OXY 250 Capsules

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

OXY 250 Capsules

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

OXY 250 Capsules

COMPOSITION:
Each capsule contains Oxytetracycline hydrochloride 250,0 mg equivalent to 231,48 mg oxytetracycline.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and Medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
OXY 250 is a bacteriostatic antibiotic and inhibits bacterial protein synthesis (30 S ribosomes). It is particularly effective in vitro against the following organisms (in vitro sensitivity does not necessarily imply in vivo efficacy): Vibrio cholerae, Ureaplasma urealuticum, Mycoplasma pneumoniae, Chlamydia trachematis (see below), Chlamydia psittaci, Borrelia recurrensis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonerrhoeae ad Rickettsiae.

OXY 250 is also effective in virto against the following organisms:
Chlostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelli, Francisella tularensis, Pasteurella multicoda, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae.

OXY 250 may also show some effect against the following organisms: in vitro:
Bactercides spp. and Fusobacterium nucleatum.
* = in vitro sensitivity tests must be performed.

RESISTANT PATHOGENS:
Many straiins of the following are resistant:–
–Staphylococci
–Enterococci
–Proteus vulgaris
–Fungi and yeasts (except Actinomyces)
–Pseudomonas aeruginosa (all strains)
–E-Coli
–Shigella
–Strep. pneumoniae

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 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, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever. Leptospirosis, during the early infective phase.

CONTRA-INDICATIONS:
Hypersensitivity to tetracyclines. Patients with renal impairment. Safety has not been established in pregnancy and 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 foetus if given to pregnant women).
*	Symptoms of myasthenia gravis may be aggravated.
*	Photosensitivity may occur (see "Side-effects and special precautions").
*	Pseudotumor cerebri may occur.

DOSAGE AND DIRECTIONS FOR USE:
OXY 250 is not indicated for treating common infections in children under 12 years of age.
OXY 250 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 bodymass/day for children.
The usual dose is 250 mg to 500 mg four times daily for commonly occuring infections due to sensitive organisms, depending on the severity of the infection. For acne, the adult dosage is 250 mg twice daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

*	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 species may cause diarrhoea. Superinfections 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, eosiniophilia, neutropenia and thrombocytopenia.
*	Vitamin deficiencies may occur.
*	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.
*	Local irritation after intravenous administration and thrombophlebitis may follow.
*	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 aminociduria.
*	Raised intracranial pressure in infants (pseudotumor cerebri).
*	Raised intracranial pressure in adults may also occur.
*	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.
*	Dosis 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:
Yellow and orange capsule containing a yellow powder.

PRESENTATION:
Amber plastic bottles containing 20, 100, and 1000 capsules.

STORAGE DIRECTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
X/20.1.1/77

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
BROVAR S & P (PTY) LTD
24 DOGAR STREET
DELVILLE EXT 1
GERMISTON
1401

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
22/11/1990

	Code: OXC PI/00
	Britepak