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Nasacort
Overview
What is Nasacort?
Triamcinolone acetonide, USP, the active ingredient in Nasal Inhaler, is a glucocorticosteroid with a molecular weight of 434.5 and with the chemical designation 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. (CHFO).
Nasacort
in vitro
Nasacort
After 100 actuations, the amount delivered per actuation may not be consistent and the unit should be discarded.
What does Nasacort look like?
What are the available doses of Nasacort?
Sorry No records found.
What should I talk to my health care provider before I take Nasacort?
Sorry No records found
How should I use Nasacort?
Nasacort
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. (See section).
What interacts with Nasacort?
Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
What are the warnings of Nasacort?
Contains acetone sodium bisulfite,
a sulfite that may cause allergic-type reactions including anaphylactic
symptoms and life-threatening or less severe asthmatic episodes in
certain susceptible people. The overall prevalence of sulfite sensitivity
in the general population is unknown and probably low. Sulfite sensitivity
is seen more frequently in asthmatic than in nonasthmatic people.
The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, joint and/or muscular pain, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticoids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella-zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
The use of Nasal Inhaler with alternate-day systemic prednisone could increase the likelihood of hypothalamic-pituitary-adrenal (HPA) suppression compared to a therapeutic dose of either one alone. Therefore, Nasal Inhaler should be used with caution in patients already receiving alternate-day prednisone treatment for any disease.
What are the precautions of Nasacort?
General
In clinical studies with triamcinolone acetonide administered intranasally, the development of localized infections of the nose and pharynx with has rarely occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuance of treatment with Nasal Inhaler.
Triamcinolone acetonide administered intranasally has been shown to be absorbed into the systemic circulation in humans. Patients with active rhinitis showed absorption similar to that found in normal volunteers. at 440 mcg/day for 42 days did not measurably affect adrenal response to a six hour cosyntropin test. In the same study, prednisone 10 mg/day significantly reduced adrenal response to ACTH over the same period (see section).
Nasacort
Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, a corticosteroid should be used with caution until healing has occurred. As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances.
When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, Nasal Inhaler should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
Information for Patients
Patients being treated with Nasal Inhaler should receive the following information and instructions.
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.
Patients should use Nasal Inhaler at regular intervals since its effectiveness depends on its regular use. 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. The patient should take the medication as directed and should not exceed the prescribed dosage. The patient should contact the physician if symptoms do not improve after three weeks, or if the condition worsens. Nasal irritation and/or burning or stinging after use of the spray occur only rarely with this product. The patient should contact the physician if they occur.
For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully. Spraying triamcinolone acetonide directly onto the nasal septum should be avoided. Because the amount dispensed per puff may not be consistent, it is important to shake the canister well. Also, the canister should be discarded after 100 actuations.
Carcinogenesis, Mutagenesis
No evidence of treatment-related carcinogenicity was demonstrated after 2 years of once daily gavage administration of triamcinolone acetonide at doses of 0.05, 0.2 and 1.0 mcg/kg (approximately 0.1, 0.4 and 1.8% of the recommended clinical dose on a mcg/m basis) in the rat and 0.1, 0.6 and 3.0 mcg/kg (approximately 0.1, 0.6 and 3.0% of the recommended clinical dose on a mcg/m basis) in the mouse.
Mutagenesis studies with triamcinolone acetonide have not been conducted.
Impairment of Fertility
No evidence of impaired fertility was demonstrated when oral doses up to 15 mcg/kg (approximately 28% of the recommended clinical dose on a mcg/m basis) were administered to female and male rats. However, triamcinolone acetonide at oral doses of 8.0 mcg/kg (approximately 15.0% of the recommended clinical dose on a mcg/m basis) caused dystocia and prolonged delivery and at oral doses of 5.0 mcg/kg (approximately 9.0% of the recommended clinical dose on a mcg/m basis) and above produced increases in fetal resorptions and stillbirths as well as decreases in pup body weight and survival. At an oral dose of 1.0 mcg/kg (approximately 2.0% of the recommended clinical dose on a mcg/m basis), it did not manifest the above mentioned effects.
Pregnancy
Pregnancy Category C
Triamcinolone acetonide was teratogenic at inhalational doses of 20, 40 and 80 mcg/kg in rats (approximately 0.4, 0.75 and 1.5 times the recommended clinical dose on a mcg/m basis, respectively) and rabbits (approximately 0.75, 1.5 and 3.0 times the recommended dose on a mcg/m basis, respectively). Triamcinolone acetonide was also teratogenic at an inhalational dose of 500 mcg/kg in monkeys (approximately 18 times the recommended clinical dose on a mcg/m basis). Dose-related teratogenic effects in rats and rabbits included cleft palate, internal hydrocephaly, and axial skeletal defects. Teratogenic effects observed in the monkey were CNS and cranial malformations. There are no adequate and well-controlled studies in pregnant women. Triamcinolone acetonide should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Experience with oral corticoids since their introduction in pharmacologic as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from corticoids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous steroid dose and many will not need corticoid treatment during pregnancy.
