Kalfoxim Injection
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Saat Anda membutuhkan Antibiotika Terbaik
Composition
Cefotaxime Sodium
Indication
Treatment of serious and life-threatening infections caused by the following organisms: Gram-negative : E. coli, H. influenzae (especially ampicillin-resistant strains), Klebsiella, Proteus (both indole-positive and indole-negative), Enterobacter, Neisseria (especially b-lactamase producing strains of N. gonorrheae), Shigella, Providencia, Serratia, Citrobacter, Pseudomonas (some strains are less sensitive) and Bacteroides (some strains of B. fragilis are resistant). Gram-positive : Staphylococci (especially penicillinase-producing strains), Streptococci (S. pyogenes, S. viridans, S. pneumoniae), Clostridium. Many strains of Streptococci (S. faecalis) are relatively resistant. Kalfoxim is indicated for treatment of the following serious infections which are caused by the susceptible strains as it mentioned before : 1. Lower respiratory tract infections, including pneumonia. 2. Genitourinary infections : urinary tract infections and gonorrhea (particularly if penicillin-resistant). 3. Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis. 4. Bacteremia / Septicemia. 5. Skin and skin structure infections. 6. Intra-abdominal infections, including peritonitis. 7. Bone and/ or joint infections. 8. Central nervous system infections, eg. meningitis and ventriculitis. Kalfoxim is also indicated for prophylaxis of certain post-operative infections in contaminated or potentially contaminated surgical procedures or in clean operations where infections would have serious effects.
Treatment of serious and life-threatening infections caused by the following organisms: Gram-negative : E. coli, H. influenzae (especially ampicillin-resistant strains), Klebsiella, Proteus (both indole-positive and indole-negative), Enterobacter, Neisseria (especially b-lactamase producing strains of N. gonorrheae), Shigella, Providencia, Serratia, Citrobacter, Pseudomonas (some strains are less sensitive) and Bacteroides (some strains of B. fragilis are resistant). Gram-positive : Staphylococci (especially penicillinase-producing strains), Streptococci (S. pyogenes, S. viridans, S. pneumoniae), Clostridium. Many strains of Streptococci (S. faecalis) are relatively resistant. Kalfoxim is indicated for treatment of the following serious infections which are caused by the susceptible strains as it mentioned before : 1. Lower respiratory tract infections, including pneumonia. 2. Genitourinary infections : urinary tract infections and gonorrhea (particularly if penicillin-resistant). 3. Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis. 4. Bacteremia / Septicemia. 5. Skin and skin structure infections. 6. Intra-abdominal infections, including peritonitis. 7. Bone and/ or joint infections. 8. Central nervous system infections, eg. meningitis and ventriculitis. Kalfoxim is also indicated for prophylaxis of certain post-operative infections in contaminated or potentially contaminated surgical procedures or in clean operations where infections would have serious effects.
Contra Indication
Hypersensitivity to cephalosporins.
Hypersensitivity to cephalosporins.
Warning
1. Careful inquiry should be made before therapy with Kalfoxim to detect any previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Kalfoxim should be given with caution to patients who are hypersensitive to penicillins, because cross reactions have been reported. Special care is indicated in patients who have had an anaphylactic response to penicillin. If an allergic reaction to Kalfoxim occurs, discontinue the drug. 2. As with other broad spectrum antibiotics, prolonged use of Kalfoxim may result in overgrowth of nonsusceptible bacteria and fungi (including C. difficile). If superinfections (including pseudomembraneous colitis) occur during therapy, appropriate measures should be taken. 3. Use Kalfoxim with caution in patients with a history of gastrointestinal disease, particularly colitis. 4. In severe renal dysfunction, Kalfoxim dosage should be reduced (see Dosage and Administration). 5. Kalfoxim at high dosage may enhance the nephrotoxicity of aminoglycoside antibiotics or potent diuretics such as furosemide, therefore this combination should be given with caution. At recommended dosage, however, Kalfoxim is unlikely to cause this enhancement. 6. Pregnancy: although in animal studies cefotaxime has not been shown to produce harmful effects on the fetus, its safety in human pregnancy has not been established. Therefore, Kalfoxim should be used during pregnancy (especially during the first trimester of pregnancy) only if absolutely needed. 7. Lactation: cefotaxime is excreted in human milk in low concentrations. Therefore, it should be used with caution in nursing mothers.
