INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CLOXlN 125 mg/mL SYRUP
CLOXIN 250 mg CAPSULES
CLOXlN 500 mg CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CLOXlN 125 mg/mL SYRUP
CLOXIN 250 mg CAPSULES
CLOXlN 500 mg CAPSULES

COMPOSITION:
Syrup: When reconstituted as directed, each 5 mL of the syrup contains cloxacillin sodium equivalent to 125 mg cloxacillin.
Preservative: sodium benzoate 0,1% m/v.
Capsules: Each capsule contains cloxacillin sodium equivalent to 250 mg or 500 mg cloxacillin.
PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Cloxacillin is a semi-synthetic penicillin, resistant to penicillinase, and is therefore active against penicillinase-producing staphylococci.
Cloxacillin is in general less effective against organisms susceptible to benzylpenicillin, such as streptococci, pneumococci and non-penicillinase-producing staphylococci, and is not useful against gram-negative bacteria.

INDICATIONS:
Cloxacillin is indicated for the treatment of infections due to penicillinase-producing staphylococci that are resistant to benzylpenicillin. It is used against gram-positive staphylococcus aureus in:
  skin and soft tissue infections, e.g. abscesses, cellulitis.
  pneumonia
  endocarditis
  osteomyelitis
CONTRA-INDICATIONS:
Cloxacillin should not be given to patients with a history of penicillin allergy or administered to neonates born of mothers hypersensitive to penicillin.
Patients allergic to cephalosporins may also be allergic to penicillins.
Cloxacillin is incompatible with aminoglycosides, tetracyclines, erythromycin and polymyxin B.

WARNINGS:
Use with caution in patients with a known history of allergy to penicillins.
When administered to a patient with penicillin sensitivity anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis.
Due to the variability in intestinal absorption, oral administration is not a suitable substitute for the parenteral treatment of serious infections.

DOSAGE AND DIRECTIONS FOR USE:
SYRUP: To reconstitute the syrup, add 57 mL of water, and shake well to dissolve.
Adults: 500 mg (20 mL syrup) six hourly, administered one hour before meals
Children:
(2-10 yrs)
250 mg (10 mL syrup) six hourly, administered one hour before meals.
CAPSULES:
Adults: One 500 mg capsule six hourly, administered one hour before meals.
Children:
(2-10 yrs)
One 250 mg capsule six hourly, administered one hour before meals.
SIDE-EFFECTS ANO SPECIAL PRECAUTIONS:
Sensitivity reactions may include skin rashes, angioedema, bronchospasm, serum sickness and anaphylaxis, and sometimes death within minutes. Treatment with adrenaline, corticosteroids, aminophyllin or antihistamines may be necessary. A generalised sensitivity reaction can develop within a few hours or weeks of commencing treatment, including urticaria, fever, joint pains and eosinophilia. Other allergic reactions include exfoliative dermatitis and maculopapular rashes, interstitial nephritis and vasculitis. Haemolytic anaemia, leucopenia, prolonged bleeding time and defective platelet function can occur.
Oral administration may produce diarrhoea, heartburn and nausea, and hepatitis and cholestatic jaundice have been reported. A sore mouth or tongue, and a black hairy tongue have also been reported.
Supra-infection with C. albicans, other fungi or organisms resistant to cloxacillin may occur.
Care should be taken when administering high doses of cloxacillin especially to patients with impaired renal function as there is a risk of neuro-toxicity and congestive heart failure.
Disturbance of electrolyte balance may occur following administration of large doses. Increases in liver enzyme values have been reported.
Renal and haematological systems should be monitored during prolonged and high dose therapy, patients with syphilis may exhibit the Jarish-Herxheimer reaction and should also therefore be monitored.
A skin test for sensitivity may be used to determine those patients most likely to develop allergic reactions to penicillins.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Convulsions and other signs of toxicity to the central nervous system may occur with very high doses, particularly when administered intravenously to patients with renal failure. Nephrotoxicity may occur in patients with diminished renal function. Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
Syrup A salmon-pink free-flowing powder for the preparation of an orange fruit-flavoured syrup.
Capsules 250 mg Size 2 hard gelatin capsule with a white body and orange cap, printed with 'Cloxin 250' and the Lennon logo.
Capsules 500 mg Size 0 hard gelatin capsule with a white body and orange cap, printed with 'Cloxin 500' and the Lennon logo.
PRESENTATION:
Syrup Glass bottles containing powder for reconstitution with water.
Capsules Securitainers containing 20, 100 or 500 capsules.
STORAGE DIRECTIONS.
Store in a dry place below 25°C. Reconstituted syrup should be stored in a refrigerator and used within 7 days.

REGISTRATION NUMBERS:
Cloxin 125 mg/5 mL Syrup N/20.1.2/7.
Cloxin 250 mg Capsules N/20.1.2/90.
Cloxin 500 mg Capsules N/20.l.2/91.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1982
12-038/10-93

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