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OXYTETRACYCLINE 250MG TABLETS

Active substance(s): OXYTETRACYCLINE DIHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Oxytetracycline 250mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytetracycline 250mg (as dihydrate)
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Coated tablet
Yellow, round, bi-convex, sugar coated.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
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
acne vulgaris.

4.2

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
hours after).
The above regimen is suitable for adults and the elderly.
The tablets must not be given to children below the age of 12.

4.3

Contraindications
Must not be given to children below 12 years. Hypersensitivity, renal or
hepatic impairment, pregnancy, porphyria, and systemic lupus erythematosus
(SLE).

4.4

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.

4.5

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.

4.6

Fertility, Pregnancy and lactation
The product should not be used unless absolutely essential as use of
Tetracyclines during teeth development may bring about permanent
discolouration.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects
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.

4.9

Overdose
No specific overdose problems or symptoms. Gastric lavage and
administration of milk or antacids.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2

Pharmacokinetic properties
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.

5.3

Preclinical safety data
No data of relevance to that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tablet Core:
Lactose

Potato Starch
Sodium Lauryl Sulphate
Gelatin
Magnesium Stearate
Tablet Coat
Talc
Gelatin
Sucrose
Titanium Dioxide (E171)
Tartrazine Aluminium Lake (E102)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Do not store above 25°C.
Keep the container tightly closed.

6.5

Nature and contents of container
Securitainer - high density polyethylene bottle - low density polyethylene caps
Pack size: 1000 tablets

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.

Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0091

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28th January 2005

10

DATE OF REVISION OF THE TEXT
11/01/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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