INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ROXY* CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ROXY* CAPSULES

COMPOSITION:
Each capsule contains
Oxytetracycline HCl 250 mg.
Contains no Tartrazine.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and Medium Spectrum Antibiotics

PHARMACOLOGICAL ACTION:
Tetracyclines are bacteriostatic antibiotics which inhibit bacterial growth by binding to the 30S ribosomal subunit 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 cholera, Ureaplasma urealyticum, Mycoplasma pneumoniae, 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 israelii, 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
Streptococcus

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-orchitus, endocervical infections, syphilis and gonorrhoea (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:
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 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:
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 oespohagus 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 are as follows, depending on the severity of the infection:
250 to 500 mg (one to two capsules) every six hours.

For acne, the adult dosage is as follows:
250 mg (one capsule) 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.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with tetracycline.
The use of expired tetracylines may lead to a Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, aminoaciduria, hypophosphatemia and hypokalaemia.
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 anticoagulants 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 ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
ROXY* CAPSULES
are opaque green and yellow capsules with RIO imprinted on each half.

PRESENTATION:
Securitainers of 60 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture. Keep the container tightly closed, out of the reach of children.

REGISTRATION NUMBER:
A/20.1.1/85

NAME AND BUSINESS ADDRESS OF THE 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:
3 March 1995

* Registered Trade Mark

New addition to this site: May 2004
Source: Pharmaceutical Industry

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