Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/448
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Nasacort (Aerosol, Metered)
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A decrease in symptoms may occur as soon as 12 hours after starting steroid therapy and generally can be expected to occur within a few days of initiating therapy in allergic rhinitis. If improvement is not evident after 2 to 3 weeks, the patient should be re-evaluated. .<br/>Adults and Children 12 years of age and older: The recommended starting dose of Nasacort Nasal Inhaler is 220 mcg per day given as two sprays (55 mcg/spray) in each nostril once a day. If needed, the dose may be increased to 440 mcg per day (55 mcg/spray) either as once-a-day dosage or divided up to four times a day, i.e., twice a day (two sprays/nostril), or four times a day (one spray/nostril). After the desired effect is obtained, some patients may be maintained on a dose of as little as one spray (55 mcg) in each nostril once a day (total daily dose 110 mcg per day).<br/>Children 6 through 11 years of age: The recommended starting dose of Nasacort Nasal Inhaler is 220 mcg per day given as two sprays (55 mcg/spray) in each nostril once a day. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose. Nasacort Nasal Inhaler is not recommended for children below 6 years of age since adequate numbers of patients have not been studied in this age group.<br/>Directions for Use: Illustrated Patient's Instructions for use accompany each package of Nasacort Nasal Inhaler.
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Triamcinolone acetonide, USP, the active ingredient in Nasacort Nasal Inhaler, is a glucocorticosteroid with a molecular weight of 434.5 and with the chemical designation 9-Fluoro-11��,16��,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. (CHFO). Nasacort Nasal Inhaler is a metered-dose aerosol unit containing a microcrystalline suspension of triamcinolone acetonide in dichlorodifluoromethane and dehydrated alcohol USP 0.7% w/w. Each canister contains 15 mg triamcinolone acetonide. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator to the patient (estimated from in vitro testing). There are at least 100 actuations in one Nasacort Nasal Inhaler canister. After 100 actuations, the amount delivered per actuation may not be consistent and the unit should be discarded. Patients are provided with a check-off card to track usage as part of the Information for Patients tear-off sheet.
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Triamcinolone acetonide is a more potent derivative of triamcinolone. Although triamcinolone itself is approximately one to two times as potent as prednisone in animal models of inflammation, triamcinolone acetonide is approximately 8 times more potent than prednisone. Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids are very effective. However, they do not have an immediate effect on allergic signs and symptoms. When allergic symptoms are very severe, local treatment with recommended doses (microgram) of any available topical corticosteroids are not as effective as treatment with larger doses (milligram) of oral or parenteral formulations. When corticosteroids are prematurely discontinued, symptoms may not recur for several days. Based upon intravenous dosing of triamcinolone acetonide phosphate ester, the half-life of triamcinolone acetonide was reported to be 88 minutes. The volume of distribution (Vd) reported was 99.5 L (SD��27.5) and clearance was 45.2 L/hour (SD��9.1) for triamcinolone acetonide. The plasma half-life of corticosteroids does not correlate well with the biologic half-life. When administered intranasally to man at 440 mcg/day dose, the peak plasma concentration was<1 ng/mL and occurred on average at 3.4 hours (range 0.5 to 8.0 hours) postdosing. The apparent half-life was 4.0 hours (range 1.0 to 7.0 hours); however, this value probably reflects lingering absorption. Intranasal doses below 440 mcg/day gave sparse data and did not allow for the calculation of meaningful pharmacokinetic parameters. In animal studies using rats and dogs, three metabolites of triamcinolone acetonide have been identified. They are 6��-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6��-hydroxytriamcinolone acetonide. All three metabolites are expected to be substantially less active than the parent compound due to (a) the dependence of anti-inflammatory activity on the presence of a 21-hydroxyl group, (b) the decreased activity observed upon 6-hydroxylation, and (c) the markedly increased water solubility favoring rapid elimination. There appeared to be some quantitative differences in the metabolites among species. No differences were detected in metabolic pattern as a function of route of administration.
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Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
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Nasacort Nasal Inhaler is supplied as an aerosol canister which will provide 100 metered dose actuations. Each actuation delivers 55 mcg triamcinolone acetonide through the nasal actuator. The Nasacort Nasal Inhaler canister and accompanying nasal actuator are designed to be used together. The Nasacort Nasal Inhaler canister should not be used with other nasal actuators and the supplied nasal actuator should not be used with other products' canisters. Nasacort Nasal Inhaler is supplied with a white plastic nasal actuator and patient instructions. Net weight of the canister contents is 10 grams. NDC 0075-1505-43.
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triamcinolone acetonide
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Nasacort (Aerosol, Metered)
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Adults and Children 12 years of age and older: In controlled and uncontrolled studies, 1257 adult and adolescent patients received treatment with intranasal triamcinolone acetonide. Adverse reactions are based on the 567 patients who received a product similar to the marketed Nasacort canister. These patients were treated for an average of 48 days (range 1 to 117 days). The 145 patients enrolled in uncontrolled studies received treatment from 1 to 820 days (average 332 days). The most prevalent adverse experience was headache, being reported by approximately 18% of the patients who received Nasacort. Nasal irritation was reported by 2.8% of the patients receiving Nasacort. Other nasopharyngeal side effects were reported by fewer than 5% of the patients who received Nasacort and included: dry mucous membranes, naso-sinus congestion, throat discomfort, sneezing, and epistaxis. The complaints do not usually interfere with treatment and in the controlled and uncontrolled studies approximately 1% of patientshave discontinued because of these nasal adverse effects. In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely .<br/>Children 6 through 11 years of age: Adverse event data in children 6 through 11 years of age are derived from two controlled clinical trials of two and four weeks duration. In these trials, 127 patients received fixed doses of 220 mcg/day of triamcinolone acetonide for an average of 22 days (range 8 to 33 days). Adverse events occurring at an incidence of 3% or greater and more common among children treated with 220 mcg triamcinolone acetonide daily than vehicle placebo were: Adverse events occurring at a rate of 3% or greater that were more common in the placebo group were upper respiratory tract infection, headache and concurrent infection. Only 1.6% of patients discontinued due to adverse experiences. No patient discontinued due to a serious adverse event related to Nasacort therapy. Though not observed in controlled clinical trials of Nasacort Nasal Inhaler in children, cases of nasal septum perforation among pediatric users have been reported in post-marketing surveillance of this product.
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Nasacort Nasal Inhaler is indicated for the nasal treatment of seasonal and perennial allergic rhinitis symptoms in adults and children 6 years of age and older.
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Nasacort
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