ORAL SUSPENSION 30ML:
Each 5ml contains:
Cefixime (U.S.P.) ………………..100mg
ORAL SUSPENSION DS 30ML:
Each 5ml contains:
Cefixime (U.S.P.) ………………..200mg
IN VITRO ACTIVITY AGAINST MICROORGANISMS:
Streptococcus sp., Streptococcus pneumoniae. Neisseria gonorrhoea, Neisseria meningitides, Escherichia coil, Klebsiella sp., Serratia sp., Proteus sp., Providencia sp., Morganella morganii. Haemophilus influenzae, Heamophilus Parainfluenzae, Salmonella sp., Shigella sp., Aeromonas as hydrophila, Pasteurella. Citrobacter freundii, Citrobacter amalonaticus, Citrobacter diversus. Enterobacter sp., Acinetobacter Iwoffi, Yersinia Enteroclitica, Campylobactor Jejuni.
RESPIRATORY TRACT INFECTIONS:
Infections of the upper and lower airways Pulmonary infections of bacterial etiology. Bronchitis (acute, achronic), Bronchiectasis with infection, Secondary infections in chronic respiratory diseases, pneumonia.
EAR, NOSE AND THROAT INFECTIONS:
Laryngitis, Pharyngitis, Tonsillitis, Otitis media, Sinusitits.
URINARY TRACT INFECTIONS:
uncomplicated urinary tract infections except for prostatitis, Pyelonephritis, Cystitis, Gonococcal urethritis, Uncomplicated gonorrhoea (cervicai/urethral).
BILIARY TARCT INFECTIONS:
Infections of the biliary tract, Cholecystitis, Cholangitis
Oral Suspension DS 30ml (200mg/5ml after reconstitution)
DOSAGE AND ADMINISTRATION:
Absorption of Reyan is not significantly modified by the presence of food. The usual course of treatment is 5 – 14 days.
ADULTS & CHILDREN OVER 12 YEAR:
CHILDREN (ORAL SUSPENSION):
The recommended dosage for children is 8mg/kg/day administered as a single dose. As a general for prescribing in children. the following daily doses is term’s of Volume of Paediatric Oral Suspension are suggested Age For 100mg/5ml For 200mg/5ml
Children 1- 4 years : 5ml daily 2.5ml daily
Children 5 – 9 years : 10ml daily 5ml daily
Children 10 – 12 years : 15ml daily 7.5ml daily
Children Over 12 years : 10ml daily
The dosage in children aged 6 months to one year should be calculated on mg/kg basis.
Children weighing more than 30kg or older than 12 year should be treated with the
recommended adult dose. The safety and efficacy of cefixime has not been established
in children aged less than 6 month.
Elderly patients may be given the same dose as recommended for adults. Renal Function should be assessed and dosage should be adjusted in severe renal impairment.
DOSAGE IN RENAL IMPAIRMENT:
Reyan may be administered in the presence of impaired renal function. Normal dose and frequency may be given in patients with creatinine clearance 20 ml/min or greater. In patients whose creatinine clearance is less than 20 ml/min. it is recommended that a dose of 200mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearance of less than 20 ml/min.
Patients with known allergy to the Cephalosporin group of antibiotics.
PRECAUTIONS & WARNINGS:
As a general rule, the duration of treatment with this drug should be limited to a minimum period required for the treatment of the patients conditions. After susceptibility of the micro
– organism to the drug has been confirmed, in order to prevent emergence of drug – resistant microorganisms
. Careful inquiry should be made to determine whether the patient has/had previous hypersensitivity to cephalosporins, penicillin or other drugs.
Particular care should be exercised in patients with a personal or familial predisposition to allergic, reaction such as bronchial asthma, rash or urticaria. Particular care should be exercised in patients with severe gastrointestinal disturbances involving vomiting and diarrhoea. Particular care should be exercised in patients with severe renal function. Patients with poor oral nutrition, patients receiving parental nutrition elderly or in a debilitated state.
Renal function should be monitored with particular care when combining cefixime with aminoglycoside antibiotic. polymyxin B, colistin or high – dosed loop diuretics (e.g. Furosemide).
This is applied especially to patients with pre existing renal impairment.
Adverse reactions to drugs are liable occur more frequently in the elderly patients since
they usually have physiological hypo function. Bleeding tendency due to vitamin K deficiency
may occur in the elderly.
USE IN PREGNANCY AND BREAST FEEDING:
Like other cephalosporins, cefixime is included in therapeutic category B of FDA for use in
pregnancy. Reproduction studies have been performed in mice and rats at doses, up to 400 times the human does and have revealed no evidence of harm to the fetus due to cefixime.
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 whether cefixime is excreted in human milk. Consideration should be given to discontinue nursing treatment with use of this drug.
A prolonged prothrombin times has been reported in patients who had been administered cefixime and anticoagulants the of coumarin-type.
There have been limited clinical experiences with overdose of cefixime.
Anaphylactic reaction including shock, internal welling of the larynx with airways constriction,
Fever, stevens – johnson syndrome.
Rash, Erythema (erythema multiforme). Pruritus, Leukopenia
Eosinophilia, Thrombocytopenia, Increases in SGOT, SGPT and alkaline phosphatases.
Serious colitis (such as pseudomembranous colitis), Diarrhoea.
Transient elevation m BUN or creatinine.
Store in a cool and dry palce. Protect from light and heat. Keep out of the reach of children.
To be sold on the prescription of registered medical practitioner.