Celestamine® tablets combine the anti-inflammatory and anti-allergic effects of the corticosteroid betamethasone with the antihistaminic activity of dexchlorpheniramine maleate. By using betamethasone and dexchlorpheniramine maleate in combination, comparable results usually are obtained with similar amounts of corticosteroid than when the corticosteroid is given alone.
Indication and usage
Celestamine® tablets are recommended in the treatment of difficult cases of respiratory, dermatologic and ocular allergies, as well as ocular inflammatory disorders, where adjunctive systemic corticosteroid therapy is indicated.
Representative conditions include severe hay fever (pollenosis), severe bronchial asthma, perennial allergic rhinitis, atopic dermatitis (eczema), contact dermatitis, drug reactions and serum sickness.
Inflammatory ocular disorders include allergic conjuctivitis, keratitis, non-granulomatous iritis, iridocyclitis, choroiditis, chorioretinitis and uveitis.
Celestamines® tablets control the exudative and inflammatory aspects of ocular diseases, thus helping to preserve the functional integrity of the eye while allowing treatment of the specific infection or other cause with appropriate therapy.
Dosage and administration
Dosage should be individualized and adjusted according to the specific disease being treated, its severity and the response of the patient. As improvement occurs, the dosage should be reduced gradually to the minimum maintenance level and discontinued where possible. When symptoms of respiratory allergies are adequately controlled, slow withdrawal of the combination product and treatment with an antihistamine alone should be considered.
The recommended initial dosage of Celestamine® tablets for adults and chhildren over 12 years is 1 to 2 tablets four times daily after meals and at bed time. The dose is not to exceed 8 tablets per day. In younger children dosage should be adjusted according to the severity of the aondition and the response of the patient, rather than by age or body weight.
Children 6 to 12 years: The recommended dosage is 1/2 tablet three times a day. If an additional daily dose is required, it should be taken preferably at bedtime. The dose is not to exceed 4 tablets a day
Adverse reactions to this component, which have been the same as those with other corticosteroids, are related to dose and duration of the therapy. The small amount of corticosteroid in the combination makes the incidence of side effects less likely. Adverse reactions reported for corticosteroids include:
Fluid and electrolyte disturbances: Sodium retention, potassium loss, hypokalaemic alkalosis, fluid retention, congestive heart failure in susceptible patients, hypertension.
Musculoskeletal: Muscle weakness, corticosteroid myopathy, loss of muscle mass, aggravation of myasthenic symptoms in myasthenia gravis, osteoporosis, vertebral compression fracture, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, tendon rupture.
Gastrointestinal: Peptic ulcer with possible subsequent perforation and haemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis
Dermatologic: Impaired wound healing, skin atrophy, thin fragile skin, petechiae and ecchymosis, facial erythema, increased sweating, suppressed reactions to skin test, reactions such as allergic dermatitis, urticaria, angio-neurotic oedema.
Neurologic: Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache.
Endocrine: Menstrual irregularities, development of cushingoid state, suppression of foetal intrauterine or childhood growth, secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, decreased carbohydrates tolerance, manifestations of latent diabetes mellitus, increased requirements of insulin or oral hypoglycaemic agents in diabetics.
Ophthalmic: Posterior sub-capsular cataracts, increased intraocular pressure, glaucoma, exophthalmos, vision blurred.
Metabolic: Negative nitrogen balance due to protein catabolism
Psychiatric: Euphoria, mood swings, severe depression to frank psychotic manifestations, personality changes, hyperirritability, insomnia
Other: Anaphylactoid or hypersensitivity and hypotensive or shock-like reactions
Adverse reactions to this component have been the same as those reported with other conventional (sedating) antihistamines and rarely cause toxicity. Slight to moderate drowsiness is the most frequent side effect of dexchlorpheniramine maleate.
Adverse effects of sedating antihistamines vary in incidence and severity. Among these are cardiovascular, hematologic (pancytopenia, thrombocytopenia, haemolytic anemia), neurologic (confusion, hallucinations, tremor), gastrointestinal, genitourinary (urinary retention), respiratory adverse reactions and mood changes.
The most common effects include sedation, sleepiness, dizzness, disturbed coordination, epigastric distress, rash, dry mouth and thickening of bronchial secretions
Celestamines are contraindicated in patients with systemic fungal infections, new-born and premature infants, patients receiving MAO inhibitor therapy and in those who have shown hypersensitivity or idiosyncrasy to any component of these products or drugs of similar chemical structures.
Pregnancy and nursing mothers
The use of celestamine during pregnancy, in nursing mothers or women of child-bearing age requires that the possible benefits of the drug be weighed against potential hazards to mother and foetus or infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism