CEROXIM Tablet, Suspension Ref.[50620] Active ingredients: Cefuroxime

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2015  Publisher: RANBAXY PHARMACEUTICALS (PTY) LTD, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

4.1. Therapeutic indications

Ceroxim is indicated for the treatment of infections caused by susceptible organisms in the following infections:

  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes. Penicillin is the usual medicine of choice in the treatment and prevention of streptococcal infections including the prophylaxis of rheumatic fever. Ceroxim is generally effective in the eradication of streptococci from the oral pharynx. Ceroxim is not indicated for the prophylaxis of subsequent rheumatic fever due to insufficient data available to support such use.
  • Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (methicillin-sensitive strains), Moraxella (Branhamella) catarrhalis, and Streptococcus pyogenes.
  • Sinusitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (methicillinsensitive strains) and Haemophilus parainfluenzae (ampicillin-sensitive strains).
  • Acute uncomplicated cystitis caused by Escherichia coli and Klebsiella pneumoniae.
  • Lyme disease caused by Borrelia burgdorferi. Ceroxim is indicated for the treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children over the age of 12 years.

4.2. Posology and method of administration

Adults

Pharyngitis and tonsillitis: 250 mg twice daily for seven days (range 5-10 days).

Otitis media: 500 mg twice daily for seven days (range 5-10 days).

Sinusitis and bronchitis: 250 mg twice daily for seven days (range 5-10 days).

Acute, uncomplicated cystitis: 250 mg twice daily for seven days (range 5-10 days).

Lyme disease: Adults and children over 12 years of age: 500 mg twice daily for 14 days (range 10-21 days).

Children

Usual dose: 125 mg twice daily for 7 days (range 5-10 days).

There is no experience with Ceroxim in children under 3 months of age.

Pharyngitis and tonsillitis: 10 mg/kg twice daily to a maximum of 125 mg twice daily for seven days (range 5-10 days).

For otitis media in children 3 months to 2 years of age the usual dose is: 10 mg/kg twice daily to a maximum of 125 mg twice daily (range 5-10 days).

For otitis media in children over 2 years of age the usual dose is: 15 mg/kg twice daily to a maximum of 250 mg twice daily for seven days (range 5-10 days).

Sinusitis and bronchitis: 10 mg/kg twice daily to a maximum of 125 mg twice daily for seven days (range 5-10 days).

Acute, uncomplicated cystitis: 15 mg/kg twice daily to a maximum of 250 mg twice daily for seven days (range 5-10 days).

Because of the bitter taste of cefuroxime axetil, tablets should not be crushed. Ceroxim should be taken half an hour after food for optimum absorption.

Directions for use of the Ceroxim and Ceroxim Forte Suspensions:

  1. Shake the bottle to loosen the granules and remove the cap.
  2. Use the measure cup to add water to the bottle (23 or 22 ml water for the 50 ml pack of Ceroxim Suspension or Ceroxim Forte Suspension respectively; and 44 or 43 ml water for the 100 ml pack of Ceroxim Suspension or Ceroxim Forte Suspension respectively) and replace the cap.
  3. Invert and shake the bottle vigorously until the sound of granules in the bottle disappear.
  4. Turn the bottle into an upright position and shake vigorously.
  5. Patient Instructions: SHAKE THE BOTTLE BEFORE USE.

4.9. Overdose

See SIDE EFFECTS.

Symptoms of overdosage

Seizures have been reported.

Treatment of overdose

Treatment is symptomatic and supportive. Serum levels of Ceroxim can be reduced by haemodialysis or peritoneal dialysis.

6.4. Special precautions for storage

Ceroxim 250 / 500 Tablets: Store at or below 25°C, protected from moisture.

Ceroxim and Ceroxim Forte Suspension: The unconstituted suspension is stored at or below 25°C, protected from moisture.

Keep the container tightly closed.

The constituted suspension is stored in a refrigerator at 2 to 8°C for 10 days.

Discard the unused portion of reconstituted suspension after 10 days.

KEEP OUT OF REACH OF CHILDREN.

6.5. Nature and contents of container

Ceroxim 250 / 500 Tablets: Cartons containing PVC/Aclar Blister strips of 10 or 5x10 tablets.

Ceroxim and Ceroxim Forte Suspensions are packed in 50 ml and 100 ml HDPE bottle packs, that comprise of natural translucent HDPE bottles with Child resistant closure caps. Each packet also contains a measuring cup with graduated markings. Bottles are labelled and packed in cartons.

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