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

Logo CLOXIN INJECTION 250 mg
CLOXIN INJECTION 500 mg

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CLOXIN INJECTION 250 mg
CLOXIN INJECTION 500 mg

COMPOSITION
Injection: Vials containing
cloxacillin 250 mg or 500 mg as the sodium salt.

PHARMACOLOGICAL CLASSIFICATION
A 20.1.2 - Penicillins

PHARMACOLOGICAL ACTION
Cloxacillin is an isoxazolyl penicillin and is stable to penicillinase. It is active against penicillinase-producing staphylococci and, in general, is less effective against organisms susceptible to penicillin G e.g. streptococci and pneumococci, and is not useful against gram negative organisms.

INDICATIONS
Cloxacillin is indicated for the treatment of infections caused by penicillinase producing staphylococci that are resistant to Benzyl-penicillin, such as in:
abscesses (skin and soft tissue);
cellulitis;
bacteraemia (septicaemia);
endocarditis;
pneumonia (respiratory tract);
osteomyelitis (bone and joints).

CONTRA-INDICATIONS
Patients with a history of penicillin allergy. Neonates born of mothers sensitive to penicillin.
Patients allergic to cephalosporins may also be allergic to penicillins. Cloxacillin should not be administered by subconjunctival injection or used as an eye drop.
The intrathecal route should be avoided.

WARNINGS
Use with care in jaundiced neonates. Incompatible with aminoglycosides, tetracyclines, erythromycin and polymyxin B.

DOSAGE AND DIRECTIONS FOR USE
Please note: The reconstituted solution must be shaken well before use.
Route Dosage (for Adults) Administration
IM injection 250 mg 4 to 6 hourly The contents of each vial should be dissolved in 1,5 mL of Water for Injections
Slow IV Injection 500 mg every 4 to 6 hours given over 3 to 4 minutes 500 mg of Cloxacillin to be dissolved in 10 to 20 mL Water for Injections.
IV Infusion 500 mg every 4 to 6 hours All systemic dosages may be doubled in severe infections. Cloxacillin is compatible with the commonly used I.V. fluids and may be added to the drip container, or preferably, injected directly into the drip tube over a period of 2-3 minutes.
Intrapleural
Injections
500 mg daily 250 mg to 500 mg Cloxacillin to be dissolved in 2 to 5 mL of Water for Injections.
Intra-articular 500 mg daily 250 mg to 500 mg Cloxacillin to be dissolved in 2 mL to 5 mL of Water for Injections. 0,5% Lignocaine hydrochloride may be used as a local anaesthetic, if desired.

Dosage for Children:         12,5 to 25 mg/kg every 6 hours
Under 2 years:         ¼ of adult dose
2 to 10 years:         ½ of adult dose

SIDE-EFFECTS AND 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 antihistamine 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 other skin reactions, interstitial nephritis and vasculitis. Haemolytic anaemia, leucopenia, prolonged bleeding time and defective platelet function. Suprainfection 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 neurotoxicity.
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
Disturbance of electrolyte balance may occur following administration of large doses. 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
Injection 250 mg: A white crystalline hygroscopic powder in a clear glass vial.
  500 mg: A white crystalline hygroscopic powder in a clear glass vial.

PRESENTATION
Containers of 10 and 50 vials.

STORAGE INSTRUCTIONS
Store below 25°C.
Solutions for injection should preferably be freshly prepared but will retain their anti-bacterial potency for 24 hours at room temperature or for 4 days at 4°C.

REGISTRATION NUMBER
Cloxin Injection 250 mg –M/20.1.2/227
Cloxin Injection 500 mg –M/20.1.2/228

NAME AND BUSINESS ADDRESS OF APPLICANT:       
PHARMACARE LIMITED
7 Fairclough Road
Port Elizabeth 6001
South Africa
        Marketed by:         Intramed, Division of Pharmacare
6 Gibaud Road
Port Elizabeth 6001
South Africa

DATE AND PUBLICATION OF THIS PACKAGE INSERT:
August 1980
                                12-474/2-99
                KOHLER C&P P.E.

Updated on this site: November 1999

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