1. Careful inquiry should be made before therapy with Kalfoxim to detect any previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Kalfoxim should be given with caution to patients who are hypersensitive to penicillins, because cross reactions have been reported. Special care is indicated in patients who have had an anaphylactic response to penicillin. If an allergic reaction to Kalfoxim occurs, discontinue the drug. 2. As with other broad spectrum antibiotics, prolonged use of Kalfoxim may result in overgrowth of nonsusceptible bacteria and fungi (including C. difficile). If superinfections (including pseudomembraneous colitis) occur during therapy, appropriate measures should be taken. 3. Use Kalfoxim with caution in patients with a history of gastrointestinal disease, particularly colitis. 4. In severe renal dysfunction, Kalfoxim dosage should be reduced (see Dosage and Administration). 5. Kalfoxim at high dosage may enhance the nephrotoxicity of aminoglycoside antibiotics or potent diuretics such as furosemide, therefore this combination should be given with caution. At recommended dosage, however, Kalfoxim is unlikely to cause this enhancement. 6. Pregnancy: although in animal studies cefotaxime has not been shown to produce harmful effects on the fetus, its safety in human pregnancy has not been established. Therefore, Kalfoxim should be used during pregnancy (especially during the first trimester of pregnancy) only if absolutely needed. 7. Lactation: cefotaxime is excreted in human milk in low concentrations. Therefore, it should be used with caution in nursing mothers.
Dosage
· Kalfoxim may be administered IM or IV · Dosage, route and frequency of administration should be determined by susceptibility of the causative organisms, severity of the injection, and condition of the patient. · Therapy may be started after the result of sensitivity tests are known. 1. Adults and children over 12 years : The usual daily dosage is 2-6 g, with a maximum of 12 g. - Mild to moderate or uncomplicated infections such as UTI : 1 g every 12 hours. - Moderate to serious infections : 1 g every 8 hours - Life-threatening infections : 2 g every 8 hours - Gonorrhea : 1 g single dose (IM or IV). 2. Infants and children (1 month to 12 years) : The recommended daily dose is 50 - 180 mg/kg IM or IV in 4 -6 equally divided doses. The higher dosage is used for more severe or serious infections, including meningitis. 3. Neonates and premature babies (birth to 1 month) : The recommended dosage is as follows: 0 - 1 week of age : 50 mg / kg IV every 12 hours. 1 - 4 weeks of age : 50 mg / kg IV every 8 hours. 4. Dosage in impaired renal function : In severe renal failure (creatinine clearance <= 5 ml /minute) : half the maintenance dose without changing the initial dose and the frequency of dosing. 5. Dosage in contaminated or potentially contaminated surgery : A single 1 gram IM or IV 30 - 90 minutes prior to start of surgery. 6. Dosage in Cesarean Section : 1st dose : 1 g IV as soon as the umbilical cord is clamped. 2nd dose : 1 g IV or IM 6 hours later 3rd dose : 1 g IV or IM 12 hours after the 1st dose 7. Duration of treatment - In general : continue therapy for at least 48 - 72 hours after the body temperature becomes normal or after evidence of bacterial eradication. - Infections caused by Group A beta-hemolytic streptococci : minimum 10 days. - Persistent infections : may require several weeks. · IV and IM Injection : Dissolve the contents of one vial in water for injection as follows: Kalfoxim® Water for injection 0.25 g 2 ml 0.5 g 2 ml 1.0 g 4 ml 2.0 g 10 ml For IV injection, the above solution should be injected slowly (over a period of 3-5 minutes). For IM injection, the above solution should be injected deep into the gluteus muscle. It is advisable not to inject more than 4 ml into either side. The pain of injection can be avoided by dissolving Kalfoxim in 1 % lignocaine solution; this solution must not be injected IV. If the daily dose exceeds 2 g, IV injection is preferred. · IV infusion : Dissolve 1 - 2 g in 50 - 100 ml of water for injection or in the following infusion fluids : Sodium Chloride Injections, 5% Dextrose Injection, Dextrose and Sodium Chloride Injection, Compound Sodium Lactate Injection (Ringer-Lactate injection), or in any of the current infusion solutions having pH 5 - 7 (cefotaxime solution have maximum stability in this pH range, but not in Sodium Bicarbonate Injection (pH above 7.5)). The prepared solution should be infused over 20 - 60 minutes. · Storage and stability of solutions : It is preferable to use only freshly prepared solutions for IV and IM injection and for IV infusion. Cefotaxime solutions for IV and IM injection retain satisfactory potency for 24 hours at room temperature (at or below 22° C), for 10 days in the refrigerator (below 5° C), and for at least 13 weeks in the frozen state. Solutions for IV infusion maintain potency for 24 hours at room temperature (at or below 22° C), and at least 5 days under refrigeration. Some increase in colour of prepared solutions may occur in storage. However, in the recommended storage conditions, this dose not indicate change in potency or safety. Do not heat frozen samples but thaw at room temperature before use. After the periods mentioned above, discard any unused solutions or frozen materials. Do not refreeze. When cefotaxime is dissolved in 1% lignocaine solution for IM injection, only freshly prepared solutions should be used.
