PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 Antimicrobial (chemotherapeutic) agents. Broad and medium spectrum antibiotics.
PHARMACOLOGICAL ACTION: Oxytetracycline is a bacteriostatic antibiotic and inhibits bacterial growth by binding to the 30S ribosomal sub unit with consequent misreading of information for protein synthesis. 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 recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae. Oxytetracycline is also effective against the following organisms in vitro: Hemophilus ducreyi, Actinomyces israelli, Treponema pertenue, Francisella tularensis.
Resistant Pathogens: Many of the following strains are resistant:
Fungi and yeasts (except Actinomyces)
Pseudomonas aeroginosa (all strains)
Pharmacokinetics: Oxytetracycline is adequately but incompletely absorbed from the gastro-intestinal tract. Effective blood levels are reached in about two to four hours after administration and are maintained with the recommended dosages. Oral therapy yields very low cerebrospinal fluid concentrations. Penetration into most other fluids and tissues is excellent. 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 reabsorbed. Excretion in the urine also takes place.
INDICATIONS: Infections caused by susceptible strains of pathogens: Upper and lower respiratory tract infections: Sinusitis, pharyngitis, Mycoplasma pneumonia, psittacosis and chronic bronchitis. Genito-urinary tract infections: Non-specific urethritis (only if the strain is sensitive), lymphogranuloma venereum, chancroid and granuloma inguinale, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections, syphilis and gonorrhoea (in case 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: Patients with renal impairment.
Hypersensitivity to any tetracycline. Oxypan should not be given in pregnancy. Oxytetracyline crosses the placenta and are deposited in foetal bones and teeth. Pregnant women are particularly susceptible to severe tetracyline-induced liver damage. Oxypan should not be given to lactating women and to children younger than 12 years of age as permanent discolouration of the child's teeth may occur. Should not be given to patients with systemic erythematosus.
WARNINGS: Use with care in patients with liver function impairment
Frail or elderly patients are susceptible to the hepatotoxic and antianabolic effects of tetracyclines.
Do not use concomitantly with hepatotoxic medicines.
Symptoms of Myasthenia gravis may be aggravated.
Photosensitivity may occur (see side-effects and special precautions)
Raised intracranial pressure may occur particularly in infants and especially if Vitamin A or other retinoids are given concomitantly.
DOSAGE AND DIRECTIONS FOR USE:
Oxypan should be taken either one hour before meals or two hours after meals. Oxypan should be taken with adequate liquid to avoid lodging of capsules in the distal oesophagus as this may result in local corrosive irritation and ulceration.
The maximum dose should not exceed 3 g daily for adults and 50 mg/kg bodymass per 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 (1 - 2 capsules) every six hours.
For acne the adult dose is 250 mg (one capsule) twice daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Oxypan 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 and enterocolitis.
Secondary fungal overgrowth (Candida albicans): Oral candidiasis, vulvovaginitis and pruritis ani.
Secondary bacterial overgrowth infections may occur: Resistant coliform organisms such as Proteus spp. may cause diarrhoea; Pseudomembranous colitis due to Clostridium difficile may occur; 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
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with tetracycline.
Allergic (hypersensitivity) reactions: Urticaria, maculopapular and erythematous rashes, exfoliative dermatitis, exacerbation of systemic lupus erythematosus, pericarditis, Henoch-Schönlein purpura (anaphylactoid purpura), angioneurotic oedema, anaphylaxis.
Photosensitivity of the skin and nails; onycholysis and nail discolouration may occur.
The use of expired Oxypan may lead to a Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, amino aciduria, hypophosphatemia and hypocalcaemia.
In the elderly a negative nitrogen balance may be induced.
INTERACTIONS Absorption of Oxypan 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.
Penicillin should not be given concomitantly with Oxypan as antagonism in action may occur. Oxypan may diminish the effectiveness of oral contraceptives. Methoxyflurane: serious nephrotoxicity may follow concomitant use.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See side effects and special precautions.
Treatment is symptomatic and supportive.
IDENTIFICATION: Opaque pink and white capsules containing a yellow powder.
PRESENTATION: Securitainers with 100 capsules
Polykan and/or bucket with 1 000 capsules.
STORAGE INSTRUCTIONS: Store below 30°C in airtight containers.
Protect from light.
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBER: A/20.1.1/0543
NAME AND BUSINESS ADDRESS OF APPLICANT: Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 14 June 1996
New addition to this site: May 2004
Source: Pharmaceutical Industry