Find Medicines

Third generation Cephalosporins

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.

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.

• 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.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• 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.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

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 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.

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.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

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: 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.

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.

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.

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.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Third generation Cephalosporins

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.

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.

• 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.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• 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.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

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 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.

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.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

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: 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.

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.

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.

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.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Third generation Cephalosporins

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.

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.

• 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.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• 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.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

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 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.

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.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

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: 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.

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.

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.

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.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Third generation Cephalosporins

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.

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.

• 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.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• 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.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

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 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.

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.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

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: 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.

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.

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.

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.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Third generation Cephalosporins

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.

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.

• 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.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• 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.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

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 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.

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.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

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: 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.

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.

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.

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.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Third generation Cephalosporins

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.

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.

• 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.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• 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.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

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 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.

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.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

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: 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.

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.

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.

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.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Third generation Cephalosporins

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.

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.

• 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.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

• 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.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

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 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.

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.

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

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: 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.

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.

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.

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.

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Broad spectrum penicillins, Other beta-lactam Antibiotics

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.

Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.

Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.

Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).

Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.

Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.

Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.

Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.

Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.

Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.

Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.

Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.

Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.

Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.

Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients

There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.

Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.

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

Broad spectrum penicillins, Other beta-lactam Antibiotics

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.

Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.

Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.

Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).

Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.

Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.

Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.

Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.

Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.

Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.

Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.

Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.

Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.

Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.

Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients

There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.

Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.

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

Broad spectrum penicillins, Other beta-lactam Antibiotics

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.

Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.

Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.

Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).

Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.

Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.

Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.

Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.

Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.

Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.

Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.

Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.

Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.

Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.

Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients

There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.

Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.

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

Broad spectrum penicillins, Other beta-lactam Antibiotics

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.

Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.

Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.

Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).

Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.

Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.

Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.

Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.

Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.

Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.

Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.

Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.

Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.

Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.

Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients

There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.

Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.

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

Broad spectrum penicillins, Other beta-lactam Antibiotics

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.

Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.

Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.

Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).

Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.

Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.

Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.

Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.

Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.

Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.

Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.

Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.

Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.

Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.

Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients

There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.

Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.

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

Broad spectrum penicillins, Other beta-lactam Antibiotics

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.

Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.

Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.

Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).

Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.

Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.

Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.

Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.

Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.

Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.

Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.

Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.

Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.

Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.

Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients

There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.

Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.

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

Tazarotene is used to treat plaque psoriasis of the skin. It also works to treat acne on the face.

Topical retinoid and related preparations

Tazarotene is a retinoid prodrug which is converted to its active form, the cognate carboxylic acid of tazarotene, by rapid deesterification in animals and man. In cell culture and in vitro models of skin, tazarotene suppresses expression of MRP8, a marker of inflammation present in the epidermis of psoriasis patients at high levels. In human keratinocyte cultures, it inhibits cornified envelope formation, whose build-up is an element of the psoriatic scale.

For psoriasis: Tazarotene cream should be applied once per day, in the evening, to psoriatic lesions, using enough (2 mg/cm²) to cover only the lesion with a thin film. If a bath or shower is taken prior to application, the skin should be dried before applying the cream. If emollients are used, they should be applied at least one hour before application of Tazarotene cream.

For acne: Cleanse the face gently. After the skin is dry, apply a thin layer (2mg/cm²) of Tazarotene cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.

The most frequent adverse events reported with Tazarotene cream were limited to the skin. Those occurring in 10 to 23% of patients, in descending order, included pruritus, erythema and burning. For acne treatment, in 10 to 30% patients, it is reported desquamation, dry skin, face pain, irritation and stinging sensation.

Retinoids may cause fetal harm when administered to a pregnant woman. Tazarotene cream is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be warned to the potential risk and use adequate birth-control measures when Tazarotene cream is used.

Tazarotene cream should be applied only to the affected areas. For external use only. Avoid contact with eyes, eyelids and mouth. If contact with eyes occurs, rinse thoroughly with water. Retinoids should not be used on eczematous skin, as they may cause severe irritation. Patients must be warned to use sunscreens and protective clothing when using Tazarotene cream. Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced

Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient’s skin until the effects of such preparations subside before use of Tazarotene cream is begun. Topical steroid may be hazardous in psoriasis; careful patient supervision is important. Consider if infection spreads. Do not use near a naked flame.

Pregnancy: Tazarotene is not recommended during pregnancy. It has been shown to cause serious birth defects and problems in animals. Be sure you have discussed this with your doctor.

Nursing Mothers: It is not known whether tazarotene passes into breast milk. However, Tazarotene is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.

Pediatric Use: Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of Tazarotene in children up to 12 years of age (gel) and up to 18 years of age (cream) with use in other age groups.

Elderly Use (Over 65 year): There is no specific information comparing the use of Tazarotene in the elderly with use in other age groups.

Excessive topical use cause marked redness, peeling or discomfort. Accidental oral ingestion produces similar adverse effects as those associated with excessive oral intake of Vitamin A or other retinoids. Monitor and take supportive measures as necessary.

Store at 25° C.

Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.

Anti-diarrhoeal Antiprotozoal

Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.

Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.

It is recommended to be administered with food.

