Dispersible Cefixime we care/Cefixime we care

Dispersible Cefixime we care/Cefixime we care

cefixime

Manufacturer:

Mega Lifesciences

Distributor:

Maxxcare
Full Prescribing Info
Contents
Cefixime.
Description
Each dispersible tablet contains: Cefixime as Trihydrate Equivalent to anhydrous cefixime 100 mg.
Each film coated tablet contains: Cefixime as Trihydrate Equivalent to Anhydrous cefixime 200 mg.
Action
Pharmacotherapeutic Group: Antibacterial (Semisynthetic cephalosporin Antibiotic).
Pharmacology: Pharmacodynamics: Mechanism of action: Bactericidal action of cefixime results from inhibition of cell-wall synthesis.
Pharmacokinetics: Cefixime, given orally is about 40% - 50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when administered with food. A single 200 mg tablet of cefixime produces an average peak serum concentration of approximately 2 mcg/ml (range 1 to 4 mcg/ml). Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. The serum half-life of cefixime in healthy subjects is independent of dosage form and averages 3.0-4.0 hours but may range up to 9 hours in some normal volunteers. There is no evidence of metabolism of cefixime in vivo.
Indications/Uses
Indicated in the treatment of following infections: Uncomplicated Urinary Tract Infections; Otitis Media; Pharyngitis and Tonsillitis; Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis; Uncomplicated gonorrhea.
Dosage/Direction for Use
Adults: The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet daily or as 200 mg tablet every 12 hours.
For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.
Children: The recommended dose is 8 mg/kg/day,
Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose in the treatment of infections due to S. pyogenes, a therapeutic dosage of Cefixime should be administered for at least 10 days.
Cefixime 100 mg: Disperse one tablet in a teaspoonful of water immediately before administration.
Route of administration: Oral Route.
Overdosage
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.
Contraindications
Cefixime is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Warnings
Before therapy with cefixime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefixime occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
Special Precautions
General: The possibility of the emergence of resistant organisms which might result in overgrowth should be kept in mind, particularly during prolonged treatment. In such use, careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully.
Cefixime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Adverse Reactions
The following adverse reaction may occur: Gastrointestinal: Diarrhea, loose stools, abdominal pain, dyspepsia, nausea, and vomiting.
Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions, Skin rashes, pruritus, urticaria, angioedema.
Hepatic: Transient elevations in SGPT, SGOT, and alkaline phosphatase.
Renal: Transient elevations in BUN or creatinine.
Central Nervous System: Headaches or dizziness.
Hemic and Lymphatic Systems: Transient thrombocytopenia, leukopenia, and eosinophilia. Prolongation in prothrombin time was seen rarely.
Abnormal Laboratory Tests: Hyperbilirubinemia.
Other: Genital pruritus, vaginitis, candidiasis.
Drug Interactions
Carbamazepine: Elevated carbamazepine levels have been reported when cefixime is administered concomitantly.
Warfarin & Anti coagulants: Increased prothrombin time with or with out clinical bleeding when cefixime is administered concomitantly.
Storage
Store below 30°C in a dry place.
Protect from light and moisture.
MIMS Class
Cephalosporins
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Dispersible Cefixime we care: Dispersible tab 100 mg x 1 x 10's.
Cefixime we care: FC tab 200 mg x 1 x 10's.
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