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Apevit-Z
Vitamin B Complex + Zinc
Apevit-Z
Vitamin B Complex + Zinc
Indications
Vitamins B and Zinc deficiencies
Indication detailsView
This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.
Therapeutic classView
Specific mineral & vitamin combined preparations
PharmacologyView
Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.
B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.
DosageView
Syrup-
- Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
- Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
- Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.
- Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.
Side effectsView
This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.
ContraindicationsView
Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
PrecautionsView
In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.
InteractionsView
Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.
Pregnancy & lactationView
This is recommended in pregnancy and lactation.
Overdose effectsView
In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.
StorageView
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.
Aphrin
Cephradine
Aphrin
Cephradine
Indications
Urinary tract infection
Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
- Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
- Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
- Urinary tract infections: cystitis, urethritis and pyelonephritis.
- Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
- Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
- Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
For injectable administration-
Adults:
- Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
- Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
- Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
- Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
- Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
- Maximum daily dosage: 4 gm
For injectable administration-
- Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
- Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
- Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
- Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
- Psychiatric disorders- Unknown: Confusion, sleep disturbances
- Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
- Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
- Renal and urinary disorders- Unknown: Reversible interstitial nephritis
- Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
- Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
- Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
- Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
- Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
- Dosage adjustment is necessary in renal impairment.
- This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
- CrCl: >20 ml/min: 500 mg every 6 hours
- CrCl: 5-20 ml/min: 250 mg every 6 hours
- CrCl: <5 ml/min: 250 mg every 50-70 hours.
- 250 mg at the start of haemodialysis
- 250 mg 6 to 12 hours after the start
- 250 mg 36 to 48 hours after the start
- 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician
Aphrin
Cephradine
Aphrin
Cephradine
Indications
Urinary tract infection
Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
- Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
- Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
- Urinary tract infections: cystitis, urethritis and pyelonephritis.
- Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
- Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
- Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
For injectable administration-
Adults:
- Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
- Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
- Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
- Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
- Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
- Maximum daily dosage: 4 gm
For injectable administration-
- Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
- Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
- Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
- Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
- Psychiatric disorders- Unknown: Confusion, sleep disturbances
- Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
- Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
- Renal and urinary disorders- Unknown: Reversible interstitial nephritis
- Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
- Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
- Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
- Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
- Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
- Dosage adjustment is necessary in renal impairment.
- This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
- CrCl: >20 ml/min: 500 mg every 6 hours
- CrCl: 5-20 ml/min: 250 mg every 6 hours
- CrCl: <5 ml/min: 250 mg every 50-70 hours.
- 250 mg at the start of haemodialysis
- 250 mg 6 to 12 hours after the start
- 250 mg 36 to 48 hours after the start
- 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician
Apiban
Apixaban
Apiban
Apixaban
Indications
Venous thrombosis
Indication detailsView
Apixaban is a factor Xa inhibitor indicated:
- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery
- For the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy
Therapeutic classView
Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants
PharmacologyView
Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.
DosageView
Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.
Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.
CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.
Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.
Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.
Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.
Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.
Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.
CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.
Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.
Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.
Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.
Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.
Side effectsView
Apixaban can cause a skin rash or severe allergic reaction.
ContraindicationsView
Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).
PrecautionsView
Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
InteractionsView
Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.
Pregnancy & lactationView
Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.
Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.
Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.
Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.
Pediatric usageView
Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment
Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.
Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.
Overdose effectsView
There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.
StorageView
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.
Apidone
Domperidone Maleate
Apidone
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Apidone
Domperidone Maleate
Apidone
Domperidone Maleate
Indications
Vomiting
Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
- Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
- Eructation, flatulence, early satiety
- Nausea and vomiting
- Heartburn with or without regurgitations of gastric contents in the mouth
- Non-ulcer dyspepsia
Parkinson's disease: In dopamine-agonist induced nausea and vomiting.
Radiological studies: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.
The usual recommended oral dose of Domperidone is as follows:
The usual recommended oral dose of Domperidone is as follows:
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
- Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
- Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
- Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
- Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
- Adults (including elderly): 30-60 mg every 4-8 hours.
- Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
- The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.
Apidra
Insulin Glulisine
Apidra
Insulin Glulisine
Indications
Type 1 DM
Indication detailsView
Insulin Glulisine is indicated to improve glycemic control in adults and children with diabetes mellitus.
