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Ingovax ACWY
Meningococcal Polysaccharide Vaccine
Ingovax ACWY
Meningococcal Polysaccharide Vaccine
Indications
Septic arthritis
Indication detailsView
Meningococcal Polysaccharide Vaccine is indicated for the active immunization of children from 2 years of age, adolescents and adults against meningococcal disease caused by meningococci of serogroups A, C, W135 and Y. The vaccine may also be used for:
- Subjects who are living in closed communities and close contacts of patients with disease caused by meningococci of serogroups A, C, W135 and Y.
- Travellers to countries where the disease is epidemic or highly endemic
Therapeutic classView
Vaccines, Anti-sera & Immunoglobulin
PharmacologyView
Meningococcal Polysaccharide Vaccine is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis Group A, Group C, Group Y and Group W135. When reconstituted, the vaccine is a clear, colorless sterile solution for subcutaneous use.
DosageView
The immunizing dose is a single injection of 0.5 ml administered subcutaneously. Primary Immunization For both adults and children from 2 years of age, vaccine is administered subcutaneously as a single 0.5 ml dose. Protective antibody levels may be achieved within 7 to 10 days after vaccination.
Side effectsView
Meningococcal polysaccharide vaccine is generally well tolerated. Adverse reactions usually occur within 48 hours following vaccination.
Metabolism and nutrition disorders-
Metabolism and nutrition disorders-
- Common: appetite lost Psychiatric disorders:
- Very common: irritability
- Very common: drowsiness, headache.
- Uncommon: dizziness
- Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhea
- Common: myalgia
- Very common: pain and redness at the injection site, fatigue
- Common: swelling at the injection site, fever
ContraindicationsView
Hypersensitivity to the active substances or to any of the excipients.
PrecautionsView
As with other vaccines, the administration of Meningococcal polysaccharide vaccine should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for immunization. This vaccine gives no protection against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y. If administered to subjects with impaired immune responses, the vaccine may not induce an effective response.As with all injectable vaccines, appropriate medication (e.g. adrenaline) should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Pregnancy & lactationView
Pregnancy: Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. This vaccine should be used during pregnancy only when clearly needed and when the possible advantages outweigh the possible risks for the fetus.
Lactation: Adequate data on the administration of this vaccine to women who are breast-feeding are not available. This vaccine should be administered to women who are breast-feeding when needed and the possible advantages outweigh the possible risks.
Lactation: Adequate data on the administration of this vaccine to women who are breast-feeding are not available. This vaccine should be administered to women who are breast-feeding when needed and the possible advantages outweigh the possible risks.
StorageView
Keep out of the reach and sight of children .Store and transport at 2°C to 8°C. Do not freeze Protect from light .The vaccine should be used within 30 minutes after reconstitution
Inhibita
Omeprazole
Inhibita
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inhibita
Omeprazole
Inhibita
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Initer
Erythropoietin Alfa
Initer
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Initer
Erythropoietin Alfa
Initer
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Initer
Erythropoietin Alfa
Initer
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Initer
Erythropoietin Alfa
Initer
Erythropoietin Alfa
Indications
To reduce the need for allogenic blood tranfusion
Indication detailsView
Erythropoietin alfa is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 gm and gestational age of less than 34 weeks.
Therapeutic classView
Drugs for Haemolytic Hypoplastic & Renal Anemia
DosageView
Evaluation of Iron Stores and Nutritional Factors: Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Erythropoietin alfa.
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
Dose Adjustment-
For all patients with CKD: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to reduce rapid responses.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the Erythropoietin alfa dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Erythropoietin alfa if responsiveness does not improve.
- Initiate Erythropoietin alfa treatment when the hemoglobin level is less than 10 g/dL.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Erythropoietin alfa.
- The recommended starting dose for adult patients is 50 to 100 units/kg3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.
- The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
- Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
- If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Erythropoietin alfa, and use the lowest dose of Erythropoietin alfa sufficient to reduce the need for RBC transfusions.
- The recommended starting dose for adult patients is 50 to 100 units/kg 3 times weekly intravenously or subcutaneously.
Dose Adjustment-
- If hemoglobin does not increase after 8 weeks of therapy, increase Erythropoietin alfa dose by approximately 50 to 100 units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 units/kg.
- Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
- Discontinue Erythropoietin alfa if an increase in hemoglobin is not achieved at a dose of 300 units/kg for 8 weeks.
- Adults: 150 units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 units subcutaneously weekly until completion of a chemotherapy course.
- Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until completion of a chemotherapy course.
- Prevention of anemia of prematurity: Erythropoietin alfa is administered subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa treatment are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
AdministrationView
Preparation and Administration-
- Do not shake. Do not use Erythropoietin alfa that has been shaken or frozen.
- Protect syringe from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any syringe exhibiting particulate matter or discoloration.
- Discard unused portions of Erythropoietin alfa.
Side effectsView
Adverse reactions in 5% of Erythropoietin alfa treated patients in clinical studies were:
- Patients with CKD: Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
- Zidovudine-treated HIV-infected Patients: Pyrexia, cough, rash, and injection site irritation.
- Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia, and thrombosis.
- Surgery Patients: Nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
- Premature infants: A fall in serum ferritin values is very common (>10%)
ContraindicationsView
- Uncontrolled hypertension.
- Serious allergic reactions to Erythropoietin alfa.
- Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.
InteractionsView
There are no known clinically significant drug interactions but the effect of Erythropoietin alfa may be potentiated by the simultaneous therapeutic administration of a haematinic agent such as ferrous sulphate when a deficiency state exists.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Studies in animals have shown reproduction toxicology. Consequently:
- In chronic renal failure patients, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
- In pregnant or lactating surgical patients participating in an autologous blood predonation programme, the use of Erythropoietin alfa is not recommended.
Overdose effectsView
The therapeutic margin of Erythropoietin alfa is very wide. Erythropoietin alfa overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Erythropoietin alfa dosage and/or with phlebotomy, as clinically indicated. Cases of severe hypertension have been observed following overdose with ESAs.
StorageView
Store at 2ºC to 8ºC. Do not freeze or shake. This temperature range should be closely maintained until administration to the patient. Store in original package in order to protect from light.
Inj. K MM
Phytomenadione (Injection)
Inj. K MM
Phytomenadione (Injection)
Indications
Vitamin K deficiency
Indication detailsView
Phytomenadione (Vitamin K-1) is indicated in following indications-
- Prophylaxis and treatment of haemorrhagic disease in the newborn.
- Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates).
- Prevention and treatment of bleeding due to vitamin K deficiency.
Therapeutic classView
Vitamin-K Preparations
PharmacologyView
Phytomenadione is a procoagulant factor. As a component of a hepatic carboxylase system, Phytomenadione is involved in the post translational carboxylation of clotting factors II (prothrombin), VII, IX and X and the clotting inhibitors protein C and protein S. Phytomenadione is ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia induced by severe hepatic failure. Lack of Phytomenadione leads to an increased tendency to haemorrhagic disease in the newborn. Phytomenadione administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to Phytomenadione deficiency.
DosageView
Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4th-5th day and another 2 mg on 28th-30th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route.
Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.
Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics-
Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.
Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics-
- 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
- Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
- The size and frequency of further doses should be based on coagulation status
Side effectsView
There are isolated unconfirmed reports on the possible occurrence of anaphylactoid reactions and venous irritation or phlebitis after parenteral use of Phytomenadione injections.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to any of its constituents.
PrecautionsView
Careful monitoring of the coagulation parameters is necessary for patients with severely impaired liver function after administration of Phytomenadione .
InteractionsView
Phytomenadione antagonises the effect of coumarin-type anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K-1.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Inj. K MM
Phytomenadione (Injection)
Inj. K MM
Phytomenadione (Injection)
Indications
Vitamin K deficiency
Indication detailsView
Phytomenadione (Vitamin K-1) is indicated in following indications-
- Prophylaxis and treatment of haemorrhagic disease in the newborn.
- Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates).
- Prevention and treatment of bleeding due to vitamin K deficiency.
Therapeutic classView
Vitamin-K Preparations
PharmacologyView
Phytomenadione is a procoagulant factor. As a component of a hepatic carboxylase system, Phytomenadione is involved in the post translational carboxylation of clotting factors II (prothrombin), VII, IX and X and the clotting inhibitors protein C and protein S. Phytomenadione is ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia induced by severe hepatic failure. Lack of Phytomenadione leads to an increased tendency to haemorrhagic disease in the newborn. Phytomenadione administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to Phytomenadione deficiency.
