Cefixime Trihydrate USP
Orfix Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200mg.
Orfix Suspension: Each 5ml reconstituted suspension contains Cefixime Trihydrate USP equivalent to Cefixime 100mg.
Orfix (Cefixime) is a broad spectrum cephalosporin antibiotic of third generation for oral administration. It is bactericidal antibiotic and is stable to hydrolysis by many beta-lactamases. Orfix kills bacteria byinterfering in the synthesis of the bacterial cell wall.
Orfix is highly active against Neisseria gonorrhoeae, Haemophilus influenza, Moraxella catarrhalis including beta lactamase products, most of the Enterobacteriaceae beta-haemolytic Streptococcus (group A & B) and Streptococcus peumoniae. Orfix is more active than other oral cephalosporins against Escherichia coli, Klebsiella spp, Proteus mirabilis and Serratia marcescens. Orfix is also active against Streptococcus pyogenes, 40-50% of an oral dose is absorbed from gastrointestinal tract, whether taken with meals or not. The plasma half life is usually about 3 to 4 hours and amy be prolonged when there is renal impairment. About 65% of Orfix in the circulation is bound to plasma protein. Orfix is mainly excreted unchanged in bile and urine.
• Upper and Lower respiratory tract infections
• Urinary tract infections
• Gonococcal urethritis
• Acute otitis media
Orfix (cefixime) capsule: 1 or 2 capsule as a single dose or two divided dosage daily for 7-14 days, according to the severity of infection.
Orfix (cefixime) Suspension: Child dose: 8mg/kg body weight daily as single dose or two divided doses for 7-14 days, according to the severity of infection for children of age.
½ to 1 year: 3.75 ml or 75 mg 1-4 years: 5 ml or 100 mg
5-10 years: 10 ml or 200 mg 11 to 12 years: 15 ml or 300 mg
Above 12 years: Adult dose.
Direction for reconstitution of Suspension: To prepare 50 m suspension 35 ml boiled and cooled water is required. Shake the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, then shake again.
Patients with known hypersensitivity to cephalosporin group of drugs.
Orfix (cefixime) should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance <20ml/min).
No data are available, so it is probably best to avoid using the drug during pregnancy and by the lactating mothers.
Use in Elderly: No special precautions are cecessary. Old patients are not an indication for dose adjustment.
Orfix (Cefixime) is generally well tolerated. The major side effects observed in clinical trials were mild and self-limiting in nature. Gastro-intestinal disturbances: Diarrhoea, changes in the colour of stool, nausea, abdominal pain, dyspepsia, vomiting and flatulence have been reported.
Central nervous system disturbances: Headache, dizziness.
Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy, infrequent and reversible haematological changes, elevation of serum amylase.
No significant drug interactions have been reported to data.
Keep in a cool dry place and protect from light.
Keep out of the reach of children.
Orfix (cefixime) Capsule: Box containing 2×4’s capsules in alu-alu blister pack.
Orfix (Cefixime) Suspension: Bottle containing dry powder for preparation of 50 ml Suspension.