Therapeutic classView
Rapid Acting Insulin
PharmacologyView
Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis. The glucose lowering activities of Insulin Glulisine and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration, the effect of Insulin Glulisine is more rapid in onset and of shorter duration compared to regular human insulin.
DosageView
Insulin Glulisine is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of Insulin Glulisine has the same glucose lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, Insulin Glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.
The dosage of Insulin Glulisine must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy. The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
The dosage of Insulin Glulisine must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy. The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
AdministrationView
Subcutaneous administration: Insulin Glulisine should be given within 15 minutes before a meal or within 20 minutes after starting a meal. Insulin Glulisine given by subcutaneous injection should generally be used in regimens with an intermediate or long acting insulin. Insulin Glulisine should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy
Continuous subcutaneous infusion (insulin pump): Insulin Glulisine may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.
Intravenous administration: Insulin Glulisine can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Glulisine should be used at concentrations of 0.05 Units/mL to 1 Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. Insulin Glulisine has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.
Continuous subcutaneous infusion (insulin pump): Insulin Glulisine may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.
Intravenous administration: Insulin Glulisine can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Glulisine should be used at concentrations of 0.05 Units/mL to 1 Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. Insulin Glulisine has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.
Side effectsView
Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:
- rash all over your body
- shortness of breath
- wheezing (trouble breathing)
- fast pulse
- sweating
- low blood pressure
ContraindicationsView
Insulin Glulisine is contraindicated during episodes of hypoglycemia, in patients who are hypersensitive to Insulin Glulisine or to any of its excipients.
When used in patients with known hypersensitivity to Insulin Glulisine or its excipients, patients may develop localized or generalized hypersensitivity reactions
When used in patients with known hypersensitivity to Insulin Glulisine or its excipients, patients may develop localized or generalized hypersensitivity reactions
PrecautionsView
Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Rotate Inj sites to reduce lipodystrophy . Pregnancy, lactation.
InteractionsView
Possible absence of hypoglycaemic warning symptoms with beta-blockers. Decreased hypoglycaemic effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents, thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotics (e.g. olanzapine and clozapine). Increased hypoglycaemic effect with oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.
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
Nursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
Nursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
Pediatric usageView
Pediatric use: The safety and effectiveness of subcutaneous injections of Insulin Glulisine have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes. Insulin Glulisine has not been studied in pediatric patients with type 1 diabetes younger than 4 years of age and in pediatric patients with type 2 diabetes. As in adults, the dosage of Insulin Glulisine must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose
Geriatric use: In clinical trials (n=2408), Insulin Glulisine was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of elderly patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when Insulin Glulisine is administered to geriatric patients.
Renal impairment: Dose reduction may be needed
Hepatic impairment: Dose reduction may be needed
Geriatric use: In clinical trials (n=2408), Insulin Glulisine was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of elderly patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when Insulin Glulisine is administered to geriatric patients.
Renal impairment: Dose reduction may be needed
Hepatic impairment: Dose reduction may be needed
Overdose effectsView
Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.
StorageView
Unopened Insulin Glulisine vials and cartridge systems should be stored in a refrigerator 2°C-8°C. Protect from light. Insulin Glulisine should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen. Unopened vials/cartridge systems not stored in a refrigerator must be used within 28 days.
Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 25°C.
Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 25°C.
Apidra SoloStar
Insulin Glulisine
Apidra SoloStar
Insulin Glulisine
Indications
Type 1 DM
Indication detailsView
Insulin Glulisine is indicated to improve glycemic control in adults and children with diabetes mellitus.
Therapeutic classView
Rapid Acting Insulin
PharmacologyView
Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis. The glucose lowering activities of Insulin Glulisine and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration, the effect of Insulin Glulisine is more rapid in onset and of shorter duration compared to regular human insulin.
DosageView
Insulin Glulisine is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of Insulin Glulisine has the same glucose lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, Insulin Glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.
The dosage of Insulin Glulisine must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy. The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
The dosage of Insulin Glulisine must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy. The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
AdministrationView
Subcutaneous administration: Insulin Glulisine should be given within 15 minutes before a meal or within 20 minutes after starting a meal. Insulin Glulisine given by subcutaneous injection should generally be used in regimens with an intermediate or long acting insulin. Insulin Glulisine should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy
Continuous subcutaneous infusion (insulin pump): Insulin Glulisine may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.
