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| Cefotax Pamphlet |
For the Medical Profession Only
CEFOTAX
CEFOTAX
IV or IM Vials
Broad Spectrum Antibiotic
Composition:
Each via1contains:
Cefotaxime (as sodium salt) 250 mg, 500 mg ,lg,or 2g.
Properties:
CEFOTAX® (cefotaxime) is a third generation cephalosporin antibiotic which acts by inhibition of cell wall synthesis. It has greater bactericidal activity than first or second generation cephalosporins against Gram negative bacteria, cEFYIAX® is highly stable in the presence of beta-lactamases produced by certain Gram negative and Gram positive bacteria.CEFOTAX® is generally effective against the following pathogens:
E.coli. Kiebsiefla, Proteus, Providontia, Enterobacter, Serratia, Salmonella. Shigella. Citrobacter, Versinia, Neisseria, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa species
Staphylococcus aureus (penicilunase and nori-penicillinase producing str.), Staphylococcus epidermidis (non-penicillinase producing str.), and Streptococci including Strep. Group A, group B and pneumoniae.
Cefotax is also active against some anaerobic bacteria such as Bacteroides fragilis, and Clostridium perfringens. Other micro-organisms sensitive to CEF fl..Xinclude the spirochaete Borreha Burgdorfori and the causative organism of chancroid Haemophilus ducreyi. Desacetylcefotaxime is an active metabolite of cetotaxime which exerts an additive or synergistic effect against some species.
Pharmacokinetics:
CERYFAX is administered by injection as the sodium salt. It is rapidly absorbed after IM injection and peak serum concentrations have been attained within 30 minutes. After IV injection. cefotaxime peak serum concentrations have been immediately achievedThe plasma half-life is about 1 hour and that of the major active metabolite.desacetyl derivative is about 1.5 hours. Half-lives are prolonged in patients with severe renal impairment. Cefotaxime is about 40 % bound to plasma proteins. Cefotaxime and the desacetyl metabolite, contributing to the bactericidal activity, are widely distributed in body tissues and fluids. Elimination is mainly by the kidneys and about 40-60 % of a dose has been recovered unchanged in the urine within 24 hours; a further 20 % is eliminated as the desacetyl metabolite. Relatively high concentrations of cefotaxime and desacetylcefotaxime are achieved in bile and about 20 % of a dose has been recovered in faeces.
Indications: -
CEFOTAX® is used in the treatment of infecjions_duG to— U3CeptibIe oranisins especially serious
infectjona inckiding:
— Lower respiratory tract infections including pneumonia.
- Genito-urinary tract infections.
- G.l.tract infections including Typhoid fever.
- Gynecological infections, including pelvic inflammatory disease, eridometritis and pelvic cellulitis.
- Skin and soft tissue infections.
- Bone and joint infections.
• Intra-abdominal infections including peritonitis.
- CNS infections including meningitis and veritriculitis.
- Bacteremia / Septicemia.
- Brain abscess and endocarditis.
- Penoperative prophylaxis.
Dosage:
Adults:Administer IV or IM. Maximum daily dosage should not exceed 12 g. The dose should be determined
by the nature and the severity of infection and by the patients condition.
CEFOTAX Guidelines for Adults:
Composition:
Each via1contains:
Cefotaxime (as sodium salt) 250 mg, 500 mg ,lg,or 2g.
Properties:
CEFOTAX® (cefotaxime) is a third generation cephalosporin antibiotic which acts by inhibition of cell wall synthesis. It has greater bactericidal activity than first or second generation cephalosporins against Gram negative bacteria, cEFYIAX® is highly stable in the presence of beta-lactamases produced by certain Gram negative and Gram positive bacteria.CEFOTAX® is generally effective against the following pathogens:
E.coli. Kiebsiefla, Proteus, Providontia, Enterobacter, Serratia, Salmonella. Shigella. Citrobacter, Versinia, Neisseria, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa species
Staphylococcus aureus (penicilunase and nori-penicillinase producing str.), Staphylococcus epidermidis (non-penicillinase producing str.), and Streptococci including Strep. Group A, group B and pneumoniae.