· Kalfoxim may be administered IM or IV · Dosage, route and frequency of administration should be determined by susceptibility of the causative organisms, severity of the injection, and condition of the patient. · Therapy may be started after the result of sensitivity tests are known. 1. Adults and children over 12 years : The usual daily dosage is 2-6 g, with a maximum of 12 g. - Mild to moderate or uncomplicated infections such as UTI : 1 g every 12 hours. - Moderate to serious infections : 1 g every 8 hours - Life-threatening infections : 2 g every 8 hours - Gonorrhea : 1 g single dose (IM or IV). 2. Infants and children (1 month to 12 years) : The recommended daily dose is 50 - 180 mg/kg IM or IV in 4 -6 equally divided doses. The higher dosage is used for more severe or serious infections, including meningitis. 3. Neonates and premature babies (birth to 1 month) : The recommended dosage is as follows: 0 - 1 week of age : 50 mg / kg IV every 12 hours. 1 - 4 weeks of age : 50 mg / kg IV every 8 hours. 4. Dosage in impaired renal function : In severe renal failure (creatinine clearance <= 5 ml /minute) : half the maintenance dose without changing the initial dose and the frequency of dosing. 5. Dosage in contaminated or potentially contaminated surgery : A single 1 gram IM or IV 30 - 90 minutes prior to start of surgery. 6. Dosage in Cesarean Section : 1st dose : 1 g IV as soon as the umbilical cord is clamped. 2nd dose : 1 g IV or IM 6 hours later 3rd dose : 1 g IV or IM 12 hours after the 1st dose 7. Duration of treatment - In general : continue therapy for at least 48 - 72 hours after the body temperature becomes normal or after evidence of bacterial eradication. - Infections caused by Group A beta-hemolytic streptococci : minimum 10 days. - Persistent infections : may require several weeks. · IV and IM Injection : Dissolve the contents of one vial in water for injection as follows: Kalfoxim® Water for injection 0.25 g 2 ml 0.5 g 2 ml 1.0 g 4 ml 2.0 g 10 ml For IV injection, the above solution should be injected slowly (over a period of 3-5 minutes). For IM injection, the above solution should be injected deep into the gluteus muscle. It is advisable not to inject more than 4 ml into either side. The pain of injection can be avoided by dissolving Kalfoxim in 1 % lignocaine solution; this solution must not be injected IV. If the daily dose exceeds 2 g, IV injection is preferred. · IV infusion : Dissolve 1 - 2 g in 50 - 100 ml of water for injection or in the following infusion fluids : Sodium Chloride Injections, 5% Dextrose Injection, Dextrose and Sodium Chloride Injection, Compound Sodium Lactate Injection (Ringer-Lactate injection), or in any of the current infusion solutions having pH 5 - 7 (cefotaxime solution have maximum stability in this pH range, but not in Sodium Bicarbonate Injection (pH above 7.5)). The prepared solution should be infused over 20 - 60 minutes. · Storage and stability of solutions : It is preferable to use only freshly prepared solutions for IV and IM injection and for IV infusion. Cefotaxime solutions for IV and IM injection retain satisfactory potency for 24 hours at room temperature (at or below 22° C), for 10 days in the refrigerator (below 5° C), and for at least 13 weeks in the frozen state. Solutions for IV infusion maintain potency for 24 hours at room temperature (at or below 22° C), and at least 5 days under refrigeration. Some increase in colour of prepared solutions may occur in storage. However, in the recommended storage conditions, this dose not indicate change in potency or safety. Do not heat frozen samples but thaw at room temperature before use. After the periods mentioned above, discard any unused solutions or frozen materials. Do not refreeze. When cefotaxime is dissolved in 1% lignocaine solution for IM injection, only freshly prepared solutions should be used.
Presentation
Vial 500 mg dan 1000 mg Simpan di bawah suhu 30° C. Terlindung dari cahaya.
Vial 500 mg dan 1000 mg Simpan di bawah suhu 30° C. Terlindung dari cahaya.
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