Intravenous administration: Insulin Glulisine can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Glulisine should be used at concentrations of 0.05 Units/mL to 1 Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. Insulin Glulisine has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.
Continuous subcutaneous infusion (insulin pump): Insulin Glulisine may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.
Intravenous administration: Insulin Glulisine can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, Insulin Glulisine should be used at concentrations of 0.05 Units/mL to 1 Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. Insulin Glulisine has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.
Side effectsView
Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:
- rash all over your body
- shortness of breath
- wheezing (trouble breathing)
- fast pulse
- sweating
- low blood pressure
ContraindicationsView
Insulin Glulisine is contraindicated during episodes of hypoglycemia, in patients who are hypersensitive to Insulin Glulisine or to any of its excipients.
When used in patients with known hypersensitivity to Insulin Glulisine or its excipients, patients may develop localized or generalized hypersensitivity reactions
When used in patients with known hypersensitivity to Insulin Glulisine or its excipients, patients may develop localized or generalized hypersensitivity reactions
PrecautionsView
Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Rotate Inj sites to reduce lipodystrophy . Pregnancy, lactation.
InteractionsView
Possible absence of hypoglycaemic warning symptoms with beta-blockers. Decreased hypoglycaemic effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents, thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotics (e.g. olanzapine and clozapine). Increased hypoglycaemic effect with oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.
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
Nursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
Nursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
Pediatric usageView
Pediatric use: The safety and effectiveness of subcutaneous injections of Insulin Glulisine have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes. Insulin Glulisine has not been studied in pediatric patients with type 1 diabetes younger than 4 years of age and in pediatric patients with type 2 diabetes. As in adults, the dosage of Insulin Glulisine must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose
Geriatric use: In clinical trials (n=2408), Insulin Glulisine was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of elderly patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when Insulin Glulisine is administered to geriatric patients.
Renal impairment: Dose reduction may be needed
Hepatic impairment: Dose reduction may be needed
Geriatric use: In clinical trials (n=2408), Insulin Glulisine was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of elderly patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when Insulin Glulisine is administered to geriatric patients.
Renal impairment: Dose reduction may be needed
Hepatic impairment: Dose reduction may be needed
Overdose effectsView
Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.
StorageView
Unopened Insulin Glulisine vials and cartridge systems should be stored in a refrigerator 2°C-8°C. Protect from light. Insulin Glulisine should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen. Unopened vials/cartridge systems not stored in a refrigerator must be used within 28 days.
Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 25°C.
Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 25°C.
Apilac
Ketorolac Tromethamine
Apilac
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.
Apilast
Apremilast
Apilast
Apremilast
Indications
Psoriatic arthritis
Indication detailsView
Apremilast is indicated for the treatment of adult patients with active psoriatic arthritis and moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Therapeutic classView
Disease-modifying antirheumatic drugs (DMARDs)
PharmacologyView
Apremilast is a novel, orally available small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4). PDE-4 is a cyclic adenosine monophosphate (cAMP)-specific phosphodiesterase that is predominantly located in inflammatory cells. By inhibiting PDE-4, apremilast increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. By targeting a central component of the inflammatory signaling cascade rather than a single inflammatory marker, PDE-4 inhibition may restore the homeostatic balance between pro- and anti-inflammatory signalling.
DosageView
The recommended initial dosage titration of Apremilast from Day 1 to Day 5 is shown below. Following the 5-day titration, the recommended maintenance dosage is 30 mg twice daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Apremilast can be administered without regard to meals.
Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6: 30 mg twice daily
Dosage adjustment in patients with severe renal impairment. Apremilast dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Apremilast be titrated using only the morning schedule and the evening doses be skipped.
Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6: 30 mg twice daily
Dosage adjustment in patients with severe renal impairment. Apremilast dosage should be reduced to 30 mg once daily in patients with severe renal impairment. For initial dosage titration, it is recommended that Apremilast be titrated using only the morning schedule and the evening doses be skipped.
