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Epomax

Erythropoietin

IV/SC Injection 3000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Epomax

Erythropoietin

IV/SC Injection 5000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Eporen

Erythropoietin

IV/SC Injection 3000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Eporen

Erythropoietin

IV/SC Injection 5000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Eposide

Etoposide

IV Infusion 100 mg/5 ml Allopathic Cytotoxic Chemotherapy

Indications

Testicular cancer

Indication detailsView

Small Cell Lung Cancer: Etoposide Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

Etoposide is also indicated in Testicular cancer, Small cell lung cancer

Therapeutic classView

Cytotoxic Chemotherapy

PharmacologyView

Etoposide is a derivative of podophyllotoxin that inhibits DNA synthesis resulting in the arrest of the cell cycle. At low doses, it inhibits cells from entering cell cycle and at high doses, cells entering mitosis are lysed.

DosageView

Intravenous (Adult)-

Small cell lung cancer: 35 mg/m²/day for 4 days to 50 mg/m²/day for 5 days. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes. When given via oral capsules: the recommended dose is twice the IV dose rounded to the nearest 50 mg.

Testicular cancer: For combination therapy: 50-100 mg/m²/day from days 1-5, or 100 mg/m² on days 1, 3 and 5. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes.

Oral (Adult)-

Small cell lung cancer: Twice the IV dose, rounded to the nearest 50 mg.

Side effectsView

Leukopenia, Nausea and Vomiting, Thrombocytopenia, Alopecia, Anorexia, Diarrhea, Leukopenia, Anemia, Pancytopenia, Stomatitis, Hepatic toxicity, Type 1 hypersensitivity, Orthostatic hypotension, Peripheral neuropathy

Malaise,Shivering,Asthenia,Fever,Mucous membrane inflammation, Hyperuricemia, Local soft tissue toxicity has been reported following extravasation;

ContraindicationsView

Hypersensitivity, pregnancy, lactation.

PrecautionsView

Skin reactions may occur with accidental exposure; renal or hepatic disease. Periodic CBCs should be done before, during and after therapy. Increased risk of etoposide-toxicity in patients with low serum albumin. Acrylic material has been shown to crack and leak when used with undiluted etoposide inj.

InteractionsView

Synergism with other cytotoxic drugs. Caution when admin with drugs that inhibit phosphatase activity. Cyclosporin A may reduce the clearance of etoposide.

Pregnancy & lactationView

Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: not known if excreted in breast milk, discontinue drug or do not nurse

Pediatric usageView

Renal impairment: CrCI: 15-50 ml/min- 75% of the recommended dose.

Eposide

Etoposide

Capsule 50 mg Allopathic Cytotoxic Chemotherapy

Indications

Testicular cancer

Indication detailsView

Small Cell Lung Cancer: Etoposide Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

Etoposide is also indicated in Testicular cancer, Small cell lung cancer

Therapeutic classView

Cytotoxic Chemotherapy

PharmacologyView

Etoposide is a derivative of podophyllotoxin that inhibits DNA synthesis resulting in the arrest of the cell cycle. At low doses, it inhibits cells from entering cell cycle and at high doses, cells entering mitosis are lysed.

DosageView

Intravenous (Adult)-

Small cell lung cancer: 35 mg/m²/day for 4 days to 50 mg/m²/day for 5 days. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes. When given via oral capsules: the recommended dose is twice the IV dose rounded to the nearest 50 mg.

Testicular cancer: For combination therapy: 50-100 mg/m²/day from days 1-5, or 100 mg/m² on days 1, 3 and 5. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes.

Oral (Adult)-

Small cell lung cancer: Twice the IV dose, rounded to the nearest 50 mg.

