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

Logo SPECTRAMOX

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SPECTRAMOX

SPECTRAMOX C 250 CAPSULES
SPECTRAMOX S 125 POWDER FOR SUSPENSION
SPECTRAMOX SF 250 POWDER FOR SUSPENSION

COMPOSITION:
Amoxycillin trihydrate available as:
Spectramox C 250- Gelatin capsules containing the equivalent of 250 mg amoxycillin.
Spectramox S 125- Each 5 mL of the reconstituted suspension contains the equivalent of 125 mg amoxycillin.
Spectramox SF 250 - Each 5 mL of the reconstituted suspension contains the equivalent of 250 mg amoxycillin.

PHARMACOLOGICAL CLASSIFICATION:
A20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Amoxycillin is a penicillinase-susceptible penicillin. Amoxycillin exhibits in vitro bactericidal activity against a wide range of Gram-negative and Gram-positive organisms including: (in vitro sensitivity does not necessarily imply in vivo efficacy).

Gram-positive bacteria: Gram-negative bacteria:
* Staphylococcus aureus (Penicillin-sensitive) Neisseria gonorrhoeae
Streptococcus pyogenes Neisseria meningitidis
* Streptococcus viridans Haemophilus influenzae
* Streptococcus faecalis (except type b-strains causing meningitis in children)
* Streptococcus pneumoniae Bordetella pertussis
* Corynebacterium species * Escherichia coli
* Clostridium species Salmonella typhi
* Bacillus anthracis Salmonella species
                Shigella species
  Proteus mirabilis
* Sensitivity tests must be performed
Amoxycillin is well absorbed orally. After oral administration, there is no significant difference between the peak serum levels in fasting and non-fasting subjects.
The presence of food does not interfere with the absorption of amoxycillin. Amoxycillin may, therefore, be taken with meals.
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.
Approximately 60% of an oral dose of amoxycillin is excreted unchanged in the active form into the urine within six hours.

INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:
Upper respiratory tract infections         Skin and soft tissue infections
Lower respiratory tract infections         Gonorrhoea
Otitis media         Non-specific urethritis
Upper urinary tract infections         Typhoid Fever
Lower urinary tract infections         Gastro-intestinal tract infections

CONTRA-INDICATIONS:
Allergy to penicillins or any of the cephalosporins. 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 allo-purinol may also be at increased risk of developing skin rashes.
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for amoxycillin is 750 mg to 1,5 gram per day.
To reconstitute 100 mL suspension, add 57 mL of distilled water, invert the bottle and shake until all powder is dispersed.
a) GENERAL DOSAGES:
Adults:
250 mg (1 x 250 mg capsule or 5 mL of 250 mg/5 mL suspension) three times a day.
Children 6 months-10 years: 125 mg (5 mL of 125 mg/5 mL suspension) three times a day.
Infants 0-6 months: 62,5 mg (2,5 mL of 125 mg/5 mL suspension) three times a day.

b) SPECIFIC DOSAGE:
Indications Daily dosages
Adults
Daily dosages
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:
Gastro-intestinal disturbances, including diarrhoea, nausea and vomiting occur frequently. Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event withdrawal of amoxycillin is necessary.
Should a serious anaphylactic reaction occur, amoxycillin should be discontinued and the patient treated with adrenalin, corticosteroids and antihistamines.
Treatment with amoxycillin may give rise to a maculopapular rash during therapy or within a few days after completion thereof. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
Pseudomembranous colitis has been reported. Super-infections with non-susceptible organisms may occur. Caution must be exercised in treating patients with dehydration or oliguria because of the possibility of crystalluria.
The use of this antibiotic may lead to the appearance of resistant strains or organisms and sensitivity testing should, therefore be carried out whenever possible, to ensure the appropriateness of the therapy.

SPECIAL PRECAUTIONS:
The dose should be reduced in patients with renal failure. Caution is needed when administering amoxycillin to patients with syphillis, as the Jarisch-Herxheimer reaction may occur in these patients. Amoxycillin may decrease the efficacy of oestrogen-containing oral contraceptives. Due to amoxycillin's effect on the intestinal flora, the absorption of other medicines may be affected.

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

IDENTIFICATION:
SPECTRAMOX C 250 - Pale yellow/black capsules.
SPECTRAMOX S 125 - free-flowing, slightly pink powder, light mauve suspension.
SPECTRAMOX SF 250 - free-flowing, slightly pink powder, light mauve suspension.

PRESENTATION:
SPECTRAMOX C 250 - Canisters containing 15, 100 or 500 capsules.
SPECTRAMOX S 125 - Bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL suspension.
SPECTRAMOX SF 250 - Bottles containing powder for reconstitution to 100 mL of 250 mg/5 mL suspension.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
The reconstituted suspension must be used within 14 days if stored in a refrigerator between 2°C and 8°C, or within 7 days if stored at room temperature below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
SPECTRAMOX C 250 - Z/20.1.2/327
SPECTRAMOX S 125 - Z/20.1.2/328
SPECTRAMOX SF 250 - Z/20.1.2/329

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alliance Pharma (Pty) Limited
Reg. No. 89/07635/07
17 Faraday Street, Village Main,
JOHANNESBURG 2001.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1992

                PM 0504-12/99

Updated on this site: July 2003
Source: Hospital Pharmacy

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