Cefix

Cefix

cefixime

Manufacturer:

Hanmi

Distributor:

AA Medical
Full Prescribing Info
Contents
Cefixime.
Description
Each hard capsule, with yellow-colored cap and body, is filled with white or light yellow crystalline powder.
Action
Toxicology: Acute Toxicity: The inhibition of spermatocytogenesis has been reported when the oral LD50 of cefixime exceeds 1 g/kg in young rats.
Indications/Uses
Treatment of infections caused by the following susceptible organisms: Streptococcus, Pneumococcus, Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella spp, Serratia spp, Proteus spp, Haemophilus influenzae.
Bronchiolitis, bronchiectasis, chronic secondary respiratory infection, pneumonia, nephropyelitis, cystitis, gonorrheal urethritis, cholecystitis, cholangitis, scarlatina, otitis media, sinusitis.
Dosage/Direction for Use
Adults and Children >30 kg: 50-100 mg twice daily.
In patients with severe symptoms or insufficient effect, the dosage may be increased to 200 mg twice daily.
The dosage may be adjusted according to the patient's age and symptoms.
Contraindications
Patients who have a history of shock due to cefixime; history of hypersensitivity to the cephalosporin group of antibiotics.
Special Precautions
Prior to administration, susceptibility to cefixime should be tested to prevent manifestation of resistant bacteria, and the duration of therapy should be the minimum needed for the treatment.
A patient should be asked about his/her condition in order to predict the reaction eg, shock and also previous skin reaction should be tested.
Cefix should be administered to patients with hypersensitivity to cephem antibiotic only when the treatment is justified.
Patients who are hypersensitive to penicillin antibiotics; who have allergic reactions to cefixime eg, bronchiectasis, eruption, hives; with severe renal disorder; who cannot ingest orally or parenterally; who are elderly and patients with poor systemic condition.
Use in pregnancy & lactation: Since safety in pregnancy has not been established, cefixime should be used in pregnancy only when the expected benefits clearly outweigh the potential risks.
It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with Cefix.
Use in children: Safe use in neonates and prematures has not been established.
Use in the elderly: Because physiological function decreases with age, adverse effects may manifest easily. Hemorrhage may occur due to deficiency in vitamin K.
Use In Pregnancy & Lactation
Since safety in pregnancy has not been established, cefixime should be used in pregnancy only when the expected benefits clearly outweigh the potential risks.
Adverse Reactions
Shock: Shock may rarely occur so careful observation should be considered. If malaise, intraoral abnormal sense, stridor, dizziness, feeling of defecation, tinnitus, diaphoresis occur, administration should be discontinued and/or appropriate therapy should be instituted.
Anaphylactic: Anaphylactoid symptoms may occur so careful observation should be considered.
Hypersensitivity: Skin rashes, urticaria, drug fever and pruritus. Erythema multiforme, Stevens-Johnson syndrome and serum sickness-like reactions have been reported.
Hematologic: Occasionally, eosinophilia and thrombocythemia may occur. Rarely, hemolytic anemia, thrombocytopenia and prothrombin disorder may occur.
Hepatic: Occasionally, elevations of GOT, GPT, AL-P may occur.
Renal: Rare cases of severe renal disorder including acute kidney failure have been reported; therefore, tests should be performed regularly. If any symptom occurs, administration should be discontinued and/or appropriate therapy should be instituted.
Gastrointestinal: Rarely, severe colitis accompanied by hemafecia of pseudomembranous colitis may occur. If aneilemia, frequent diarrhea occur, appropriate therapy should be instituted eg, discontinuance of administration. Occasionally, nausea, vomiting, loose stool, diarrhea, or rarely, aneilemia, anorexia may also occur.
Superinfection: Rarely, stomatitis and candidiasis may occur.
Avitaminosis: Rarely, avitaminosis K (eg, hypoprothrombinemia, bleeding tendency) and avitaminosis B group (eg, glossitis, stomatitis, anorexia, neuritis) may occur.
Skin: Rarely, Lyell's syndrome and Stevens-Johnson syndrome may occur. In this case, administration should be discontinued and/or appropriate therapy should be instituted.
Respiratory: Interstitial pneumonia accompanied by flush, cough, dyspnea, disorder of chest x-ray, eosinophilia and PIE syndrome may occur rarely. If these symptoms occur, administration should be discontinued and/or appropriate therapy including administration of adrenocortical hormone should be instituted.
Others: Occasionally, ache and dizziness may occur.
Drug Interactions
Laboratory Test: The administration of cefixime may result in false-positive reaction for glucose in the urine using Clinitest, Benedict's solution or Fehling's solution. A false-positive direct Coombs' test has been reported during treatment with other cephalosporin antibiotics.
Storage
Store at room temperature in well-closed containers.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Cap 100 mg x 5 x 10's.
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