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

Logo PURIUM-100 TABLETS
PURIUM-200 TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PURIUM-100 TABLETS
PURIUM-200 TABLETS

COMPOSITION:
Tablets containing 100 mg or 200 mg
Trimethoprim

PHARMACOLOGICAL CLASSIFICATION:
A 20.2 Antimicrobial (chemotherapeutic) substances, other than antibiotics.

PHARMACOLOGICAL ACTION:
Trimethoprim has
antimicrobial activity due to its inhibition of bacterial dihydrofolate reductase.
Trimethoprim is not active in concentrations achievable in the plasma against Mycobacteria and Pseudomonas, but is effective against E. coli, Klebsiella, Enterobacter, Indole-negative and Indole-positive Proteus species and Streptococcus faecalis.
Trimethoprim is rapidly absorbed by the oral route. After ingestion of a single dose, peak plasma levels are reached within 2 to 4 hours.
The terminal elimination half-life varies in healthy subjects, averaging 16 hours.

INDICATIONS:
Treatment of acute and chronic urinary tract infections caused by sensitive organisms.

CONTRA-INDICATIONS:
Trimethoprim is contra-indicated in patients with folic acid deficiency or megaloblastic anaemia. It is also contra-indicated in pregnant women, premature infants and children under the age of four months. Contra-indicated in patients with severe hepatic insufficiency.

In patients with severe renal insufficiency, trimethoprim should not be administered unless serum concentrations can be monitored frequently. Contra-indicated in patients hypersensitive to trimethoprim.

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children over 12 years
For the treatment of acute urinary tract infections the usual dose is 200 mg twice daily. A dose of 300 mg daily is also used.
For long-term prophylaxis a dose of 100 mg at night is recommended.

In Patients with Renal Insufficiency
Creatinine clearance less than 15 mL/minute –half the normal dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting, headache, pruritis, gastro-intestinal disturbances and eczema have been reported. The potentially most detrimental side-effects of Trimethoprim are haematologic, mostly associated with folic acid metabolism. If any such change is seen, folinic acid should reverse the effect. Elderly people may be more susceptible and a lower dose may be advisable.

In patients with impairment of renal function , care should be taken to avoid accumulation and resulting adverse haematological effects.
Regular haematological tests should be undertaken in patients receiving long-term treatment and those predisposed to folate deficiency.
Particular care should be exercised in the haematological monitoring of children over 12 years on long-term therapy.

Trimethoprim is excreted in breast milk, but this should not contra-indicate its use for short term therapy in lactating women.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Nausea and vomiting. Treatment is symptomatic. Depression of haematopoiesis by trimethoprim can be counteracted by intra-muscular administration of calcium folinate.

IDENTIFICATION:
Flat, white, bisected tablets with bevelled edges.

PRESENTATION:
Purium-100
Securitainers containing 100 and 500 tablets.
Purium-200 Securitainers containing 20 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in tightly closed containers and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
100 mg –Q/20.2/115
200 mg –W/20.2/51

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1983.11.11 K372

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