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

Logo PROMOXIL 250 Capsules
PROMOXIL 500 Capsules
PROMOXIL S Powder for suspension
PROMOXIL SF Powder for suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PROMOXIL 250 Capsules
PROMOXIL 500 Capsules
PROMOXIL S Powder for suspension
PROMOXIL SF Powder for suspension

COMPOSITION:
Amoxycillin trihydrate BP are available as:
PROMOXIL 250 Capsules Gelatin capsules containing the equivalent of 250 mg amoxycillin.
PROMOXIL 500 Capsules Gelatin capsules containing the equivalent of 500 mg amoxycillin.
PROMOXIL S Each 5 mL of the reconstituted suspension contains the equivalent of 125 mg amoxycillin.
PROMOXIL SF Each 5 mL of the reconstituted suspension contains the equivalent of 250 mg amoxycillin.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 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 aganisms including:
(in vitro sensitivity does not necessarily imply in vivo efficacy)
Gram-positive bacteria: Gram-negative bacteria:
Staphylococcus aureus* Neisseria gonorrhoeae
(penicillin-sensitive) Neisseria meningitidis
Streptococcus pyogenes Haemophilus influenzae**
Streptococcus viridans* Bordetella pertussis
Streptococcus faecalis* Escherichia coli*
Streptococcus pneumoniae* Salmonella typhi
Corynebacterium species* Salmonella species
Clostridium species* Shigella species
Bacillus anthracis* Brucella species
  Proteus mirabilis
* Sensitivity tests must be performed. ** Except type B-strains causing meningitis in children.

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 a linear dose response in peak serum levels after oral administration.
There is insufficient evidence at present to show that PROMOXIL 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 & 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 allopurinol, may also be at increased risk of developing skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for PROMOXIL is 750 mg - 1,5g per day.
(a) General dosages:
Adults:
250 mg ( 1 x 250 mg capsule or 5 mL of 250 mg/5 mL suspension) three times a day.
To reconstitute 100 mL suspension, add 57 mL of water, invert the bottle and shake until all powder is dispersed.
Children 2 - 10 years: 125 mg (5 mL of 125 mg/5 mL suspension) three times a day.
Children 6 months - 2 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 Dosages:
Indications Daily Dosages
Adults
Daily Dosages
Children
Duration
Gastro-intestinal tract infections 1 - 2 g - 4 - 5 days
Acute Typhoid Fever 4 g

-
-

100 mg/kg
14 days

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 PROMOXIL is necessary.
Should a serious anaphylactic reaction occur, PROMOXIL should be discontinued and the patient treated with: Adrenalin, corticosteroids and antihistamines.
Treatment with PROMOXIL may give rise to a maculopapular rash during therapy or within a few days after completion thereof. The incidence of a 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 of organisms and sensitivity testing should, therefore, be carried out wherever possible; to ensure the appropriateness of therapy.

SPECIAL PRECAUTIONS:
The dose should be reduced in patients with renal failure.
Caution is needed when administering PROMOXIL to patients with syphillis, as the Jarisch-Herxheimer reaction may occur in these patients. PROMOXIL may decrease the efficacy of oestrogen-containing oral contraceptives. Due to PROMOXIL's effect on 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:
PROMOXIL 250 Capsules Opaque maroon/Flesh coloured capsules
PROMOXIL 500 Capsules Opaque maroon/Flesh coloured capsules
PROMOXIL S Free-flowing, slightly pink powder, light mauve suspension.
PROMOXIL SF Free-flowing, slightly pink powder, light mauve suspension.

PRESENTATION:
PROMOXIL 250 Capsules Canisters containing 15, 100 or 500 x 250 mg amoxycillin capsules
PROMOXIL 500 Capsules Canisters containing 15, 100 or 500 x 500 mg amoxycillin capsules
PROMOXIL S Bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL suspension
PROMOXIL SF 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 - 8°C or within 7 days if stored at room temperature below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
PROMOXIL 250 Capsules: 28/20.1.2/0239
PROMOXIL 500 Capsules: 28/20.1.2/0240
PROMOXIL S Powder for suspension: 28/20.1.2/0269
PROMOXIL SF Powder for suspension: 28/20.1.2/0270

NAME AND ADDRESS OF THE APPLICANT:
Medpro Pharmaceutica (Pty) Ltd.,
Unit 9 Rosen Heights, Pasita Street, Rosenpark, 7530, BELLVILLE

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
MARCH 1994.

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