Pacxime

Pacxime

cefixime

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Cefixime trihydrate.
Action
Pharmacotherapeutic Group: Antimicrobial (chemotherapeutic) agents, broad and medium spectrum antibiotics.
Pharmacology: Pharmacodynamics: Cefixime is an orally-active cephalosporin antibiotic which has in vitro bactericidal activity against a wide variety of gram-positive and gram-negative organisms including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella sp, Haemophilus influenzae (positive and negative β-lactamases), Moxarella (Branhamella) catarrhalis (positive and negative β-lactamases). Cefixime is stable in the presence of β-lactamase enzymes.
Most strains of enterococci (Streptococcus faecalis, group D streptococci) and staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to Cefixime. In addition, most strains of Enterobacter and Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to Cefixime.
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 hrs when administered with food. A single Cefixime 200 mg tablet produces an average peak serum concentration (Cmax) of approximately 2 mcg/mL (range 1-4 mcg/mL); a single Cefixime 100 mg dispersible tablet produces an average Cmax of approximately 1 mcg/mL (range 0.5-2 mcg/mL). Peak serum concentrations occur between 2 and 6 hrs following oral administration of a single 200 mg tablet or a single 100 mg tablet of cefixime.
Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hrs. In animal studies, it was noted that cefixime is also excreted in the bile in excess of 10% of the administered dose. Serum protein-binding is concentration-independent with a bound fraction of approximately 65%.
The serum half-life (t½) of cefixime in healthy subjects is independent of dosage form and averages from 3-4 hrs but may range up to 9 hrs in some normal volunteers. Average area under time curve (AUC) at steady state in elderly patients are approximately 40% higher than average AUC in other healthy adults.
In subjects with moderate renal impairment [creatinine clearance (CrCl) 20-40 mL/min], the average serum t½ of cefixime is prolonged to 6.4 hrs. In severe renal impairment (CrCl 5-20 mL/min), the t½ increased to an average of 11.5 hrs. Cefixime is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar profiles as subjects with CrCl 21-60 mL/min. There is no evidence of metabolism of cefixime in vivo.
Indications/Uses
Treatment of infections caused by susceptible microorganisms: Upper respiratory tract infections (eg, bacterial pharyngitis, tonsilitis, otitis media, sinusitis), lower respiratory tract infections (eg, bronchitis), urinary tract infections (eg, acute cystitis) and uncomplicated gonorrhoea.
Dosage/Direction for Use
Adults and Children >12 Years: The recommended adult dose is 200-400 mg daily given either as a single or in divided doses. Usual Treatment Course: 5-14 days.
Lower Respiratory Tract Infections: 400 mg daily is recommended.
Upper Respiratory Tract Infections and Uncomplicated Urinary Tract Infections: 200 mg once daily is usually effective.
Sinusitis: Therapeutic dosage must be administered for 10-14 days.
Treatment of Uncomplicated Gonorrhoea: The recommended dosage is 400 mg as single dose.
Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearance (CrCl) >20 mL/min.
In patients whose CrCl <60 mL/min, it is recommended that a dose of 200 mg once daily should not be exceeded.
The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with CrCl <20 mL/min.
Elderly: May be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment.
Overdosage
No specific antidote exists.
Cefixime is not removed from the circulation in significant quantities by dialysis. Treatment of overdosage should be symptomatic and supportive.
Contraindications
Hypersensitivity to cephalosporins. Patients with renal impairment (CrCl <60 mL/min).
Warnings
Pacxime should be given with caution to patients who have shown hypersensitivity to other medicines. Cephalosporins should be given with caution to penicillin-sensitive patients as there are some evidence of partial cross-allergenicity between penicillins and cephalosporins.
If an allergic effect occurs with Pacxime, discontinue treatment and treat patient with appropriate agents if necessary.
Pacxime should be administered with caution in patients with markedly-impaired renal function.
Prolonged use of Pacxime may result in the overgrowth of nonsusceptible organisms. Cefixime has been shown to alter the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin/s produced by Clostridium difficile is the primary cause of antibiotic-associated pseudomembranous colitis. Pacxime should be discontinued if diarrhoea occurs.
Use in pregnancy and lactation: Safe use in human pregnancy has not been established and it is not known whether cefixime is excreted in human breastmilk.
Use In Pregnancy & Lactation
Safe use in human pregnancy has not been established and it is not known whether cefixime is excreted in human breastmilk.
Side Effects
Gastrointestinal Disturbances: The most frequent side effects seen with Pacxime are diarrhoea and stool changes. Moderate to severe diarrhoea has been reported. Other gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has also been reported.
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Haematological and Clinical Chemistry: Thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were frequent and reversible. Changes in liver and renal function tests have been observed.
Miscellaneous: Other possible reactions include genital pruritus and vaginitis.
Drug Interactions
No significant interactions have been reported up to date. A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose-oxidase reactions. A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs test may be due to the medicine.
Storage
Store below 30°C in a dry place. Protect from light.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 200 mg x 3 x 10's. Dispersable tablet 100 mg x 3 x 10's.
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