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Tav
Drotaverine
Tav
Drotaverine
Indications
Tetanus
Indication detailsView
Spastic conditions of the gastrointestinal tract, irritable bowel syndrome-
- Biliary colics and spastic conditions of the biliary tract: Cholecystolithiasis, cholecystitis, cholangitis.
- Renal colics and spastic conditions of the urogenital tract: Nephrolithiasis, ureterolithiasis, pyelitis, cystitis.
- Spastic conditions of the uterus: Dysmenorrhea, imminent abortion, uterine tetanus.
Therapeutic classView
Anticholinergics
PharmacologyView
Drotaverine has antispasmodic effect mediated via inhibition of phosphodiesterase-IV, specific for smooth muscle. It has a rapid and direct action on the smooth muscle. It acts to correct cyclic AMP and Ca imbalance at the spastic site, thereby relieving smooth muscle spasm and pain.
DosageView
Oral-
- Adults: 1 to 2 tablets, 3 times daily
- Children (over 6 years): 1/2 to 1 tablet, 1-2 times daily.
- Children (1-6 years): 1/4 to 1/2 tablet, 1-2 times daily.
- Adults: 1 to 2 ampoules, intramuscularly or subcutaneously, 1-3 times daily.
- For the management of acute stone colics: 1 or 2 ampoules by slow intravenous injection.
Side effectsView
The common side effects are headache, dizziness, rhinitis, sinusitis, gastrointestinal upset, nausea, pharyngitis, edema and fatigue.
ContraindicationsView
Drotaverine is contraindicated in patients with known hypersensitivity to the products and its constituents.
PrecautionsView
Caution should be taken for patients suffering from liver and kidney disease.
InteractionsView
May attenuate the action of levodopa. Concurrent use of analgesics, antimuscarinics or benzodiazepines. Additive beneficial effect with concurrent use of analgesics, antimuscarinics or benzodiazepines.
Pregnancy & lactationView
As with most drugs, the use of Drotaverine Hydrochloride should be avoided during pregnancy and lactation unless essential.
Taven
Atorvastatin Calcium
Taven
Atorvastatin Calcium
Indications
Reducing cholesterol levels
Indication detailsView
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
DosageView
Primary hypercholesterolaemia and combined hyperlipidaemia-
- Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
- Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
- Adults: Initially 10 mg once daily adjusted according to response.
Side effectsView
Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
ContraindicationsView
Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
PrecautionsView
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
Pregnancy & lactationView
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Pediatric usageView
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Overdose effectsView
Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Taven
Atorvastatin Calcium
Taven
Atorvastatin Calcium
Indications
Reducing cholesterol levels
Indication detailsView
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
DosageView
Primary hypercholesterolaemia and combined hyperlipidaemia-
- Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
- Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
- Adults: Initially 10 mg once daily adjusted according to response.
Side effectsView
Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
ContraindicationsView
Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
PrecautionsView
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
Pregnancy & lactationView
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Pediatric usageView
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Overdose effectsView
Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Taven
Atorvastatin Calcium
Taven
Atorvastatin Calcium
Indications
Reducing cholesterol levels
Indication detailsView
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
DosageView
Primary hypercholesterolaemia and combined hyperlipidaemia-
- Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
- Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
- Adults: Initially 10 mg once daily adjusted according to response.
Side effectsView
Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
ContraindicationsView
Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
PrecautionsView
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
Pregnancy & lactationView
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Pediatric usageView
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Overdose effectsView
Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Taverin
Drotaverine
Taverin
Drotaverine
Indications
Tetanus
Indication detailsView
Spastic conditions of the gastrointestinal tract, irritable bowel syndrome-
- Biliary colics and spastic conditions of the biliary tract: Cholecystolithiasis, cholecystitis, cholangitis.
- Renal colics and spastic conditions of the urogenital tract: Nephrolithiasis, ureterolithiasis, pyelitis, cystitis.
- Spastic conditions of the uterus: Dysmenorrhea, imminent abortion, uterine tetanus.
Therapeutic classView
Anticholinergics
PharmacologyView
Drotaverine has antispasmodic effect mediated via inhibition of phosphodiesterase-IV, specific for smooth muscle. It has a rapid and direct action on the smooth muscle. It acts to correct cyclic AMP and Ca imbalance at the spastic site, thereby relieving smooth muscle spasm and pain.
DosageView
Oral-
- Adults: 1 to 2 tablets, 3 times daily
- Children (over 6 years): 1/2 to 1 tablet, 1-2 times daily.
- Children (1-6 years): 1/4 to 1/2 tablet, 1-2 times daily.
