Oticlor Pediatric Drops

Indications

Oticlor is prescribed for the treatment of various infections, including:

• Respiratory Tract Infections: Conditions like pneumonia and bronchitis caused by bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes.
• Otitis Media: Middle ear infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococci, and Streptococcus pyogenes.
• Pharyngitis and Tonsillitis: Throat and tonsil infections due to Streptococcus pyogenes.
• Urinary Tract Infections: Includes pyelonephritis and cystitis caused by Escherichia coli, Proteus mirabilis, Klebsiella species, and coagulase-negative Staphylococci.
• Skin and Soft Tissue Infections: Resulting from Staphylococcus aureus and Streptococcus pyogenes.

Pharmacology

Cefaclor, a second-generation cephalosporin antibiotic, is resistant to b-lactamase enzymes and boasts a broad spectrum of antibacterial activity. It is effective against various pathogens such as Streptococci (alpha and beta haemolytic), Staphylococci (both coagulase-positive and negative, including penicillinase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species, and Haemophilus influenzae, including strains resistant to ampicillin. Cefaclor is effective in eliminating Streptococci from the nasopharynx.

Dosage & Administration

Capsules for Adults:

• Usual dose: 250 mg every 8 hours.
• For severe or resistant infections: Dosage may be doubled with a maximum daily dose of 4 g.
• For β-hemolytic Streptococcal infections, a minimum 10-day therapy is recommended.

Suspension & Pediatric Drops for Children:

• Standard daily dose: 20 mg/kg/day in divided doses every 8 hours.
• For severe infections: Up to 40 mg/kg/day, with a maximum dose of 1 g/day.
• Not established for infants under 1 month of age.

Dosage by Age Group:

• <1 year (9 kg): ½ tsp or 0.625 ml three times daily.
• 1-5 years (9-18 kg): 1 tsp or 1.25 ml three times daily.
• Over 5 years: 2 tsp three times daily.

Renal Impairment:
In patients with renal impairment, dose adjustment is typically unnecessary.

Hemodialysis Patients:
Dialysis reduces serum half-life by 25-30%. A pre-dialysis loading dose of 250 mg-1 g is suggested, followed by 250-500 mg every 6 hours between dialysis sessions.

Geriatric Patients:
No significant differences in response between older and younger patients, though sensitivity in elderly individuals cannot be completely ruled out.

Drug Interactions

Oticlor may cause false-positive results for glucose in urine when using Benedict’s or Fehling’s solution. Concurrent use with oral anticoagulants, such as Warfarin, can lead to increased anticoagulant effects and elevated prothrombin times, with or without bleeding. Monitoring prothrombin time regularly is advised when combining Oticlor with anticoagulants, adjusting the dose if needed.

Contraindications

Patients allergic to cephalosporins should not use Oticlor.

Side Effects

Common side effects include gastrointestinal issues like diarrhea, nausea, and vomiting. Rare cases of transient hepatitis, cholestatic jaundice, fever, abdominal pain, renal dysfunction, and pancytopenia have been reported.

Use in Pregnancy & Lactation

There are no adequate studies in pregnant women, so Oticlor should only be used if clearly necessary. Trace amounts of Cefaclor have been detected in breast milk, and its effect on nursing infants is unknown. Exercise caution when administering to breastfeeding mothers.

Precautions & Warnings

Oticlor should only be prescribed when bacterial infection is confirmed or highly suspected to reduce the risk of drug-resistant bacteria. Prolonged use may lead to an overgrowth of resistant organisms. Caution is advised when prescribing to patients with gastrointestinal disease, particularly colitis.

Before starting treatment, always confirm whether the patient has previously experienced allergic reactions to cephalosporins, penicillins, or other medications. Use caution with penicillin-sensitive individuals.

Overdose Symptoms

Overdose may lead to nausea, vomiting, abdominal pain, and diarrhea.

Therapeutic Class

Second-generation cephalosporin antibiotics.

Reconstitution Instructions

For Powder for Suspension: Shake the bottle thoroughly before adding water. Add 62.5 ml of boiled and cooled water in two parts, shaking until fully mixed. Store at room temperature for up to 7 days or in the refrigerator for up to 14 days.
For Pediatric Drops: Add 10 ml of boiled and cooled water to 15 ml of powder in two parts, shaking well. Use within 7 days at room temperature or 14 days in the refrigerator.

Storage Guidelines

Store Oticlor at room temperature, away from light. After reconstitution, the suspension can be kept at room temperature for up to 7 days or refrigerated for up to 14 days. Always keep the container tightly closed.