Betadex

Betadex

Manufacturer:

Interphil

Distributor:

Interphil
Full Prescribing Info
Contents
Betamethasone, dexchlorpheniramine maleate.
Description
Each tablet contains: Betamethasone 250 mcg, Dexchlorpheniramine 2 mg.
Betamethasone is a corticosteroid used in the treatment of conditions for which corticosteroid therapy is indicated, except adrenal-deficiency states. Its virtual lack of mineralocorticoid properties makes betamethasone particularly suitable for treating conditions in which water retention would be a disadvantage.
Dexchlorpheniramine maleate, an alkylamine derivative, is an antihistamine that causes a moderate degree of sedation; it also has antimuscarinic activity.
Action
Pharmacology: Pharmacokinetics: Betamethasone is rapidly absorbed from the gastro-intestinal tract upon oral administration and rapidly distributed to all body tissues. It also crosses the placenta and distributed in small amounts of breast milk.
Dexchlorpheniramine maleate is absorbed relatively slowly from the gastro-intestinal tract, peak plasma concentrations occurring about 2.5 to 6 hours after oral doses. Bioavailability is low, values of 25 to 50% having been reported. Dexchlorpheniramine appears to undergo considerable first-pass metabolism. About 70% of dexchlorpheniramine in the circulation is bound to plasma proteins. Dexchlorpheniramine is widely distributed in the body, and enters the CNS.
Indications/Uses
Betamethasone and dexchlorpheniramine maleate are indicated for difficult cases of respiratory, ocular and dermatologic allergies, as well as ocular inflammatory disorders where adjunctive systemic corticosteroid therapy is indicated.
Dosage/Direction for Use
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.
For adults and children 12-years or older, start with 1-2 tablets 4 times a day (after meals and at bedtime), or as prescribed by the physician.
Overdosage
As a combination product, toxicity from excessive use is primarily due to the dexchlorpheniramine component; the lethal dose is at 2.5-5 mg/kg body weight.
Contraindications
Patients with systemic fungal infections, patients receiving Monoamine oxidase (MAO) inhibitor therapy and in those who have shown hypersensitivity or idiosyncrasy to any of the components.
Special Precautions
Do not take this product unless directed by a physician, if the patient has a breathing problem such as emphysema or chronic bronchitis, or if has glaucoma or difficulty in urination due to enlargement of the prostate gland.
May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages, and do not take this product if the patient is taking sedatives or tranquilizers without first consulting the physician. Use caution when driving a motor vehicle or operating machinery.
The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradually. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.
Cardio-renal: As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.
Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual; reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt retaining properties, rather than betamethasone, are the appropriate choices as replacement therapy in adrenocortical deficiency states.
Use in Pregnancy: US FDA PREGNANCY RISK FACTOR C: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Use in Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman.
Use In Pregnancy & Lactation
Use in Pregnancy: US FDA PREGNANCY RISK FACTOR C: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Use in Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman.
Adverse Reactions
Adverse reactions to betamethasone are related to dose and duration of therapy. This may include fluid and electrolyte disturbances, gastrointestinal, dermatologic, neurologic, endocrine ophthalmic, metabolic, and psychiatric. However, the small amount of the corticosteroid in the combination make the incidence of these side effects less likely.
Adverse reactions to dexchlorpheniramine is similar to other sedating antihistamines. Slight to moderate drowsiness is the most frequent side effect. Others include 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.
Drug Interactions
Betamethasone: Concurrent use of phenobarbital, phenytoin, rifampicin or ephedrine may enhance the metabolism of betamethasone, reducing its therapeutic effects.
Patients receiving estrogen should be observed for excessive corticosteroid effects.
Concurrent use with potassium-depleting diuretics may enhance hypokalemia. Concurrent use with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Betamethasone may enhance the potassium depletion caused by amphotericin B.
Concurrent use 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 betamethasone may result in an increased occurrence or increased severity of gastrointestinal ulceration.
Dexchlorpheniramine maleate: MAO inhibitors prolong and intensify the effects of chlorpheniramine; severe hypotension may occur. Concomitant use with alcohol, tricyclic antidepressants, barbiturates or other CNS depressants may potentiate the sedative effect of dexchlorpheniramine. The action of oral anticoagulants may be inhibited by dexchlorpheniramine.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
R06AB52 - dexchlorpheniramine, combinations ; Belongs to the class of substituted alkylamines used as systemic antihistamines.
Presentation/Packing
Tab 100's.
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