Oracef

Oracef

cefixime

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Cefixime.
Action
Microbiology: As with other cephalosporins, the bactericidal action of cefixime results from inhibition of cell wall synthesis. Cefixime is highly stable in the presence of β-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of β-lactamases, may be susceptible to cefixime.
Gram-Positive: Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-Negative: Haemophilus influenzae (β-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are β-lactamase positive), Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase- and nonpenicillinase-producing strains).
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 200-mg tab of cefixime produces an average peak serum concentration of approximately 2 mcg/mL.
Peak serum concentrations occur between 2 and 6 hrs following oral administration of single 200-mg tab, a single 400-mg tab, or 400 mg of suspension of cefixime.
Approximately 50% of the absorbed dose is excreted unchanged in the urine within 24 hrs.
Indications/Uses
Diseases Caused by the Following Organisms: Uncomplicated Urinary Tract Infections: Escherichia coli and Proteus mirabilis.
Otitis Media: Haemophilus influenzae, Moraxella catarrhalis and Moraxella pyogenes.
Pharyngitis and Tonsillitis: S. pyogenes.
Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis: Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated Gonorrhea: Neisseria gonorrhoeae.
Dosage/Direction for Use
Adults: Treatment of Uncomplicated Cervical/Urethral Gonococcal Infections: Recommended Dose: 400 mg daily.
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
Patients with known allergy to the cephalosporin group of antibiotics.
Special Precautions
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 Oracef is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among β-lactam antibiotics has been clearly documented and may occur to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefixime occurs, discontinue Oracef. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, IV fluids, IV antihistamines, corticosteroids, pressors amines and airway management, as clinically indicated.
Use in pregnancy & lactation: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Oracef should be used during pregnancy only if clearly needed.
It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with Oracef.
Use In Pregnancy & Lactation
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Oracef should be used during pregnancy only if clearly needed.
It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with Oracef.
Adverse Reactions
Gastrointestinal: Diarrhea, loose stools, abdominal pain, dyspepsia, nausea and vomiting.
Hypersensitivity Reactions: Skin rashes, urticaria, drug fever and pruritus. Erythema multiforme, Stevens-Johnson syndrome and serum sickness-like reactions have been reported.
Hepatic: Transient elevations in SGPT, SGOT and alkaline phosphatase.
Renal: Transient elevations in BUN or creatinine.
Central Nervous System: Headaches or dizziness.
Drug Interactions
No significant drug interactions have been reported to date.
Storage
Store in a cool, dry place.
MIMS Class
Cephalosporins
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 1 x 4's. 200 mg x 1 x 4's.
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