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Logo ADCO-AMOXYCILLIN 125 mg/5 mL Suspension
ADCO-AMOXYCILLIN 250 mg/5 mL Suspension
ADCO-AMOXYCILLIN 250 mg Capsules
ADCO-AMOXYCILLIN 500 mg Capsules

SCHEDULING STATUS:
S4

PROPRIETARY NAME:
(and dosage form)

ADCO-AMOXYCILLIN 125 mg/5 mL Suspension
ADCO-AMOXYCILLIN 250 mg/5 mL Suspension
ADCO-AMOXYCILLIN 250 mg Capsules
ADCO-AMOXYCILLIN 500 mg Capsules

COMPOSITION:
Capsules:
Each capsule contains
amoxycillin trihydrate equivalent to 250 mg amoxycillin and 500 mg amoxycillin.

Powder for Oral Suspension:
The powder contains amoxycillin trihydrate equivalent to 125 mg or 250 mg amoxycillin per 5 mL and 0,1% m/v sodium benzoate as preservative when reconstituted.

PHARMACOLOGICAL CLASSIFICATION:
A. 20.1.2 Antimicrobial agents - Penicillins

PHARMACOLOGICAL ACTION:
Amoxycillin is a semi-synthetic, broad-spectrum penicillin derived from the 6-amino- penicillanic acid nucleus. Chemically it is 6-[D(-)-alpha-amino-p-hydroxyphenyl -acetamido] penicillanic acid trihydrate.
Amoxycillin is rapidly absorbed after oral administration and provides high blood levels and very high concentrations in the tissues and urine. Amoxycillin does not readily diffuse into the brain and spinal fluid except when the meninges are inflamed.
The ingestion of food does not greatly reduce the absorption of amoxycillin. Amoxycillin does not appear to be metabolized in the body. Urinary excretion is rapid, and only unchanged amoxycillin is recovered in the urine. Its excretion can be delayed by concurrent administration of probenecid. Approximately 17% of amoxycillin is bound by serum proteins.
Amoxycillin does not resist destruction by penicillinase and is thus not effective against penicillinase-producing bacteria, particularly resistant Staphylococci. All strains of Pseudomonas and most strains of Klebsiella, indole-positive Proteus, Serratia, Acinetobacter and Enterobacter are resistant to amoxycillin.
Amoxycillin is particularly effective in-vitro against the following organisms; Gram-positive cocci, Strep. agalactiae,Strep. faecalis, Strep. pneumoniae and penicillin-sensitive N. gonorrhoea, Gram-negative bacilli, Listeria monocytogenes. Amoxycillin is also effective in-vitro against the following organisms (penicillin G is preferred for routine use): Penicillin-sensitive Staph. aureus, Strep. pyogenes, Strep. viridans, group N. meningitidis. Amoxycillin is also active in-vitro against the following organisms (sensitivity tests must be performed as these organisms may produce beta-lactamase); E. coli, Proteus mirabilis, Salmonella, Shigella and Haemophilus influenzae. In-vitro sensitivity does not necessarily imply in-vivo efficacy.
Amoxycillin may be effective against the following organisms (Sensitivity tests must be performed): Bordetella pertussis, Bacteroides fragilis and Nocardia.

INDICATIONS:
Amoxycillin is indicated in the treatment of all infections caused by susceptible (non-penicillinase producing) micro-organisms.
Respiratory infections such as:-
Acute typical pneumonia, acute and chronic bronchitis and epiglottitis, tonsillitis, pharyngitis, laryngitis, otitis media, and sinusitis.
Urinary tract infections and uncomplicated gonococcal infections.
Bacteraemia, enteric fever.
Meningitis (sensitivity tests must be performed).
Skin and soft tissue infections such as:-
Pyoderma, erysipelas, lymphangitis, cellulitis.
Gastro-intestinal infections such as:-
Typhoid, Salmonella (uncomplicated gastro-enteritis).
Indicated surgical procedures should be performed.

CONTRA-INDICATIONS:
Patients hypersensitive to penicillins and cephalosporins. Patients with infectious mononucleosis are susceptible to skin rashes.

WARNINGS:
Amoxycillin may cause reactions typical of penicillin allergy, especially in sensitive patients. Should an allergic reaction occur, the drug should be discontinued and the patient treated with the usual agents (pressor amines, corticosteroids and/or antihistamines).

