C-MOX 250 (capsules); C-MOX 500 (capsules); C-MOX 125S (suspension); C-MOX 250S (suspension)

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

C-MOX 250 (capsules)
C-MOX 500 (capsules)
C-MOX 125S (suspension)
C-MOX 250S (suspension)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

C-MOX 250 (capsules)
C-MOX 500 (capsules)
C-MOX 125S (suspension)
C-MOX 250S (suspension)

COMPOSITION:
Amoxycillin trihydrate available as:

C-MOX 250 -	Gelatin capsules containing the equivalent of 250 mg amoxycillin.
C-MOX 500 -	Gelatin capsules containing the equivalent of 500 mg amoxycillin.
C-MOX 125S -	Each 5 mL of reconstituted suspension contains the equivalent of 125 mg amoxycillin. The powder contains 0,148% (m/v) Nipastat as preservative.
C-MOX 250S -	Each 5 mL of reconstituted suspension contains the equivalent of 250 mg amoxycillin The powder contains 0,148% (m/v) Nipastat as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
C-MOX is a semisynthetic aminopenicillin with an in vitro bactericidal action against a broad spectrum of gram-positive and gram-negative pathogens. The presence of the enzyme penicillinase has a major influence on the degree and extent of its activity against organisms. Being acid stable it is well absorbed when given orally. The peak serum level is achieved within 2 hours after oral administration. The presence of food does not interfere with the absorption of C-MOX. About 20% of C-MOX is protein bound in plasma. Approximately 50% is excreted in an active form in the urine, within six hours. In vitro sensitivity does not necessarily imply in vivo efficacy:
C-MOX is particularly active in vitro against the following gram-positive organisms: Streptococcus pneumoniae*, Streptococcus faecalis* (enterococci), Streptococcus agalactiae (group B), penicillin-sensitive Neisseria gonorrhoeae, Listeria monocytogenes; C-MOX also has in vitro activity against the following organisms:

gram-positive	gram-negative (these organisms may produce beta-lactamase)
Staphylococcus aureus * (penicillin senst)	Escherichia coli *
Streptococcus pyogenes	Haemophilus influenzae (except type
Streptococcus viridans *	b-strains causing meningitis in
Streptococcus bovis	children)
Neisseria meningitidis (except carrier state)	Salmonella species *
Bacillus anthracis *	Shigella species *
Corynebacterium species *	(Amoxycillin is less active in vitro
Clostridium species	against Shigella than ampicillin)

C-MOX may also have some effect against the following organisms:
Bacteroides fragalis*, Proteus mirabalis* and Nocardia*.
* = Sensitivity tests must be performed.
Most species of the following organisms are resistant to C-MOX:
Enterobacter, Pseudomonas, Klebsiella, Serratia, Acinetobacter and indole-positive Proteus.

INDICATIONS:
Infections caused by susceptible, non-penicillinase producing organisms:
Respiratory tract infections:
Sinusitis, pharyngitis, otitis media, epiglottitis, acute and chronic bronchitis and acute typical pneumoniae;
Urinary tract infections;
Uncomplicated gonococcal infections;
Meningitis (sensitivity tests must be performed);
Gastro-intestinal infection including Salmonella, Shigella and typhoid. Uncomplicated gastro-enteritis and enteric fever;
Miscellaneous:
Skin and soft tissue infection, bacteremia and as an adjunct in the treatment of sepsis caused by gram-negative bacteria.

CONTRA-INDICATIONS:
Allergy to penicillins or cephalosporins is an absolute contra-indication to the use of C-MOX.

WARNINGS:
Patients with infectious mononucleosis since they are especially susceptible to amoxycillin induced skin rashes. Patients with lymphatic leukemia and hyperuricaemia being treated with allopurinol may be at increased risk of developing skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for C-MOX is 750 mg to 1,5 g per day.

Children 0 - 6 months-	62,5 mg three times a day.
Children 6 months to 10 years-	125 mg three times a day.
Adults and children above 12 years-	250 mg - 500 mg three times a day.

Directions for reconstituting the suspension:

C-MOX 125S:	Add 83 mL distilled water to the dry powder in the bottle and shake well.
C-MOX 250S:	Add 81 mL distilled water to the dry powder in the bottle and shake well.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Allergic reactions may occur presenting with a pruritic skin rash, an erythematous skin reaction or urticaria. Should a serious anaphylactic reaction occur, C-MOX must be discontinued and the patient treated with the usual agents: adrenalin, corticosteroids and antihistamines.
Caution must be exercised in treating patients with dehydration or oliguria because of the possibility of crystalluria.
The use of this antibiotic may lead to the appearance of resistant strains of organisms, causing super-infections:
Gastro-intestinal side-effects that may occur are diarrhoea, nausea and vomiting. Pseudomembranous collitis has been reported.
C-MOX should be used with caution in patients with syphilis; as the Jarisch-Herxheimer reaction may occur.
C-MOX may decrease the efficacy of oestrogen containing oral contraceptives.
C-MOX may affect the absorption of other medicines due to its effect on the gastrointestinal flora.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to “Side-effects and Special Precautions”.
Treatment is symptomatic and supportive.

IDENTIFICATION:

C-MOX 250-	Size 2, opaque lavender and pink capsule.
C-MOX 500-	Size 0, elongated, opaque lavender and pink capsule.
C-MOX 125S-	Amber glass bottle containing a white to slightly pink coloured powder which on reconstitution produces a dark pink, raspberry flavoured suspension
C-MOX 250S-	Amber glass bottle containing a white to slightly pink coloured powder which on reconstitution produces a dark pink, raspberry flavoured suspension

PRESENTATION:

C-MOX 250-	Securitainers with 15, 100 and 500 capsules
C-MOX 500-	Securitainers with 15, 100 capsules
C-MOX 125S-	150 mL amber glass bottles containing powder for reconstitution of 100 mL suspension
C-MOX 250S-	150 mL amber glass bottles containing powder for reconstitution of 100 mL suspension

STORAGE INSTRUCTIONS:
Keep in a dry place below 25°C.
Keep out of reach of children.
Potency of the reconstituted suspensions will be maintained for 7 days at temperatures below 25°C and two weeks at 2 - 8°C.

REGISTRATION NUMBERS:

C-MOX 250:	Y20.1.2/38
C-MOX 500:	Y20.1.2/39
C-MOX 125S:	Z20.1.2/305
C-MOX 250S:	Z20.1.2/306

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd
Tempelhof-South
Bonaero Park

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

15 July 1992

Britepak