3rd Generation Cephalosporin
Antibiotic
AntiInfective Agent
DOSE OF CEFIXIME:
Adult dose
:General Dosage Information:
Oral
tablets
are not bioequivalent to oral chewabletablets
or suspension.Acute infective exacerbation of chronic obstructive pulmonary disease:
400 mg orally once a day OR 200 mg every 12 hours
Gonorrhea:
Uncomplicated infections: 400 mg orally as a single
dose
(FDA dosage).Uncomplicated cervical; urethral; or rectal infections: 400 mg orally as a single
dose
plus azithromycin 1 g orally as a singledose
(guideline dosage).Otitis media:
400 mg orally once a day OR 200 mg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
Pharyngitis:
400 mg orally once a day OR 200 mg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
Tonsillitis:
400 mg orally once a day OR 200 mg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
Urinary tract infectious disease; Uncomplicated:
400 mg orally once a day OR 200 mg every 12 hours
Pediatric Dose:
General Dosage Information:
Oral
tablets
are not bioequivalent to oral chewabletablets
or suspension.Acute infective exacerbation of chronic obstructive pulmonary disease:
(6 months to 12 years; 45 kg or less)
8 mg/kg orally once a day OR 4 mg/kg every 12 hours
(Older than 12 years or more than 45 kg)
400 mg orally once a day OR 200 mg every 12 hours
Gonorrhea:
(6 months to 12 years; 45 kg or less)
8 mg/kg orally once a day OR 4 mg/kg every 12 hours (FDA
dosage
)(Older than 12 years or more than 45 kg)
400 mg orally as a single
dose
(FDAdosage
)(Greater than 45 kg)
Uncomplicated cervical; urethral; or rectal infections: 400 mg orally as a single
dose
plus azithromycin 1 g orally as a singledose
(guidelinedosage
).Otitis media:
(6 months to 12 years; 45 kg or less)
8 mg/kg orally once a day OR 4 mg/kg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
(Older than 12 years or more than 45 kg)
400 mg orally once a day OR 200 mg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
Pharyngitis:
(6 months to 12 years; 45 kg or less)
8 mg/kg orally once a day OR 4 mg/kg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
(Older than 12 years or more than 45 kg)
400 mg orally once a day OR 200 mg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
Sinusitis:
(Beta Lactam allergy; second line)
8 mg/kg/day orally in 2 divided
doses
plus clindamycin 30 to 40 mg/kg/day orally in 3 divideddoses
(guidelinedosage
).Tonsillitis:
(6 months to 12 years; 45 kg or less)
8 mg/kg orally once a day OR 4 mg/kg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes.
(Older than 12 years or more than 45 kg)
400 mg orally once a day OR 200 mg every 12 hours; treat for at least 10 days for infections due to Streptococcus pyogenes
Urinary tract infectious disease; Uncomplicated:
(6 months to 12 years; 45 kg or less)
8 mg/kg orally once a day OR 4 mg/kg every 12 hours
(Older than 12 years or more than 45 kg)
400 mg orally once a day OR 200 mg every 12 hours
INDICATIONS:
FDA-LABELED INDICATIONS:
Acute infective exacerbation of chronic obstructive pulmonary disease
Gonorrhea
Otitis media
Pharyngitis
Tonsillitis
Urinary tract infectious disease; Uncomplicated
NON-FDA LABELED INDICATIONS:
Salmonella infection
Sinusitis
MECHANISM OF ACTION:
Cefixime
; a semisynthetic cephalosporin; is a broad spectrum bactericidal agent that inhibits cell wall synthesis and is stable in the presence of certain beta lactamases.ADVERSE EFFECT:
Common:
Gastrointestinal:
Abdominal pain (3%)
Diarrhea (16%)
Flatulence (4%)
Indigestion (3%)
Loose stool (6%)
Nausea (7%)
Serious:
Dermatologic:
Erythema multiforme
Stevens Johnson syndrome
Toxic epidermal necrolysis
Gastrointestinal:
Clostridium difficile colitis
Immunologic:
Anaphylaxis
Renal:
Acute renal failure (less than 2%)
Other:
Angioedema (less than 2%)
CONTRAINDICATION:
Known allergy to Cefixime or other cephalosporin
DRUG Interaction with cefixime:
Carbamazepine:
Elevated carbamazepine levels have been reported in postmarketing experience when Cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.
Warfarin and Anticogulants:
Increased prothrombin time; with or without clinical bleeding has been reported when Cefixime is administered concomitantly.
