Description:

Afix(Cefixime) is a broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic and is stable to hydrolysis by many beta-lactamases. Afix kills bacteria by interfering the synthesis of the bacterial cell wall. Afix is highly active against Neisseria gonorrhoeae, Haemophilus influenzae, Morexella catarrhalis including beta-lactamase producers, most of the Enterobacteriaceae, beta-haemolytic Streptococci (Group A & B) and Streptococcus pneumoniae. Afix is more active than other oral cephalosporins against Escherichia coli, Klebsiella spp, Proteus mirabilis and Serratia marcescens. Afix is also active against Streptococcus pyogenes. 40-50% of an oral dose is absorbed from gastro-intestinal tract, whether taken with meals or not. The plasma half-life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% is bound to plasma protein. Afix is mainly excreted unchanged in bile and urine.

Composition:

Afix Capsule: Each capsule contains Cefixime trihydrate BP equivalent to Cefixime anhydrous 200 mg.

Afix Powder for Suspension: After preparation, each 5 ml reconstituted suspension contains Cefixime trihydrate BP equivalent to Cefixime anhydrous 100 mg.

Indications:

It is indicated for the treatment of the following acute infections, when caused by susceptible microorganisms.

Urinary tract infections: Cystitis, cystourethritis, pyelonephritis, gonococcal urethritis.

Upper respiratory tract infections: Otitis media, and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics.

Lower respiratory tract infection: Bronchitis etc.

Typhoid fever.

Dosage & Administration:

Afix Capsule:

Adult: 1 or 2 capsules (200-400 mg) as once or in 2 divided doses daily for 7-14 days, according to the severity of the infection.

Afix Powder for Suspension:

Children above 6 months: 8 mg per kg body weight as a single dose or in two divided doses for 7-14 days according to the severity of the infection or as following:

6 months-1year: 3.75 ml or 75 mg

1-4 years: 5 ml or 100 mg

5-10 years: 10 ml or 200 mg

11-12 years: 15 ml or 300 mg

Above 12 years: Adult dose may be administered

Children under 6 months: Not recommended.

Contraindications: Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.

Side-effects:

Afix is generally well tolerated. The majority of adverse reactions observed in clinical trials was mild and self-limiting in nature.

Gastro-intestinal disturbances: Diarrhoea (if severe diarrhoea occurs, Afix should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported.

Central nervous system disturbances: Headache, dizziness, etc.

Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible haematological changes; elevation of serum amylase, etc.

Use in pregnancy and lactation:

No data is available, so it is probably the best to avoid using the drug during pregnancy and by the nursing mothers.

Cautions:

Afix should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min).

Packing:

Afix Capsule: Box containing 1 x 4's/ 2 x 4's capsules in alu-alu blister pack.

Afix Powder for Suspension: Bottle containing dry powder for preparation of 50 ml suspension.