- Adults: 1 to 2 ampoules, intramuscularly or subcutaneously, 1-3 times daily.
- For the management of acute stone colics: 1 or 2 ampoules by slow intravenous injection.
Side effectsView
The common side effects are headache, dizziness, rhinitis, sinusitis, gastrointestinal upset, nausea, pharyngitis, edema and fatigue.
ContraindicationsView
Drotaverine is contraindicated in patients with known hypersensitivity to the products and its constituents.
PrecautionsView
Caution should be taken for patients suffering from liver and kidney disease.
InteractionsView
May attenuate the action of levodopa. Concurrent use of analgesics, antimuscarinics or benzodiazepines. Additive beneficial effect with concurrent use of analgesics, antimuscarinics or benzodiazepines.
Pregnancy & lactationView
As with most drugs, the use of Drotaverine Hydrochloride should be avoided during pregnancy and lactation unless essential.
Taxceph
Cefotaxime
Taxceph
Cefotaxime
Indications
Urinary tract infection
Indication detailsView
Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.
DosageView
Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Side effectsView
Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
ContraindicationsView
Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
PrecautionsView
Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
InteractionsView
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Pregnancy & lactationView
Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
Pediatric usageView
Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
StorageView
Store below 25°C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8°C.
Taxceph
Cefotaxime
Taxceph
Cefotaxime
Indications
Urinary tract infection
Indication detailsView
Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.
DosageView
Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Side effectsView
Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
ContraindicationsView
Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
PrecautionsView
Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
InteractionsView
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Pregnancy & lactationView
Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
Pediatric usageView
Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
StorageView
Store below 25°C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8°C.
Taxceph
Cefotaxime
Taxceph
Cefotaxime
Indications
Urinary tract infection
Indication detailsView
Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.
DosageView
Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Side effectsView
Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
ContraindicationsView
Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
PrecautionsView
Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
InteractionsView
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Pregnancy & lactationView
Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
Pediatric usageView
Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
StorageView
Store below 25°C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8°C.
Taxedol
Docetaxel Trihydrate
Taxedol
Docetaxel Trihydrate
Indications
Stomach carcinoma
Indication detailsView
Docetaxel is a microtubule inhibitor indicated for:
- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
- Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
- Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
- Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
- Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Docetaxel is an antineoplastic agent, which acts by disrupting the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. Docetaxel promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Docetaxel binds to free tubulin thereby decreasing the critical intracellular concentration of tubulin. The promoted polymerization of microtubules leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, resulting in the inhibition of mitosis in cells. The binding of Docetaxel to microtubules does not alter the number of protofilaments in the bound microtubules; in that, it differs from other spindle poisons. Docetaxel was found to be cytotoxic in vitro against various murine and human tumor cell lines, and against freshly excised human tumor cells in clonogenic assays. In addition, Docetaxel was found to be active on a number of cell lines overexpressing the p-glycoprotein, which is encoded by the multidrug resistant gene.
DosageView
Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.
For all patients:
- BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent
- BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles
- NSCLC: after platinum therapy failure: 75 mg/m2 single agent
- NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2
- HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
- GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
- SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
- SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles
For all patients:
- Premedicate with oral corticosteroids
- Adjust dose as needed
Side effectsView
The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ContraindicationsView
Docetaxel is contraindicated in patients with:
- Neutrophil counts of <1500 cells/mm3
- A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
PrecautionsView
- Docetaxel should be administered under the supervision of a physician experienced in the use of antineoplastic agents
- There is a higher risk of developing severe adverse reactions including toxic death and fatal gastrointestinal hemorrhage in patients with hepatic impairment
- Docetaxel therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3
- Fatal cases of enterocolitis, including ischemic colitis, colitis and neutropenic enterocolitis have been reported
- Severe hypersensitivity reactions, with a potential fatal outcome, requiringb immediate discontinuation of Docetaxel may occur. Patients should be closely monitored
- Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel
InteractionsView
Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.
Pregnancy & lactationView
Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted.
Overdose effectsView
There were a few reports of overdosage. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In case of overdosage, exacerbation of adverse events may be expected. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
StorageView
Store between 2°C and 25°C and protected from light. Freezing does not adversely affect the product.
