INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MAXCIL P SYRUP
MAXCIL PF SYRUP

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MAXCIL P SYRUP
MAXCIL PF SYRUP

COMPOSITION:
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 presence of food does not interfere with the absorption of Amoxycillin. Amoxycillin may, therefore, be taken with meals.
The in vitro antibacterial spectrum of Amoxycillin is as follows (in vitro sensitivity does not necessarily imply in vivo efficacy):
Amoxycillin 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:
Amoxycillin 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*:
Amoxycillin also has in vitro activity against the following gram-negative organisms (these organisms may produce beta-lactamase):
Escherichia coli*, Haemophilus influenzae*, (except beta-strains causing meningitis in children), Salmonella* and Shigella* species.
(Note that amoxycillin is less active in vitro against Shigella than ampicillin).
Amoxycillin may also have some effect against the following organisms: Bacteroides fragilis*, Proteus mirabilis* and Nocardia*.
* = sensitivity tests must he performed.
Most species of the following organisms are resistant to Amoxycillin.
Enterobacter, Pseudomonas, Klebsiella, Serratia, Acinetobacter and indole-positive Proteus.
Distribution:

(i)	Sputum: The concentration of amoxycillin in sputum does not decrease as occurs with ampicillin as purulence subsides.
(ii)	Bile: Amoxycillin is present in bile obtained from a common bile duct drain of a healthy gall-bladder, however, biliary levels are lower when the gall-bladder is diseased and absent in the presence of biliary tract obstruction.
(iii)	Urine: The average concentration of Amoxycillin in urine collected during the first six hours after 250 mg oral dose is 580 mg/mL.

Excretion:

(i)	Renal: Approximately 60% of an oral dose of Amoxycillin is excreted unchanged in the active form into the urine within six hours. Approximately 70% - 80% of an intramuscular dose and 90% of an intravenous dose is excreted unchanged in the active form, into the urine within 12 hours.
(ii)	Biliary: A variable percentage of Amoxycillin is excreted into the bile.

Probenecid
Even higher Amoxycillin serum levels may be achieved after oral administration to patients with normal renal function, by the simultaneous administration of a renal blocking agent such as probenecid. Probenecid should not be given in the presence of abnormal renal function.

INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:

*	Respiratory tract infections (upper and lower): sinusitis, pharyngitis, epiglottitis, acute and 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.

WARNINGS:
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. Before commencing therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergies.
If an allergic reaction occurs, appropriate therapy should be instituted and amoxycillin therapy discontinued. There is insufficient evidence at present to show that Amoxycillin penetrates into the cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections.

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.
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.

Note:
(1)	Patients with renal insufficiency may possibly require a reduced dose.
(2)	During treatment with high doses of Amoxycillin, an adequate fluid intake and urinary output must be maintained. Indwelling catheters should be checked regularly for potency since at room temperature high urinary concentration of Amoxycillin may precipitate out of solution.

Specific dosages:

	DAILY	DOSAGES
Indications	Adults	Children	Duration
Gastro-intestinal tract infections	1-2 g	-	4-5 days
Acute Typhoid Fever	4 g	-	14 days
	-	100 mg/kg	21 days
Gonorrhoea	2-3 g	-	Stat

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-Effects:
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, MAXCIL should be discontinued and the patient treated with adrenaline, corticosteroids and antihistamines.
Other reactions including angio-oedema, anaphylaxis, erythema multiforma, Stevens-Johnson syndrome and exfoliative dermatitis may occur in exceptional cases.
Blood:
Blood dyscrasias such as neutropenia and pancytopenia have been reported less frequently. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Liver:
A moderate rise in SGOT and for SGPT has been reported in exceptional cases.
Gastro-intestinal:
Gastro-intestinal discomfort, diarrhoea, nausea and vomiting may occur. Pseudo-membranous colitis has been reported, if this condition occurs, treatment should be discontinued and appropriate therapy, e.g. vancomycin, should be initiated.
Other:
Raised serum transaminase concentrations have been reported.
Other adverse effects that have been reported include photosensitivity, and auditory and visual hallucinations.
Special Precautions:
The dose should be reduced in patients with renal failure. Periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy.
Penicillin therapy changes the normal bacterial flora and lead to supra-infection with penicillin-resistant organisms including Pseudomonas and Candida, particularly with prolong use.
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 the therapy. Amoxycillin should be used with caution in patients with glandular fever and possibly HIV infection since they are especially susceptible to ampicillin-induced skin rashes.
Caution is needed when administering Amoxycillin to patients with syphillis, as the Jarisch-Herxheimer reaction may occur in these patients.

Interactions:
Due to Amoxycillin's effect on intestinal flora, the absorption of other medicine may be affected. Amoxycillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
The absorption of concurrently administered digoxin may be increased during treatment with Amoxycillin. Hepatitis and cholestatic jaundice have been reported with the combination amoxycillin with clavulanic acid; the clavulanic acid component has been implicated. Erythema multiforme (including the Stevens-Johnson syndrome), toxic epidermal necrolysis, and exfoliative dermatitis have also been attributed occasionally to amoxycillin with clavulanic acid.
The possibility of a prolonged bleeding time following oral treatment with a broad-spectrum antibiotic like amoxycillin should be borne in mind in patients receiving anticoagulants.

Pregnancy and Lactation:
Animal reproduction studies have failed to demonstrate a risk to the foetus. There are no adequate and well controlled studies in pregnant women.
Amoxycillin is excreted in breast milk, and should be used with caution when administered to lactating women.

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

IDENTIFICATION:
An off-white free-flowing powder, which when reconstituted as directed, forms a yellow-coloured syrup.

PRESENTATION:
Bottles containing powder for reconstitution to 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 syrup 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 NUMBER:

MAXCIL P SYRUP:	Y/20.1.2/382
MAXCIL PF SYRUP:	Y/20.1.2/383

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Triomed (Pty) Ltd.
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 April 1998

308579        031001        Harry's Printers-K30760 J03

Updated on this site: December 2004
Source: Community Pharmacys
SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004