DosageView
Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4th-5th day and another 2 mg on 28th-30th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route.
Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.
Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics-
Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.
Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.
Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics-
- 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
- Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
- The size and frequency of further doses should be based on coagulation status
Side effectsView
There are isolated unconfirmed reports on the possible occurrence of anaphylactoid reactions and venous irritation or phlebitis after parenteral use of Phytomenadione injections.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to any of its constituents.
PrecautionsView
Careful monitoring of the coagulation parameters is necessary for patients with severely impaired liver function after administration of Phytomenadione .
InteractionsView
Phytomenadione antagonises the effect of coumarin-type anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K-1.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Injefer
Ferric Carboxymaltose
Injefer
Ferric Carboxymaltose
Indications
Iron deficiency anemia
Indication detailsView
Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-
- Who have intolerance to oral iron or have had unsatisfactory response to oral iron
- Who have non-dialysis dependent chronic kidney disease.
Therapeutic classView
Parenteral Iron Preparations
PharmacologyView
Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.
DosageView
For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.
When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.
When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
Side effectsView
Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions
ContraindicationsView
Hypersensitivity to any of its components.
PrecautionsView
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
StorageView
Do not store above 30°C. Do not freeze.
Injefer
Ferric Carboxymaltose
Injefer
Ferric Carboxymaltose
Indications
Iron deficiency anemia
Indication detailsView
Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-
- Who have intolerance to oral iron or have had unsatisfactory response to oral iron
- Who have non-dialysis dependent chronic kidney disease.
Therapeutic classView
Parenteral Iron Preparations
PharmacologyView
Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.
DosageView
For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.
When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.
When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
Side effectsView
Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions
ContraindicationsView
Hypersensitivity to any of its components.
PrecautionsView
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
StorageView
Do not store above 30°C. Do not freeze.
Injefer
Ferric Carboxymaltose
Injefer
Ferric Carboxymaltose
Indications
Iron deficiency anemia
Indication detailsView
Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-
- Who have intolerance to oral iron or have had unsatisfactory response to oral iron
- Who have non-dialysis dependent chronic kidney disease.
Therapeutic classView
Parenteral Iron Preparations
PharmacologyView
Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.
DosageView
For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.
When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.
The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.
Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.
When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.
Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.
Side effectsView
Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions
ContraindicationsView
Hypersensitivity to any of its components.
PrecautionsView
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
StorageView
Do not store above 30°C. Do not freeze.
Inket
Ketorolac Tromethamine
Inket
Ketorolac Tromethamine
Indications
Soft tissue inflammation
Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView
Tablet-
Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection-
Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.Single-Dose Treatment-
IM Dosing (Adult):
- Patients <65 years of age: One dose of 60 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
- Patients <65 years of age: One dose of 30 mg.
- Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
- IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
- IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
- Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Innocan
Fluconazole
Innocan
Fluconazole
Indications
Vaginal candidiasis or thrush
Indication detailsView
Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).
Therapeutic classView
Drugs for subcutaneous and mycoses
PharmacologyView
Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.
DosageView
Adult (oral)-
Intravenous-
- Vaginal candidiasis: 150 mg as a single dose.
- Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
- Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
- Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
- Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
- Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
- Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.
- Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.
Intravenous-
- Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
- Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.
Side effectsView
Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.
ContraindicationsView
Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.
PrecautionsView
Fluconazole should be administered with caution to patients having proarrhythmic conditions.
InteractionsView
Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.
Pregnancy & lactationView
US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Innocan
Fluconazole
Innocan
Fluconazole
Indications
Vaginal candidiasis or thrush
Indication detailsView
Fluconazole is indicated for the treatment of vaginal candidiasis, oropharyngeal & esophageal candidiasis and cryptococcal meningitis. It is also effective for the treatment of urinary tract infection caused by candida, peritonitis and systemic candida infections (including candidemia, disseminated candidiasis and pneumonia).
Therapeutic classView
Drugs for subcutaneous and mycoses
PharmacologyView
Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.
DosageView
Adult (oral)-
Intravenous-
- Vaginal candidiasis: 150 mg as a single dose.
- Oropharyngeal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of this infection generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
- Esophageal candidiasis: 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used. Patients should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.
- Systemic candida infections: Optimal therapeutic dosage and duration of therapy have not been established. Sometimes, doses of up to 400 mg daily have been used.
