TRIXIM® – Cefixime BP
COMPOSITION
Available in two dosage forms.
TRIXIM®200 Capsule: Each capsule contains Cefixime Trihydrate BP equivalent to Cefixime 200 mg.
TRIXIM®400 Capsule: Each capsule contains Cefixime Trihydrate BP equivalent to Cefixime 400 mg.
TRIXIM® Powder for Suspension: After reconstitution, each 5 ml suspension contains Cefixime Trihydrate BP equivalent to Cefixime 100 mg.
PHARMACOLOGY
Cefixime is a semi-synthetic, broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. Cefixime is highly stable in the presence of beta-lactamase enzymes. Cefixime has marked in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including beta lactamase producers. Clinical efficacy of Cefixime has been demonstrated in infections caused by commonly occurring pathogens including Gram-positive organism Streptococcus pneumoniae, Streptococcus pyogenes and Gram-negative organism Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), Salmonella typhi and Enterobacter species.
Pharmacokinetics:
Absorption
Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg tablet or 400 mg of cefixime suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of suspension. Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg capsule.
Distribution
Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the tablet or suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Adequate data on CSF levels of cefixime are not available.
Metabolism
There is no evidence of metabolism of cefixime in vivo.
Elimination
Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. In animal studies, it was noted that cefixime is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of cefixime in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers.
INDICATIONS
Trixim is indicated in the following infectious diseases-Respiratory Tract Infections: Pneumonia, Sinusitis, Pharyngitis, Tonsillitis, Acute Bronchitis and Acute Exacerba¬tions of Chronic Bronchitis (AECB). Also indicated to Otitis Media, Typhoid, Urinary Tract Infections, Uncomplicated gonorrhea (cervical/urethral) etc.
DOSAGE AND ADMINISTRATION
Trixim® Capsule: Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.
Trixim® Suspension: Child over 6 months: 8mg/kg daily as a single or in 2 divided doses. The usual treatment of Trixim is 7 days. This may be continued for up to 14 days according to the severity of infection.
SIDE EFFECT
Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self-limiting in nature. Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported.
CNS disturbances: Headache, dizziness.
Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.
PRECAUTION
Cefixime should be prescribed with caution in individuals with a history of gastrointesti¬nal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min).
CONTRAINDICATION
Patients with known hypersensitivity to Cefixime or cephalosporin group of drugs.
DRUG INTERACTIONS
Carbamazepine: Elevated carbamazepine levels have been reported in post marketing experience when Cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.
Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.
USE IN PREGNANCY & LACTATION
Pregnancy: Pregnancy category B. There are 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.
Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.
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 in a cool and dry place, protect from light. Keep out of the reach of children.
PACKAGING
Trixim® 200 Capsule: Box containing 3 x 7’s Capsule in Alu-Alu blister.
Trixim® 400 Capsule: Box containing 1 x 7’s Capsule in Alu-Alu blister.
Trixim® Powder for Suspension: Bottle containing powder for the preparation of 50 ml