The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.

It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.

Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.

It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.

US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.

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

Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.

Anti-diarrhoeal Antiprotozoal

Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.

Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.

It is recommended to be administered with food.

The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.

It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.

Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.

It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.

US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.

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

The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab is a mediator of antibody-dependent cellular cytotoxicity (ADCC). In vitro, Trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.

Recommended Doses and Schedules: Do not administer as an intravenous push or bolus. Do not mix Trastuzumab with other drugs.

Adjuvant Treatment, Breast Cancer: Administer according to one of the following doses and schedules for a total of 52 weeks of Trastuzumab therapy:

During and following paclitaxel, docetaxel, or docetaxel/carboplatin:

• Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
• One week following the last weekly dose of Trastuzumab, administer Trastuzumab at 6 mg/kg as an intravenous infusion over 30−90 minutes every three weeks.

As a single agent within three weeks following completion of multi-modality, anthracycline-based chemotherapy regimens:

• Initial dose at 8 mg/kg as an intravenous infusion over 90 minutes
• Subsequent doses at 6 mg/kg as an intravenous infusion over 30−90 minutes every three weeks.
• Extending adjuvant treatment beyond one year is not recommended

Metastatic Treatment, Breast Cancer: Administer Trastuzumab, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90 minute intravenous infusion followed by subsequent once-weekly doses of 2 mg/kg as 30-minute intravenous infusions until disease progression.

Metastatic Gastric Cancer: Administer Trastuzumab at an initial dose of 8 mg/kg as a 90-minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks until disease progression. Or, as directed by the registered physician.

The most serious adverse reactions caused by Trastuzumab includes Cardiomyopathy, Infusion Reactions, Embryo-Fetal Toxicity, Pulmonary Toxicity, Exacerbation of Chemotherapy-Induced Neutropenia. The most common adverse reactions in patients receiving Trastuzumab in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

Cardiomyopathy: Trastuzumab can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 4-6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Trastuzumab as a single agent or in combination therapy compared with those not receiving Trastuzumab. The highest absolute incidence occurs when Trastuzumab is administered with an anthracycline. Withhold Trastuzumab for ≥ 16% absolute decrease in LVEF from pre treatment values or an LVEF value below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values. The safety of continuation or resumption of Trastuzumab in patients with Trastuzumab-induced left ventricular cardiac dysfunction has not been studied.

Cardiac Monitoring: Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:

• Baseline LVEF measurement immediately prior to initiation of Trastuzumab
• LVEF measurements every 3 months during and upon completion of Trastuzumab
• Repeat LVEF measurement at 4 week intervals if Trastuzumab is withheld for significant left ventricular cardiac dysfunction.
• LVEF measurements every 6 months for at least 2 years following completion of Trastuzumab as a component of adjuvant therapy.

Infusion Reactions: Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. Serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable, including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction. Interrupt Trastuzumab infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions. There are no data regarding the most appropriate method of identification of patients who may safely be retreated with Trastuzumab after experiencing a severe infusion reaction. Prior to resumption of Trastuzumab infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. While some patients tolerated Trastuzumab infusions, others had recurrent severe infusion reactions despite pre-medications.

Embryo-Fetal Toxicity: Trastuzumab can cause fetal harm when administered to a pregnant woman. Use of Trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab.

Pulmonary Toxicity: Trastuzumab use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.

Exacerbation of Chemotherapy-Induced Neutropenia: In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received Trastuzumab and those who did not.

Patients who receive anthracycline after stopping Trastuzumab may be at increased risk of cardiac dysfunction because of Trastuzumab’s long washout period based on population PK analysis. If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Trastuzumab. If anthracyclines are used, the patient’s cardiac function should be monitored carefully.

It can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of Trastuzumab. Advise pregnant women and females of reproductive potential that exposure to Trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab. There is no information regarding the presence of Trastuzumab in human milk, the effects on the breastfed infant, or the effects on milk production.

Pediatric Use: The safety and effectiveness in pediatric patients have not been established.

Reconstitute each 440 mg vial of Trastuzumab with 20 ml of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative to yield a multi-dose solution containing 21 mg/ml Trastuzumab. In patients with known hypersensitivity to benzyl alcohol, reconstitute with 20 ml of Sterille Water for Injection (SWFI) without preservative to yield a single use solution.

Store the vial in original carton at 2 o -8 o C. Protect from light. Keep out of the reach of children. Store reconstituted Trastuzumab in the refrigerator at 2°C to 8°C, discard unused Trastuzumab after 28 days. If Trastuzumab is reconstituted with SWFI without preservative, use immediately and discard any unused portion. Do not freeze. The solution of Trastuzumab for infusion diluted in 0.9% Sodium Chloride Injection, USP, should be stored at 2°C to 8°C for no more than 24 hours prior to use. Do not freeze.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

• ½-1 year: 75 mg daily.
• 1-4 years: 100 mg daily.
• 5-10 years: 200 mg daily.
• 11-12 years: 300 mg daily
• In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.