- Urinary tract infections caused by candida and peritonitis: 50-200 mg daily have been used.
- Cryptococcal meningitis: 400 mg on the first day, followed by 200 mg once daily.
- Prophylaxis in patients undergoing bone marrow transplantation: 400 mg once daily.
- Doses of 3-6 mg/kg daily have been used. Doses up to 12 mg/kg is recommended.
Intravenous-
- Adult: Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by IV, 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)
- Child: 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily. Prevention of relapse of cryptococcal meningitis, by IV, 100-200 mg daily.
Side effectsView
Fluconazole is well tolerated. Most common side effects of using Fluconazole includes nausea, vomiting, abdominal pain, diarrhoea, headache and skin rash.
ContraindicationsView
Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.
PrecautionsView
Fluconazole should be administered with caution to patients having proarrhythmic conditions.
InteractionsView
Concomitant use of cyclosporin or phenytoin with Fluconazole increases the plasma level of cyclosporin or phenytoin. Concomitant use of Fluconazole & warfarin prolongs the prothrombin time. Rifampicin level is decreased when used with Fluconazole.
Pregnancy & lactationView
US FDA Pregnancy category of Fluconazole is C. So, Fluconazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inofar
Iron Sucrose Injection [Elemental Iron]
Inofar
Iron Sucrose Injection [Elemental Iron]
Indications
Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
Indication detailsView
This is indicated for the treatment of Iron deficiency in the following indications:
- Where there is a clinical need for a rapid Iron supply
- In patients who can not tolerate oral Iron therapy or who are non-compliant
- In active inflammatory bowel disease where oral Iron preparations are ineffective
- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
- Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
- Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
- Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
- It is also indicated in the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Therapeutic classView
Parenteral Iron Preparations
PharmacologyView
The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow and that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.
DosageView
Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level.
Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
AdministrationView
Intravenous injection: Iron Sucrose Injection can also be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml Iron Sucrose Injection (20 mg Iron) per minute [5 ml Iron Sucrose Injection (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml Iron Sucrose Injection (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient, a test dose of 1 ml Iron Sucrose Injection (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.
Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.
Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.
Side effectsView
- Adverse reactions, whether or not related to Iron Sucrose injection are as follows: hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving intravenous iron.
- Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury. Cardiovascular Disorders
- General: hypotension, chest pain, hypertension, hypervolemia.
- Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes.
- Central and Peripheral Nervous System: dizziness.
- Musculoskeletal System: cramps/leg cramps, musculoskeletal pain.
- Respiratory System: dyspnea pneumonia, cough.
- Skin and appendages: pruritus, application site reaction.
- Hypersensitivity reactions: In safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Iron Sucrose administration can occur. So, patients should be given a small test dose initially.
ContraindicationsView
The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.
PrecautionsView
General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.
Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.
Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.
InteractionsView
Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.
Pregnancy & lactationView
Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug 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 Iron Sucrose is administered to a nursing woman.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.
Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, 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.
Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.
Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.
Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, 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.
Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.
Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.
Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.
Overdose effectsView
Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.
StorageView
Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.
Inolac
Lactulose
Inolac
Lactulose
Indications
Osmotic laxative
Indication detailsView
Constipation (Chronic Constipation): In every case of chronic constipation, initial treatment should consist of a diet rich in fiber (vegetables, salads, fruits etc.) a generous amount of liquids and much physical exercise. Lactulose is only to be taken when these measures prove insufficient.
Intestinal flora disturbances:
Intestinal flora disturbances:
- In damaged to intestinal flora (e.g. following long-term antibiotic treatment)
- gall bladder diseases
- intestinal diseases ( Colitis, Diverticulosis, Megacolon)
Therapeutic classView
Osmotic purgatives
PharmacologyView
Lactulose is a synthetic disaccharide. Lactulose is metabolized in the colon by the saccharolytic bacteria, producing low molecular weight organic acids (mainly lactic acid), which lowers the pH of the colon contents, promote the retention of water by an osmotic effect; thus increasing peristaltic activity. Lactulose is minimally absorbed; therefore, the pharmacokinetics of the absorbed material are not relevant to the principal therapeutic action.