Nonteratogenic Effects
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.
Nursing Mothers
It is not known whether triamcinolone acetonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Nasal Inhaler is administered to nursing women.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 6 have not been established. Oral corticosteroids have been shown to cause growth suppression in children and teenagers, particularly with higher doses over extended periods. If a child or teenager on any corticosteroid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of steroids should be considered.
What are the side effects of Nasacort?
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 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 . Nasal irritation was reported by 2.8% of the patients receiving . Other nasopharyngeal side effects were reported by fewer than 5% of the patients who received 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 patients have 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 (see section).
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 therapy.
Though not observed in controlled clinical trials of Nasal Inhaler in children, cases of nasal septum perforation among pediatric users have been reported in post-marketing surveillance of this product.
| Adverse Events | 220 mcg oftriamcinolone acetonide daily(n=127) | Vehicleplacebo(n=322) |
|---|---|---|
| Epistaxis | 11.0% | 9.3% |
| Cough | 9.4% | 9.3% |
| Fever | 7.9% | 5.6% |
| Nausea | 6.3% | 3.1% |
| Throat discomfort | 5.5% | 5.3% |
| Otitis | 4.7% | 3.7% |
| Dyspepsia | 4.7% | 2.2% |
What should I look out for while using Nasacort?
Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, joint and/or muscular pain, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticoids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella-zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
The use of Nasal Inhaler with alternate-day systemic prednisone could increase the likelihood of hypothalamic-pituitary-adrenal (HPA) suppression compared to a therapeutic dose of either one alone. Therefore, Nasal Inhaler should be used with caution in patients already receiving alternate-day prednisone treatment for any disease.
What might happen if I take too much Nasacort?
Acute overdosage with this dosage form is unlikely. The acute topical application of the entire 15 mg of the canister would most likely cause nasal irritation and headache. It would be unlikely to see acute systemic adverse effects even if the entire 15 mg of triamcinolone acetonide was administered intranasally all at once.
How should I store and handle Nasacort?
Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007NasacortNasacortNasacortNasacortNDC 0075-1505-43.NasacortNasacortNasacortNasacortNDC 0075-1505-43.NasacortNasacortNasacortNasacortNDC 0075-1505-43.NasacortNasacortNasacortNasacortNDC 0075-1505-43.NasacortNasacortNasacortNasacortNDC 0075-1505-43.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 6β-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6β-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.
Non-Clinical Toxicology
Hypersensitivity to any of the ingredients of this preparation contraindicates its use.The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, joint and/or muscular pain, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticoids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella-zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
The use of Nasal Inhaler with alternate-day systemic prednisone could increase the likelihood of hypothalamic-pituitary-adrenal (HPA) suppression compared to a therapeutic dose of either one alone. Therefore, Nasal Inhaler should be used with caution in patients already receiving alternate-day prednisone treatment for any disease.
Concurrent use of butorphanol with central nervous system depressants (e.g., alcohol, barbiturates, tranquilizers, and antihistamines) may result in increased central nervous system depressant effects. When used concurrently with such drugs, the dose of butorphanol should be the smallest effective dose and the frequency of dosing reduced as much as possible when administered concomitantly with drugs that potentiate the action of opioids.
It is not known if the effects of butorphanol are altered by other concomitant medications that affect hepatic metabolism of drugs (erythromycin, theophylline, etc.), but physicians should be alert to the possibility that a smaller initial dose and longer intervals between doses may be needed.
Array
No information is available about the use of butorphanol concurrently with MAO inhibitors.
In clinical studies with triamcinolone acetonide administered intranasally, the development of localized infections of the nose and pharynx with has rarely occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuance of treatment with Nasal Inhaler.
Triamcinolone acetonide administered intranasally has been shown to be absorbed into the systemic circulation in humans. Patients with active rhinitis showed absorption similar to that found in normal volunteers. at 440 mcg/day for 42 days did not measurably affect adrenal response to a six hour cosyntropin test. In the same study, prednisone 10 mg/day significantly reduced adrenal response to ACTH over the same period (see section).
Nasacort
Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, a corticosteroid should be used with caution until healing has occurred. As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances.
When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, Nasal Inhaler should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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