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

Logo ORBENIN 250 (capsules)
ORBENIN 500 (capsules)
ORBENIN S (syrup)
ORBENIN 250 I (injection)
ORBENIN 500 I (injection)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ORBENIN 250 (capsules)
ORBENIN 500 (capsules)
ORBENIN S (syrup)
ORBENIN 250 I (injection)
ORBENIN 500 I (injection)

COMPOSITION:
Cloxacillin Sodium BP available as:

Orbenin 250 Capsules each containing the equivalent of 250 mg cloxacillin.
Orbenin 500 Capsules each containing the equivalent of 500 mg cloxacillin.
Orbenin S Syrup containing in each 5 mL of reconstituted syrup the equivalent of 125 mg cloxacillin, and as preservative 0,13 % m/m sodium benzoate.
Orbenin 250 I Vials each containing the equivalent of 250 mg cloxacillin for solution before use.
Orbenin 500 I Vials each containing the equivalent of 500 mg cloxacillin for solution before use.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Orbenin
is a semi-synthetic penicillin derived from the penicillin nucleus 6-aminopenicillanic acid.
Orbenin is stable to penicillinase and is highly active against streptococci, pneumococci and staphylococci, irrespective of their sensitivity to other penicillins.

Chemistry: Orbenin is chemically the monohydrate of sodium 6-[3-(2-chlorophenyl)-5-methylisoxazole-4-carboxamido] penicillanate.

Bacteriology: Orbenin is rapidly bactericidal to all Gram-positive organisms except Strep. faecalis but is primarily of interest for its activity against staphylococci and in particular against the high proportion of staphylococci that are resistant to penicillin G. This makes Orbenin ideal for the treatment of mixed Gram-positive infections.

Absorption and excretion: Orbenin is relatively stable to gastric acid, is well absorbed when given by mouth and is active for four to six hours. Effective blood, tissue and urine levels are readily achieved and the peak serum levels are obtained about one hour after an oral dose and about half an hour after an intramuscular injection. Doubling the dose doubles the serum concentration.
Orbenin is metabolized to about ten percent in the human body. The metabolite has been isolated and found to have antibacterial activity very similar to that of the parent compound.
Orbenin is predominantly excreted by glomerular filtration and renal tubular secretion in a similar manner to the other penicillins.
Orbenin should be taken about one hour before meals for optimum absorption.

INDICATIONS:
Orbenin
is indicated for the treatment of all staphylococcal infections occurring in hospitals or general practice, particularly where the infection is severe and where treatment must be initiated before the results of sensitivity tests are available. Orbenin is of particular value in treating mixed Gram-positive infections, e.g. infected burns where the presence of a penicillinase-producing staphylococci may inactivate other penicillins before they can exert any effect on the otherwise sensitive organisms. Orbenin is indicated in the following:
Pneumonia Tonsillitis and pharyngitis
Osteomyelitis Infected burns
Wound infections Acute and sub-acute endocarditis
Boils and carbuncles Staphylococcal enteritis
Abscesses and cellulitis Staphylococcal meningitis
Otitis media Staphylococcal urinary tract infection

CONTRA-INDICATIONS:
Allergy to penicillins is an absolute contra-indication to the use of Orbenin.

DOSAGE AND DIRECTIONS FOR USE:
Dosage and administration

ROUTE DOSAGE (for adults) ADMINISTRATION
Oral 500 mg six hourly Administer one hour before meals
Intramuscular injection 250 mg - 500 mg six hourly The contents of each vial should be dissolved in 1,5 mL of Water for Injections BP
Intravenous injection 500 mg four to six hourly 500 mg of Orbenin to be dissolved in 10 mL - 20 mL of Water for Injections BP
Intravenous infusion Up to 3 g daily depending on the severity of the infection. Orbenin is compatible with the commonly used intravenous fluids and may be added to the drip bottle or, preferably, injected directly into the drip tube over a period of two or three minutes
Intrapleural injection 500 mg daily 500 mg of Orbenin to be dissolved in 5 mL - 10 mL of Water for Injections BP
Intra-articular injection 500 mg daily 500 mg of Orbenin to be dissolved in 2 mL - 5 mL of Water for Injections BP. 0,5% lignocaine hydrochloride may be used as a local anaesthetic, if desired.

Dosage for children: Under two years: Quarter adult dose.
  Two to ten years: Half adult dose.
Note: In severe infections the dosage may safely be increased.
As with other penicillins, concomitant administration of probenecid to patients with normal renal function raises the serum level of Orbenin two to five fold and the duration of inhibitory serum concentrations is prolonged to at least six hours. Probenecid may be given either as six hourly 0,5 g doses, or as twice daily 1 g doses. Such combinations are valuable in the treatment of conditions which may require higher Orbenin blood levels, e.g. osteomyelitis and bacterial endocarditis.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Allergic reactions may occur presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event, withdrawal of Orbenin and administration of an antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, Orbenin should be discontinued and the patient treated with the usual agents (adrenaline, corticosteroids and antihistamines). The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should, therefore, be carried out wherever possible to ensure the appropriateness of therapy.

IDENTIFICATION:
Orbenin 250 –Black and orange gelatine capsules with “Orbenin 250”imprinted in white.
Orbenin 500 –Black and orange gelatine capsules with “Orbenin 500”imprinted in grey.
Orbenin S –Bottles containing powder for the preparation of 100 mL fruit-flavoured syrup.
Orbenin 250 I –White powder. Clear solution.
Orbenin 500 I –White powder. Clear solution.

PRESENTATION:
Orbenin 250 –(Black/orange) capsules printed with “Orbenin 250”in amber glass bottles of 20 and 100
Orbenin 500 –(Black/orange) capsules printed with “Orbenin 500”in amber glass bottles of 20 and 100
Orbenin S –Bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL syrup.
Orbenin 250 I –250 mg cloxacillin :is cloxacillin sodium.
Orbenin 500 I –500 mg cloxacillin as cloxacillin sodium.

STORAGE INSTRUCTIONS:
Containers of Orbenin 250 and Orbenin 500 should be kept tightly closed in a cool (below 25°C) dry place. Once dispensed, Orbenin S should be used within seven days if stored in a cool place (below 25°C), or 14 days if stored in a refrigerator (5°C). Solutions of Orbenin 250 I and Orbenin 500 I should preferably be freshly prepared but will retain their anti-bacterial potency for 24 hours at room temperature (23°C), or for four days in a refrigerator (5°C).
Keep out of reach of children.

INTRAVENOUS FLUID STABILITY PERIOD OF ORBENIN AT 23°C
Normal saline 24 hours
5% dextrose 24 hours
Dextrose saline 24 hours
M/6 sodium lactate 6 hours
Ringer’s solution 24 hours
1,4% sodium bicarbonate 6 hours
Dextran 40 injection in normal saline 24 hours
Dextran 40 injection in 5% dextrose 24 hours

REGISTRATION NUMBERS:
Orbenin 500 D/20.1.2/18
Orbenin 500 I D/20.1.2/9

REFERENCE NUMBERS
Orbenin 250 A.614 (Act 101/1965)
Orbenin S A.601 (Act 101/1965)
Orbenin 250 I A.611 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd.
6 Carey Street, Wynberg Ext. 6, Johannesburg 2090.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
09.09.1991

Orbenin and the SB logo are trade marks.

        P0662

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