(and dosage form):
Each capsule contains: Oxytetracycline Hydrochloride equivalent to 250 mg Oxytetracycline base. Contains Tartrazine
A 20.1.1 Broad and medium spectrum antibiotics.
Oxytetracycline is a bacteriostatic antibiotic and inhibits bacterial protein synthesis (30S ribosomes). It is particularly effective in vitro against the following organisms (in vitro activity does not necessarily imply in vivo efficacy): Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrensis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoea and Rickettsiae;
Oxytetracycline is also effective against the following organisms in vitro: Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelii, Bacillus anthracis*, Pasteurella multocida, Streptobaccillus moniliformis, Erysipelothrix rhusiopathiae.
Oxytetracycline may also show some effect against the following organisms: Bacteroides species and Fusobacterium nucleatum.
* = in vitro sensitivity tests must be performed.
Many strains of the following are resistant: Staphylococci, Enterococci, Proteus vulgaris, Fungi and yeasts (except Actinomyces), Pseudomonas aeruginosa (all strains), E. coli, Shigella, Strep. pneumoniae.
Oxytetracycline is adequately but incompletely absorbed from the intestinal tract. Effective blood levels are reached in about two to four hours after oral administration and are maintained with the recommended dosages. Absorption is diminished by the presence of iron, aluminium, calcium and magnesium and milk products. Oxytetracycline is bound to serum proteins in varying degrees.
Oral therapy yields very low spinal fluid concentrations. It passes the placental barrier readily and is also present in the milk of lactating patients. It is concentrated by the liver and excreted, by way of the bile, into the intestine from which it is partially re-absorbed. Excretion in the urine also takes place.
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 salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections and syphilis (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, tuleremia, actinomycosis, Lyme disease, yaws, relapsing fever. Leptospirosis, during the early infective phase.
In patients with renal impairment. Hypersensitivity to any tetracycline.
Oxytetracycline should not be given in pregnancy, lactation and in young children.
This product contains FD and C Yellow No. 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.
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:
Oxytetracycline should be taken either one hour before meals or two hours after meals. The maximum dose for oxytetracycline should not exceed 3 g daily for adults and 50 mg/kg body mass/day for children.
The usual dose for the commonly occuring infections is as follows, depending on the severity of the infection: Oxytetracycline: 250 to 500 mg every six hours;
For acne, the adult dose is 250 mg twice daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Oxytetracycline is not indicated for treating commonly occurring infections in children under 12 years of age.
Gastro-intestinal: nausea, vomiting, diarrhoea, glossitis, dysphagia related to oesophagitis, 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, eosinophilia, neutropenia, thrombocytopenia.
Vitamin deficiencies may occur;
Allergic (hypersensitivity) reactions: urticaria, maculopapular and 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;
Local irritation after intravenous administration and thrombophlebitis may follow;
The use of expired oxytetracycline 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 (pseudotumor cerebri) may occur;
In the elderly a negative nitrogen balance may be induced.
Oxytetracycline may interfere with some diagnostic tests including determination of urine catecholamine or glucose.
Absorption of oxytetracycline 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 oxytetracycline;
Penicillin should not be given concomitantly with oxytetracycline as antagonism in action may occur.
Oxytetracycline may diminish the effectiveness of oral contraceptives.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and special precautions.Treatment is symptomatic and supportive.
A No. 1 capsule with an opaque green cap and opaque yellow body, printed in black ink with a Lennon Logo and LENNONon the one part and OXYMYCIN on the other part, containing a yellowish powder.
Packs of 100 and 1000 capsules.
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF APPLICANT:
SOUTH AFRICAN DRUGGISTS LIMITED
7 Fairclough Road
PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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