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Logo SPECTRATET CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME:
(and dosage form)

SPECTRATET CAPSULES

COMPOSITION:
Each SPECTRATET capsule contains:
       
Oxytetracycline hydrochloride equivalent to oxytetracycline 250 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
SPECTRATET is a bacteriostatic antibiotic and inhibits bacterial protein synthesis (30S ribosomes). It is particularly effective against the following organisms:
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis (see also below), Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.

SPECTRATET is also effective against the following organisms in vitro:
Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelli, Bacillus anthracis*, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae.

SPECTRATET may also show some effect against the following organisms:
Bacteroides species and Fusobacterium nucleatum.

* = in vitro sensitivity tests must be performed.

Resistant pathogens:
Many strains of the following are resistant:
Staphylococci Pseudomonas aeruginosa
Enterococci (all strains)
Proteus vulgaris E. coli
Fungi and yeasts (except Shigella)
Actinomyces Streptococcus pneumoniae
INDICATIONS:
Infections caused by susceptible stains of pathogens:

Upper and lower respiratory tract:
Sinusitis, pharyngitis, pneumonia (Legionella and Mycoplasma) and psittacosis;

Genito-urinary tract:
Non-specific urethritis, lymphogranuloma venereum, chancroid and granuloma inguinale, gonorrhoea, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections and syphillis (in cases of penicillin allergy);

Soft tissue:
Acne;

Ophthalmic:
Trachoma and inclusion conjunctivitis;

Intestinal:
Cholera, Whipple's disease, and tropical sprue;

Miscellaneous:
Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever. Leptospirosis, during the early infective phase.

CONTRA-INDICATIONS:
In patients with renal impairment.
Hypersensitivity to any tetracycline.
SPECTRATET should not be given in pregnancy, lactation and in young children.

WARNINGS:
Use with care in patients with liver function impairment.
Do not use concomitantly with hepatotoxic medicines.
Tooth discolouration, enamel hypoplasia and retarded bone growth may occur in children under the age of 12 years. (These effects may also occur in the fetus if given to pregnant women).
Symptoms of myasthenia may be aggravated.
Photosensitivity may occur (see "Side-Effects and Special Precautions").
Pseudotumor cerebri may occur.

DOSAGE AND DIRECTIONS FOR USE:
SPECTRATET should be taken either one hour before meals or two hours after meals. The maximum dose for tetracycline should not exceed 3 g daily for adults and 50 mg/kg bodymass/day for children.

The usual dose for the commonly occurring infections are as follows, depending on the severity of the infection: 250 to 500 mg every six hours.

For acne, the adult dosages are as follows: 250 mg twice daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Tetracyclines are not indicated for treating commonly occurring infections in children under 12 years of age.
Gastro-Intestinal:
        nausea, glossitis
        vomiting dysphagia related to oesophagitis
        diarrhoea enterocolitis
Secondary fungal overgrowth(Candida albicans):
        oral candidiasis
        vulvovaginitis
        pruritus ani
Secondary bacterial overgrowth infections may occur:
        resistant coliform organisms such as Proteus spp. may cause diarrhoea;
        super-infection due to resistant staphylococcus may cause fulminating enteritis;
Increased severity of uraemia and hepatotoxicity in patients with renal disease given in high doses;
Blood abnormalities:
        haemolytic anaemia
        eosinophilia
        neutropenia
        thrombocytopenia
Vitamin deficiencies may occur;
Allergic (hypersensitivity) reactions:
        urticaria
        maculopapular & erythematous rashes,
        exfoliative dermatitis,
        exacerbation of systemic lupus erythematosus
        pericarditis,
        Henoch-Schonlein purpura (anaphylactoid purpura)
        angioneurotic oedema
        anaphylaxis
Photosensitivity of the skin and nails; onycholysis and nail discolouration may occur;
The use of expired tetracyclines may lead to the Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis and aminoaciduria;
Raised intracranial pressure may occur;
In the elderly a negative balance may be induced.

INTERACTIONS:
Absorption of tetracyclines is diminished by milk, alkalis, aluminium hydroxide and other di-and trivalent cations such as calcium, iron and magnesium if they are given concomitantly;
Doses of anticoagulants may need to be reduced if given concomitantly with tetracyclines.
Penicillin should not be given concomitantly with tetracyclines as antagonism of action may occur.

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

IDENTIFICATION:
Yellow/blue opaque capsules

PRESENTATION:
Plastic containers containing 20, 100 or 1 000 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/20.1.1/331

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo. Schwulst Laboratories Limited
1 Manchester Road
Wadeville
Germiston, 1407

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1992

PSO-70-9/92

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