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PROMOXIL250 Capsules; PROMOXIL500 Capsules; PROMOXILS Powder
PROMOXIL250 Capsules
PROMOXIL500 Capsules
PROMOXILS Powder for suspension
PROMOXILSF Powder for suspension
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
PROMOXIL250 Capsules
PROMOXIL500 Capsules
PROMOXILS Powder for suspension
PROMOXILSF Powder for suspension
COMPOSITION:
Amoxycillin trihydrate BP are available as:
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PROMOXIL250 Capsules |
Gelatin capsules containing the equivalent of 250mg amoxycillin. |
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PROMOXIL500 Capsules |
Gelatin capsules containing the equivalent of 500mg amoxycillin. |
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PROMOXILS |
Each 5mL of the reconstituted suspension contains the equivalent of 125mg amoxycillin. |
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PROMOXILSF |
Each 5mL of the reconstituted suspension contains the equivalent of 250mg 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)
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Gram-positive bacteria: |
Gram-negative bacteria: |
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Staphylococcus aureus* |
Neisseria gonorrhoeae |
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(penicillin-sensitive) |
Neisseria meningitidis |
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Streptococcus pyogenes |
Haemophilus influenzae** |
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Streptococcus viridans* |
Bordetella pertussis |
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Streptococcus faecalis* |
Escherichia coli* |
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Streptococcus pneumoniae* |
Salmonella typhi |
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Corynebacterium species* |
Salmonella species |
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Clostridium species* |
Shigella species |
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Bacillus anthracis* |
Brucella species |
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Proteus mirabilis |
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* 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:
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Upper respiratory tract infections |
Skin & soft tissue infections |
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Lower respiratory tract infections |
Gonorrhoea |
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Otitis media |
Non-specific urethritis |
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Upper urinary tract infections |
Typhoid Fever |
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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 750mg - 1,5g per day.
(a) General dosages:
Adults: 250mg ( 1 x 250mg capsule or 5mL of 250mg/5mL suspension) three times a day.
To reconstitute 100mL suspension, add 57mL of water, invert the bottle and shake until all powder is dispersed.
Children 2 - 10years: 125mg (5mL of 125mg/5mL suspension) three times a day.
Children 6 months - 2years: 125mg (5mL of 125mg/5mL suspension) three times a day.
Infants 0 - 6months: 62,5mg (2,5mL of 125mg/5mL suspension) three times a day.
(b) Specific Dosages:
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Indications |
Daily Dosages
Adults |
Daily Dosages
Children |
Duration |
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Gastro-intestinal tract infections |
1 - 2g |
- |
4 - 5days |
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Acute Typhoid Fever |
4g
- |
-
100mg/kg |
14days
21days |
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Gonorrhoea |
2 - 3g |
- |
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:
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PROMOXIL250 Capsules |
Opaque maroon/Flesh coloured capsules |
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PROMOXIL500 Capsules |
Opaque maroon/Flesh coloured capsules |
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PROMOXILS |
Free-flowing, slightly pink powder, light mauve suspension. |
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PROMOXILSF |
Free-flowing, slightly pink powder, light mauve suspension. |
PRESENTATION:
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PROMOXIL250 Capsules |
Canisters containing 15, 100 or 500 x 250mg amoxycillin capsules |
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PROMOXIL500 Capsules |
Canisters containing 15, 100 or 500 x 500mg amoxycillin capsules |
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PROMOXILS |
Bottles containing powder for reconstitution to 100mL of 125mg/5mL suspension |
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PROMOXILSF |
Bottles containing powder for reconstitution to 100mL of 250mg/5mL suspension |
STORAGE INSTRUCTIONS:
Store below 25°C in a dry place. The reconstituted suspension must be used within 14days if stored in a refrigerator between 2°C - 8°C or within 7days if stored at room temperature below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBERS:
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PROMOXIL250 Capsules: |
28/20.1.2/0239 |
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PROMOXIL500 Capsules: |
28/20.1.2/0240 |
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PROMOXILS Powder for suspension: |
28/20.1.2/0269 |
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PROMOXILSF 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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