Taxedol
Docetaxel Trihydrate
Taxedol
Docetaxel Trihydrate
Indications
Stomach carcinoma
Indication detailsView
Docetaxel is a microtubule inhibitor indicated for:
- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
- Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
- Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
- Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
- Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Docetaxel is an antineoplastic agent, which acts by disrupting the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. Docetaxel promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Docetaxel binds to free tubulin thereby decreasing the critical intracellular concentration of tubulin. The promoted polymerization of microtubules leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, resulting in the inhibition of mitosis in cells. The binding of Docetaxel to microtubules does not alter the number of protofilaments in the bound microtubules; in that, it differs from other spindle poisons. Docetaxel was found to be cytotoxic in vitro against various murine and human tumor cell lines, and against freshly excised human tumor cells in clonogenic assays. In addition, Docetaxel was found to be active on a number of cell lines overexpressing the p-glycoprotein, which is encoded by the multidrug resistant gene.
DosageView
Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.
For all patients:
- BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent
- BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles
- NSCLC: after platinum therapy failure: 75 mg/m2 single agent
- NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2
- HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
- GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
- SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
- SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles
For all patients:
- Premedicate with oral corticosteroids
- Adjust dose as needed
Side effectsView
The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ContraindicationsView
Docetaxel is contraindicated in patients with:
- Neutrophil counts of <1500 cells/mm3
- A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
PrecautionsView
- Docetaxel should be administered under the supervision of a physician experienced in the use of antineoplastic agents
- There is a higher risk of developing severe adverse reactions including toxic death and fatal gastrointestinal hemorrhage in patients with hepatic impairment
- Docetaxel therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3
- Fatal cases of enterocolitis, including ischemic colitis, colitis and neutropenic enterocolitis have been reported
- Severe hypersensitivity reactions, with a potential fatal outcome, requiringb immediate discontinuation of Docetaxel may occur. Patients should be closely monitored
- Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel
InteractionsView
Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.
Pregnancy & lactationView
Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted.
Overdose effectsView
There were a few reports of overdosage. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In case of overdosage, exacerbation of adverse events may be expected. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
StorageView
Store between 2°C and 25°C and protected from light. Freezing does not adversely affect the product.
Taxetil
Cefpodoxime Proxetil
Taxetil
Cefpodoxime Proxetil
Indications
Urinary tract infection
Indication detailsView
Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
- Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
- Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
- Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
- Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
- Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
DosageView
Adults and Adolescents (13 years and older)
- Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
- Community acquired pneumonia: 200 mg 12 hourly, 14 days
- Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
- Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
- Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
- Uncomplicated gonorrhea: single dose of 200 mg
- Rectal gonococcal infections in women: single dose of 200 mg
- Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
- Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
Side effectsView
Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
PrecautionsView
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
InteractionsView
Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
Pediatric usageView
Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
ReconstitutionView
Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Taxetil
Cefpodoxime Proxetil
Taxetil
Cefpodoxime Proxetil
Indications
Urinary tract infection
Indication detailsView
Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
- Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
- Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
- Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
- Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
- Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
DosageView
Adults and Adolescents (13 years and older)
- Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
- Community acquired pneumonia: 200 mg 12 hourly, 14 days
- Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
- Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
- Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
- Uncomplicated gonorrhea: single dose of 200 mg
- Rectal gonococcal infections in women: single dose of 200 mg
- Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
- Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
Side effectsView
Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
PrecautionsView
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
InteractionsView
Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
Pediatric usageView
Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
ReconstitutionView
Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Taxetil DS
Cefpodoxime Proxetil
Taxetil DS
Cefpodoxime Proxetil
Indications
Urinary tract infection
Indication detailsView
Cefpodoxime is indicated for the treatment of infections caused by susceptible microorganism, listed below:
- Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
- Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
- Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
- Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
- Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
- Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.
DosageView
Adults and Adolescents (13 years and older)
- Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
- Community acquired pneumonia: 200 mg 12 hourly, 14 days
- Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
- Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
- Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
- Uncomplicated gonorrhea: single dose of 200 mg
- Rectal gonococcal infections in women: single dose of 200 mg
- Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
- Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
- Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days
Side effectsView
Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.
ContraindicationsView
Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.
PrecautionsView
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.
InteractionsView
Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.
Pregnancy & lactationView
US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.
Pediatric usageView
Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.
ReconstitutionView
Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Taxiclot
Tranexamic Acid
Taxiclot
Tranexamic Acid
Indications
Uterine bleeding
Indication detailsView
In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.
In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.
In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.
In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.
In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.
In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.
Therapeutic classView
Anti-fibrinolytic drugs, Haemostatic drugs
PharmacologyView
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of tranexamic acid is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Tranexamic Acid, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
The acute toxicity of Tranexamic Acid is extremely low and chronic toxicity almost non-existent. Tranexamic Acid is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Tranexamic Acid effect more lasting than those conventional hemostatics. Considerably lower single doses of Tranexamic Acid can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.
Tranexamic Acid at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.
