Special Warning : אזהרת שימוש

PRECAUTIONS

General
Oracort E may cause local adverse reactions. If irritation develops, Oracort E should be discontinued and appropriate therapy instituted.
Allergic contact sensitization with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant mucosal infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Oracort E should be discontinued until the infection has been adequately controlled. If significant regeneration or repair of oral tissues has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, glucosuria, and other adverse effects known to occur with parenterally-administered steroid preparations; therefore, it may be advisable to periodically evaluate patients on prolonged therapy with corticosteroid-containing dental pastes for evidence of HPA axis suppression (see PRECAUTIONS, Laboratory Tests ). If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Recovery of HPA axis function is generally prompt and complete upon discontinuation of therapy.

Although the absorbed quantity of lidocaine after local use is much lower than after infiltration or regional anaesthesia, systemic effects cannot be completely ruled out if the absorption conditions are very unfavourable (severely damaged mucosa). Oracort E should therefore only be used with special care in patients with severe disorders of the pacemaker/conduction system of the heart, acute decompensated heart failure and severe renal or hepatic disorders.

Information for the Patient
Patients using topical corticosteroids should receive the following information and instructions:
1. This medication is to be used as directed by the physician or dentist. It is for oral use only; it is not intended for ophthalmic or dermatological use.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. Patients should report any signs of adverse reactions.
4. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician or dentist.

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