Betamethasone (Diprolene) Contraindications and Precautions
- acne rosacea
- acne vulgaris
- breast-feeding
- Cushing’s syndrome
- measles
- occlusive dressing
- ophthalmic administration
- perioral dermatitis
- varicella
- abrupt discontinuation
- asthma
- cataracts
- children
- coagulopathy
- corticosteroid hypersensitivity
- diabetes mellitus
- diverticulitis
- elderly
- fungal infection
- GI disease
- GI perforation
- glaucoma
- heart failure
- hemophilia
- hepatic disease
- herpes infection
- hypertension
- hypothyroidism
- immunosuppression
- infants
- infection
- inflammatory bowel disease
- intravenous administration
- myasthenia gravis
- myocardial infarction
- ocular exposure
- ocular infection
- osteoporosis
- peptic ulcer disease
- peripheral vascular disease
- pregnancy
- psychosis
- renal disease
- seizure disorder
- skin abrasion
- skin atrophy
- sulfite hypersensitivity
- surgery
- thromboembolic disease
- tuberculosis
- ulcerative colitis
- vaccination
- viral infection
- visual disturbance
Betamethasone (Diprolene) Contraindications and Precautions
Systemic corticosteroids can aggravate Cushing’s syndrome and should be avoided in patients with Cushing’s syndrome. Prolonged administration of pharmacological doses of systemic corticosteroids or topical preparations (resulting in systemic absorption) may result in hypothalamic-pituitary-adrenal (HPA) suppression and/or manifestations of Cushing’s syndrome in some patients. Acute adrenal insufficiency and even death may occur following abrupt discontinuation of prolonged systemic therapy. In addition, a withdrawal syndrome unrelated to adrenocortical insufficiency may occur following sudden discontinuation of corticosteroid therapy. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels (betamethasone_diprolene_adverse_reactions/">see Adverse Reactions). Withdrawal from prolonged systemic corticosteroid therapy should be gradual. HPA suppression can last for up to 12 months following cessation of systemic therapy. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. HPA-suppressed patients may need supplemental corticosteroid treatment during periods of physiologic stress, such as surgical procedures, acute blood loss, or infection, even after the corticosteroid has been discontinued. Conditions that increase systemic absorption of topical corticosteroids include use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of an occlusive dressing. Diapers or plastic pants may be considered occlusive dressings, therefore, topical betamethasone should not be used for the treatment of diaper dermatitis. Patients receiving large doses of hydrocortisone applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression and/or manifestations of Cushing’s syndrome. If these effects are noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Chronic corticosteroid therapy in children may also interfere with growth and development. Children and infants may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore are more susceptible to developing systemic toxicity, especially with very-high-potency products. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and increased intracranial pressure have been reported in children receiving topical corticosteroids. Use of Diprolene® AF Cream or Diprosone® ointment in pediatric patients < 12 years is not recommended. In an open label study, 19 of 60 (32%) and 15 of 53 (28%) evaluable pediatric patients (< 12 years) using Diprolene® AF Cream or Diprosone® Ointment, respectively, demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group.
Patients receiving high-dose (e.g., equivalent to 1 mg/kg or more of prednisone daily) or systemic corticosteroid therapy for any period of time, particularly in conjunction with corticosteroid sparing drugs (e.g., troleandomycin) are at risk to develop immunosuppression; however, patients receiving moderate dosages of systemic corticosteroids for short periods or low dosages for prolonged periods also may be at risk. When given in combination with other immunosuppressive agents, there is a risk of over-immunosuppression (betamethasone_diprolene_interactions/">see Drug Interactions).
Systemic corticosteroid therapy can mask the symptoms of infection and should not be used in cases of viral infection, fungal infection, or bacterial infection that are not adequately controlled by antiinfective agents. Although the manufacturers state that systemic betamethasone is contraindicated in patients with systemic fungal infections, most clinicians believe that systemic corticosteroids can be administered to these patients as long as appropriate antiinfective therapy is administered simultaneously. Systemic corticosteroids can reactivate tuberculosis and should not be used in patients with a history of active tuberculosis, except when chemoprophylaxis is instituted concomitantly. Patients receiving immunosuppressive doses of systemic corticosteroids should be advised to avoid exposure to viral infections (i.e., measles or varicella) because these diseases may be more serious or even fatal in immunosuppressed patients. Pediatric patients dependent on systemic corticosteroids should undergo anti-varicella-zoster virus antibody testing. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, varicella), should be initiated or continued only if the appropriate antiinfective treatment is instituted. If the infection does not respond to the antimicrobial therapy, the concurrent use of the topical corticosteroid should be discontinued until the infection is controlled. Topical corticosteroids should not be used to treat acne vulgaris acne rosacea or perioral dermatitis as they may exacerbate these conditions. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers. Use topical betamethasone preparations with caution in patients with markedly impaired circulation or peripheral vascular disease; skin ulceration has been reported in these patients following topical corticosteroid use.
If surgery is required, patients should advise their physician that they received systemic corticosteroid therapy within the last 12 months and state the disease for which they were being treated. Identification cards that include disease state, type and dose of corticosteroid, and physician should always be carried with the patient.
Systemic corticosteroid therapy has been associated with left ventricular free-wall rupture in patients with recent myocardial infarction, so its use should be employed with extreme caution in these patients.
