OXYTETRACYCLINE 250MG TABLETS
Active substance(s): OXYTETRACYCLINE DIHYDRATE
NAME OF THE MEDICINAL PRODUCT
Oxytetracycline 250mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytetracycline 250mg (as dihydrate)
For excipients, see 6.1.
Yellow, round, bi-convex, sugar coated.
The treatment of infection due to chlamydia, Brucella, Mycoplasma, Rickettsia
and other sensitive organisms.
It can also be used in the prophylaxis and treatment of chronic bronchitis, non
gonococcal urethiritis, gonorrhoea, syphilis, urinary tract infection and severe
Posology and method of administration
The tablets are for oral administration and the normal dose is 250-500mg
every six hours
(4 times a day). This may be increased in severe infections.
For acne the dose is usually 250mg three times a day for four weeks but this
may be prolonged if necessary.
The tablets are best taken on an empty stomach (1 hour before food or two
The above regimen is suitable for adults and the elderly.
The tablets must not be given to children below the age of 12.
Must not be given to children below 12 years. Hypersensitivity, renal or
hepatic impairment, pregnancy, porphyria, and systemic lupus erythematosus
Special warnings and precautions for use
Absorption is adversely affected by milk, antacids and zinc and iron salts.
Tetracyclines depress plasma prothrombin activity, therefore reduced dosages
of concurrent anticoagulants may be required. Lower doses are indicated in
cases of renal impairment to avoid excessive systemic accumulation and if
therapy is prolonged serum level determinations are advisable. Special care
should be taken when treating the elderly or patients receiving potentially
hepatotoxic drugs. Not to be used with penicillins and discontinue treatment if
supra infection develops.
Interaction with other medicinal products and other forms of interaction
Oxytetracycline may potentiate action of some anti-coagulants. Antacids, Iron
and Zinc salts, dairy products and food may interfere with absorption. There is
a slight risk of adverse effect on oral contraception.
Fertility, Pregnancy and lactation
The product should not be used unless absolutely essential as use of
Tetracyclines during teeth development may bring about permanent
Effects on ability to drive and use machines
Photosensitivity and dermatological reactions are rare, G.I. disturbances e.g.
vomiting or diarrhoea may occur. As with all antibiotics, overgrowth of
resistant organisms may cause stomatitis, glossitis, vaginitis or enterocolitis.
Candidiasis has also been seen.
Occurrences of enamel hypoplasia have been reported and bulging fontanelles
in infants and benign intercranial hypertension in adults has also been seen.
Treatment should cease if evidence of raised intercranial pressure develops.
No specific overdose problems or symptoms. Gastric lavage and
administration of milk or antacids.
Oxytetracycline is a broad spectrum tetracycline antibiotic with activity
against a large number of gram positive and gram negative bacteria.
The product acts by interfering with bacterial protein synthesis.
Oxytetracycline is absorbed from the GI tract irregularly and incompletely.
Absorption may be affected by food, drinks and other medication.
It should preferably be given before food and milk drinks, antacids and iron
containing medicines should be avoided.
In circulation oxytetracycline is bound to plasma proteins (20-35%) and is also
widely distributed in body tissues and fluids.
Biological half life is in order of 91/2 hours. Excretion is in urine and faeces.
Preclinical safety data
No data of relevance to that already included in other sections of the SPC.
List of excipients
Sodium Lauryl Sulphate
Titanium Dioxide (E171)
Tartrazine Aluminium Lake (E102)
Special precautions for storage
Do not store above 25°C.
Keep the container tightly closed.
Nature and contents of container
Securitainer - high density polyethylene bottle - low density polyethylene caps
Pack size: 1000 tablets
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
28th January 2005
DATE OF REVISION OF THE TEXT
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