Side effectsView

Leukopenia, Nausea and Vomiting, Thrombocytopenia, Alopecia, Anorexia, Diarrhea, Leukopenia, Anemia, Pancytopenia, Stomatitis, Hepatic toxicity, Type 1 hypersensitivity, Orthostatic hypotension, Peripheral neuropathy

Malaise,Shivering,Asthenia,Fever,Mucous membrane inflammation, Hyperuricemia, Local soft tissue toxicity has been reported following extravasation;

ContraindicationsView

Hypersensitivity, pregnancy, lactation.

PrecautionsView

Skin reactions may occur with accidental exposure; renal or hepatic disease. Periodic CBCs should be done before, during and after therapy. Increased risk of etoposide-toxicity in patients with low serum albumin. Acrylic material has been shown to crack and leak when used with undiluted etoposide inj.

InteractionsView

Synergism with other cytotoxic drugs. Caution when admin with drugs that inhibit phosphatase activity. Cyclosporin A may reduce the clearance of etoposide.

Pregnancy & lactationView

Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: not known if excreted in breast milk, discontinue drug or do not nurse

Pediatric usageView

Renal impairment: CrCI: 15-50 ml/min- 75% of the recommended dose.

Eposin

Etoposide

IV Infusion 100 mg/5 ml Allopathic Cytotoxic Chemotherapy

Indications

Testicular cancer

Indication detailsView

Small Cell Lung Cancer: Etoposide Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

Etoposide is also indicated in Testicular cancer, Small cell lung cancer

Therapeutic classView

Cytotoxic Chemotherapy

PharmacologyView

Etoposide is a derivative of podophyllotoxin that inhibits DNA synthesis resulting in the arrest of the cell cycle. At low doses, it inhibits cells from entering cell cycle and at high doses, cells entering mitosis are lysed.

DosageView

Intravenous (Adult)-

Small cell lung cancer: 35 mg/m²/day for 4 days to 50 mg/m²/day for 5 days. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes. When given via oral capsules: the recommended dose is twice the IV dose rounded to the nearest 50 mg.

Testicular cancer: For combination therapy: 50-100 mg/m²/day from days 1-5, or 100 mg/m² on days 1, 3 and 5. May repeat course at 3-4 wkly intervals after recovery from any toxicity. Inj must be diluted with 5% dextrose or normal saline to give a final concentration of 0.2-0.4 mg/ml and injected over 30-60 minutes.

Oral (Adult)-

Small cell lung cancer: Twice the IV dose, rounded to the nearest 50 mg.

Side effectsView

Leukopenia, Nausea and Vomiting, Thrombocytopenia, Alopecia, Anorexia, Diarrhea, Leukopenia, Anemia, Pancytopenia, Stomatitis, Hepatic toxicity, Type 1 hypersensitivity, Orthostatic hypotension, Peripheral neuropathy

Malaise,Shivering,Asthenia,Fever,Mucous membrane inflammation, Hyperuricemia, Local soft tissue toxicity has been reported following extravasation;

ContraindicationsView

Hypersensitivity, pregnancy, lactation.

PrecautionsView

Skin reactions may occur with accidental exposure; renal or hepatic disease. Periodic CBCs should be done before, during and after therapy. Increased risk of etoposide-toxicity in patients with low serum albumin. Acrylic material has been shown to crack and leak when used with undiluted etoposide inj.

InteractionsView

Synergism with other cytotoxic drugs. Caution when admin with drugs that inhibit phosphatase activity. Cyclosporin A may reduce the clearance of etoposide.

Pregnancy & lactationView

Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: not known if excreted in breast milk, discontinue drug or do not nurse

Pediatric usageView

Renal impairment: CrCI: 15-50 ml/min- 75% of the recommended dose.

Eposis

Erythropoietin

IV/SC Injection 5000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Eposis

Erythropoietin

IV/SC Injection 3000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Eposis

Erythropoietin

IV/SC Injection 2000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Eposis

Erythropoietin

IV/SC Injection 4000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Eposis

Erythropoietin

IV/SC Injection 10000 IU Allopathic Drugs for Haemolytic Hypoplastic & Renal Anemia

Indications

Increase yield of autologous blood

Indication detailsView

Erythropoietin is indicated for the treatment of-

Anemia associated with Chronic Renal Failure, including patients on dialysis and patients not on dialysis.
Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
Anemic patients (hemoglobin >10 to <13 g/dL) are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
Anemia related to therapy with zidovudine in HIV-infected patients.