Systemic corticosteroids can cause edema and weight gain. Patients with congestive heart failure or hypertension can have an exacerbation of their condition. Systemic corticosteroids should be used with caution in these patients.
Prolonged systemic corticosteroid therapy can lead to osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humoral heads, and pathologic fractures of long bones secondary to protein catabolism. Use cautiously in elderly, debilitated, or postmenopausal patients because they are especially susceptible to these adverse effects. A high-protein diet may alleviate or prevent the adverse effects associated with protein catabolism. Topical corticosteroids should be used for brief periods, or under close medical supervision in patients with evidence of pre-existing skin atrophy. Elderly patients may be more likely to have preexisting skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients. Use of lower potency topical corticosteroids also may be necessary in some patients.
Systemic corticosteroids may decrease glucose tolerance, produce hyperglycemia, and aggravate or precipitate diabetes mellitus. This may especially occur in patients predisposed to diabetes mellitus. When corticosteroid therapy is necessary in patients with diabetes mellitus, changes in insulin, oral antidiabetic agent dosage, and/or diet may be required. Topical corticosteroids should be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.
Oral corticosteroids can cause gastrointestinal irritation. The drugs should be used with caution in patients with GI disease, diverticulitis, nonspecific ulcerative colitis, or intestinal anastomosis (because of the possibility of perforation). While used for the short-term treatment of acute exacerbations of chronic inflammatory bowel disease such as ulcerative colitis and Crohn’s disease, corticosteroids should not be used in patients where there is a possibility of impending GI perforation, abscess, or pyogenic infection. Some patients may require long-term corticosteroid therapy to suppress disease activity, but generally this practice is not recommended. Corticosteroids should not be used in patients with peptic ulcer disease except under life-threatening circumstances.
Systemic corticosteroids should be used with extreme caution in patients with psychosis, emotional instability, renal disease, and seizure disorder because the drugs can exacerbate these conditions. Patients with hepatic disease, such as cirrhosis, or hypothyroidism can have an exaggerated response to systemic corticosteroids. Use systemic corticosteroids with caution in these patients.
Systemic glucocorticoids should be used with caution in patients with myasthenia gravis who are being treated with anticholinesterase agents (betamethasone_diprolene_interactions/">see Interactions).
Systemic corticosteroids rarely may increase blood coagulability, causing intravascular thrombosis, thrombophlebitis, and thromboembolism. Therefore, systemic corticosteroids should be used with caution in patients with preexisting coagulopathy (e.g., hemophilia) or thromboembolic disease.
Systemic corticosteroids should be used cautiously in patients with glaucoma or other visual disturbance. Corticosteroids are well known to cause cataracts and can exacerbate glaucoma during long-term administration. Patients receiving corticosteroids chronically should be periodically assessed for cataract formation. There is also an increase in the propensity for secondary ocular infection caused by fungal or viral infections. Betamethasone topical preparations are generally not recommended to be applied to the face, groin, or axillae. Care should be taken to avoid ocular exposure; ophthalmic administration of topical betamethasone preparations is contraindicated. Visual impairment, ocular hypertension and worsened cataracts have been reported with ocular exposure to other high potency topical corticosteroids. Preexisting glaucoma may be aggravated if betamethasone is applied in the periorbital area.
Betamethasone is classified FDA pregnancy risk category C. Complications, including cleft palate, still birth, and premature abortion, have been reported when systemic corticosteroids were administered during pregnancy. If these drugs must be used during pregnancy, the potential risks should be discussed with the patient. Infants born to women receiving large doses of systemic corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency, and appropriate therapy should be initiated, if necessary. Topical corticosteroids should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.
Corticosteroids distribute into breast milk; therefore, the manufacturer recommends that women receiving pharmacological dosages of systemic corticosteroids not engage in breast-feeding. It is not known whether topical administration of betamethasone could result in sufficient systemic absorption to produce detectable quantities in breast milk. Increased blood pressure has been reported in an infant whose mother applied a topical corticosteroid ointment directly to the nipples. Most authorities recommend caution when prescribing topical corticosteroids to lactating women.
Corticosteroid therapy usually does not contraindicate vaccination with live-virus vaccines when such therapy is of short-term (< 2 weeks); low to moderate dose; long-term alternate day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administration topically (skin or eye), by aerosol, or by intra-articular, bursal or tendon injection. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live-virus vaccines. In general, patients with severe immunosuppression due to large doses of corticosteroids should not receive vaccination with live-virus vaccines. When cancer chemotherapy or immunosuppressive therapy is being considered (e.g., for patients with Hodgkin’s disease or organ transplantation), vaccination should precede the initiation of chemotherapy or immunotherapy by >= 2 weeks. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy. In patients who have received high-dose, systemic corticosteroids for >= 2 weeks, it is recommended to wait at least 3 months after discontinuation of therapy before administering a live-virus vaccine.
Some commercially available formulations of betamethasone may contain sulfites. Sulfites may cause allergic reactions in some people. They should be used with caution in patients with known sulfite hypersensitivity. Patients with asthma are more likely to experience this sensitivity reaction than non-asthmatic patients.
Certain dosage forms of betamethasone injection should not be given via intravenous administration. Do not give betamethasone acetate formulations (e.g. Celestone Soluspan®) intravenously.
Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to betamethasone should not receive any form of betamethasone. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
[ Last revised: 10/18/2005 11:41:00 AM ]
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