Gramotax

Gramotax

cefotaxime

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Cefotaxime sodium.
Description
Each vial contains cefotaxime sodium equivalent to cefotaxime 1000 mg. It also contains water for injection as solvent.
The sodium content of Gramotax is 2.09 micromole/g.
Action
Gramotax is an antibiotic of the cephalosporin group and has a bactericidal effect. Its antibacterial activity against gram-negative and rod-shaped bacteria is many times stronger than that of the known cephalosporins and penicillins and in most pathogens its minimum bactericidal concentration is slightly higher than its minimum inhibitory concentration.
Resistance develops slowly, as with penicillin.
As a rule, in vitro studies of a combination of Gramotax with aminoglycoside antibiotics reveal a synergistic effect.
The serum protein-binding of Gramotax is 32-50% depending on the method used.
High Gramotax concentrations that clearly exceed the sensitivity of most pathogens are obtained at the site of injection in serum, tissues and body fluids.
Gramotax is excreted mainly through the kidneys in an active form.
Microbiology: Cefotaxime is generally effective against the following pathogens: Staphylococci, aerobic and anaerobic Streptococci, Streptococcus pneumoniae, Neisseria sp, Haemophilus influenzae, Escherichia coli, Citrobacter, Salmonella and Klebsiella spp, Enterobacter aerogenes, Serratia sp, indole-positive and -negative Proteus sp, Yersinia enterocolitica, Clostridium and Bacteroides spp.
Pathogens with varying susceptibility are Streptococcus faecalis, Enterobacter cloacae, Pseudomonas aeruginosa and Bacteroides fragilis.
There is not yet sufficient clinical experience with Salmonella typhi and paratyphi A and B infections.
Cefotaxime is not effective against Treponema pallidum and Clostridium difficile.
Indications/Uses
Severe infections caused by cefotaxime-sensitive pathogens.
Infections of the respiratory tract including nose and throat; ear; kidneys and urinary tract; skin and soft tissues; bones and joints; genital organs, including gonorrhoea; and abdominal region.
Septicaemia, bacterial endocarditis, meningitis, for perioperative prophylaxis in patients who are at increased risk of infection and for the prophylaxis of infections in patients with reduced resistance.
Combined Treatment: In severe, life-threatening infections, the combination of Gramotax with aminoglycosides is indicated without awaiting results of sensitivity tests. The 2 preparations must be administered separately, not mixed in 1 syringe.
Infections with Pseudomonas aeruginosa may require concomitant treatment with other antibiotics effective against Pseudomonas.
Dosage/Direction for Use
Dosage, mode of administration and intervals between injections depend on the severity of the infection, sensitivity of the pathogens and condition of the patient.
Unless otherwise prescribed, adults and children >12 years are given 1 vial every 12 hrs.
In severe infections, the daily dose may be raised to a maximum of 12 g. If the daily dose is 4 g, it may be divided into 2 doses of 2 g each administered at intervals of 12 hrs. For higher daily doses, the intervals are reduced from 8-6 hrs.
The following may serve as a guide:
Typical Infections in Which a Highly Sensitive Pathogen is Known or Suspected: 1 g as a single dose at 12-hr intervals with a daily dose of 2 g.
Infections in Which Several Pathogens of High to Medium Sensitivity are Known or Suspected: 1-2 g as a single dose at 12-hr intervals with a daily dose of 2-4 g.
Unidentified Infections that cannot be Localized and Life-Threatening Conditions: 2-3 g as a single dose at 8- to 6-hr intervals with a daily dose of 6-12 g.
Perioperative Prophylaxis of Infections: 1-2 g before the start of surgery is recommended. Depending on the risk of infection, the same dose may be repeated after an interval of 12 hrs.
Patients with Impaired Renal Function: In patients with a creatinine clearance ≤5 mL/min, the maintenance dose should be reduced to ½ the normal dose.
Administration: Gramotax solutions should be administered as soon as they have been prepared. A pale yellowish colour of the solution does not mean impairment of the antibiotic efficacy. The solution must not be stored at temperatures above 25°C and not longer than 24 hrs.
The duration of treatment depends on the patient's response. It must be continued for at least 3 days after the body temperature has returned to normal.
IV Injection: Dissolve contents of 1 vial in at least 4 mL water for injection and then inject over a period of 3-5 min either directly into a vein or into the distal part of a clamped-off infusion tube.