DosageView
Adults-
- The usual dose: 500-1000 mg 3 times daily.
- For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route.
- For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses.
- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses.
- For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules.
Side effectsView
- Tranexamic Acid is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems.
- After oral administration there may be sign of nausea, diarrhea, gastric pyrosis.
- There are rare cases of postural hypotension.
- In the case of hypersensitivity to tranexamic acid, avoid or suspend treatment and start a suitable therapy.
ContraindicationsView
Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.
PrecautionsView
- Tranexamic Acid should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it.
- The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared.
- In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract.
- Tranexamic Acid must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions.
- The administration of product requires particular care in cardiopathic and hepatopathic subjects.
InteractionsView
Tranexamic Acid is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Tranexamic Acid. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Tranexamic Acid with whole blood should be avoided during Transfusion.
Pregnancy & lactationView
Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Tranexamic Acid should not be administered during known and presumed pregnancy. Tranexamic Acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
StorageView
Store in a dry place at 15-30°C, away from light and keep out of children's reach.
Taxim
Cefotaxime
Taxim
Cefotaxime
Indications
Urinary tract infection
Indication detailsView
Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.
DosageView
Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Side effectsView
Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
ContraindicationsView
Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
PrecautionsView
Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
InteractionsView
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Pregnancy & lactationView
Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
Pediatric usageView
Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
StorageView
Store below 25°C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8°C.
Taxim
Cefotaxime
Taxim
Cefotaxime
Indications
Urinary tract infection
Indication detailsView
Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.
DosageView
Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Side effectsView
Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
ContraindicationsView
Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
PrecautionsView
Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
InteractionsView
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Pregnancy & lactationView
Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
Pediatric usageView
Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
StorageView
Store below 25°C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8°C.
Taxim
Cefotaxime
Taxim
Cefotaxime
Indications
Urinary tract infection
Indication detailsView
Cefotaxime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemia Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections Bone and Joint Infections such as osteomyelitis, septic arthritis Obstetric and gynaecological infections: such as pelvic inflammatory disease Gonorrhoea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy Prophylaxis: The administration of Cefotaxime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.
DosageView
Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.
Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.
Dosage in gonorrhoea: 500 mg as a single dose.
Side effectsView
Adverse reactions to Cefotaxime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotaxime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.
ContraindicationsView
Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.
PrecautionsView
Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.
InteractionsView
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Pregnancy & lactationView
Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.
Pediatric usageView
Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.
StorageView
Store below 25°C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8°C.
Taxotere
Docetaxel Trihydrate
Taxotere
Docetaxel Trihydrate
Indications
Stomach carcinoma
Indication detailsView
Docetaxel is a microtubule inhibitor indicated for:
- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
- Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
- Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
- Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
- Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Docetaxel is an antineoplastic agent, which acts by disrupting the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. Docetaxel promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Docetaxel binds to free tubulin thereby decreasing the critical intracellular concentration of tubulin. The promoted polymerization of microtubules leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, resulting in the inhibition of mitosis in cells. The binding of Docetaxel to microtubules does not alter the number of protofilaments in the bound microtubules; in that, it differs from other spindle poisons. Docetaxel was found to be cytotoxic in vitro against various murine and human tumor cell lines, and against freshly excised human tumor cells in clonogenic assays. In addition, Docetaxel was found to be active on a number of cell lines overexpressing the p-glycoprotein, which is encoded by the multidrug resistant gene.
DosageView
Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.
For all patients:
- BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent
- BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles
- NSCLC: after platinum therapy failure: 75 mg/m2 single agent
- NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2
- HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
- GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
- SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
- SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles
For all patients:
- Premedicate with oral corticosteroids
- Adjust dose as needed
Side effectsView
The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ContraindicationsView
Docetaxel is contraindicated in patients with:
- Neutrophil counts of <1500 cells/mm3
- A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
PrecautionsView
- Docetaxel should be administered under the supervision of a physician experienced in the use of antineoplastic agents
- There is a higher risk of developing severe adverse reactions including toxic death and fatal gastrointestinal hemorrhage in patients with hepatic impairment
- Docetaxel therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3
- Fatal cases of enterocolitis, including ischemic colitis, colitis and neutropenic enterocolitis have been reported
- Severe hypersensitivity reactions, with a potential fatal outcome, requiringb immediate discontinuation of Docetaxel may occur. Patients should be closely monitored
- Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel
InteractionsView
Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.
Pregnancy & lactationView
Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted.
Overdose effectsView
There were a few reports of overdosage. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In case of overdosage, exacerbation of adverse events may be expected. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
StorageView
Store between 2°C and 25°C and protected from light. Freezing does not adversely affect the product.
