Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT
Oxytetracycline is a bacteriostatic broad-spectrum antibiotic, active against a wide variety of Gram-positive and Gram-negative organisms. Infections caused by oxytetracycline-sensitive organisms include:
Oxytetracycline is an alternative drug in the treatment of leptospirosis, gas-gangrene and tetanus.
The tablets are for oral administration and are best taken on an empty stomach (1 hour before food or two hours after). If gastric irritation occurs, tablets should be taken with food. Tablets should be taken well before going to bed. Therapy should be continued for up to three days after symptoms have subsided.
The tablets must not be given to children below the age of 12.
All infections due to Group A beta-haemolytic streptococci should be treated for at least 10 days.
The minimum recommended dosage is 250mg every six hours. Therapeutic levels are attained more rapidly by the administration of 500mg initially, followed by 250mg every six hours. For severe infections, the dosage may be increased to 500mg every six hours.
Usual adult dose. Caution should be observed as subclinical renal insufficiency may lead to drug accumulation.
In general, tetracyclines are contraindicated in renal impairment and the dosing recommendations only apply if use of this class of drug is deemed absolutely essential. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.
250-500mg daily in single or divided doses should be administered for at least 3 months in the treatment of acne vulgaris and severe rosacea.
A therapeutic dose of oxytetracycline should be administered for at least 10 days.
Brucellosis: 500mg four times daily accompanied by streptomycin.
500mg four times daily for 7 days is recommended in the following infections: uncomplicated gonococcal infections (except anorectal infections in men); uncomplicated urethra; endocervical or rectal infection caused by Chlamydia trachomatis; non-gonoccocal urethritis caused by Ureaplasma urealyticum.
Acute epididymo-orchitis caused by Chlamydia trachomatis, or Neisseria gonorroeae: 500mg four times daily for 10 days.
500mg four times daily for 15 days. Syphilis of more than one year’s duration, (latent syphilis of uncertain or more than one year’s duration, cardiovascular or late benign syphilis) except neurosyphilis, should be treated with 500mg four times daily for 30 days. Patient compliance with this regimen may be difficult so care should be taken to encourage optimal compliance. Close follow-up including laboratory tests, is recommended.
No specific overdose problems or symptoms. Gastric lavage and administration of milk or antacids.
Shelf life: Three years.
Store below 25°C.
The tablets are available in Al/PVC blister packs of 28 tablets enclosed in a carton.
No special precautions required.
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