Each tablet contains: Betamethasone 0.5 mg.
Pharmacology: Betamethasone, like other corticosteroids, act by controlling the rate of synthesis of proteins. Betamethasone react with receptor proteins in the cytoplasm of sensitive cells in many tissues to form a steroid-receptor complex. The complex undergoes a modification, and then moves into the nucleus, where it binds to cromation and regulates transcription of specific genes.
Substitution therapy: Rheumatic disorders: As adjunctive therapy for short-term administration in: post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis, acute and sub-acute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.
Congenital adrenal hyperplasia: A familial disorder in deficiency of several enzymes required for biosynthesis of corticosteroids.
Secondary adrenal insufficiency due to adenohypophysis insufficiency.
Therapeutic uses in non-endocrine diseases: Progressive rheumatoid arthritis with severe joint pain and edema.
Rheumatic carditis: Patients failing to respond to salicylates.
Renal diseases: Patients with some form of nephrotic syndrome attributable to systemic lupus erythematosus or to primary renal disease (except renal amyloidosis) may benefit from corticosteroid therapy.
Collagen diseases: Systemic lupus erythematosus, acute rheumatic carditis.
Allergic conditions: Bronchial asthma/contact dermatitis, atopia dermatitis, serum sickness, drug hypersensitivity reaction.
Ophthalmic disease: Severe, acute and chronic allergic and inflammatory processes involving the eye which are not caused by viral infections such as herpes zoster ophthalmicus, iritis, iridocylitis, chorioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcer, keratitis.
Dermatologic diseases: Pemphigus, severe erythema multiforme (Steven's-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.
Diseases of the liver: Sub-acute hepatic necrosis and chronic active hepatitis, alcoholic hepatitis, and non-alcoholic cirrhosis in women.
Edematous state: To induce diuresis or remission of proteinuria in nephrotic syndrome without uremia, of the idiopathic type or that due to lupus erythematous.
Adults: the dosages depending on severity of the disease and clinically respond.
Short-term therapy: 2-3 mg daily for a few days, and then the daily dosage decreased up to 0.25-0.5 mg per 2-5 days (depending on respond).
Rheumatoid arthritis: 0.5-2 mg daily.
Other conditions: 1.5-5 mg daily for 1-3 weeks, and then the dosage is reduced until reach effective minimum dose.
Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses, systemic fungal infections, live vaccines, hypersensitivity to this drug.
In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Drug-induced secondary adrenocortical insufficiency may be minimised 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, hormone therapy should be reinstituted.
If the patients is already receiving steroids, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used.
Corticosteroids may effect the nitroblue-tetrazolinum test for bacterial infection and produce false negative results.
In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding.
Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropic of with unexplained diarrhoea.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, galucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
The use of corticosteroid in pregnancy, nursing mother, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.
Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects. Mother taking pharmacological dose of corticosteroids should be advice not to nurse.
All corticosteroids increase calcium excretion. Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppresive dose of corticosteroids.
If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppresive dose of corticosteroid the expected serum antibody response may not be obtained. However, immunisation procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy i.e., for Addison's disease.
The use of betamethasone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculous regimen. If corticosteroid are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Literature reports suggest an apparent association between the use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction, therefore, therapy with corticosteroids should be used with great caution in these patients.
Fluid and electrolyte disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.
Musculoskeletal: Muscle weakness, steroid's myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones.
Gastrointestinal: Peptic ulcer with possible subsequent perforation and haemorrhage, pancreatitis, abdominal distension, ulcerative esophagitis.
Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, erythema, increase sweating, possible suppressed reactions to skin tests.
Neurological: Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache, psychic disturbances.
Endocrine: Menstrual irregularities, development of cushingoid state, suppression of growth in children, 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 for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exopthalmos.
Metabolic: Negative nitrogen balance due to protein catabolism.
Cardiovascular: Myocardial rupture following recent myocardial infarction.
Other: Hypersensitivity, thromboembolism, weight gain, increased appetite, nausea, malaise, hiccups.
Efficacy of the drug may be reduced by phenytoin, phenobarbital, rifampicin.
May reduce the effects of diuretics, hypoglycemic, anticholinesterases, salicylates.
H02AB01 - betamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Exabet tab 0.5 mg
10 × 10's
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