DosageView
In constipation ( chronic constipation):
- Adults: Initially 3-6 tea-spoons daily, In long-term therapy 1½-6 tea-spoons daily
- Children up to 14 years: Initially 3 tea-spoons daily, In long-term therapy 1-2 tea-spoons daily
- Infants and toddlers: Initially 1-2 tea-spoons daily, In long-term therapy 1 tea-spoon daily
- Adults: 1-2 tea-spoons daily
- Children: 1 tea-spoon daily
- Hyper-ammoniemia in hepatopathy: a maximum of 18-30 tea-spoons daily.
- In portal systemic encephalopathy: hourly doses of 6-9 tea-spoons of Lactulose solution may be used to induce the rapid laxation. When the laxative effect has been achieved, the dose may then be reduced.
Side effectsView
Occasionally flatulence, cramp and abdominal discomfort can occur at the beginning of treatment; this is rapidly eliminated by reducing the dose. Overdose can result in diarrhoea. In abuse, loss of electrolytes (primarily potassium).
ContraindicationsView
Hypersensitivity to either galactose and or lactose; galactose-free diet, gastro-cardial symptom complex, suspected intestinal obstruction.
PrecautionsView
Lactulose should be administered with care to patients who are intolerant to lactulose. The dose used in the treatment of (pre) coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.
InteractionsView
There is no significant drug interactions with lactulose. The glycosidic effect of cardiac glycosides can be intensified by potassium deficiency in abuse.
Pregnancy & lactationView
US FDA Pregnancy Category of Lactulose is B. Studies show that Lactulose has no adverse effects. Decisions regarding use during pregnancy and lactation must be made by registered physician.
Overdose effectsView
There have been no reports of accidental overdosage. In the event of acute overdosage it is expected that diarrhoea and abdominal cramps would be the major symptoms.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Inomet
Fluorometholone Acetate
Inomet
Fluorometholone Acetate
Indications
Ocular inflammation
Indication detailsView
Fluorometholone Acetate ophthalmic suspension is indicated for the treatment of-
- Acute and chronic non-infectious conjunctivitis and keratitis of allergic origin.
- Non-infectious inflammation of the anterior chamber of the eye (including anterior uveitis, episcleritis and scleritis).
- Post-operative irritative conditions after strabismus, cataract and glaucoma surgery.
Therapeutic classView
Ophthalmic Steroid preparations
PharmacologyView
Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.
DosageView
1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.
Side effectsView
Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.
ContraindicationsView
- Hypersensitivity to any ingredient of the formulation.
- Infectious conjunctivitis or keratitis.
- Injuries and ulcerous processes of cornea, especially infections caused by virus, bacteria and fungi.
- Dry eyes, especially keratoconjunctivitis sicca.
- Glaucoma.
PrecautionsView
Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.
InteractionsView
Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.
Pregnancy & lactationView
Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
StorageView
Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.
Inophos
Sevelamer Hydrochloride
Inophos
Sevelamer Hydrochloride
Indications
End-stage renal failure
Indication detailsView
Sevelamer Hydrochloride is indicated for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).
Therapeutic classView
Drugs for reduction of serum phosphorus in patients with ESRD
PharmacologyView
Sevelamer Hydrochloride is a new treatment for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Elevated serum phosphorus levels or uncontrolled hyperphosphatemia leads to development of secondary hyperparathyroidism, renal bone disease, calcification of vascular and nonvascular tissues, and cardiovascular disease. It is a calcium-free and aluminium-free nonabsorbed polymer phosphate binder, it does not cause calcium and aluminium toxicity. When taken with meals it inhibits intestinal absorption of ingested phosphate.
DosageView
Patients not taking a Phosphate Binder: The recommended starting dose of Sevelamer is 800 to 1600 mg, which can be administered as two to four 400 mg Sevelamer tablets, with meals based on serum phosphorus level. Renophos 400 Recommendation for the patients with hyperphosphatemia is given below-
Starting dose of Renophos for dialysis patients not taking any phosphate binder:
Starting dose of Renophos for dialysis patients not taking any phosphate binder:
- Serum Phosphorus >5.5 and <7.5 mg/dL: 800 mg (2 tablets) three times daily with meals
- Serum Phosphorus ≥7.5 and <9.0 mg/dL: 1200 mg (3 tablets) three times daily with meals
- Serum Phosphorus ≥9.0 mg/dL: 1600 mg (4 tablets) three times daily with meals
- Calcium Acetate 667 mg (1 tablet): Sevelamer 800 mg (2 tablets)
- Calcium Acetate 1334 mg (2 tablets): Sevelamer 1200 mg (3 tablets)
- Calcium Acetate 2001 mg (3 tablets): Sevelamer 2000 mg (5 tablets)
- Serum Phosphorus >5.5 mg/dL: Increase 400 mg (1 tablet) per meal at 2 week intervals
- Serum Phosphorus 3.5-5.5 mg/dL: Maintain current dose
- Serum Phosphorus <3.5 mg/dL: Decrease 400 mg (1 tablet) per meal
Side effectsView
Sevelamer may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.