DOSAGE AND DIRECTIONS FOR USE:
Adults and children with a mass of more than 40 kg:-
250 mg to 500 mg three times per day. The latter dosage is for the more severe infections.
Age and Mass % of Adult Dose Usual Total Daily
Dose Range*
Adults (65 kg) 100% 750 mg - 1,5 g
12 years (40 kg) 75% 525 mg - 1,125 mg
7 years (23 kg) 50% 375 mg - 750 mg
1 year (10 kg) 25% 187 mg - 375 mg
* Administered in divided doses three times per day.
For in-between ages, in-between percentages are used, e.g. at 10 years 66% and at three years 33% of the adult dose. The above percentage method of calculating dosage is based on the formula:-
Surface area of child X 100 = Percentage of Adult dose
Surface area of adult 
Infants:-
The recommended dosage is 20 mg/kg/day in three equally divided doses.
Note:-
In the case of severe infections the dosage should be doubled. Treatment should be continued for a minimum of forty-eight to seventy-two hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A MINIMUM OF TEN DAYS' TREATMENT IS RECOMMENDED FOR ANY INFECTION CAUSED BY GROUP A BETA-HAEMOLYTIC STREPTOCOCCI.
Chronic urinary tract infections may require prolonged, intensive therapy with continued bacteriological and clinical follow-up.
For the treatment of gonorrhoea:-
3 g as a single oral dose. In the treatment of complications of gonococcal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended.
Patients with gonorrhoea in whom syphilis is suspected should have darkfield examinations before receiving treatment and monthly serological tests for a minimum of four months.
Reconstitution of powders:-
The 125 mg/5 mLpowder and the 250 mg/5 mL powder are reconstituted with 59 mL of water to yield 100 mL of suspension.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:-
Adverse events associated with amoxycillin are allergic reactions which commonly include urticarial or maculopapular skin rashes.
Amoxycillin may cause reactions typical of penicillin allergy in patients sensitive to penicillin. See under "Warnings".
Gastro-intestinal adverse effects particularly diarrhoea and also nausea and vomiting occur quite frequently, usually following administration by mouth. Glossitis, stomatitis and black-"hairy" tongue have been reported. Pseudomembranous colitis has also been reported. Supra-infections with non-susceptible organisms may occur particularly with prolonged use.
Precautions:-
Amoxycillin should not be given to patients with infectious mononucleosis, lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol, since these patients appear to have a higher incidence of skin rashes.
Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Periodic assessment of organ system function including renal, hepatic and haematopoietic, should be made during prolonged therapy.
A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted particularly in infants but the significance of this finding is unknown.
On account of the slow physiological renal development in newborns, amoxycillin is excreted slowly in infants aged between two and three weeks.
The use of this antibiotic may lead to appearance of resistant strains of organisms and sensitivity testing should therefore be carried out wherever possible to ensure the appropriateness of the therapy.
Amoxycillin may decrease the efficacy of oestrogen-containing oral contraceptives and it may also affect the absorption of other drugs due to its effect on the gastro-intestinal flora.
Safety of use during pregnancy has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS". Treatment is symptomatic and supportive.

IDENTIFICATION:
Powder for Oral Suspension:-
Off-white, crystalline powder having a fruity odour. Reconstitution with water as per label instructions produces a yellow suspension with a fruity odour.
Capsules:-
250 mg and 500 mg Hard gelatin capsules with an opaque maroon cap and opaque maroon body: overprinted with "ADCO 250" or "ADCO 500".

PRESENTATION:
Powders for Oral Suspension:-
Powder for oral suspension is available in glass bottles providing 100 mL of the suspension when reconstituted.
Capsules:-
The 250 mg capsules are packed in containers of 15, 100, 500 and 1000 capsules.
The 500 mg capsules are packed in containers of 15 and 100 capsules.

STORAGE INSTRUCTIONS:
Capsules and Powders:-
Store below 25°C. Protect from moisture.
The potency of reconstituted suspensions will be maintained for one week at temperatures not exceeding 25°C and for two weeks under refrigeration(2°C –8°C).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
ADCO-AMOXYCILLIN 125 mg/5 mL
: X/20.1.2/198
ADCO-AMOXYCILLIN 250 mg/5 mL: X/20.1.2/199
ADCO-AMOXYCILLIN 250 mg Capsules: X/20.1.2/196
ADCO-AMOXYCILLIN 500 mg Capsules: X/20.1.2/197

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited       
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69
Bryanston 2021.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 1990

New addition to this site: April 2004
Source: Pharmaceutical Industry

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