Prescription Information for Periostat (doxycycline 20mg)

Do some of your patients suffer with periodontitis? Why not recommend Periostat? Periostat, distributed by Alliance Pharmaceuticals, is one of the latest products to be introduced to the dental market for the treatment of chronic periodontitis.

Periostat is an orally administered tablet containing a novel formulation of 23.08mg doxycycline hyclate. Designed to be taken twice a day as an adjunct to scaling and root planning (SRP), Periostat increases clinical attachment level gain and reduces probing depths in patients with chronic periodontitis.

Periodontitis is characterised by periods of quiescence and unpredictable episodes of exacerbation. The underlying risk factors amplify tissue- destructive enzymes, resulting in disease progression which may manifest itself as attachment loss, bone loss and, in severe cases, tooth loss. The duration of treatment with Periostat, a prescription only medicine, will depend on the individual case but is recommended to be at least three months, and its use is approved for up to nine months to suppress the destructive collagenase enzymes and help stabilise the periodontium.

Clinical evidence shows that Periostat produces clinically and statistically significant increases in attachment level gains as well as pocket depth reduction, in patients with moderate to severe periodontitis.

Periostat is not intended to eliminate the need for clinical interventions or procedures that reduce the bacterial load in the periodontal pocket. Periostat is an adjunctive therapy, and is the only approved product formulated specifically to suppress the tissue destroying enzymes primarily responsible for the breakdown of the periodontium.



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 Alliance Pharmaceuticals Ireland
Avonbridge House United Drug House
Bath Road Magna Drive
Chippenham Magna Business Park
Wiltshire Citywest Road
SN15 2BB Dublin 24
UK Ireland

Adverse Event Reporting
Information about adverse event reporting can be found at www.yellowcard.gov.uk (UK) and www.imb.ie (Ireland).

Adverse events should be reported to Pharmacovigilance at Alliance Pharmaceuticals, tel: 01249 466966 (UK) 01 4041805 (Ireland), email: pharmacovigilance@alliancepharma.co.uk.

www.alliancepharma.co.uk

Date of preparation/last revised: November 2006

Periostat and PS20 are registered trademarks of CollaGenex International Limited under licence by Alliance Pharmaceuticals Ltd.
Periostat, distributed by Alliance Pharmaceuticals, is one of the latest products to be introduced to the dental market for the treatment of chronic periodontitis.

Periostat is an orally administered tablet containing a novel formulation of 23.08mg doxycycline hyclate. Designed to be taken twice a day as an adjunct to scaling and root planning (SRP), Periostat increases clinical attachment level gain and reduces probing depths in patients with chronic periodontitis.

Periodontitis is characterised by periods of quiescence and unpredictable episodes of exacerbation. The underlying risk factors amplify tissue- destructive enzymes, resulting in disease progression which may manifest itself as attachment loss, bone loss and, in severe cases, tooth loss. The duration of treatment with Periostat, a prescription only medicine, will depend on the individual case but is recommended to be at least three months, and its use is approved for up to nine months to suppress the destructive collagenase enzymes and help stabilise the periodontium.

Clinical evidence shows that Periostat produces clinically and statistically significant increases in attachment level gains as well as pocket depth reduction, in patients with moderate to severe periodontitis.

Periostat is not intended to eliminate the need for clinical interventions or procedures that reduce the bacterial load in the periodontal pocket. Periostat is an adjunctive therapy, and is the only approved product formulated specifically to suppress the tissue destroying enzymes primarily responsible for the breakdown of the periodontium.

To order or for further information on Periostat call Oraldent on 01480 862080/862084