Source: Marketing Authorisation Holder Revision Year: 2023 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Tetracycline is a bacteriostatic broad-spectrum antibiotic, active against a wide variety of Gram-positive and Gram-negative organisms.
Infections caused by tetracycline-sensitive organisms include:
Tetracycline is an alternative drug in the treatment of leptospirosis, gas-gangrene and tetanus.
Tetracycline should be given one hour before or two hours after meals, since food and some dairy products interfere with absorption. The tablets should be taken with a good drink of water. Therapy should be continued for up to three days after symptoms have subsided.
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.
Contraindicated in this age group.
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 three months in the treatment of acne vulgaris and severe rosacea.
A therapeutic dose of tetracycline should be administered for at least 10 days.
500mg tetracycline four times daily accompanied by streptomycin.
500mg four times daily for seven days is recommended in the following infections: Uncomplicated gonococcal infections (except anorectal infections in man); uncomplicated urethral, endocervical or rectal infection caused by Chlamydia trachomatis; non-gonococcal urethritis caused by Ureaplasma urealyticum. Acute epididymo-orchitis caused by Chlamydia trachomatis, or Neisseria gonorrhoea, 500mg four times daily for 10 days.
Primary and secondary syphilis: 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.
For oral administration.
Symptoms:
Treatment:
There is no specific antidote.
Three years from the date of manufacture (tablet containers & caps/bottles & screw caps).
Three years from the date of manufacture (blisters).
Shelf-life after dilution/reconstitution: Not applicable.
Shelf-life after first opening: Not applicable.
Do not store above 25°C.
Keep the container tightly closed (polypropylene containers).
Store in the original package (blisters).
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil.
Pack sizes: 7’s, 10’s, 14’s, 21’s, 28’s, 30’s, 50’s, 56’s, 60’s, 84’s, 100’s, 112’s, 250’s, 500’s, 1000’s.
Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.
Maximum size of bulk packs: 50,000
Not applicable.
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