ContraindicationsView
Sevelamer is contraindicated in patients with hypophosphatemia or bowel obstruction and in patients with known hypersensitivity to Sevelamer hydrochloride or any of its constituents.
PrecautionsView
The safety and efficacy of Sevelamer in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Caution should be exercised when Sevelamer is used in patients with these GI disorders.
InteractionsView
Sevelamer has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.
Pregnancy & lactationView
Pregnancy Category C. No adequate and controlled studies have been conducted using Sevelamer in nursing mothers. Sevelamer should be used during breastfeeding only if the potential benefit justifies the potential risks.
Overdose effectsView
Over dosages of Sevelamer in patients was never reported. Since Sevelamer is not absorbed, the risk of systemic toxicity is low.
Inospiron
Spironolactone
Inospiron
Spironolactone
Indications
Severe congestive heart failure
Indication detailsView
Spironolactone is indicated in Congestive heart failure, Hepatic cirrhosis with ascites and oedema, Nephrotic syndrome, Primary hyperaldosteronism, Essential hypertension, For the treatment of patients with hypokalemia
Therapeutic classView
Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists
PharmacologyView
Spironolactone is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents which act more proximally in the renal tubule. Aldosterone interacts with a cytoplasmic mineralocorticoid receptor to enhance the expression of the Na+ K+ ATPase and the Na+ channel involved in a Na+ K+ transport in the distal tubule . Spironolactone bind to this mineralcorticoid receptor, blocking the actions of aldosterone on gene expression. Aldosterone is a hormone; its primary function is to retain sodium and excrete potassium in the kidneys.
DosageView
Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome): An initial daily dosage of 100 mg of Spironolactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. Combined therapy with other diuretics is indicated when more rapid diuresis is desired.
Primary hyperaldosteronism: After the diagnosis of hyperaldosteronism has been established, Spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Spironolactone administered in either single or divided doses is recommended.
Hypokalemia: Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia.
Primary hyperaldosteronism: After the diagnosis of hyperaldosteronism has been established, Spironolactone may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Essential hypertension: For adults, an initial daily dosage of 50 to 100 mg of Spironolactone administered in either single or divided doses is recommended.
Hypokalemia: Spironolactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia.
Side effectsView
Gynaecomastia may develop in association with the use of Spironolactone. Other adverse reactions are: GI symptoms including cramping and diarrhoea, drowsiness, lethargy, headache, urticaria, mental confusion, impotence, irregular menses or amenorrhoea and post-menopausal bleeding.
ContraindicationsView
Spironolactone is contraindicated in patients with acute renal insufficiency, significant impairment of renal function, anuria, hyperkalaemia or sensitivity to Spironolactone.
PrecautionsView
All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance. Hyperkalemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities, which may be fatal.
InteractionsView
ACE inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia.
Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.
Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.
Digoxin: Spironolactone has been shown to increase the half-life of digoxin.
Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.
Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.
Digoxin: Spironolactone has been shown to increase the half-life of digoxin.
Pregnancy & lactationView
Pregnancy: Spironolactone should not be used during pregnancy
Lactation: Canrenone, an active metabolite of Spironolactone, appears in breast milk. If use of the drug is deemed essential an alternative method of infant feeding should be instituted.
Lactation: Canrenone, an active metabolite of Spironolactone, appears in breast milk. If use of the drug is deemed essential an alternative method of infant feeding should be instituted.
Overdose effectsView
Symptoms of overdosage include drowsiness, mental confusion, dizziness, diarrhea and vomiting etc. Patients should induce vomiting or evacuate the stomach by lavage during Spironolactone overdoasge.
StorageView
Store in a cool and dry place protected from light. Keep out of reach of children.