Dexaltin

Dexaltin

dexamethasone

Manufacturer:

Nippon Kayaku

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Dexamethasone.
Description
Each gram of Dexaltin oral paste contains dexamethasone 1 mg and sodium polyacryle 300 mg. Dexaltin is a paste for application to the oral mucosa, containing dexamethasone with a potent anti-inflammatory action as the active ingredient. The use of sodium polyacrylate which has a potent adhesive and coating activity on the moist surface as the base is greatly contributory to the prolonged action of dexamethasone and the protection of wound surface: Dexaltin is thus effective against inflammatory diseases of the oral cavity.
Dexamethasone is 9α-Fluoro-11β, 17α, 21-trihydroxy-16α-methyl-pregna-1, 4-diene-3, 20-dione. It has a molecular formula C22H29FO5 and a molecular weight of 392.47.
Dexamethasone occurs as white to light yellow crystals or a crystalline powder. It is sparingly soluble in methanol, in ethanol, in acetone or in dioxane, slightly soluble in chloroform, and practically insoluble in ether.
Action
Pharmacology: Dexamethasone is a compound with 9α-fluorine and 16α-methyl substitutions of the prednisolone molecule. The fluorine atom in the 9α position is greatly contributory to the improved anti-inflammatory action. It has been reported that cortisone 25 mg, hydrocortisone 20 mg, prednisone 5 mg, prednisolone 5 mg, triamcinolone 4 mg, and betamethasone 0.6 mg are required to obtain an anti-inflammatory effect equivalent to that obtained with dexamethasone 0.75 mg, respectively.
Clinical Application: The results of clinical trials of Dexaltin, including double-blind, controlled trials, on a total of 49 patients mostly with radiation stomatitis, at 8 medical institutions in Japan, are given in summary from as follows. (See Tables 1, 2 and 3.)

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Click on icon to see table/diagram/image


Click on icon to see table/diagram/image
Indications/Uses
Intractable stomatitis or glossitis associated with erosion or ulceration.
Dosage/Direction for Use
Usually, apply an adequate amount of Dexaltin to the affected area several times daily. The dose may be increased or decreased, depending on the condition of the patient.
Others: Dexaltin when applied to the oral mucosa, remained attached to the lesion for ≥1 hr in 54%, for ≥2 hrs in 29% and "even during an after meal" in 55% of patients.
Warnings
Dexaltin should not be used on the following patients: Patients with tuberculotic, viral or other purulent infections of the oral cavity.
Patients with a past history of hypersensitivity to Dexaltin.
Special Precautions
No food or fluid should be ingested for a short time after application of Dexaltin.
Dexaltin should by no means be applied to the eye.
Use in pregnancy: The safety of Dexaltin when used during pregnancy has not yet been established. Its prolonged use on pregnant women or women suspected of pregnancy should be avoided.
Use in children: The prolonged use of Dexaltin may be associated with growth and development disturbances.
Use In Pregnancy & Lactation
Use in pregnancy: The safety of Dexaltin when used during pregnancy has not yet been established. Its prolonged use on pregnant women or women suspected of pregnancy should be avoided.
Adverse Reactions
Infection of the Oral Cavity: Fungal or bacterial infection of the oral cavity may occur in the course of treatment with Dexaltin. In case that any symptom or sign of such an infection has appeared, an appropriate antifungal or antibacterial treatment should concomitantly be instituted. In cases where the symptoms or signs of the infection fail to subside rapidly, withdraw Dexaltin.
Hypersensitivity: On manifestation of any allergic reaction, withdraw Dexaltin.
Function of the Pituitary-Adrenocortical System: The prolonged use of Dexaltin may be associated with hypofunction of the pituitary-adrenocortical system.
No severe adverse effects of Dexaltin have been reported, except for the withdrawal of the Dexaltin from one patient for complaint of numbness at the site of application.
Storage
Preserve Dexaltin in light-resistant, tight containers.
ATC Classification
A01AC02 - dexamethasone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
Presentation/Packing
Paste 1 mg/g (oral, white, smooth, odorless) x 2 g, 5 g.
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