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ACU-OXYTET CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ACU-OXYTET CAPSULES

COMPOSITION:
Each ACU-OXYTET capsule contains:
Oxytetracycline hydrochloride equivalent to oxytetracycline 250 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
ACU-OXYTET is a bacteriostic antibiotic and inhibits bacterial protein synthesis (30S ribosomes). It is particularly effective in vitro against the following organisms:
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis (see also below), Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomastis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
ACU-OXYTET 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 rhusiopathia.
ACU-OXYTET 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 (all strains)
Enterococci	E. coli
Proteus vulgaris	Shigella
Fungi and yeasts	Streptococcus pneumoniae
(except Actinomyces)

INDICATIONS:
Infections caused by susceptible strains 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 salpingits, 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.
ACU-OXYTET 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:
ACU-OXYTET 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 dosage is 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 staphylococci may cause fulminating enteritis;
Increased severity of uraemia and hepatotoxicity in patients with renal disease given high doses;
Blood abnormalities:
haemolytic anaemia
eosinophilla
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 nitrogen balance may be induced.

INTERACTIONS:
Absorption of tetracyclines is dimished 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 in action may occur.

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

IDENTIFICATION:
Size 1 opaque yellow hard gelatine capsule with red cap, containing a yellow powder.

PRESENTATION:
Plastic containers containing 20, 100, 500 or 1 000 capsules.

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

REGISTRATION NUMBER:
27/20.1.1/0011

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Apotex SA (Pty) Ltd
C/o Watt and Fleming Streets
Meadowdale Ext. 1
Isando

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1993
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