Cefotax is also active against some anaerobic bacteria such as Bacteroides fragilis, and Clostridium perfringens. Other micro-organisms sensitive to CEF fl..Xinclude the spirochaete Borreha Burgdorfori and the causative organism of chancroid Haemophilus ducreyi. Desacetylcefotaxime is an active metabolite of cetotaxime which exerts an additive or synergistic effect against some species.
Pharmacokinetics:
CERYFAX is administered by injection as the sodium salt. It is rapidly absorbed after IM injection and peak serum concentrations have been attained within 30 minutes. After IV injection. cefotaxime peak serum concentrations have been immediately achievedThe plasma half-life is about 1 hour and that of the major active metabolite.desacetyl derivative is about 1.5 hours. Half-lives are prolonged in patients with severe renal impairment. Cefotaxime is about 40 % bound to plasma proteins. Cefotaxime and the desacetyl metabolite, contributing to the bactericidal activity, are widely distributed in body tissues and fluids. Elimination is mainly by the kidneys and about 40-60 % of a dose has been recovered unchanged in the urine within 24 hours; a further 20 % is eliminated as the desacetyl metabolite. Relatively high concentrations of cefotaxime and desacetylcefotaxime are achieved in bile and about 20 % of a dose has been recovered in faeces.
Indications: -
CEFOTAX® is used in the treatment of infecjions_duG to— U3CeptibIe oranisins especially serious
infectjona inckiding:
— Lower respiratory tract infections including pneumonia.
- Genito-urinary tract infections.
- G.l.tract infections including Typhoid fever.
- Gynecological infections, including pelvic inflammatory disease, eridometritis and pelvic cellulitis.
- Skin and soft tissue infections.
- Bone and joint infections.
• Intra-abdominal infections including peritonitis.
- CNS infections including meningitis and veritriculitis.
- Bacteremia / Septicemia.
- Brain abscess and endocarditis.
- Penoperative prophylaxis.
Dosage:
Adults:Administer IV or IM. Maximum daily dosage should not exceed 12 g. The dose should be determined
by the nature and the severity of infection and by the patients condition.
CEFOTAX Guidelines for Adults:
type of infection
|
Daily Dosage (g)
|
Frequency and Route
|
Uncomplicated infections
|
2
|
1 9/12 hours IM or IV
|
Moderate to Severe infections
|
3-6
|
1-2 9/5 hours lM or IV
|
lnfectons commonly needing higher dosage (e.g. Septicemia)
|
6-8
|
2 g/6-8 hours IV
|
Gonococcal urethritis/cervicits In males and females
|
0.5
|
0.5 g IM (single dose)
|
Rectal gonorrhea in females
|
0.5
|
0.5 g IM (single dose)
|
Rectal gonorrhea in males
|
1
|
1 g IM (single dose)
|
Life•threatening infections
|
12
|
2 g/4 hours IV
|
Perioperative prophylaxis:1 g IV or IM, 30 to 90 minutes prior to surgery.
Caesarian Section:Administer the first 1 g dose IV as soon as the umbilical cord is clamped.Administer the second and third doses as 1 g IV or IM at 6 and 12 hour intervals after the first dose.
Renal function impairment: In patients with severe impaired renal function (creatinirie clearance <20 ml/ mm.), the dose should be reduced to half the normal dose
Pediatrics:
It is not necessary to differentiate between premature and normal gestatiorial age infants. The following
dosage recommendations may serve as a guide.
CEFOTAX Guidelines for Pediatrics
Renal function impairment: In patients with severe impaired renal function (creatinirie clearance <20 ml/ mm.), the dose should be reduced to half the normal dose
Pediatrics:
It is not necessary to differentiate between premature and normal gestatiorial age infants. The following
dosage recommendations may serve as a guide.
CEFOTAX Guidelines for Pediatrics
0 - 1 week of age
|
50 mg/kg/12 hours
|
IV
|
- 1 - 4 weeks of age
|
50 mg;’kg/8 hours
|
IV
|
1 month - 12 years (<50 kg)
|
50 - 180 mg/kg/day
in 4-6 divided doses |
IV or IM
|
Children 50 kg: Use adult dose.
