for treatment of Myocardial infarction: Study showed a significant benefit to patients treated with these two agents after acute myocardial infarction. Mortality (both short and longer term) was reduced in these patients to a greater extent than in those treated with either agent alone.
Unless contraindicated, the concomitant use of Acetylsalicylic acid (ASA, Aspirin), starting prior to Streptokinase infusion and continued for one month thereafter may be instituted at the discretion of the physician. The benefit of combination therapy should therefore be weighed against the risk of increased haemorrhage.
Anticoagulation treatment following Streptokinase: Following high dose (1.5 million IU), short term treatment with Streptokinase, for acute myocardial infarction, the use of subsequent anticoagulant treatment has not yet been shown to be of unequivocal benefit. Therefore, in this situation, the use of anticoagulants should be decided by the physician.
Pregnancy & lactationView
Pregnancy category C. It is not known whether Streptokinase is excreted in the breast milk, nor whether it has harmful effects on the newborn. In the absence of further information, it is recommended that breast-feeding be discontinued in women who are to receive Streptokinase.
Pediatric usageView
Pediatric use: Safety & effectiveness in children have not been established.
Overdose effectsView
If uncontrollable bleeding occurs as a result of overdosage, Streptokinase infusion should be ceased immediately. Bleeding can be reversed and blood loss managed effectively with appropriate replacement therapy. Administration of aminocaproic acid or aprotinin may be useful.
ReconstitutionView
The protein nature and lyophilized form of Streptokinase, require careful reconstitution and dilution. The following reconstitution and dilution procedures are recommended for vials & infusion bottles:
- Slowly add 5 mL Sodium Chloride Injection or 5% Dextrose Injection to the Streptokinase vial directing the diluent at the side of the vacuum-packed vial rather than into the drug powder.
- Roll and tilt the vial gently to reconstitute. Avoid shaking. (Shaking may cause foaming.) (If necessary, total volume may be increased to a maximum of 50 mL in plastic containers and the infusion pump rate should be adjusted. To facilitate setting the infusion pump rate, a total volume of 45 mL, or a multiple thereof, is recommended.
- Withdraw the entire reconstituted contents of the vial; slowly and carefully dilute further to a total volume as recommended. Avoid shaking and agitation on dilution.
- When diluting the 1 500 000 IU infusion bottle (50 mL), slowly add 5 mL Sodium Chloride Injection or 5% Dextrose Injection, directing it at the side of the bottle rather than into the drug powder. Roll and tilt the bottle gently to reconstitute. Avoid shaking as it may cause foaming. Add an additional 40 mL of diluent to the bottle, avoiding shaking and agitation. (Total volume = 45 mL). Now administer by infusion pump.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (Human albumin may impart a slightly yellow color to the solution)
- As Streptokinase contains no preservatives, it should be reconstituted immediately before use. The solution may be used for direct intravenous administration within eight hours following reconstitution if stored at 2-8° C
- Do not add other medication to the container of Streptokinase.
- Unused reconstituted drug should be discarded.
StorageView
Streptokinase vial should be stored at 2 to 25° C. Once reconstituted with physiological saline, the physico-chemical stability has been demonstrated for 24 hours at 2 to 8° C. From a microbiological point of view and as Streptokinase 1500000 contains no preservative, the reconstituted product should be used immediately. If it is not administered immediately, storage shall not exceed 24 hours at 2 to 8° C. Keep out of the reach of children.
Equra
Urea (10%)
Equra
Urea (10%)
Indications
Psoriasis
Indication detailsView
Urea 10% cream is indicated for-
- Ichthyosis and dry skin conditions
- Management of eczemas
- Management of psoriasis
Therapeutic classView
Topical urea preparations
PharmacologyView
Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose dependent. Most of its therapeutic applications depend on its hygroscopic properties. The hygroscopic property is due to its ability to cause configurational change in proteins in the stratum corneum. A 10% urea cream has been shown to increase the water holding capacity of ichthyotic scale by 100% after 3 weeks of treatment. There is no information available about percutaneous absorption of urea. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.
