Natrofen

Uses

Natrofen is used for the treatment of patients with mild to moderate infections caused by susceptible strains. Infections include:

• Lower respiratory tract infections: acute bronchitis, acute exacerbations of chronic bronchitis, community acquired pneumonia.
• Upper respiratory tract and ear infections: otitis media, sinusitis, tonsillitis and pharyngitis.
• Uncomplicated skin and soft tissue infections.

Natrofen is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Bacterial Infections, Community Acquired Pneumonia (CAP), Streptococcal Pharyngitis, Streptococcal tonsillitis, Urinary Tract Infection, Bacterial otitis media, Uncomplicated skin and subcutaneous tissue bacterial infections

How Natrofen works

Natrofen, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefprozil interferes with an autolysin inhibitor.

Dosage

Natrofen dosage

Adult: 500 mg daily as a single or in 2 divided doses, increased to 500 mg bid if necessary. Duration: 10 days.Child (6 month to 2 year):

• For otitis media: 15 mg/kg 12 hrly.
• For acute sinusitis: 7.5 mg/kg or 15 mg/kg 12 hrly.
• For pharyngitis or tonsillitis: 7.5 mg/kg 12 hourly.

Child (>2 yr):

• For skin and skin structure infections: 20 mg/kg daily. Max: 1 g daily.

Side Effects

Natrofen was usually well tolerated in controlled clinical trials. The most common adverse effects of cefprozil are diarrhea, nausea, vomiting, abdominal pain, rash, urticaria, dizziness, hyperactivity, insomnia, confusion etc.

Toxicity

Single 5000 mg/kg oral doses of cefprozil caused no mortality or signs of toxicity in adult, weaning or neonatal rats, or adult mice. A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus monkeys, but no mortality.

Precaution

History of hypersensitivity to penicillins and GI disease esp colitis. Renal impairment. Pregnancy and lactation.

Interaction

May enhance the nephrotoxic effect of aminoglycosides. May enhance the anticoagulant effect of vit K antagonists. May diminish the therapeutic effect of BCG, typhoid vaccine and Na picosulfate. May increase serum concentrations w/ probenecid.

Food Interaction

• Take with or without food. The absorption is unaffected by food.

Natrofen Drug Interaction

Unknown: fluticasone / salmeterol, fluticasone / salmeterol, diphenhydramine, diphenhydramine, polyethylene glycol 3350, polyethylene glycol 3350, mometasone nasal, mometasone nasal, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, alprazolam, alprazolam, cetirizine, cetirizine

Natrofen Disease Interaction

Major: colitisModerate: renal dysfunction, PKU, dialysis, liver disease, seizure disorders

Volume of Distribution

• 0.23 L/kg

Elimination Route

Oral bioavailability is approximately 95%.

Half Life

1.3 hours

Clearance

• 3 mL/min/kg [fasting subjects]

Pregnancy & Breastfeeding use

Pregnancy category B. 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 cefprozil (<0.3% of dose) have been detected in human milk following administration of a single 1 gram dose to lactating women. Caution should be exercised when cefprozil is administered to a nursing woman, since the effect of cefprozil on nursing infants is unknown.

Contraindication

Hypersensitivity to cephalosporin antibiotics.

Storage Condition

Store between 20-25°C. Reconstituted powder for suspension: Store between 2-8°C.

Innovators Monograph

You find simplified version here Natrofen