Therapeutic classView

Drugs for Haemolytic Hypoplastic & Renal Anemia

DosageView

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Treatment of Anemia in Cancer Patients on Chemotherapy:

Starting dose:

Adult: 150 lU/kg TIW by Subcutaneous route or 40,000 IU Subcutaneous route weekly.
Pediatric: 25 to 300 lU/kg 3 to 7 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased to 300 lU/kg TIW. If the hematocrit exceeds 40%, the dose should be withheld until the hematocrit falls to 36%.The dose should be reduced to 25% when treatment is resumed and titrated to maintain the desired hematocrit.

Surgery Patients: The recommended dose is 300 lU/kg/day subcutaneously for 10 days before surgery, on the day of surgery, and for 4 days after surgery. An alternate dose schedule is 600 lU/kg subcutaneously in once weekly dose (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.

Zidovudine-treated HIV-infected Patients:
Starting dose

Adult: 100 lU/kg as an IV or Subcutaneous injection TIW for 8 weeks.
Pediatric: 50 to 400 lU/kg 2 to 3 times per week by Subcutaneous or IV route.

Dose adjustment: If the response is not satisfactory, the dose should be increased by 50-1001U/kg TIW. Response should be evaluated every 4 to 8 weeks thereafter and the dose adjusted accordingly by 50 to 100 lU/kg increments TIW.

Maintenance dose: The dose is titrated to maintain the hematocrit between 33-36%.

AdministrationView

Do not shake. It is not necessary to shake Erythropoietin. Prolonged vigorous shaking may denature any glycoprotein, rendering it biologically inactive.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Administer as an intravenous injection over 1-2 minutes. In patients on dialysis, the injection should follow the dialysis procedure. Slow injection over 5 minutes may be beneficial to those who experience flu-like symptoms.
Do not administer by intravenous infusion or in conjunction with other drug solutions.
For the subcutaneous route, a maximum of 1 ml_ at one injection site should generally not be exceeded. In the case of larger volumes, more than one site should be chosen for the injection.

Side effectsView

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

ContraindicationsView

Erythropoietin is contraindicated in patients with:

Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
A history of hypersensitivity to Erythropoietin or any component of the preparation.

PrecautionsView

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Pregnancy & lactationView

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Overdose effectsView

Doses of up to 1500 lU/kg TIW for 3 to 4 weeks have been administered to adults without any direct toxic effects. If the suggested target range is exceeded, drug therapy may be temporarily withheld until the hemoglobin returns to the suggested target range. If polycythemia is of concern, phlebotomy may be indicated to decrease the hemoglobin.

StorageView

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Epoxim

Cefpodoxime Proxetil

Tablet 100 mg Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:

Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

DosageView

Adults and Adolescents (13 years and older)

Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
Community acquired pneumonia: 200 mg 12 hourly, 14 days
Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
Uncomplicated gonorrhea: single dose of 200 mg
Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)

Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Side effectsView

Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

ContraindicationsView

Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.

PrecautionsView

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.

InteractionsView

Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.

Pregnancy & lactationView

US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study 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. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Pediatric usageView

Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.

ReconstitutionView

Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Epoxim

Cefpodoxime Proxetil

Tablet 200 mg Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:

Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

DosageView

Adults and Adolescents (13 years and older)

Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
Community acquired pneumonia: 200 mg 12 hourly, 14 days
Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
Uncomplicated gonorrhea: single dose of 200 mg
Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)

Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Side effectsView

Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

ContraindicationsView

Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.

PrecautionsView

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.

InteractionsView

Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.

Pregnancy & lactationView

US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study 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. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Pediatric usageView

Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.