Use higher doses for more severe or serious infections including meningitis.
Administration:
CEFOTAXis given by deep lM injection or IV by slow injection over 3-5 minutes or by infusion over 20-60 minutes.
Higher doses (>2 g daily dose) of CEFYI)’IXe are injected preferably by IV administration or by IV infusion. Preparation of Solutions:
To prepare initial dilution for IM use, 2,3 ml of sterile water for injection or Bacteriostatic water for injection should be added to each 500 mg. 1 g vials respectively.
To prepare initial dilution for IV use, 10 ml of sterile water for injection should be acded to each 500 mg, 1 g vial and 2 § vial.
To prepare initial dilution for IV infusion, 50-100 ml of 0.9 % Sodium Chloride injection or 5 e/ Dextrose injection should be added to each 500 mg. 1 g vial and 2 g vial.
Solutions range in color from pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
This does not affect their potency when stored per recommendations.
Do not use with diluents having a pH above 7.5 (eg. Sodium bicarbonate injection).
Storage/Stability
CEFtJI’AX® vials in the dry state should be stored below 20°C. The dry material as well as the solutions tend to darken depending on storage conditions. Protect from elevated temperatures and excessive light. Reconstituted solutions of Cefotax maintain potency for 24 hours at room temperature. for 10 days under refrigeration and for at least 13 weeks frozen.
Admixture:
CEFtTI’AX® solution should not be admixed with aminoglycoside solutions. If both solutions are to be given to the same patient, administer separately.
Drug Interactions:
As with many cephalosporins, probenecid reduces the renal clearance of CEFOTAXIX resulting in higher plasma levels.
Concomitant administration of cephalosporins. including CEFOFAX®, and aminoglycoside
antibiotics may cause increased nephrotoxicity. Renal function should be monitored closely.
Concomitant administration of ureidopenicillins decrease CEF(J[AX® total body clearance.
Precautions:
Great care shp.sld be taken if- CEFOTAX’ is to be given to penicillin-sensitive patients or to patients with a history of allergy to other drugs.
Cefotax vial should be given with caution to patients with renal impairment; a dosage reduction may be necessary.
CEFOTAX® vial may be used in association with an aminoglycoside. another beta-lactam or with rnetronidazole. The drugs should be administered separately.
CEFOTAX vials should be used with caution, and only if clearly needed, in patients with colitis. Pregnancy and lactation;the drug may be used only if potential benefit justifies the potential risk to the fetus or to the breast-ted infant, respectively.
For courses of treatment lasting lonr than 10 days, blood counts should be monitored.
To minimize the potential for tissue inflammation, infusion sites should be monitored regularly and changed when appropriate.
Contra-indications:
A known hypersensitivity to cephalosporins or to related antibiotics.
Side Effects:
CEFIYEAX®is generally well-tolerated. The most common side effects are local reactions: e.g. pain at the l.M. injection site, or inflammatory irritation with IV administration.Other side effects may include hypersensitivity reactions : e.g. rash, pruritus, effects on blood pressure, transient elevation in SGOT and SGPT, nausea, vomiting, diarrhea, pseudomembranous colitis, or granulocytopenia.
Packaging: - - -
CEF(TfA.X250 mg, 500 mg, and 1 g ,2g vials : Boxor’rviaT 1 or 2 ampoules Solvent.
This is a Mcdicamcnt.
•Medicament is a product which affects your health, and its consumption contrary to instructions
is dangerous for you.
•Foltow strictly the doctor’s prescription, the method of use, and the instructions of the pharmacist
who sold the medicament.
•The doctor and the pharmacist are experts in medicine, its benefits and risks.
•Do not interrupt the period of treatment prescrioed by yourself.
•Do not repeat the same prescription without consulting your doctor.
•Keep medicines out of the reach of children.
26-06.2007 PMS-BLACK C V2 56gm/m20..95X300MM 319 300 PAM 000
EGYPTIAN INT. PHARMACEUTiCAL INDUSTRIES CO.
