MAXCIL 250 (CAPSULES)
MAXCIL 500 (CAPSULES)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MAXCIL 250 (CAPSULES)
MAXCIL 500 (CAPSULES)

COMPOSITION:
Capsules containing amoxycillin trihydrate equivalent to amoxycillin 250mg and 500mg .

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Amoxycillin is a penicillinase-susceptible semi-synthetic 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 4micrograms/mL when 250mg 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 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 b-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 mirabili* and Nocardia*.
* = sensitivity tests must be 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 purulence subsides, as occurs with ampicillin.
(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 250mg oral dose, is >300micrograms/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 12hours.
(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 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.
Little amoxycillin passes into the cerebro-spinal fluid unless the meninges are inflamed and MAXCIL is therefore not recommended for treatment of cerebro-spinal infections.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 10years
250mg of amoxycillin three times a day; 500mg of amoxycillin may be required in some severe infections.
In gonorrhoea the usual dose is the equivalent of 3g given as a single dose, usually combined with 1 g probenecid.
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 patency since at room temperature high urinary concentration of amoxycillin may precipitate out of solution.

Specific dosages

Indications	DAILY Adults	DOSAGES Children	Duration
Gastro-intestinal tract infections	1-2g	---	4-5days
Acute typhoid fever	4g	---	14 days
	---	100mg/kg	21 days
Gonorrhoea	2-3g	---	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 multiforme, 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 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 leads to supra-infection with penicillin-resistant organisms including Pseudomonas and Candida, particularly with prolonged 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 syphilis, 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:
250mg capsules: Opaque yellow body and an opaque red cap, printed in black ink "250" on one section. (size no.2 hard gelatin capsule.)
500mg capsules: Opaque yellow body and an opaque red cap, printed in black ink "500" on one section. (size no. 0 hard gelatin capsule.)

PRESENTATION:
MAXCIL250 (CAPSULES): White containers containing 15, 100 and 1000 capsules.
MAXCIL500 (CAPSULES): White containers containing 15, 100 and 1000 capsules.

STORAGE INSTRUCTIONS:
Containers should be kept tightly closed and stored below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

MAXCIL 250 (CAPSULES):	Y/20.1.2/380
MAXCIL 500 (CAPSULES):	Y/20.1.2/381

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Triomed (Pty) Ltd.
Gardener Place
Cnr. of Howard Drive & Gardener Way Pinelands
7405

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 April 1998

PSD 1084
03/2002
Britepak

Updated on this site: April 2005
Source: Community Pharmacy