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

Logo AUGMAXCIL S (Powder for Suspension)
AUGMAXCIL SF (Powder for Suspension Forte)
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

AUGMAXCIL S (Powder for Suspension)
AUGMAXCIL SF (Powder for Suspension Forte)

COMPOSITION:
AugMaxcil S: 5 mL reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg amoxicillin and potassium clavulanate equivalent to 31,25 mg clavulanic acid.
Contains 0,042% (2,09 mg/5 mL) Sodium Benzoate as a preservative.
AugMaxcil SF: 5 mL reconstituted suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin and potassium clavulanate equivalent to 62,5 mg clavulanic acid.
Contains 0,042% (2,09 mg/5 mL) Sodium Benzoate as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
AugMaxcil is a combination of amoxicillin and clavulanic acid.
Amoxicillin is a broad spectrum bactericidal antibiotic, which is active against both Gram-positive and Gram-negative organisms.
Clavulanic acid itself has only a minimal antibacterial action. However, by binding irreversibly to the beta-lactamases produced by many strains of organisms usually resistant to penicillins, the clavulanic acid protects the amoxicillin from hydrolysis.
Clavulanic acid has been shown in vitro, to be an irreversible inhibitor of beta-lactamases produced by many bacteria including: Escherichia coli; Haemophilus influenzae; Klebsiella pneumoniae; Bacteroides fragilis; Staphylococcus aureus as well asProteus vulgaris; Proteus mirabilis and Neisseria gonorrhoeae.
Type 1 beta-lactamases of the Richmond-Sykes classification are not inactivated by clavulanic acid, and this includes those produced byEnterobacter; Citrobacter and Serratia marcescens as well as the Acinetobacter and Providencia species and indole positive Proteus.
The combination of amoxicillin and clavulanic acid has shown in vitro, to have a synergistic action against amoxicillin resistant organisms. There is no evidence of antagonism. ( In vitro activity does not necessarily imply in vivo efficacy).

INDICATIONS:
AugMaxcil is indicated for the treatment of infections caused by all organisms sensitive to amoxicillin, as well as those organisms which produce beta-lactamases that are sensitive to clavulanic acid. This includes:
- Infections of the upper respiratory tract (otitis media)
- Infections of the lower respiratory tract (bronchitis)
- Infections of the genito-urinary tract
- Infections of the skin and soft tissues

CONTRA-INDICATIONS'
AugMaxcil is contra-indicated in patients with:
- A history of allergic reactions to either penicillins and/or cephalosporins.
- A previous history of jaundice and/or hepatic dysfunction associated with amoxicillin and clavulanic acid.
Safety in pregnancy has not been established.
Safety in children under 6 months of age has not been established.

WARNINGS:
When administered to a patient with a penicillin allergy, serious and occasionally fatal hypersensitivity (anaphylactoid) reactions may occur and although this occurs more frequently after intravenous administration, oral therapy has been known to illicit the same response.
When considering starting therapy with AugMaxcil, previous history of hypersensitivity to penicillins cephalosporins or other allergens must therefore be excluded.
If an allergic reaction occurs, AugMaxcil should be discontinued. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis.
Reversible hepatitis and cholestatic jaundice has been reported with amoxicillin and clavulanic combination so that AugMaxcil should be used with caution in patients with evidence of hepatic dysfunction.

DOSAGE AND DIRECTIONS FOR USE:
Directions for reconstitution:
Use 86 mL water for AugMaxcil S and 85 mL water for AugMaxcil SF in two portions and shake vigorously to prepare a 100 mL oral suspension.
Directions for use:
Suspension should be taken immediately before a meal.
DOSAGES:
Children: The dose of AugMaxcil S and AugMaxcil SF in children is 25-50 mg/kg/day. This corresponds to a daily dose equivalent to 20-40 mg/kg amoxicillin and 5-10 mg/kg clavulanic acid, to be taken in divided doses 3 times a day at the start of a meal.

