INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MOXYPEN®-250 CAPSULES
MOXYPEN®-500 CAPSULES
MOXYPEN® 125 mg/5 mLPOWDER FOR SYRUP
MOXYPEN® 250 mg/5 mLPOWDER FOR SYRUP

SCHEDULING STATUS:
S4

PROPRIETARY NAME:
(and dosage form)

MOXYPEN^®-250 CAPSULES
MOXYPEN^®-500 CAPSULES
MOXYPEN^® 125 mg/5 mLPOWDER FOR SYRUP
MOXYPEN^® 250 mg/5 mLPOWDER FOR SYRUP

COMPOSITION:
Capsules containing Amoxycillin trihydrate equivalent to Amoxycillin 250 mg and 500 mg, and powder for preparing fruit-flavoured syrups.
When dispensed as directed, each 5 mL of the syrup contains Amoxycillin trihydrate equivalent to 125 mg or 250 mg Amoxycillin.
The powder contains 0,1% m/v Sodium benzoate B.P. as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Amoxycillin is a penicillinase-susceptible semisynthetic penicillin. It is bactericidal in vitro against a broad spectrum of gram-positive and gram-negative pathogens. Being acid stable Amoxycillin is well absorbed when given orally. Peak plasma concentrations are reached at 2 hours and average about 4 micrograms/mL when 250 mg is administered.
The in vitro antibacterial spectrum of Moxypen is as follows (in vitro sensitivity does not necessarily imply in vivo efficacy):
Moxypen is particularly active in vitro against the following organisms:

Gram-positive organisms: Streptococcus pneumoniae*, Streptococcus faecalis* (enterococci), Streptococcus agalactiae (group B), penicillin-sensitive Neisseria gonorrhoeae, Listeria monocytogenes:

Moxypen is also active in vitro against the following organisms:
Gram-positive organisms:
Staphylococcus aureus* (penicillin sensitive), Streptococcus pyogenes, Streptococcus viridans*, Streptococcus bovis, Neisseria meningitidis (except the carrier state), Bacillus anthracis*, Corynebacterium species*, Clostridium species*:Moxypen also has in vitro activity against the following gram-negative organisms (these organisms may produce beta-lactamase):
Escherichia coli*, Haemophilus influenzae* (except type b-strains causing meningitis in children), Salmonella* and Shigella* species.
(Note that amoxycillin is less active in vitro against Shigella than ampicillin).Moxypen may also have some effect against the following organisms:
Bacteroides fragilis*, Proteus mirabilis* and Nocardia*.
* = sensitivity tests must be performed.Most species of the following organisms are resistant to Moxypen^®.
Enterobacter, Pseudomonas, Klebsiella, Serratia, Acinetobacter and indole-positive Proteus.
INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:

*	Respiratory tract infections (upper and lower): sinusitis, pharyngitis, epiglottitis, acute and chronic bronchitis and acute typical pneumonia.
*	Otitis media
*	Urinary tract infections
*	Uncomplicated gonococcal infections
*	Meningitis (sensitivity tests must be performed)
*	Gastro-intestinal infections including Salmonella and typhoid
*	Uncomplicated gastro-enteritis and enteric fever
*	Miscellaneous:
	Skin and soft tissue infections, bacteremia and as an adjunct in the treatment of sepsis caused by gram-negative bacteria.

CONTRA-INDICATIONS:
Patients known to be sensitive to penicillins or cephalosporins.
Should not be given to patients with infectious mononucleosis, since they are especially susceptible to amoxycillin-induced skin rashes; patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol, may be at increased risk of developing skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 10 years
250 mg of amoxycillin three times a day; 500 mg of amoxycillin may be required in some severe infections.
In gonorrhoea the usual dose is the equivalent of 3 g given as a single dose, usually combined with 1 g probenecid.
To reconstitute:

100 mL Syrup -	Add 59 mL water, invert bottle and shake well until all the powder is dissolved.
75 mL Syrup -	Add 44,25 mL water, invert bottle and shake well until all the powder is dissolved. (Hospital pack)

Children
The normal dose for children 6 months to 10 years of age is the equivalent of 125 mg (i.e. 5 mL of 125 mg/5 mL syrup) three times a day.
0-6 months: 62,5 mg three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Supra-infections with non-susceptible organisms, for example with Candida and Pseudomonas, may occur.
Pseudomembranous colitis has been reported.
Allergic reactions can occur in persons sensitised to penicillins, presenting with a pruritic skin rash, an erythematous skin reaction or urticaria.
Should a serious anaphylactic reaction occur, Moxypen should be discontinued and the patient treated with adrenaline, corticosteroids and antihistamines.
Gastro-intestinal discomfort, diarrhoea, nausea and vomiting may occur. Reduced doses may be required in patients with impaired renal function.
Raised serum transaminase concentrations have been reported.
Other adverse effects that have been reported include photosensitivity, blood dyscrasias such as neutropenia and pancytopenia and auditory and visual hallucinations.
Moxypen should be used with caution in patients with syphilis, as the Jarisch-Herxheimer reaction may occur.
Moxypen may decrease the efficacy of oestrogen-containing oral contraceptives. Moxypen may affect the absorption of other medicines, due to its effect on the gastro-intestinal flora.

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

IDENTIFICATION:
250 mg capsules A No. 2 hard gelatin capsule comprising a transparent purple body and transparent blue cap, printed in white ink with a Lennon logo and “LENNON”on the one section and “'MOXYPEN 250”on the other section of the capsule, containing white granules.
500 mg capsules A No. 0 elongated hard gelatin capsule comprising a transparent purple body and transparent blue cap, printed in white ink with a Lennon logo and “LENNON”on the one section and “MOXYPEN 500”' on the other section of the capsule, containing white granules.
Syrups A white free-flowing powder, which when reconstituted as directed, forms an orange-coloured syrup.

PRESENTATION:
Capsules Packs of 15, 100 or 500 capsules.
Syrups Bottles containing powder for reconstitution to 75 mL and 100 mL of 125 mg/5 mL or 250 mg/5 mL syrups.

STORAGE INSTRUCTIONS:
Containers should be kept tightly closed and stored below 25°C.
Once dispensed, the syrups must be used within 7 days when stored below 25°C, or within 14 days when stored in a refrigerator (below 7°C).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

250 mg Capsules	M/20.1.2/293
500 mg Capsules	M/20.1.2/294
Syrup 125 mg/5 mL	M/20.1.2/540
Syrup 250 mg/5 mL	M/20.1.2/541

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
(Co. Reg. No 04/00252/06)
7 Fairclough Road
KORSTEN
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 April 1991

Code 308251 990304        LH&SEL-K 13988 H99

Updated on this site: December 2001
Current: September 2004
Source: Community Pharmacy
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