Indications
Oticlor is indicated in the treatment of the following infections:
Otitis media
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
Sinusitis
Dosage & Administration
Oticlor is administered orally.
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.
Side Effects
Most adverse effects reported with Cefaclor are similar to those reported with other oral cephalosporins. The most frequent adverse effects reported include gastrointestinal effects (nausea, vomiting, diarrhea) headache and rash. Rarely, Serum sickness-like reactions consisting of erythema multiforme, urticaria accompanied by arthritis, arthralgia, irritability and fever have been reported.
Precautions
Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.
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Contraindications
Cefaclor is contraindicated in patients with known hypersensitivity to cephalosporin group of antibiotics. It is also contraindicated in porphyria.
Use in Pregnancy & Lactation
Pregnancy: Animal studies have shown no evidence of impaired fertility or teratogenicity. However, since there are no adequate or well-controlled studies in pregnant women, caution should be exercised when prescribing for the pregnant women.
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.
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