Dosage guide for Children                         Organisms sensitive to amoxicillin Organisms resistant to amoxicillin
H. influenza
H. parainfluenza
Infections of the Upper respiratory tract AugMaxcil S (9-18kg) 5-10 mL1 every 8 hours 5-10 mL2 every 8 hours
e.g. Otitis media AugMaxcil SF (18-37kg) 5 mL1 every 8 hours 5-10 mL2 every 8 hours
                                                  H. Influenza
        H. parainfluenza
Infections of the
lower respiratory
tract		 AugMaxcil S (9-18kg) 5-10 mL1 every 8 hours 5-10 mL1 every 8 hours
e.g. Bronchitis AugMaxcil SF (18-37kg) 5 mL1 every 8 hours 5-10 mL1 every 8 hours
                                                  E: coli
        K. pneumoniae
Infections of the Urinary tract AugMaxcil S (9-18kg) 5-10 mL1 every 8 hours 5-10 mL1 every 8 hours
  AugMaxcil SF (18-37kg) 5 mL1 every 8 hours 5-10 mL1 every 8 hours
                    S. aureus
Infections of the Skin & Soft tissue AugMaxcil S (9-18kg) 5-10 mL1 every 8 hours 5-10 mL1 every 8 hours
  AugMaxcil SF (18-37kg) 5 mL1 every 8 hours 5-10 mL1 every 8 hours
1) To correspond to a dosage of 25-50 mg/kg/day.
2) To correspond to a dosage of 50 mg/kg/day

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The most common adverse effects are hypersensitivity reactions; especially skin rashes; anaphylaxis occasionally occurs and has sometimes been fatal.
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. Skin rashes are however the most common side-effects and are generally either urticarial or maculopapular; the urticarial reactions are typical of penicillin hypersensitivity. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
Haemolytic anaemia and neutropenia have been reported.
Treatment with AugMaxcil can cause gastro-intestinal adverse effects particularly diarrhoea, nausea and vomiting occur quite frequently, a sore mouth or tongue or a black hairy tongue have been reported usually following administration by mouth and are dose related and can be minimised by administering the medicine at the start of a meal. In addition, as these symptoms are especially related to the potassium clavulanate component, where these gastro-intestinal symptoms occur and a higher concentration of amoxicillin is required, consideration should be given to administering the additional amoxicillin separately.
Pseudomembranous colitis has also been reported.
Erythema multiforme and Stevens-Johnson syndrome have been reported.
Treatment with AugMaxcil may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore be carried out whenever possible, to demonstrate the appropriateness of therapy. Monilial overgrowth such as vaginitis and thrush have been reported.
Special Precautions:
Therapy should be discontinued if a skin rash occurs. Should a serious anaphylactic reaction occur, AugMaxcil should be discontinued and the patient treated with the usual agents: adrenaline, corticosteroids and antihistamines. Patients known to be hypersensitive to penicillin should be given an antibiotic of another class. However, sensitised patients may also react to the cephalosporins and other beta-lactam antibiotics. Desensitisation may be necessary if treatment with penicillin is essential. AugMaxcil should be given with caution to patients with a history of medicine allergy.
Care is necessary if very high doses of penicillin are given, especially if renal function is poor, because of the risk of neurotoxicity. Care is also necessary if large doses of potassium or sodium salts are given to patients with impaired renal function or heart failure. Renal and haematological status should be monitored during prolonged and high-dose therapy. Patients with syphilis may experience a Jarisch-Herxheimer reaction, symptoms like fever, chills, headache and reactions at the site of lesions may be experienced. The reaction can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.
Contact with penicillin should be avoided since skin sensitisation may occur. AugMaxcil therapy changes the normal bacterial flora and can lead to supra-infection with penicillin-resistant organisms including Pseudomonas or Candida, particularly with prolonged use.
Interactions:
Probenicid prolongs the half-life of benzylpenicillin.
An increased frequency of skin rashes has been reported in patients receiving amoxicillin together with allopurinol.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Nausea, vomiting and diarrhoea may occur with overdosing. Treatment is symptomatic and supportive.

IDENTIFICATION:
AugMaxcil S: White to yellowish white crystalline powder for reconstitution to an almost-white to yellow homogenous AugMaxcil suspension with a strawberry flavour.
AugMaxcil SF: White to yellowish white crystalline powder for reconstitution to an almost-white to yellow homogenous AugMaxcil suspension forte with a wild cherry flavour.

PRESENTATION:
AugMaxcil S: Amber glass bottles containing a white to yellowish white crystalline powder for reconstitution to AugMaxcil suspension.
AugMaxcil SF: Amber glass bottles containing a white to yellowish white crystalline powder for reconstitution to AugMaxcil suspension forte.

STORAGE INSTRUCTIONS:
Keep out of reach of children.
Before reconstitution: Keep tightly closed and store in a cool place (below 25°C).
After reconstitution: The suspension must be used within 7 days and must be kept in a refrigerator (2-8°C).

REGISTRATION NUMBERS:
AugMaxcil S (suspension): 31/20.1.2/0420
AugMaxcil SF (suspension forte): 31/20.1.2/0421

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Triomed (Pty) Ltd
6B Phumelela Park
Montague Drive
Montague Gardens
7441

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1997

                PS159
        Britepak
                05/2000

Updated on this site: October 2001
Current: October 2005
Source: Community Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005