Betamex

Tablet: Each Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) Tablet contains 250 mcg Betamethasone (Betamex), a synthetic derivative of prednisolone, and 2 mg Dexchlorphenamine Maleate.

Excipients/Inactive Ingredients: Cornstarch, lactose, dye FD & C red #3, gelatin and magnesium stearate.

Syrup: Each teaspoonful (5 mL) of Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) Syrup is equivalent to one Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) Tablet.

Excipients/Inactive Ingredients: Sucrose, sorbitol, propylene glycol, sodium benzoate, citric acid, sodium chloride, dye FD & C yellow #6, imitation strawberry flavor and purified water.

Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) Tablet and Syrup 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 conjunctivitis, keratitis, non-granulomatous iritis, iridocyclitis, choroiditis, chorioretinitis, and uveitis.

Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) Tablets and Syrup 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 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 Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) Tablet and Syrup for adults and children over 12 years is 1 to 2 tablets (or 1 to 2 teaspoonfuls) four times daily, after meals and at bedtime. The dose is not to exceed 8 tablets (or 8 teaspoonfuls) per day. In younger children dosage should be adjusted according to the severity of the condition, and the response of the patient, rather than by age or body weight.

Children 6 to 12 Years: The recommended dosage is ½ tablet (or ½ teaspoonful) 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 (or 4 teaspoonfuls) a day.

Children 2 to 6 Years: The initial dosage of Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) Syrup is ¼ to ½ teaspoonful three times a day with adjustment of dosage according to patient response. Daily dose is not to exceed 2 teaspoonfuls.

Betamethasone (Betamex)/Dexchlorphenamine Maleate (Betamex) products are contraindicated in patients with systemic fungal infections, newborn 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.

Betamethasone (Betamex): Concurrent use of phenobarbital, phenytoin, rifampicin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.

Patients receiving both a corticosteroid and an estrogen should be observed for excessive corticosteroid effects.

Concurrent use of corticosteroids with potassium-depleting diuretics may enhance hypokalemia. Concurrent use of corticosteroids with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may enhance the potassium depletion caused by amphotericin B. In all patients taking any of these drug therapy combinations, serum electrolyte determinations, particularly potassium levels, should be monitored closely.

Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects, possibly requiring adjustment in dosage.

Combined effects of non-corticosteroid anti-inflammatory drugs or alcohol with glucorticosteroids may result in an increased occurrence or increased severity of gastrointestinal ulceration.

Corticosteroids may decrease blood salicylate concentrations. Acetylsalicylic acid should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Dosage adjustments of an antidiabetic drug may be necessary when corticosteroids are given to diabetics.

Concomitant glucocorticoid therapy may inhibit the response to somatotropin.

Dexchlorphenamine Maleate: Monoamine oxidase (MAO) inhibitors prolong and intensify the effects of antihistamines; severe hypotension may occur. Concomitant use of dexchlorphenamine maleate with alcohol, tricyclic antidepressants, barbiturates or other central nervous system depressants may potentiate the sedative effect of dexchlorphenamine. The action of oral anticoagulants may be inhibited by antihistamines.

Drug/Laboratory Tests: Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false negative results.

The physician should be alerted to the possibility of any adverse effects associated with the use of corticosteroids and antihistamines, especially of the sedating type.

Betamethasone (Betamex): Adverse reactions to this component, which have been the same as those reported with other corticosteroids, are related to dose and duration of 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, hypokalemic alkalosis; fluid retention; congestive heart failure in susceptible patients; hypertension.

Muskoskeletal: Muscle weakness, corticosteroid myopathy, loss of muscle mass, aggravation of myasthenic symptoms in myasthenia gravis; osteoporosis; vertebral compression fractures; aseptic necrosis of femoral and humeral heads; pathologic fracture of long bones; tendon rupture.

Gastrointestinal: Peptic ulcer with possible subsequent perforation and hemorrhage; pancreatitis, abdominal distention; ulcerative esophagitis.

Dermatologic: Impaired would healing, skin atrophy, thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; suppressed reactions to skin tests; reactions eg, allergic dermatitis, urticaria, angioneurotic edema.

Neurologic: Convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment; vertigo; headache.

Endocrine: Menstrual irregularities; development of Cushingoid state; suppression of fetal intrauterine or childhood growth; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements of insulin or oral hypoglycemic agents in diabetics.

Ophthalmic:

Metabolic: Negative nitrogen balance due to protein catabolism.

Psychiatric: Euphoria, mood swings; severe depression to frank psychotic manifestations; personality changes; hyperirritability; insomnia.

Others: Anaphylactoid or hypersensitivity and hypotensive or shock-like reactions.

Dexchlorphenamine Maleate: 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 dexchlorphenamine maleate. Adverse effects of sedating antihistamines vary in incidence and severity. Among these are cardiovascular, hematologic (pancytopenia, thrombocytopenia, hemolytic anemia), neurologic (confusion, hallucinations, tremor), gastrointestinal (urinary retention), respiratory adverse reactions, and mood changes. The most common effects include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, rash, dry mouth and thickening of bronchial secretions.