Abbreviated prescribing information

PRESCRIBING INFORMATION
Please refer to full Summary of Product Characteristics before prescribing

Periostat® 20mg Film-coated Tablets
Presentation:
Film-coated tablets, each containing doxycycline hyclate equivalent to 20mg
doxycycline in blister packs of 56 tablets.
Indications:
For patients with adult periodontitis. Periostat is indicated as an adjunct to supra-
gingival and sub-gingival scaling and root planing, with oral hygiene instruction,
carried out by a dental practitioner or hygienist as appropriate.
Dosage and Administration:
Adults and elderly - administered twice daily, at least one hour before meals or
before bedtime. Swallow whole with at least 100ml of fluid, in an upright position.
Take for periods of 3 months. Do not administer for more than 3 consecutive three
month periods.
Contra-indications
Infancy and childhood up to 12 years of age; hypersensitivity to any of the product
excipients or to any of the tetracyclines; achlorhydria; pregnancy and lactation.
Warnings & Precautions
To avoid oesophageal irritation and ulceration, adequate fluids should be taken with
this medication in an upright sitting or standing position.
Periostat therapy may result in overgrowth of nonsusceptible microorganisms
including fungi. Periodic observation of the patient is essential and treatment
stopped if overgrowth of resistant organisms appears.
Use with caution in patients with a history of or predisposition to oral candidosis,
hepatic impairment or to those receiving potentially hepatotoxic drugs and patients
with myasthenia gravis who may be at risk of worsening of the condition.
Avoid excessive sunlight or artificial UV light and discontinue therapy if phototoxicty
occurs. Sunscreen should be considered. Treatment should cease at the first sign
of skin erythema.
In the event of the development of diarrhoea during treatment, the possibility of
pseudomembranous colitis should be considered and appropriate therapy instituted.
In the event of a severe acute hypersensitivity reaction (eg anaphylaxis) treatment
with Periostat must be stopped at once and the usual emergency measures taken.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
Interactions:
Absorption of doxycycline from the gastro-intestinal tract may be inhibited by bi-or tri-
valent ions such as aluminium, zinc, calcium, by magnesium or iron preparations,
activated charcoal, cholestyramine, bismuth chelates and sucralfate. Such
medicines or foodstuffs should be taken 2 to 3 hours following ingestion of Periostat.
Didanosine and quinapril tablets may decrease the absorption of doxycycline and
should therefore be taken at least 2 hours after doxycycline.
Doxycycline may potentiate the hypoglycaemic effect of sulphonylurea oral
antidiabetic agents. May depress plasma prothrombin activity thereby potentiating
the effect of anticoagulants of the dicoumarol type.
Avoid concomitant administration of doxycycline and isotretinoin, as there is the
possibility of potentiation between the drugs to cause reversible pressure increase in
the intracranial cavity (pseudotumour cerebri).
As bacteriostatic drugs may interfere with the bacteriocidal action of penicillin and
betalactam antibiotics, it is advisable that Periostat and betalactam antibiotics should
not be used in combination.
Rifampicin, barbiturates, carbamazepine, diphenylhydantoin, primidone, phenytoin,
and chronic alcohol abuse, may accelerate the decomposition of doxycycline due to
enzyme induction in the liver thereby decreasing its half-life. Sub-therapeutic
doxycycline concentrations may result. Doxycycline used concurrently with
cyclosporine has been reported to decrease the half-life of doxycycline.
Tetracyclines and methoxyflurane used in combination have been reported to result
in fatal renal toxicity.
Tetracyclines used concurrently with oral contraceptives have in a few cases resulted
in either breakthrough bleeding or pregnancy.
Side-effects:
Refer to SPC for full list
The most commonly reported adverse events in Phase III clinical trials were
headache and common cold.
The following adverse reactions have been observed in patients receiving
tetracyclines:
Gastro-intestinal: anorexia, nausea, vomiting, diarrhoea, glossitis, dysphagia,
enterocolitis and inflammatory lesions with monilial overgrowth in the ano-genital
region, oesophagitis and esophageal ulceration. Hepatoxicity has been reported
rarely.
Skin: maculopapular and erythematous rashes, Stevens-Johnson syndrome, skin
photosensitivity. Exfoliative dermatitis has been reported but is uncommon.
Renal: an apparently dose related increase in blood urea.
Blood: thrombocytopenia, neutropenia, haemolytic anaemia, eosiniphilia and
porphyria.
Hypersensitivity reactions: exacerbation of systemic lupus erythematosus,
anaphylaxis, anaphylactoid purpura, pericarditis, urticaria and angioneurotic oedema.
Musculoskeletal: Arthralgia
Other: bulging fontanelles in infants and benign intracranial hypertension in adults.
Treatment should cease if evidence of raised intracranial pressure develops. Brown-
black microscopic discolouration of thyroid tissue has been reported with long term
use of tetracyclines.
Adverse reactions typical of the tetracycline class of drugs are less likely to occur
during medication with Periostat, due to the reduced dosage and the relatively low
serum levels involved.
Legal Category:
POM
Packs:
PVC Aclar/aluminium foil blisters containing 14 tablets. Carton pack size 56 tablets.
Basic NHS price:
56 tablets - £16.50
Marketing Authorisation number:
PL 16853/0078
PA 943/12/1
Full prescribing information is available from:
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK

Adverse Event Reporting
Adverse events should be reported. Reporting forms and information can be found at
Adverse events should also be reported to Pharmacovigilance at Alliance
Pharmaceuticals (tel: 01249 466966, email:
)

Date of preparation/last revised: September 2008
Periostat is a registered trademarks of Alliance Pharmaceuticals Ltd, PS20 is a
registered trademarks of CollaGenex International Limited under licence by Alliance
Pharmaceuticals Ltd.

Source: http://oraldent.org/dloads/Periostat%20PI%20(UK%20and%20Ireland)%20020908.pdf