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

Logo TETREX - F capsules 250 mg

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form)

TETREX - F capsules 250 mg

COMPOSITION:
Each capsule contains 250 mg
tetracycline hydrochloride, 70 mg sodium hexametaphosphate and 250 000 units nystatin.

PHARMACOLOGICAL CLASSIFICATION:
A20.1 Antibiotics and antibiotic combinations.

PHARMACOLOGICAL ACTION:
TETREX - F contains tetracycline for broad-spectrum antibiotic therapy and nystatin for prophylaxis against fungal superinfections.

Sodium hexametaphosphate enhances the absorption of tetracycline from the gastrointestinal tract. Tetracycline is excreted primarily by the kidneys.

Laboratory and clinical studies have shown that tetracycline is effective against Diplococcus pneumoniae, Neisseria gonorrhoea, Neisseria meningitidis, certain clostridia, Haemophilus influenzae, Klebsiella pneumoniae, Shigella and Enterobacter aerogenes. Tetracycline is also effective against certain Rickettsia, large viruses of the lymphogranuloma-psittacosis-trachoma group, and Mycoplasma pneumoniae (Eaton agent).

Nystatin, the other active component, is an antifungal antibiotic that is fungistatic against Candida albicans and certain other yeast-like fungi. Nystatin is poorly absorbed from the gastrointestinal tract and is excreted almost entirely in the faeces following oral administration. It is virtually non-toxic and non-sensitizing.

Nystatin being highly effective against Candida albicans affords protection against overgrowth of this organism in the gastrointestinal tract which may occur during antibiotic therapy. This candidal overgrowth in the alimentary canal is the source of secondary candidal infections, sometimes seen during antibiotic therapy.

INDICATIONS:
TETREX - F is indicated in the treatment of infections due to tetracycline sensitive organisms in those patients in whom monilial infections are most likely to complicate antibiotic therapy. These include patients receiving high and/or prolonged dosages of tetracycline, with or without corticosteroid therapy, patients on corticosteroids requiring even short-term tetracycline therapy, elderly or debilitated patients, diabetics, pregnant women, women on oral contraceptives and women with histories of prior or recurrent vaginal moniliasis.

NOTE: As with other antibiotics, occasional resistance develops to all tetracyclines (i.e. strains of pneumococci, E. coli and Shigellae).

Indicated laboratory studies, including sensitivity tests, should be performed in the case of resistant infections.

CONTRA-INDICATIONS:
This medicine is contra-indicated in individuals known to be hypersensitive to any of its components.

WARNINGS:
Tetracycline may form a stable calcium complex in any bone-forming tissue with no serious harmful effects reported thus far in humans. However, use of tetracycline during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discolouration of the teeth (yellow-grey-brownish). This effect occurs mostly during long-term therapy, but it has been observed following short treatment courses. Enamel hypoplasia has been observed in a few children. Tetracycline therefore, should not be used in this age group unless other drugs are not likely to be effective or are contra-indicated.

If renal impairment exists, even usual oral doses of the drug may lead to excessive systemic accumulation of tetracycline and possible liver toxicity. Under such conditions, lower than usual doses are indicated and if therapy is prolonged, periodic tetracycline serum-level determinations are advisable. Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

In long-term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed.

Usage in Pregnancy: (see above warning about use during tooth development).
Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryo-toxicity has also been noted in animals treated early in pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Dosage should be based on the tetracycline content.

Adults: The usual dose is 1 g (4 capsules) per day in four divided doses of 250 mg each (1 capsule). Severe infections require higher doses.

Children: (see Warning)
Children weighing more than 40 kg should be given the recommended adult dose.

Therapy for most infections should be continued for 24-48 hours after the patient has become asymptomatic or afebrile.

Oral dosage forms of tetracycline should be given at least one hour before or two hours following meals. Tetracycline should not be given with milk or calcium-containing food. Iron salts and antacids containing aluminium, calcium or magnesium impair absorption and should not be given to patients taking oral tetracycline.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Even though the evidence of adverse reactions with tetracycline is low anorexia, nausea, vomiting, diarrhoea, stomatitis, glossitis, enterocolitis and pruritis ani may occur in some patients.

Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discolouration of the nails has been noted rarely.

Hypersensitivity reactions to tetracycline including urticaria, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis and exacerbation of systemic lupus erythematosus have been reported.

Hypersensitive individuals have been reported to develop photodynamic reactions (usually allergic) during the use of tetracycline derivatives (particularly demethylchlortetracycline, occasionally chlortetracycline or oxytetracycline and rarely tetracycline). Individuals with a history of photosensitivity should be instructed to avoid direct exposure to natural or artificial sunlight while under treatment with any tetracycline drug. Treatment should be discontinued at first evidence of skin discomfort.

Azotemia, which is apparently dose related, may occur. Cholestasis has been reported rarely and is usually associated with high dosage levels. Haemolytic anaemia, thrombocytopoenia, neutropoenia and eosinophilia have been reported in patients treated with tetracycline. While monilial overgrowth is minimized with TETREX-F, super-infection with other, non-susceptible organisms may occur. If this occurs, appropriate measures should be taken.

IDENTIFICATION:
Opaque orange capsule.

PRESENTATION:
TETREX-F capsules are available in plastic containers of 100 capsules.

STORAGE INSTRUCTIONS:
Store in a cool, dry place. Temperature should not exceed 25°C.
Keep out of reach of children.

REGISTRATION NUMBERS:
E/20.1/236

NAME AND BUSINESS ADDRESS OF APPLICANT:
Bristol-Myers Squibb (Pty) Ltd *
AMR Park, 1 Concorde Road East,
Bedfordview. 2008

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1973

8/91 Com Code 29-0052
List 4241
* Authorised user of the TM TETREX-F

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998