Side effectsView
The most frequently occurring side effects of Apremilast are nausea, diarrhea and headache. Other less frequent side effects are upper respiratory tract infection, vomiting, naospharyngitis, abdominal pain, hypersensitivity, gastroesophageal reflux disease, dyspepsia, fatigue, decrease appetite, cough, rash, insomnia.
ContraindicationsView
Apremilast is contraindicated in patients with a known hypersensitivity to Apremilast or to any of the excipients in the formulation.
PrecautionsView
Treatment with Apremilast is associated with an increase in adverse reactions of depression. Patients, their caregivers and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Apremilast if such events occur.
During the controlled period of the studies in psoriatic arthritis, weight decrease between 5-10% of body weight was reported in 10% of subjects treated with Apremilast 30 mg twice daily compared to 3.3% treated with placebo.
During the controlled period of the studies in psoriatic arthritis, weight decrease between 5-10% of body weight was reported in 10% of subjects treated with Apremilast 30 mg twice daily compared to 3.3% treated with placebo.
InteractionsView
Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in a reduction of systemic exposure of Apremilast.Therefore.the use of cytochrome P450 enzyme inducers (e.g. Rifampin, Phenobarbital,Carbamazepine, Phenytoin) with Apremilast is not recommended.
Pregnancy & lactationView
Pregnancy Category C. It is not known whether Apremilast or its metabolites are present in human milk; however, Apremilast was detected in milk of lactating mice. Caution should be exercised when Apremilast is administered to a nursing woman.
Pediatric usageView
Use in Paediatric patient: The safety and effectiveness of Apremilast in paediatric patients less than 18 years of age have not been established.
StorageView
Store at cool & dry place, protected from light & moisture. Keep the medicine out of the reach of children.
Apimox
Amoxicillin Trihydrate
Apimox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Apimox
Amoxicillin Trihydrate
Apimox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Apimox
Amoxicillin Trihydrate
Apimox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Apimox
Amoxicillin Trihydrate
Apimox
Amoxicillin Trihydrate
Indications
Skin and skin sructure infections
Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
- Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
- Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
- Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
- Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
- Venereal disease (i.e. acute uncomplicated gonorrhoea)
- In dental abscess, it is used as short-term therapy.
- It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
- Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
- Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
- Pneumonia: Recommended dose is 500-1000 mg three times daily.
- Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
- Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
- Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
- In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
- Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
- Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Apirent
Aluminium Chloride Hexahydrate
Apirent
Aluminium Chloride Hexahydrate
Indications
Oesophagitis
Indication detailsView
Aluminium Chloride Hexahydrate is indicated for the treatment of excessive perspiration of the underarms, hands, feet and scalp.
Therapeutic classView
Miscellaneous topical agents
PharmacologyView
Aluminium Chloride Hexahydrate acts locally in the stratum corneum and terminal duct to relieve hyperhidrosis. Aluminium salts cause an obstruction of the ducts of sweat glands at the skin surface. It seems that the metal (Aluminium) ions precipitate with mucopolysaccharides, damaging epithelial cells along with the duct lumen and forms a plug (gel) that blocks sweat output.
DosageView
Step 1: Apply Aluminium Chloride Hexahydrate topical solution at night after drying the affected areas carefully.
Step 2: Wash off in the morning. Do not re-apply the product during the day.
Step 3: Initially the product may be applied every night until sweating stops during the day. The frequency of application may be reduced to twice a week or less, if excess sweating is stopped during the day.
Step 2: Wash off in the morning. Do not re-apply the product during the day.
Step 3: Initially the product may be applied every night until sweating stops during the day. The frequency of application may be reduced to twice a week or less, if excess sweating is stopped during the day.
Side effectsView
Aluminium Chloride Hexahydrate is normally well tolerated and adverse effects are only mild and short-lasting. But sometimes irritation of the skin like- stinging, burning, redness, swelling, tingling or itching of treated skin areas may occur. These irritations may be alleviated by use of a weak corticosteroid cream.
ContraindicationsView
Aluminium Chloride Hexahydrate is contraindicated in patients with known hypersensitivity to any of its components.
PrecautionsView
For external use only. Do not apply this medication to broken, irritated or recently shaved skin. Avoid contact with eyes, mouth, nose and lips. Avoid direct contact with clothing and polished metal or jewellery surfaces. Keep out of reach of children.
