Fluticasone Contraindications and Precautions
- acne rosacea
- acne vulgaris
- acute bronchospasm
- nasal septal perforation
- nasal surgery
- nasal trauma
- ophthalmic administration
- perioral dermatitis
- status asthmaticus
- asthma
- breast-feeding
- children
- corticosteroid hypersensitivity
- corticosteroid therapy
- Cushing’s syndrome
- diabetes mellitus
- elderly
- fungal infection
- herpes infection
- hypothalamic-pituitary-adrenal (HPA) suppression
- immunosuppression
- infants
- infection
- measles
- milk protein hypersensitivity
- occlusive dressing
- ocular exposure
- osteoporosis
- peripheral vascular disease
- pregnancy
- skin abrasion
- skin atrophy
- surgery
- tuberculosis
- vaccination
- varicella
- viral infection
Fluticasone Contraindications and Precautions
Fluticasone is contraindicated for use in anyone who is hypersensitive to the medication or any components of the respective products. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to fluticasone should not receive any form of fluticasone. 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. Fluticasone inhalation powder should not be used in patients with milk protein hypersensitivity; fluticasone inhalation powder contains lactose and has been associated, rarely, with anaphylactoid reactions.
Inhaled formulation of fluticasone are contraindicated in patients with status asthmaticus or other types of acute bronchospasm for which intensive therapy is warranted. Patients should be advised that fluticasone is not to be used as a bronchodilator and is not indicated for relief of acute bronchospasm. Fluticasone should be used with caution when substituting the drug for oral corticosteroid administration; deaths due to adrenal insufficiency have been reported in asthma patients during and following such a transfer. Patients receiving fluticasone require initiation or resumption of systemic corticosteroids during periods of stress or during severe asthma attacks. Physicians should be notified immediately.
Systemic absorption of topical or inhaled corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Use fluticasone with caution in patients with underlying Cushing’s syndrome. Conditions which 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. Patients receiving large doses of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Although the risk of developing HPA suppression is very low with inhaled fluticasone, patients should, nevertheless, be monitored for this possibility. If HPA suppression occurs, patients will require systemic corticosteroids during periods of physiologic stress. If surgery is required, patients should notify all health care providers that they have received inhaled corticosteroids within the last 12 months. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids. Fluticasone should not be substituted for systemic corticosteroid administration because the amount of inhaled fluticasone that reaches the systemic circulation is insufficient to replace orally administered corticosteroids. Deaths due to adrenal insufficiency have been reported in asthma patients during and following such a transfer.
Systemic 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.
Topical and inhaled 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.
As with any long-term topical treatment of the nasal cavity, patients using fluticasone intranasally over several months or longer should be examined periodically for possible changes in the nasal mucosa. Further, because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal perforation or ulcer, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
The normal inflammatory response to infection can be masked by fluticasone. Use of inhaled or application of topical fluticasone to areas of infection, including tuberculosis of the skin or in patients with a history of active tuberculosis, fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, or varicella), should be initiated or continued only if the appropriate anti-infective treatment is instituted. Corticosteroid therapy can reactivate tuberculosis and should not be used except when chemoprophylaxis is instituted concomitantly. Although patients receiving systemic corticosteroid therapy are more susceptible to secondary infection than patients not receiving corticosteroids, administration via the inhaled route minimizes this risk. The incidence or course of acute bacterial or viral infection is probably minimally affected by inhaled corticosteroids in immunocompetent individuals. The manufacturers state that fluticasone is contraindicated in patients with systemic fungal infection. Inhaled corticosteroids should not be administered to patients with systemic infections unless appropriate chemotherapy is administered simultaneously.
Data from a new 1-year, placebo-controlled trial in children (3 to 9 years of age) with allergic rhinitis receiving fluticasone nasal spray (Flonase®) are available. In this trial, no statistically significant adverse effect on growth was found with treatment. No evidence of clinically significant effects on HPA axis function or bone mineral density were observed. The safety and efficacy of fluticasone inhalations (e.g., Flovent®) have not been determined for children under 4 years of age. Growth inhibition has been observed in some children following therapy with high-dose fluticasone propionate inhalations (e.g., Flovent®). Children receiving fluticasone inhalation therapy should be monitored closely for possible adverse effects on growth patterns; the effect of fluticasone on final adult height is not known. Topical fluticasone preparations are generally not recommended for use in children and infants under 12 years of age, except where the benefits of treatment would outweigh the potential risks of therapy. Pediatric approval, however, was not granted by the FDA for fluticasone ointment (e.g., Cutivate Ointment®) and this dosage form is recommended only for adult patients; in a study of 35 children with atopic dermatitis treated with fluticasone ointment, subnormal adrenal function was observed with cosyntropin stimulation testing. 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 high-potency products. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroid creams and ointments.
