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Logo O-4 CYCLINE Capsules

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

O-4 CYCLINE Capsules

COMPOSITION:
Each Capsule contains:
Oxytetracycline hydrochloride containing 250 mg oxytetracycline base
Nipastat (preservative)         0,2% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Antimicrobial (chemotherapeutic) agents. Broad and medium spectrum antibiotic.

PHARMACOLOGICAL ACTION:
Tetracyclines are bacteriostatic antibiotics which inhibit bacterial growth by binding to the 30S ribosomal sub unit with consequent misreading of information for protein synthesis. They are effective in vitro against the following organisms (In vitro activity does not necessarily imply in vivo efficacy):
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumonia, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae;
Tetracyclines are also effective against the following organisms in vitro:
Haemophilus ducreyi, Actinomyces isrealii, Francisella tularensis, Treponema pertenue.
Resistant Pathogens:
Many of the following strains are resistant: Staphylococci; Enterococci; Proteus vulgaris; Fungi and yeasts (except Actinomyces); Pseudomonas aeroginosa (all strains); E. coli; Shigella and Streptococcus

PHARMACOKINETICS:
Oxytetracyacline is adequately but incompletely absorbed from the gastro-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 concurrent ingestion of dairy products and the presence of aluminium, calcium, magnesium and iron salts as well as bismuth subsalicylate.
Oxytetracycline is readily distributed into most body fluids.
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 cases of penicillin allergy);
Soft tissue:
Acne
Opthalmic:
Trachoma and inclusion conjunctivitis
Intestinal:
Cholera, Whipple's disease and tropical sprue.
Miscellaneous:
Rickettsial infections, brucellosis, tularaemia, actinomycosis, Lyme disease, yaws, relapsing fever, leptospirosis during the early infective phase.

CONTRA-INDICATIONS:
In patients with impaired renal function.
Allergy to any tetracycline.
Tetracyclines should not be given in pregnancy. Tetracyclines cross the placenta and are deposited in foetal bones and teeth.
Pregnant women are particularly susceptible to severe tetracycline-induced liver damage.
Should not be given to lactating women or to children younger than 12 years of age as permanent discoloration of the child's teeth may occur.
Should not be given to patients with systemic lupus erythematosus.

WARNINGS:
Use with care in patients with liver function impairment.
Frail or elderly patients are susceptible to the hepatotoxic and anti-anabolic 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:
Should be taken either one hour before meals or two hours after meals.
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 for tetracyclines 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 is 250 to 500 mg every six hours depending on the severity of the infection.
For acne, the adult dosage is 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, vomiting, diarrhoea, glossitis, dysphagia related to oesophagitis, enterocolitis.
Secondary fungal overgrowth (Candida albicans):
Oral candidiasis, vulvovaginitis, 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.
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.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with tetracycline.
The use of expired tetracyclines may lead to a Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, aminoaciduria, hypophosphatemia and hypocalcaemia.
In the elderly a negative nitrogen 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 anticoagulant may need to be reduced if given concomitantly.
Penicillin should not be given concomitantly with tetracyclines as antagonism in action may occur.
Tetracyclines may diminish the effectiveness of oral contraceptives.
Methoxyflurane: serious nephrotoxicity may follow concomitant use.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See side-effects and special precautions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Size 1, gelatin capsule with a red cap and clear colourless body containing yellow powder.

PRESENTATION:
Securitainers of 100 capsules.

STORAGE INSTRUCTIONS:
Store in airtight containers below 30°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
A/20.1.1/167

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Garec (Pty) Ltd
43 Richards Drive
Halfway House
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3 MARCH 1995

                PA167/2

New addition to this site: October 2004
Source: Community Pharmacy

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