ReconstitutionView

Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Epoxim

Cefpodoxime Proxetil

Powder for Suspension 40 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:

Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

DosageView

Adults and Adolescents (13 years and older)

Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
Community acquired pneumonia: 200 mg 12 hourly, 14 days
Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
Uncomplicated gonorrhea: single dose of 200 mg
Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)

Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Side effectsView

Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

ContraindicationsView

Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.

PrecautionsView

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.

InteractionsView

Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.

Pregnancy & lactationView

US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study 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. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Pediatric usageView

Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.

ReconstitutionView

Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Epram

Escitalopram Oxalate

Tablet 5 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView

Escitalopram Oxalate is indicated in the-

Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.

Therapeutic classView

SSRIs & related anti-depressant drugs

PharmacologyView

Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.

DosageView

Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.

AdministrationView

Escitalopram should generally be administered once daily, morning or evening with or without food.

Side effectsView

SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.

ContraindicationsView

Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.

PrecautionsView

SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.

InteractionsView

As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).

Pregnancy & lactationView

When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.

Pediatric usageView

Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Overdose effectsView

Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.

StorageView

Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Epram

Escitalopram Oxalate

Tablet 10 mg Allopathic SSRIs & related anti-depressant drugs

Indications

Trichotillomania

Indication detailsView

Escitalopram Oxalate is indicated in the-

Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of social anxiety disorder (social phobia).
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.

Therapeutic classView

SSRIs & related anti-depressant drugs

PharmacologyView

Escitalopram is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake. Escitalopram has no or very low affinity for serotonergic or other receptors including alpha- and beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.

DosageView

Safety of daily doses above 20 mg has not been demonstrated. Escitalopram Oxalate is administered as a single daily dose and may be taken with or without food.

Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain an antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder: Usual dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness. Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at regular intervals.

Obsessive-Compulsive Disorder: Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom-free. Treatment benefits and dose should be re-evaluated at regular intervals.

AdministrationView

Escitalopram should generally be administered once daily, morning or evening with or without food.

Side effectsView

SSRIs are less sedating and have fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants. Side-effects of the SSRIs include gastrointestinal effects (dose-related and fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, constipation), anorexia with weight loss (increased appetite and weight gain also reported) and hypersensitivity reactions including rash, urticaria, angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other side-effects include dry mouth, nervousness, anxiety, headache, insomnia, tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions, galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania, movement disorders and dyskinesias, visual disturbances.

ContraindicationsView

Escitalopram is contraindicated in patients with known hypersensitivity to Escitalopram or Citalopram or any of the inactive ingredients of the drug product. Concomitant use of escitalopram in patients taking monoamine oxidase/pimozide is contraindicated.

PrecautionsView

SSRIs should be used with caution in patients with epilepsy (avoid if poorly controlled, discontinue if convulsions develop), concurrent electroconvulsive therapy (prolonged seizures reported with fluoxetine), history of mania, cardiac disease, diabetes mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk of bleeding, history of bleeding disorders (especially gastro-lntestinal bleeding), hepatic and renal impairment.

InteractionsView

As SSRI or related antidepressants should not be started until 2 weeks after stopping an MAOI. Conversely, an MAOI should not. be started until at least a week after an SSRI or related antidepressant has been stopped (2 weeks in the case of paroxetine and sertraline, at least 5 weeks in the case of fluoxetine).

Pregnancy & lactationView

When treating a pregnant woman with Escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. It is excreted in human breast milk. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risk of citalopram exposure for the infant and the benefits Escitalopram treatment for the mother.

Pediatric usageView

Elderly patients (>65 years of age): Initial dosage is 5 mg once daily. Depending on the individual patient response the dose may be increased to 10 mg daily. The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years): Escitalopram Oxalate should not be used in the treatment of children and adolescents under the age of 18 years.

Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function: An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Poor metabolizers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Discontinuation symptoms seen when stopping treatment. Abrupt discontinuation should be avoided.

When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Overdose effectsView

Symptoms: Symptoms seen in a reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT interval, prolongation, and arrhythmia) and electrolyte/fluid balance conditions (hypokalaemia, hyponatremia).

