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| ATEMUR GENERAL |
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Atemur- generic name is fluticasone. It is used to help prevent the symptoms of asthma. The description of Atemur side effects, use, precautions and other information you may find on our online pharmacy.
You may order Atemur on Pharmaenergy.
Pharmaenergy Online medical staff will give you a free consultation to receive the prescription on the concrete medicine in accordance with your disease.
Atemur prescription will be given to you by our licensed pharmacists. It’s necessary to fill in medical form.
Atemur online purchase is cheap and available to any customer. You can save your money buying cheap Atemur.
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| ATEMUR FULL DESCRIPTION |
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Indications: Dermatosis, corticosteroid-responsive; Rhinitis, perennial allergic; Rhinitis, seasonal allergic
Pregnancy Category C
FDA Class 1C ("Little or No Therapeutic Advantage")
FDA Approved 1990 Dec
DRUG CLASS: Corticosteroids-Inhalation/Nasal; Topical Steroids
BRAND NAMES: Atemur Mite, Cutivate, Flixonase, Flixonase Nasal Spray, Flixotide, Flixotide Disk, Flixotide Disks, Flixotide Inhaler, Flonase, Flonase Aq, Flovent, Flunase, Flutide, Flutivate, Zoflut.
DESCRIPTION:
Fluticasone propionate is a corticosteroid having the chemical name S-(fluoromethyl)6alpha,9-difluoro-11beta, 17-dihydroxy-16alpha-methyl-3-oxoandrosta-1,4-diene-17beta-carbothioate, 17-propionate.
Inhalation Powder
Flovent Rotadisk 50 mug, 100 mug, and 250 mug contain a dry powder presentation of fluticasone propionate intended for oral inhalation only. Each double-foil Rotadisk contains four blisters. Each blister contains a mixture of 50, 100, or 250 mug of microfine fluticasone propionate blended with lactose to a total weight of 25 mg. The contents of each blister are inhaled using a specially designed plastic device for inhaling powder called the Diskhaler. After a fluticasone propionate Rotadisk is loaded into the Diskhaler, a blister containing medication is pierced and the fluticasone propionate is dispersed into the air stream created when the patient inhales through the mouthpiece.
CLINICAL PHARMACOLOGY:
Fluticasone propionate is a synthetic, trifluorinated corticosteroid with potent anti-inflammatory activity. In vitro assays using human lung cytosol preparations have established fluticasone propionate as a human glucocorticoid receptor agonist with an affinity 18 times greater than dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over three times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.
The precise mechanisms of fluticasone propionate action in asthma are unknown. Inflammation is recognized as an important component in the pathogenesis of asthma. Corticosteroids have been shown to inhibit multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediator production or secretion (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the asthmatic response. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.
Though highly effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately. However, improvement following inhaled administration of fluticasone propionate can occur within 24 hours of beginning treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.
INDICATIONS AND USAGE:
Fluticasone propionate is indicated for the maintenance treatment of asthma as prophylactic therapy (for inhalation powder, in patients 4 years of age and older). It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.
Fluticasone propionate is NOT indicated for the relief of acute bronchospasm.
CONTRAINDICATIONS:
Fluticasone propionate is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Hypersensitivity to any of the ingredients of these preparations contraindicates their use.
WARNINGS:
Particular care is needed for patients who are transferred from systemically active corticosteroids to fluticasone propionate because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of HPA function.
Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although fluticasone propionate inhalation powder and aerosol may provide control of asthma symptoms during these episodes, in recommended doses they supply less than normal physiological amounts of corticosteroid systemically and do NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.
During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.
PRECAUTIONS:
General
During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.
Fluticasone propionate will often permit control of asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since fluticasone propionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of fluticasone propionate inhalation powder or aerosol in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. A relationship between plasma levels of fluticasone propionate and inhibitory effects on stimulated cortisol production has been shown after 4 weeks of treatment with fluticasone propionate inhalation aerosol. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing fluticasone propionate inhalation powder or aerosol.
Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, fluticasone propionate inhalation powder or aerosol should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.
A reduction of growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route, and weigh the benefits of corticosteroid therapy against the possibility of growth suppression if growth appears slowed. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma.Additional Information for Inhalation Powder Only: A 52-week placebo-controlled study to assess the potential growth effects of fluticasone propionate inhalation powder at 50 and 100 mug twice daily was conducted in the U.S. in 325 prepubescent children (244 males and 81 females), 4 to 11 years of age. The mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (n = 76), 6.07 cm/year in the 50-mug group (n = 98), and 5.66 cm/year in the 100-mug group (n = 89). An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. A separate subset analysis of children who remained prepubertal during the study revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mug group (n = 74), and 5.67 cm/year in the 100-mug group (n = 79). The clinical significance of these growth data is not certain. In children 8.5 years of age, the mean age of children in this study, the range for expected growth velocity is: boys--3rd percentile = 3.8 cm/year, 50th percentile = 5.4 cm/year, and 97th percentile = 7.0 cm/year; girls--3rd percentile = 4.2 cm/year, 50th percentile = 5.7 cm/year, and 97th percentile = 7.3 cm/year. The effects of long-term treatment of children with inhaled corticosteroids, including fluticasone propionate, on final adult height are not known.
The long-term effects of fluticasone propionate in human subjects are not fully known. In particular, the effects resulting from chronic use of fluticasone propionate on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown. Some patients have received inhaled fluticasone propionate on a continuous basis for periods of 3 years or longer. In clinical studies with patients treated for nearly 2 years with inhaled fluticasone propionate, no apparent differences in the type or severity of adverse reactions were observed after long- versus short-term treatment.
Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including fluticasone propionate.
In clinical studies with inhaled fluticasone propionate, the development of localized infections of the pharynx with Candida albicans has occurred. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while remaining on treatment with fluticasone propionate inhalation powder or aerosol, but at times therapy with fluticasone propionate may need to be interrupted.
Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Eosinophilic Conditions
In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established (see ADVERSE REACTIONS).
Information for Patients
Patients being treated with fluticasone propionate should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Patients should use fluticasone propionate at regular intervals as directed. Results of clinical trials indicated significant improvement may occur within the first day or two of treatment; however, the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if the condition worsens.
Patients should be warned to avoid exposure to chickenpox or measles and, if they are exposed, to consult their physicians without delay.
For the proper use of fluticasone propionate inhalation powder or aerosol and to attain maximum improvement, the patient should read and follow carefully the accompanying Patient's Instructions for Use.
DRUG INTERACTIONS:
Inhalation Powder Only
In a placebo-controlled, crossover study in eight healthy volunteers, coadministration of a single dose of fluticasone propionate (1000 mug) with multiple doses of ketoconazole (200 mg) to steady state resulted in increased mean fluticasone propionate concentrations, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. This interaction may be due to an inhibition of the cytochrome P450 3A4 isoenzyme system by ketoconazole, which is also the route of metabolism of fluticasone propionate. Care should be exercised when fluticasone propionate is coadministered with long-term ketoconazole and other known cytochrome P450 3A4 inhibitors.
OVERDOSAGE:
Chronic overdosage may result in signs/symptoms of hypercorticism (see PRECAUTIONS). Inhalation by healthy volunteers of a single dose of 4000 mug of fluticasone propionate inhalation powder or single doses of 1760 or 3520 mug of fluticasone propionate inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at doses of 1320 mug twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups. The oral and subcutaneous median lethal doses in mice and rats were >1000 mg/kg (>2000 and >4100 times, respectively, the maximum recommended daily inhalation dose in adults and >9600 and >19,000 times, respectively, the maximum recommended daily inhalation dose in children on a mg/m2 basis).
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