DosageView
Urea 10% cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream.
Use in children: Urea 10% cream can be used in all age groups.
Use in children: Urea 10% cream can be used in all age groups.
Side effectsView
No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.
ContraindicationsView
This is contraindicated in any other ingredient of this preaparation.
PrecautionsView
In some instances, urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted. Avoid application to moist or broken skin.
InteractionsView
No hazardous drug interaction has been reported.
Pregnancy & lactationView
Urea cream can be used during pregnancy and lactation.
StorageView
Keep out of the reach of children. Do not freeze. Keep at cool and dry place.
Eracef
Ceftriaxone Sodium
Eracef
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Eracef
Ceftriaxone Sodium
Eracef
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Eracef
Ceftriaxone Sodium
Eracef
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Eracef
Ceftriaxone Sodium
Eracef
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Eracef
Ceftriaxone Sodium
Eracef
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Eracef
Ceftriaxone Sodium
Eracef
Ceftriaxone Sodium
Indications
Urinary tract infection
Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
- Lower respiratory tract infections
- Acute Bacterial Otitis Media
- Skin and skin structure infections
- Urinary tract infections
- Gonorrhea
- Bacterial Septicemia
- Bone and joint infections
- Meningitis
- Prevention of postoperative infections
- Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
- Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
- Uncomplicated gonococcal infections: 250 mg IM as a single dose
- Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
- Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
- Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
- Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
- For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
- For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.
Eradex
Loratadine
Eradex
Loratadine
Indications
Urticaria
Indication detailsView
Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.
DosageView
Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.
Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.
Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.
Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Side effectsView
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
ContraindicationsView
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
PrecautionsView
Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
InteractionsView
There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
Pregnancy & lactationView
There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
Overdose effectsView
In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Eradra
Lifitegrast
Eradra
Lifitegrast
Indications
Dry eye
Indication detailsView
Lifitegrast 5% ophthalmic solution is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Therapeutic classView
Other ophthalmic preparations
PharmacologyView
Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit Tcell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known.
DosageView
Instill one drop of Lifitegrast twice daily (approximately 12 hours apart) into each eye. Contact lenses should be removed prior to the administration of Lifitegrast and may be reinserted 15 minutes following administration.
Side effectsView
The common adverse effects are instillation site irritation, dysgeusia and reduced visual acuity. Less common are blurred vision, conjunctival hyperemia, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis.
ContraindicationsView
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
PrecautionsView
Do not touch the dropper tip to surfaces since this may contaminate the solution. After one month of the opening do not use the medicine of dropper.
Pregnancy & lactationView
There are no available data on Lifitegrast use in pregnant women to inform any drug associated risks. There are no data on the presence of Lifitegrast in human milk, the effects on the breastfed infant or the effects on milk production.
Pediatric usageView
Pediatric Use: Safety and efficacy in pediatric patients below the age of 17 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
Overdose effectsView
There is no information regarding overdose in patients taking Lifitegrast. For management of a suspected drug overdose, contact your ophthalmologist.
StorageView
Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.
Erafix
Cefixime Trihydrate
Erafix
Cefixime Trihydrate
Indications
Urethritis
Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
- Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
- Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
- Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
- Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
- ½-1 year: 75 mg daily.
- 1-4 years: 100 mg daily.
- 5-10 years: 200 mg daily.
- 11-12 years: 300 mg daily
- In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.
Erafix
Cefixime Trihydrate
Erafix
Cefixime Trihydrate
Indications
Urethritis
Indication detailsView
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
- Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
- Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
- Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
- Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
- Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
DosageView
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following
- ½-1 year: 75 mg daily.
- 1-4 years: 100 mg daily.
- 5-10 years: 200 mg daily.
- 11-12 years: 300 mg daily
- In typhoid fever, dosage should be 10 mg/kg/day for 14 days.
Side effectsView
The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.
ContraindicationsView
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
PrecautionsView
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
InteractionsView
Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.
Pregnancy & lactationView
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Overdose effectsView
Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.
StorageView
Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.