Detrimental effects on bone metabolism, such as osteoporosis are expected to be much lower with inhaled, rather than systemically-administered corticosteroids. Although not conclusive, some data suggest that high-dose inhaled steroids may also decrease bone formation and increase resorption. Some patients receiving inhaled steroids may be at increased risk of bone loss compared to healthy individuals. Prospective long-term trials are needed to confirm these findings.
All fluticasone dosage forms are classified FDA pregnancy risk category C. Adequate and well-controlled studies regarding the use of fluticasone during pregnancy have not been done. In general, corticosteroids do cross the placenta, and animal studies have shown some teratogenic effects with subdermal or systemic exposure. Inhaled corticosteroids are often preferred over systemic corticosteroids when use cannot be avoided for the management of asthma during pregnancy. Low-dose inhaled corticosteroids are considered first line therapy for control of mild persistent asthma during pregnancy according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group. Data on the use of medium to high dose inhaled corticosteroid during pregnancy are limited. However, dose titration may be considered for those with moderate to severe persistent asthma, preferably using budesonide. Due to the availability of safety information during pregnancy, budesonide (FDA pregnancy category B) is preferred over other inhaled corticosteroid. However, there are no data to indicate safety concerns with other inhaled corticosteroids, and maintaining a previously established treatment regimen may be more beneficial to the patient. Selection of any pharmacologic treatment for asthma control during pregnancy should include the specific needs of the patient, based on an individual evaluation, and consideration of the potential benefits or risks to the fetus. Similarly, other fluticasone formulations should be avoided unless the potential therapeutic benefit justifies the added risk to the fetus. Fluorinated topical corticosteroid creams and ointments, like fluticasone, are not recommended for use in pregnancy. Lower potency topical corticosteroids are usually used, if needed.
The manufacturer has recommended that caution be exercised when administering fluticasone to women who are breast-feeding their infants. It is unknown whether fluticasone is excreted in breast milk. Most corticosteroids, including physiologic doses of prednisone, are excreted in human breast milk in minimal amounts. The American Academy of Pediatrics has generally considered inhaled corticosteroids and oral doses of prednisone of 20 mg/day or less to be compatible with lactation. Infant exposure to inhaled fluticasone can be minimized by holding breast-feeding for 4 hours after a corticosteroid dose. Fluticasone ointments or creams should not be applied to the nipples or areolae of lactating women; ingestion of topical corticosteroids by infants via this route has been associated with systemic effects.
Manufacturer safety data report that there were no differences in adverse reactions in elderly patients (>= 65 years of age) compared to those reported by younger patients. Additionally, there were no apparent differences in fluticasone efficacy between elderly patients and younger patients, regardless of administration route. No dosage adjustments are needed based on geriatric age alone.
As with other potent fluorinated topical corticosteroids, fluticasone creams and ointments should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis. Fluticasone may aggravate these conditions. Fluticasone topical preparations are not recommended to be applied to the face; ophthalmic administration is contraindicated. Care should be taken to avoid ocular exposure and use around the eyes as cases of visual impairment and ocular hypertension have been reported with topical corticosteroids. Topical corticosteroids should be used for brief periods or under close medical supervision in patients with evidence of pre-existing skin atrophy, especially the elderly. 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 fluticasone preparations cautiously in patients with markedly impaired circulation or peripheral vascular disease due to the potential for skin ulcer. Use of lower potency topical corticosteroids may be necessary in some patients.
[ Last revised: 1/11/2006 10:03:00 PM ]
References
. Hanania NA, Chapman KR, Kesten S. Adverse effects of inhaled corticosteroids. Am J Med 1995;98:196 - 207.
. Butani L. Corticosteroid-induced hypersensitivity reactions. Ann Allergy Asthma Immunol 2002;89:439 - 45.
. NAEPP Working Group Report on Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment - Update 2004. NIH Publication No. 05-3279. Bethesda, MD: U.S. Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute, 2004
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