Oticef Powder for Suspension

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Cefaclor Monohydrate

Indications

Oticef is indicated in the treatment of the following infections:

  • Respiratory tract infections, including pneumonia, bronchitis, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes
  • Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococci, and Streptococcus pyogenes
  • Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
  • Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative Staphylococci
  • Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes.

Pharmacology

Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.

Dosage & Administration

Capsule: Adult dose: The usual dose is 250 mg every 8 hourly. For severe infections or those caused by less susceptible organisms, doses may be doubled with a maximum dosage of 4 g/day. In case of β-hemolytic Streptococcal infections, therapy should be administered for at least 10 days.

Powder for suspension & Pediatric drops: Children: The usual daily dosage for paediatric patients over 1 month is 20 mg/kg/day in divided doses every 8 hours. In serious infections such as otitis media and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day. Safety and effectiveness of Cefaclor for use in infants less than 1 month of age have not been established.

<1 year (9 kg):

  • Powder for suspension: ½ tsp three times daily
  • Pediatric drops: 0.625 ml three times daily

1-5 years (9 kg-18 kg):

  • Powder for suspension: 1 tsp three times daily
  • Pediatric drops: 1.25 ml three times daily

Over 5 years:

  • Powder for suspension: 2 tsp three times daily

In renal impairment: Cefaclor may be administered in the presence of impaired renal function. Dose adjustments for patients with moderate or sever renal impairment are not usually required.

In patients undergoing haemodialysis: Haemodialysis shortens serum half-life by 25-30%. In patients undergoing haemodialysis, a predialysis loading dose of 250 mg-1 g is recommended. A maintaining dose of 250-500 mg every 6 hourly during interdialytic period may be used.

Geriatric use: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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Interaction

Oticef may show a false-positive reaction for glucose in the urine with tests that use Benedict’s solution, Fehling’s solutions. When Oticef and oral anticoagulants were administered concomitantly there have been reports of increased anticoagulant effect and there have been rare reports of increased prothrombin time, with or without clinical bleeding, in patients receiving Oticef and anticoagulants (Warfarin) concomitantly. It is recommended that in such patients, regular monitoring of prothrombin time should be considered, with adjustment of dosage if necessary.

Contraindications

Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.

Side Effects

Gastro-intestinal symptoms may occur include diarrhea, nausea and vomiting in some patients receiving Oticef. As with some penicillins and some other Cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. Fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, elevated LDH and pancytopenia may occur.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother’s milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.

Precautions & Warnings

Prescribing Oticef in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Prolonged use of Oticef may result in the overgrowth of nonsusceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken. As with other β-lactam antibiotics, the renal excretion of Oticef is inhibited by Probenecid. Antibiotics, including Cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Before therapy with Oticef is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to Oticef, Cephalosporins, Penicillins or other drugs. If Oticef is to be given to penicillin-sensitive patients, caution should be exercised. Oticef should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.

Overdose Effects

The toxic symptoms following an overdose of Oticef may include nausea, vomiting, epigastric distress, and diarrhea.

Therapeutic Class

Second generation Cephalosporins

Reconstitution

Powder for Suspension: Shake the bottle well before mixing the water. To prepare 100 ml suspension, add 62.5 ml (12.5 spoonfuls) of boiled & cooled water in two portions and shake till powder is completely mixed with water. The prepared suspension can be used within 7 days if it is stored at room temperature and 14 days if it is kept in refrigerator.

Pediatric Drops: Shake the bottle well before mixing the water. To prepare 15 ml pediatric drops, add 10 ml (2 spoonfuls) of boiled & cooled water in two portions and shake till powder is completely mixed with water. The prepared drops can be used within 7 days if it is stored at room temperature and 14 days if it is kept in refrigerator.

Storage Conditions

Store at room temperature and protect from light. After reconstitution the suspension can be used within 7 days if kept at room temperature and within 14 days if kept in refrigerator (2-8°C). Always keep the bottle tightly closed.