E. I. R I. CO.
10th OF RAMADAN CITY, AREA 81 P.O.BOX 149 TENTH, EGYPT
Administration:
CEFOTAXis given by deep lM injection or IV by slow injection over 3-5 minutes or by infusion over 20-60 minutes.
Higher doses (>2 g daily dose) of CEFYI)’IXe are injected preferably by IV administration or by IV infusion. Preparation of Solutions:
To prepare initial dilution for IM use, 2,3 ml of sterile water for injection or Bacteriostatic water for injection should be added to each 500 mg. 1 g vials respectively.
To prepare initial dilution for IV use, 10 ml of sterile water for injection should be acded to each 500 mg, 1 g vial and 2 § vial.
To prepare initial dilution for IV infusion, 50-100 ml of 0.9 % Sodium Chloride injection or 5 e/ Dextrose injection should be added to each 500 mg. 1 g vial and 2 g vial.
Solutions range in color from pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
This does not affect their potency when stored per recommendations.
Do not use with diluents having a pH above 7.5 (eg. Sodium bicarbonate injection).
Storage/Stability
CEFtJI’AX® vials in the dry state should be stored below 20°C. The dry material as well as the solutions tend to darken depending on storage conditions. Protect from elevated temperatures and excessive light. Reconstituted solutions of Cefotax maintain potency for 24 hours at room temperature. for 10 days under refrigeration and for at least 13 weeks frozen.
Admixture:
CEFtTI’AX® solution should not be admixed with aminoglycoside solutions. If both solutions are to be given to the same patient, administer separately.
Drug Interactions:
As with many cephalosporins, probenecid reduces the renal clearance of CEFOTAXIX resulting in higher plasma levels.
Concomitant administration of cephalosporins. including CEFOFAX®, and aminoglycoside
antibiotics may cause increased nephrotoxicity. Renal function should be monitored closely.
Concomitant administration of ureidopenicillins decrease CEF(J[AX® total body clearance.
Precautions:
Great care shp.sld be taken if- CEFOTAX’ is to be given to penicillin-sensitive patients or to patients with a history of allergy to other drugs.
Cefotax vial should be given with caution to patients with renal impairment; a dosage reduction may be necessary.
CEFOTAX® vial may be used in association with an aminoglycoside. another beta-lactam or with rnetronidazole. The drugs should be administered separately.
CEFOTAX vials should be used with caution, and only if clearly needed, in patients with colitis. Pregnancy and lactation;the drug may be used only if potential benefit justifies the potential risk to the fetus or to the breast-ted infant, respectively.
For courses of treatment lasting lonr than 10 days, blood counts should be monitored.
To minimize the potential for tissue inflammation, infusion sites should be monitored regularly and changed when appropriate.
Contra-indications:
A known hypersensitivity to cephalosporins or to related antibiotics.
Side Effects:
CEFIYEAX®is generally well-tolerated. The most common side effects are local reactions: e.g. pain at the l.M. injection site, or inflammatory irritation with IV administration.Other side effects may include hypersensitivity reactions : e.g. rash, pruritus, effects on blood pressure, transient elevation in SGOT and SGPT, nausea, vomiting, diarrhea, pseudomembranous colitis, or granulocytopenia.
Packaging: - - -
CEF(TfA.X250 mg, 500 mg, and 1 g ,2g vials : Boxor’rviaT 1 or 2 ampoules Solvent.
This is a Mcdicamcnt.
•Medicament is a product which affects your health, and its consumption contrary to instructions
is dangerous for you.
•Foltow strictly the doctor’s prescription, the method of use, and the instructions of the pharmacist
who sold the medicament.
•The doctor and the pharmacist are experts in medicine, its benefits and risks.
•Do not interrupt the period of treatment prescrioed by yourself.
•Do not repeat the same prescription without consulting your doctor.
•Keep medicines out of the reach of children.
26-06.2007 PMS-BLACK C V2 56gm/m20..95X300MM 319 300 PAM 000
EGYPTIAN INT. PHARMACEUTiCAL INDUSTRIES CO.
E. I. R I. CO.
10th OF RAMADAN CITY, AREA 81 P.O.BOX 149 TENTH, EGYPT
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