Management: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal should be considered. Gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT-interval, or in patients with altered metabolism, e.g. liver impairment.

StorageView

Store below 30°C temperature and protect from light & moisture. Keep the medicine out of the reach of children.

Eprazol

Esomeprazole

Tablet (Enteric Coated) 20 mg Allopathic

Indication detailsView

Esomeprazole is indicated:

To relieve from chronic heartburn symptoms and other symptoms associated with GERD
For the healing of erosive esophagitis
For maintenance of healing of erosive esophagitis
In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
Zollinger-Ellison Syndrome
Acid related Dyspepsia
Duodenal & Gastric ulcer

PharmacologyView

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.

Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (C_max) occur at approximately 1.5 hours (T_max). The C_maxincreases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.

Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.

Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.

Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.

Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.

DosageView

Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive

Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).

Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.

Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.

Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.

Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.

Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.

AdministrationView

Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.

Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.

Side effectsView

The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.

ContraindicationsView

Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.

PrecautionsView

General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.

Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.

InteractionsView

Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.

Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.

Pediatric usageView

Paediatric Use: Safety and effectiveness in paediatric patients have not been established.

Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.

Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.

Overdose effectsView

A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

ReconstitutionView

Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.

StorageView

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.

Eprazol

Esomeprazole

Tablet (Enteric Coated) 40 mg Allopathic

Indication detailsView

Esomeprazole is indicated:

To relieve from chronic heartburn symptoms and other symptoms associated with GERD
For the healing of erosive esophagitis
For maintenance of healing of erosive esophagitis
In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
Zollinger-Ellison Syndrome
Acid related Dyspepsia
Duodenal & Gastric ulcer

PharmacologyView

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.

Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (C_max) occur at approximately 1.5 hours (T_max). The C_maxincreases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.

Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.

Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.

Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.

Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.

DosageView

Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive

Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).

Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.

Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.

Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.

Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.

Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.

AdministrationView

Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.

Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.

Side effectsView

The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.

ContraindicationsView

Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.

PrecautionsView

General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.

Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.

InteractionsView

Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.

Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.

Pediatric usageView

Paediatric Use: Safety and effectiveness in paediatric patients have not been established.

Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.

Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.

Overdose effectsView

A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

ReconstitutionView

Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.

StorageView

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.

Eprel

Eperisone Hydrochloride

Tablet 50 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Rigidity

Indication detailsView

Improvement of muscular hypertonic symptoms in the following diseases Cervical syndrome, periarthritis of the shoulder, lumbago. Spastic paralysis in the following disease: Cerebrovascular disease,spastic spinal paralysis, cervical spondylosis, postoperative sequelae (including cerebrospinal tumor), sequelae to trauma (spinal trauma, head injury), amyotrophic lateral sclerosis, cerebral palsy, spinocerebellar degeneration, spinal vascular diseases and other encephalomyelopathies.

Therapeutic classView

Centrally acting Skeletal Muscle Relaxants

PharmacologyView

Eperisone is centrally-acting skeletal muscle relaxant used to improve myotonic symptoms.

DosageView

For adults: Usually 3 tablets per day in three divided doses after each meal. The dosage should be adjusted depending on the patient age and severity of symptoms.

Side effectsView

The side effects of Eperisone are very rare, only a few cases have been observed. These are excessive relaxation, stomachache, nausea, vertigo, anorexia, drowsiness, skin rashes, diarrhea, vomiting, indigestion, GI disturbances, insomnia, headache, constipation, etc.

ContraindicationsView

Eperisone is contraindicated in patients with a history of hypersensitivity to Eperisone Hydrochloride.

InteractionsView

Avoid concomitant use with tolperisone HCl and methocarbamol.

Pregnancy & lactationView

Eperisone should only be used in pregnant women if the expected therapeutic benefits are evaluated to outweight the possible risks of treatment. The safety of Eperisone has not been established in pregnant women. The drug should not be used during lactation.

StorageView

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