Composition
Each capsule contains Cefixime Trihydrate USP 447.86 mg equivalent to Cefixime 400 mg.
Pharmacology
Cefixime-A is a third-generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram-negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of the bacterial cell wall. It is highly stable in the presence of the Beta-lactamase enzyme. As a result, many organisms resistant to penicillin and some cephalosporins due to the presence of beta-lactamases may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.
Indications
Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:
Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media is caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. Pharyngitis and tonsillitis are caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae.
Dosage & Administration
Children (under 6 months): The safety and efficacy of Cefixime have not been established in children aged less than 6 months.
Children (6 months or older):
Usually, 8 mg/kg/day is given as a single dose or in two divided doses or may be given as follows
◦ ½-1 year: 75 mg daily
◦ 1-4 years: 100 mg daily
◦ 5-10 years: 200 mg daily
◦ 11-12 years: 300 mg daily
In typhoid fever, the dosage should be 10 mg/kg/day for 14 days.
Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.
The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.
Contraindication
It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.
Warning & Precautions
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.
Side Effects
The drug is generally well tolerated. The most frequent side effects are diarrhea and stool changes, which have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache, and dizziness. Allergies in the form of a rash, pruritus, urticaria, drug fever, and arthralgia have been reported. These reactions usually subsided upon the discontinuation of therapy.
Pregnancy & Lactation
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in breast milk. So, caution should be exercised when Cefixime is administered to a nursing woman.
Drug Interaction
Concomitant use of carbamazepine and Cefixime elevates the carbamazepine level. Warfarin and other anticoagulants Concomitant use increases prothrombin time.
Overdose
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.
Storage
Store below 30°C, protect from light & moisture. Keep out of the reach of children.
Packaging
Each box contains 2×7’s capsules in Alu-Alu blister pack.