InteractionsView
There are no known drug interactions for Aluminium Chloride Hexahydrate topical solution.
Pregnancy & lactationView
There are no restrictions on the use of this medication during pregnancy and lactation.
StorageView
Store in a cool & dry place, protected from light. Keep out of reach of children. Keep away from naked flame. Store upright.
Apit
Megestrol Acetate
Apit
Megestrol Acetate
Indication detailsView
Megestrol Tablet is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used instead of currently accepted procedures such as surgery, radiation, or chemotherapy.
Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.
Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.
PharmacologyView
Megestrol Acetate is a synthetic, antineoplastic and progestational drug. While the precise mechanism by which Megestrol Acetate produces its antineoplastic effects against endometrial carcinoma is unknown at the present time, inhibition of pituitary gonadotrophin production and resultant decrease in estrogen secretion may be factors. The antineoplastic action of megestrol acetate on carcinoma of the breast is effected by modifying the action of other steroid hormones and by exerting a direct cytotoxic effect on tumor cells. In metastatic cancer, hormone receptors may be present in some tissues but not others. The receptor mechanism is a cyclic process whereby estrogen produced by the ovaries enters the target cell, forms a complex with cytoplasmic receptor and is transported into the cell nucleus. There it induces gene transcription and leads to the alteration of normal cell functions. Pharmacologic doses of megestrol acetate not only decrease the number of hormone-dependent human breast cancer cells but also are capable of modifying and abolishing the stimulatory effects of estrogen on these cells.
Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.
Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.
DosageView
Tablet:
- Breast cancer: 160 mg/day
- Endometrial carcinoma: 40-320 mg/day in divided doses.
- At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of Megestrol.
Side effectsView
Weight Gain: Weight gain is a frequent side effect of Megestrol Acetate. This gain has been associated with increased appetite and is not necessarily associated with fluid retention.
Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.
Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.
Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.
Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.
Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.
Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.
ContraindicationsView
History of hypersensitivity to Megestrol Acetate or any component of the formulation. Known or suspected pregnancy.
PrecautionsView
General: Close surveillance is indicated for any patient treated for recurrent or metastatic cancer. Use with caution in patients with a history of thromboembolic disease.
Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.
Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.
InteractionsView
Pharmacokinetic studies show that there are no significant alterations in pharmacokinetics parameters of Zidovudine or Rifabutin to warrant dosage adjustment when Megestrol Acetate is administered with these drugs. The effects of Zidovudine or Rifabutin on the pharmacokinetics of Megestrol Acetate were not studied.
Pregnancy & lactationView
Pregnancy Category D. The use of progestational agents during the first four months of pregnancy is not recommended. Very small amounts (approximately 0.1%) are excreted in mother's milk. It is however, not known whether these amounts exert any harmful effect on the newborn. Because of the potential for adverse effects on the new born, nursing should be discontinued during treatment with Megestrol Acetate.
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Overdose effectsView
No serious unexpected side effects have resulted from studies involving Megestrol Acetate administered in dosages as high as 1600 mg/day.
StorageView
Store at or below 25°C. Protect from heat, light & moisture.
Apit
Megestrol Acetate
Apit
Megestrol Acetate
Indication detailsView
Megestrol Tablet is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used instead of currently accepted procedures such as surgery, radiation, or chemotherapy.
Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.
Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.
PharmacologyView
Megestrol Acetate is a synthetic, antineoplastic and progestational drug. While the precise mechanism by which Megestrol Acetate produces its antineoplastic effects against endometrial carcinoma is unknown at the present time, inhibition of pituitary gonadotrophin production and resultant decrease in estrogen secretion may be factors. The antineoplastic action of megestrol acetate on carcinoma of the breast is effected by modifying the action of other steroid hormones and by exerting a direct cytotoxic effect on tumor cells. In metastatic cancer, hormone receptors may be present in some tissues but not others. The receptor mechanism is a cyclic process whereby estrogen produced by the ovaries enters the target cell, forms a complex with cytoplasmic receptor and is transported into the cell nucleus. There it induces gene transcription and leads to the alteration of normal cell functions. Pharmacologic doses of megestrol acetate not only decrease the number of hormone-dependent human breast cancer cells but also are capable of modifying and abolishing the stimulatory effects of estrogen on these cells.
Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.
Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.
DosageView
Tablet:
- Breast cancer: 160 mg/day
- Endometrial carcinoma: 40-320 mg/day in divided doses.
- At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of Megestrol.
Side effectsView
Weight Gain: Weight gain is a frequent side effect of Megestrol Acetate. This gain has been associated with increased appetite and is not necessarily associated with fluid retention.
Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.
Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.
Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.
Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.
Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.
Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.
ContraindicationsView
History of hypersensitivity to Megestrol Acetate or any component of the formulation. Known or suspected pregnancy.
PrecautionsView
General: Close surveillance is indicated for any patient treated for recurrent or metastatic cancer. Use with caution in patients with a history of thromboembolic disease.
Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.
Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.
InteractionsView
Pharmacokinetic studies show that there are no significant alterations in pharmacokinetics parameters of Zidovudine or Rifabutin to warrant dosage adjustment when Megestrol Acetate is administered with these drugs. The effects of Zidovudine or Rifabutin on the pharmacokinetics of Megestrol Acetate were not studied.
Pregnancy & lactationView
Pregnancy Category D. The use of progestational agents during the first four months of pregnancy is not recommended. Very small amounts (approximately 0.1%) are excreted in mother's milk. It is however, not known whether these amounts exert any harmful effect on the newborn. Because of the potential for adverse effects on the new born, nursing should be discontinued during treatment with Megestrol Acetate.
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Overdose effectsView
No serious unexpected side effects have resulted from studies involving Megestrol Acetate administered in dosages as high as 1600 mg/day.
StorageView
Store at or below 25°C. Protect from heat, light & moisture.
Apitac
Aceclofenac
Apitac
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Apitone
Ferrous Sulfate
Apitone
Ferrous Sulfate
Indications
Anaemia
Indication detailsView
Ferrous Sulfate is indicated in the treatment and prevention of iron deficiency anaemia and anaemia of pregnancy where routine administration of iron is necessary.
Therapeutic classView
Oral Iron preparations
DosageView
Adult-
- Initial therapeutic dose: 3-4½ teaspoonful daily in divided doses or as prescribed by the physician.
- Maintenance dose: 1½ teaspoonful daily, but if needed up to 1.8g (9 teaspoonful) daily can be given.
- Under 1 year: ¼ th teaspoonful thrice daily or as directed by physician
- 1-5 years: 1 teaspoonful thrice daily
- 6-12 years: 1½ teaspoonful twice daily.
Side effectsView
Therapeutic doses of iron may cause gastrointestinal symptoms like diarrhoea, nausea and vomiting. Although iron is better absorbed between meals, side effects can be reduced by taking it with or immediately after food. Continuous administration may sometimes cause constipation. Iron containing liquid medication may cause temporary staining of teeth (this is less likely when diluted).
ContraindicationsView
Iron therapy is contraindicated in haemachromatosis and haemosiderosis.It should not be given to patients receiving repeated blood transfusion or with anaemia not produced by iron deficiency.
PrecautionsView
Should be administered with caution when given to patients with iron storage or iron absorption disease, haemoglobinopathies or existing gastrointestinal disease.
InteractionsView
Absorption of iron salt and Tetracycline is diminished when taken concomitantly by mouth. If treatment with both drugs is required iron salt should be given 3 hours before or 2 hours after Tetracycline. Absorption of iron is also decreased in the presence of antacids or when taken with tea.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Apixa
Apixaban
Apixa
Apixaban
Indications
Venous thrombosis
Indication detailsView
Apixaban is a factor Xa inhibitor indicated:
- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery
- For the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy
Therapeutic classView
Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants
PharmacologyView
Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.
DosageView
Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.
Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.
CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.
Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.
Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.
Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.
Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.
Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.
CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.
Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.
Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.
Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.
Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.
Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.
Side effectsView
Apixaban can cause a skin rash or severe allergic reaction.
ContraindicationsView
Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).
PrecautionsView
Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
InteractionsView
Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.
Pregnancy & lactationView
Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.
Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.
Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.
Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.
Pediatric usageView
Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment
Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.
Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.
Overdose effectsView
There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.
StorageView
Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.