Drug/Laboratory Test Interactions:
A false positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide. The administration of Cefixime may result in a false positive reaction for glucose in the urine using Benedict’s solution; or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. A false positive direct Coombs test has been reported during treatment with other cephalosporins; therefore; it should be recognized that a positive Coombs test may be due to the drug.
Major:
Cholera Vaccine;Live(Theoretical)
Warfarin(Probable)
Pharmacokinetics of cefixime:
Absorption:
Oral Tablet:
Maximum Plasma Concentration (Tmax): 2 to 8 hours.
200mg
Tablet Cmax: Approximately 2 mcg/mL (range 1 to 4 mcg/mL)400mg
Tablet Cmax: Approximately 3.7mcg/mL (range 1.3 to 7.7 mcg/mL)Oral Suspension
:Approximately 25% to 50% higher than the
tablets
200mg
Suspension Cmax: 3mcg/mL (range 1 to 4.5 mcg/mL)400mg
Suspension Cmax: 4.6mcg/mL (range 1.9 to 7.7 mcg/mL)Bioavailability:
About 40% to 50%.
Effect of food:
Insignificant
Distribution:
Plasma Protein binding: 65%.
Volume of Distribution (Vd): 0.6 to 1.1 L/kg.
Metabolism:
Not metabolized.
Excretion:
Bile: 5%.
Renal: 50% as unchanged drug.
Dialyzable:
Hemodialysis: No
Peritoneal dialysis: No
Elimination:
3 to 4 hours.
PRECAUTION:
Endocrine and metabolic:
Cefixime chewable
tablets
contain aspartame; which is a source of phenylalanine;use
caution and consider the total daily amount of phenylalanine intake in patients with phenylketonuria.Gastrointestinal:
Clostridium difficile associated diarrhea; including mild diarrhea to fatal colitis; has been reported and may occur more than 2 months after use; discontinuation of antibacterial use not directed against C. difficile may be required.
Hematologic:
Decreased prothrombin activity may occur; particularly in patients with renal or hepatic failure; poor nutritional state; concomitant protracted course of antimicrobial therapy; or prior stabilization on anticoagulant therapy; monitoring recommended.
Immunologic:
Anaphylactic and anaphylactoid reactions; including shock and fatalities; have been reported; discontinuation required.
Cross Sensitivity may occur in patients with penicillin sensitivity.
Drug Resistant bacteria may emerge if administered in absence of proven or strongly suspected infection.
Lab test interactions:
False positive reactions for glucose in the urine are possible with certain tests; glucose tests using enzymatic glucose oxidase reactions are recommended.
False positive reactions for ketones in the urine are possible with tests using nitroprusside;
use
of nitroferricyanide recommended.Renal:
Exercise caution and adjust
dose
in patients with renal impairment and those on continuous ambulatory peritoneal dialysis and hemodialysis; monitoring recommended.PREGNANCY CATEGORY:
B (FDA)
BREAST FEEDING:
Infant Risk cannot be ruled out.
MONITORING:
Pharyngeal Gonorrhea:
Test of cure with culture or nucleic acid amplification test; 14 days after treatment
Improvement in the signs and symptoms of the infection may indicate clinical efficacy.
Prothrombin time:
In high risk patients (ie; those with renal or hepatic impairment; poor nutritional status; prolonged treatment duration; and/or those previously stabilized on concomitant anticoagulation therapy). Dialysis patients closely
HOW TO TAKE OR ADMINISTRATION:
Oral:
Take with or without food
(Chewable
tablets
)Chew or crush prior to swallowing
(Suspension)
Reconstitute powder prior to
use
and shake well before measuringdose
.(Suspension)
Keep reconstituted suspension at room temperature or under refrigeration for up to 14 days.
DOSAGE FORM:
Oral Capsule: 400 MG.
Oral Powder for Suspension: 100 MG/5 ML
200 MG/5 ML
500 MG/5 ML
Oral Tablet: 400 MG
Oral Tablet; Chewable: 100 MG
200 MG
TOXICOLOGY:
TOXICITY: Serious toxicity is unlikely following large oral
doses
of cephalosporins. Crystalluria and hematuria has been described in a 3 year old boy who ingested 104 mg/kg of cephalexin.PATIENT COUNSELING OR CLINICAL TEACHING:
This drug may cause abdominal pain or nausea.
Instruct patient to report signs/symptoms serum sickness like reactions (rash; urticaria; arthralgia; fever; malaise; enlarged lymph nodes).
Advise patient to report severe diarrhea and consult healthcare professional prior to taking antidiarrhea medicine. Other superinfection signs/symptoms should be reported as well.
Disclaimer:
For the Registered Medical Practitioner Only. We are not recommended for self medication. self medication is may harmful for health. We are only information about medicine.
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