| BETNESOL® Preparations |
|Betamethasone Sodium Phosphate |
|Indications And Clinical Uses: Enema: For local use as a retention enema in ulcerative colitis.
Eye and Ear Drops: Inflammatory eye conditions (anterior segment) and inflammatory ear conditions, e.g., otitis externa.
Tablets: Acute asthma, intractable hay fever, severe eczema, other inflammatory skin diseases; rheumatoid arthritis, nephrotic syndrome, severe ulcerative colitis, collagen diseases.
Contra-Indications: Systemic infections, live virus immunization, hypersensitivity.
Precautions: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Corticosteroid treatment may reduce the response of the pituitary-adrenal axis to stress and relative insufficiency may persist for up to 1 year after withdrawal or prolonged therapy.
While on corticosteroid therapy patients should not be vaccinated against smallpox because of potential complications. Conversely, patients with vaccinia should not receive corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high doses, because of possible hazards of neurological complications and a lack of antibody response. Patients without a definite history of chickenpox should be advised to avoid close contact with chickenpox or herpes zoster. If exposed to chickenpox or herpes zoster, patients should seek urgent medical attention. If the patient is a child, then the parents must be aware that exposure to chickenpox must be avoided. Passive immunization with varicella/zoster immunoglobulin (VZIG) is needed by exposed nonimmune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months. VZIG should be given not later than 10 days from exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. A diagnosis of chickenpox should be considered in any patient receiving corticosteroids who presents with a fever or systemic illness. Corticosteroids should not be stopped and a dose increase may be necessary.
Pregnancy and Lactation: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers 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. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
The use of corticosteroids 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 an appropriate antituberculous regimen. If corticosteroids 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.
Corticosteroids may mask some signs of infection and new infections may appear during their use. There may be impaired resistance to and inability to localize infection when corticosteroids are used. If corticosteroids have to be used in the presence of bacterial infections, institute appropriate vigorous anti-infective therapy.
Use corticosteroids cautiously in patients with ocular herpes simplex because of possible corneal ulceration and perforation. Corticosteroids may worsen diabetes mellitus, osteoporosis, hypertension, glaucoma and epilepsy.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Corticosteroid therapy may cause hyperacidity or peptic ulcer. Since appearance of peptic ulcer may be asymptomatic until perforation or hemorrhage occurs, take x-rays when treatment is prolonged or when there is gastric distress. An ulcer regimen including an antacid should be considered as a prophylactic measure during prolonged therapy.
Use the lowest possible dose of corticosteroid to control the condition under treatment, and when dosage reduction is possible, the reduction should be gradual.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt, and water retention, and increased potassium excretion. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Because of the possibility of fluid retention, care must be taken when corticosteroids are administered to patients with congestive heart failure. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Drug induced secondary adrenocortical insufficiency may be minimized by gradual dosage reduction. This type of relative insufficiency may persist for months after discontinuation of therapy, therefore, in any stress situation occurring during that period, reinstitute hormone therapy. If the patient is receiving steroids already, the dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
Use ASA cautiously in conjunction with corticosteroids in hypoprothrombinemia.
Use steroids with caution in nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis, fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Fat embolism has been reported as a possible complication of hypercortisonism.
There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Steroids may increase or decrease motility and number of spermatozoa in some patients.
Phenytoin may enhance the rate of metabolism and clearance of corticosteroids and this may increase steroid dosage requirements.
Advise patients to inform subsequent physicians of the prior use of corticosteroids.
Corticosteroids may suppress reactions to skin tests.
Enema: There is some systemic absorption of the steroid, which can be a therapeutic advantage, as combined systemic and local therapy has been beneficial, certainly in some cases. However, adrenal function can be affected; thus it is necessary to take such precautions as apply during and after systemic therapy.
Eye and Ear Preparations: Use with care in cases of perforated ear drum or in long standing cases of chronic otitis media because of possibility of ototoxicity. In diseases due to microorganisms, infection may be masked, enhanced or activated by the steroid. Extended use of topical corticosteroids may cause increased intraocular pressure in susceptible individuals. It is advisable that the intraocular pressure be checked frequently. In those diseases causing thinning of the cornea, perforation has been known to have occurred with the use of topical steroids. If infections which are present before use do not respond promptly, the preparation should be discontinued until the infection has been adequately controlled by other measures. If new infections due to bacteria or fungi appear during therapy, appropriate measures should be taken. If sensitivity or irritation develops, discontinue use.
Adverse Reactions: Fluid and electrolyte disturbances: sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension. Musculoskeletal: muscle weakness; steroid myopathy; loss of muscle mass; osteoporosis; vertebral compression fractures; aseptic necrosis of femoral and humeral heads; pathologic fracture of long bones.
Gastrointestinal: peptic ulcer and possible subsequent perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis.
Dermatologic: impaired wound healing; thin fragile skin; petechiae and ecchymoses; erythema; increased sweating; may suppress reactions to skin tests.
Neurological: convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment; vertigo; headache.
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 diabetes.
Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos.
Metabolic: negative nitrogen balance due to protein catabolism.
Other: hypersensitivity, thromboembolism.
Dosage And Administration: Enema: Normally, 1 enema is used nightly, for 2 to 4 weeks. More prolonged treatment is permissible in patients showing progressive improvement. If the response is inadequate, it is undesirable to persist with medical treatment to a point where surgical measures are unduly delayed.
Drops: 1 or 2 drops into eye every 1 or 2 hours; or 2 or 3 drops into ear every 2 or 3 hours: in both cases until control is achieved, then frequency can be reduced.
Tablets: Depending upon the condition, 0.25 to 1 mg may be given 3 or 4 times daily.
Availability And Storage: Enema: Each disposable plastic bag of 100 mL contains: betamethasone 5 mg (as betamethasone sodium phosphate) in buffered solution. Sodium: <1 mmol (0.31 mg)/mL. Tartrazine-free. Boxes of 7´100 mL.
Eye and Ear Drops: Each mL of sterile, isotonic, buffered solution contains: betamethasone 0.1% (as betamethasone sodium phosphate). Plastic dropper bottles of 5 mL.
Tablets: Each scored, soluble, effervescent tablet contains: betamethasone 0.5 mg (as betamethasone sodium phosphate). Tablets dissolve rapidly in water to form a tinted solution for oral administration. Sodium: <1 mmol (20.8 mg). Tartrazine-free. Bottles of 100.
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