Oticlor 500 Capsule : Each capsule contains Cefaclor Monohydrate USP 524.46 mg equivalent to Cefaclor 500 mg.
Oticlor Dry suspension: After reconstitution, each 5 ml suspension contains Cefaclor Monohydrate USP 131.11 mg equivalent to Cefaclor 125 mg.
Oticlor Paediatric drops: After reconstitution, each ml drop contains Cefaclor Monohydrate USP 104.9 mg equivalent to Cefaclor 100 mg.
Aerobes, Gram-positive: Streptococcus pneumoniae, Streptococcus pyogenes (Group A beta-haemolytic streptococci) and Staphylococci.
Aerobes, Gram-negative: Moraxella catarrhalis, Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Klebsiella sp.,Citobacter diversus and Neisseria gonorrhoeae.
Anaerobes: Propionibacteria acnes, Bacteroides sp. (excluding Bacteroides fragilis), Peptococci and Peptostreptococcus sp.
Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis
Upper respiratory tract infections, including pharyngitis and tonsillitis
Urinary tract infections, including pyelonephritis and cystitis
Skin and soft tissue infections
Children: The usual recommended dosage for children is 20 mg/kg/day in divided doses every 8 hours. The dose of Oticlor suspension and paediatric drops for children is given in the following:
Age Oticlor suspension Oticlor Paediatric Drops
1 month - 1 year 2.5 ml t.i.d. 0.625 ml t.i.d
1 year - 5 year 5 ml t.i.d. 1.25 ml t.i.d
over 5 years 10 ml t.i.d 2.5 ml t.i.d
In more serious infections, such as otitis media, or those caused by less susceptible organisms, 40 mg/kg/day is recommended, with a maximum dosage of 1 gm/day. Safety and efficacy have not been established for use in infants aged less than 1 month.
Adults: The usual adult dose is 250 mg every 8 hours. For bronchitis, the dosage is 250 mg administered 3 times daily. A dosage of 250 mg administered 3 times daily for 10 days is recommended for sinusitis. For more severe infections, such as pneumonia, or those caused by less susceptible organisms, dose may be doubled.
Cefaclor may be administered safely in the presence of impaired renal function. Under such conditions, dosage is usually unchanged.
Lactation: Small amount of Cefaclor have been detected in breast milk following administration of single 500 mg dose. As the effect on nursing infants is not known, caution should be exercised when Cefaclor is administered to a nursing woman.
Direction for reconstitution of suspension
For 100 ml suspension: Add 60 ml (12 measuring spoonful) of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.
Paediatric drops: Add 10 ml (2 measuring spoonful) of boiled and cooled water to the bottle and shake vigorously.
Note: Shake the suspension and paediatric drop well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator. The made up suspension can be used within 7 days if it is stored at room temperature and 14 days if it is kept in refrigerator.
Unless 5 times the normal dose of Cefaclor has been ingested, gastrointestinal lavage will not be necessary.
Oticlor Dry suspension: Bottle containing dry powder for 100 ml suspension.
Oticlor Paediatric drops: Bottle containing dry powder for 15 ml drops.