IV Infusion: If higher doses are required, they may be administered by IV infusion.
For short infusion, 2-g Gramotax is dissolved in 40-mL water for injection, or one of the usual infusion solutions (eg, a 10% glucose solution or Haemaccel) and then infused in approximately 20 min. For continuous IV infusion, 2-g Gramotax is dissolved in 100-mL isotonic saline or glucose solution and infused in 50-60 min. Any of the infusion solutions previously mentioned may also be used as a solvent.
IM Injection: 1 vial is dissolved in 4-mL water for injection and then injected deep into the gluteal muscle. Pain resulting from the IM injection can be prevented by dissolving Gramotax in 4-mL lignocaine solution 1%. An intravascular injection must be strictly avoided. It is advisable not to inject >4 mL into either side. If the daily dose exceeds 2 g or if Gramotax is administered more than twice daily, IV injection is to be preferred.
Intra-Arterial: 2 g dissolved in 50 mL of dextran (see the manufacturer's instructions) and injected into the femoral artery within 45 min by means of a perfusion pump. The preparation may be administered twice daily. If necessary, an additional IV injection of Gramotax may be given.
Overdosage
Emergency Measures to be Taken in the Event of Anaphylactic Shock: The following emergency measures are generally recommended. At the 1st signs (sweating, nausea, cyanosis), interrupt the injection immediately but leave the venous cannula in place or perform venous cannulation. In addition to the usual emergency measures, ensure that the patient is kept flat with the legs raised and airway passage should be opened.
Emergency Drug Therapy: Immediately administer epinephrine (adrenaline) IV. Dilute 1 mL of commercially available epinephrine solution 1:1000 to 10 mL. In the first instance, slowly inject 1 mL of this dilution (equivalent to 0.1 mg epinephrine) while monitoring pulse and blood pressure (watch for disturbances of cardiac rhythm). The administration of epinephrine may be repeated.
Then glucocorticoids IV eg, 250-1000 mg methylprednisolone or betamethasone 4-20 mg. The glucocorticoid administration may be repeated.
Subsequently, volume substitution IV eg, plasma expanders, human albumin, balanced electrolyte solution.
Other Therapeutic Measure: Artificial respiration, oxygen inhalation, calcium antihistaminics.
Contraindications
Hypersensitivity to cephalosporins.
Warnings
In cases of severe and persistent diarrhoea, antibiotic-induced pseudomembranous colitis should be suspected, which may be life-threatening. In such cases, Gramotax should be discontinued immediately and suitable treatment initiated (eg, vancomycin oral 25 mg 4 times daily). Peristalsis-inhibiting drugs are contraindicated.
Local Reactions: Inflammatory irritation of the vein wall and pain at the site of injection.
Special Precautions
In patients hypersensitive to penicillins, the possibility of cross-sensitivity exists. Renal function must be checked in case of combination with aminoglycosides.
Use in pregnancy: Gramotax should not be used during pregnancy especially the first 3 months, unless strictly indicated.
Use In Pregnancy & Lactation
Use in pregnancy: Gramotax should not be used during pregnancy especially the first 3 months, unless strictly indicated.
Side Effects
Change in blood constituents: Thrombocytopenia, leukopenia, eosinophilia.
As with other β-lactam antibiotics, granulocytopenia and more rarely agranulocytosis may develop during treatment with Gramotax particularly if administered over a long period of time. For cases of treatment lasting >10 days, blood count should therefore be monitored. Rare cases of haemolytic anaemia have been reported.
Hypersensitivity: Urticaria, drug fever. In isolated cases, anaphylactic life-threatening shock may occur; in such event, appropriate emergency measures must be taken.
Liver Function: Rise in serum liver enzyme levels (SGOT, SGPT alkaline phosphatase).
Gastrointestinal Tract: Nausea and vomiting, diarrhoea, pseudomembranous colitis.
Drug Interactions
Effects on Laboratory Parameters: In rare cases, the direct Coombs' test may give false-positive results in patients on Gramotax treatment. False-positive results may be obtained for urinary glucose if it is determined by reduction methods. This can be avoided by using enzymatic methods in patients under Gramotax treatment.
Caution For Usage
Sodium bicarbonate solutions must not be mixed with Gramotax.
Storage
Do not store above 25°C. Protect from light.
MIMS Class
ATC Classification
J01DD01 - cefotaxime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Inj (vial) 1 g + amp 5 mL (solvent) x 1's.
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