Taxotere
Docetaxel Trihydrate
Taxotere
Docetaxel Trihydrate
Indications
Stomach carcinoma
Indication detailsView
Docetaxel is a microtubule inhibitor indicated for:
- Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
- Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
- Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
- Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
- Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN
Therapeutic classView
Cytotoxic Chemotherapy
PharmacologyView
Docetaxel is an antineoplastic agent, which acts by disrupting the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. Docetaxel promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Docetaxel binds to free tubulin thereby decreasing the critical intracellular concentration of tubulin. The promoted polymerization of microtubules leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, resulting in the inhibition of mitosis in cells. The binding of Docetaxel to microtubules does not alter the number of protofilaments in the bound microtubules; in that, it differs from other spindle poisons. Docetaxel was found to be cytotoxic in vitro against various murine and human tumor cell lines, and against freshly excised human tumor cells in clonogenic assays. In addition, Docetaxel was found to be active on a number of cell lines overexpressing the p-glycoprotein, which is encoded by the multidrug resistant gene.
DosageView
Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.
For all patients:
- BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent
- BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles
- NSCLC: after platinum therapy failure: 75 mg/m2 single agent
- NSCLC: chemotherapy-naive: 75 mg/m2 followed by cisplatin 75 mg/m2
- HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
- GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
- SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
- SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles
For all patients:
- Premedicate with oral corticosteroids
- Adjust dose as needed
Side effectsView
The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ContraindicationsView
Docetaxel is contraindicated in patients with:
- Neutrophil counts of <1500 cells/mm3
- A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
PrecautionsView
- Docetaxel should be administered under the supervision of a physician experienced in the use of antineoplastic agents
- There is a higher risk of developing severe adverse reactions including toxic death and fatal gastrointestinal hemorrhage in patients with hepatic impairment
- Docetaxel therapy should not be given to patients with neutrophil counts of less than 1,500 cells/mm3
- Fatal cases of enterocolitis, including ischemic colitis, colitis and neutropenic enterocolitis have been reported
- Severe hypersensitivity reactions, with a potential fatal outcome, requiringb immediate discontinuation of Docetaxel may occur. Patients should be closely monitored
- Treatment related acute myeloid leukemia may occur. No studies have been conducted to assess the carcinogenic potential of Docetaxel
InteractionsView
Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.
Pregnancy & lactationView
Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted.
Overdose effectsView
There were a few reports of overdosage. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In case of overdosage, exacerbation of adverse events may be expected. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
StorageView
Store between 2°C and 25°C and protected from light. Freezing does not adversely affect the product.
Taziaid
Ceftazidime Pentahydrate
Taziaid
Ceftazidime Pentahydrate
Indications
Urinary tract infection
Indication detailsView
Ceftazidime Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp., Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin susceptible strains).
Skin and Skin Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).
Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Klebsiella spp.; and Escherichia coli.
Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae and Staphylococcus aureus (methicillin susceptible strains).
Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin susceptible strains).
Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.
Intraabdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp.
Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis, Pseudomonas aeruginosa and Streptococcus pneumoniae.
Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp., Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin susceptible strains).
Skin and Skin Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).
Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Klebsiella spp.; and Escherichia coli.
Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae and Staphylococcus aureus (methicillin susceptible strains).
Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin susceptible strains).
Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.
Intraabdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp.
Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis, Pseudomonas aeruginosa and Streptococcus pneumoniae.
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.
DosageView
The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition, and renal function of the patient.
Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.
Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.
Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.
Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.
Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.
- In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
- In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anesthesia. A second dose should be considered at the time of catheter removal.
- Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.
Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.
AdministrationView
Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral proof of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.
Side effectsView
The most common side-effects are local reactions following IV injection and allergic and gastrointestinal reactions. Hypersensitivity reactions are pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely. Gastrointestinal symptoms are diarrhea, nausea, vomiting, and abdominal pain. Central nervous system reactions included headache, dizziness, and paresthesia.
ContraindicationsView
Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.
PrecautionsView
The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Pregnancy & lactationView
Pregnancy: No adequate and well-controlled studies in pregnant women have been conducted with Ceftazidime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.
Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage.
Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).
Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.
Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).
Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.
Overdose effectsView
Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.
ReconstitutionView
Single-dose vial Administration Amount of WFI to be added: 250 mg IM in 1.5 ml, 250 mg IV in 5 ml, 500 mg IM in 1.5 ml, 500 mg IV in 5 ml and 1 g IM in 3 ml, 1 g IV in 10 ml.
StorageView
Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.