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AllerNaze
Overview
What is AllerNaze?
Triamcinolone acetonide, the active ingredient of , is a corticosteroid with the chemical name, 9α-Fluoro-11β,16α, 17, 21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone (C H FO ). Its structural formula is:
Triamcinolone acetonide, USP, is a white crystalline powder, with a molecular weight of 434.51. It is practically insoluble in water, and sparingly soluble in dehydrated alcohol, in chloroform and in methanol. It has a melting point temperature range between 292° and 294°C.
AllerNaze
AllerNaze
After initial priming (three sprays) of the metered pump delivery system, each spray will deliver 50 mcg of triamcinolone acetonide. If the pump was not used for more than 14 days, reprime with 3 sprays or until a fine mist is observed. Each 15 mL bottle contains 7.5 mg of triamcinolone acetonide to deliver 120 metered sprays.
What does AllerNaze look like?
What are the available doses of AllerNaze?
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What should I talk to my health care provider before I take AllerNaze?
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How should I use AllerNaze?
AllerNaze
The recommended starting dose of for most patients is 200 mcg per day given as 2 sprays (approximately 50 mcg/spray) in each nostril once a day. The maximum dose should not exceed 400 mcg per day. If the 400 mcg dose is used, it may be given either as a once a day dosage (4 sprays in each nostril) or divided into two daily doses of two sprays/nostril twice a day.
The nasal spray pump must be primed before is used for the first time. To prime the pump, press down on the shoulder of the white nasal applicator using your forefinger and middle finger while supporting the base of the bottle with your thumb. Press down and release the pump until it sprays 3 times or until a fine mist is observed (see ).
Some patients may obtain relief of symptoms sooner when started on a 400 mcg per day dose of than with 200 mcg per day. Onset of significant relief of nasal symptoms was seen within two days after starting treatment at 400 mcg once daily. A starting dose of 400 mcg per day may be considered in patients when starting therapy with in cases where a faster onset of relief is desirable. Generally, maximum relief of symptoms may take several days or up to one week to occur.
After symptoms have been brought under control, patients should be titrated to the minimum effective dose to reduce the possibility of adverse effects.
If relief of symptoms is not achieved after 14-21 days of therapy given in an adequate dose, should be discontinued and alternative diagnosis and therapies considered.
AllerNaze
What interacts with AllerNaze?
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What are the warnings of AllerNaze?
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What are the precautions of AllerNaze?
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What are the side effects of AllerNaze?
In adequate, well-controlled and uncontrolled studies, 1187 patients have received triamcinolone acetonide solution. The adverse reactions summarized below, are based upon seven placebo controlled clinical trials of 2-6 weeks duration in 847 patients with seasonal or perennial allergic rhinitis (504 patients received 200 mcg or 400 mcg per day of triamcinolone acetonide solution and 343 patients received vehicle placebo). Adverse events reported by 2% or more of patients (regardless of relationship to treatment) who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with triamcinolone acetonide solution than with placebo are displayed in the table below. Overall, the incidence and nature of adverse events with triamcinolone acetonide solution 400 mcg was comparable to that seen with triamcinolone acetonide solution 200 mcg and with vehicle placebo.
Adverse events reported by 2% or more of patients who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with placebo than with triamcinolone acetonide solution included: application site reaction (e.g. transient nasal burning and stinging), rhinitis, dysmenorrhea, pain (unspecified) and allergic reaction.
The adverse effects related to the irritation of nasal mucous membranes (i.e. application site reaction) did not usually interfere with treatment. In the controlled and uncontrolled studies, approximately 0.3% of patients discontinued because of irritation of nasal mucous membranes.
| 200 mcg of triamcinolone acetonide once dailyn = 204 | 400 mcg of triamcinolone acetonide once dailyn = 300 | Combined(200 and 400 mcg) use of triamcinolone acetoniden = 504 | Vehicle Placebon = 343 | |
| BODY AS A WHOLE | ||||
| Headache | 51.0% | 44.3% | 47.0% | 41.1% |
| Back Pain | 7.8% | 4.7% | 6.0% | 3.5% |
| RESPIRATORY SYSTEM | ||||
| Pharyngitis | 13.7% | 10.3% | 11.7% | 7.9% |
| Asthma | 5.4% | 4.3% | 4.8% | 2.9% |
| Cough Increased | 2.0% | 2.7% | 2.4% | 2.3% |
| DIGESTIVE SYSTEM | ||||
| Dyspepsia | 4.9% | 2.7% | 3.6% | 2.0% |
| Nausea | 2.0% | 3.0% | 2.6% | 0.6% |
| Vomiting | 1.5% | 2.7% | 2.2% | 1.5% |
| SPECIAL SENSES | ||||
| Taste Perversion | 7.8% | 5.0% | 6.2% | 2.9% |
| Conjunctivitis | 4.4% | 1.3% | 2.6% | 1.5% |
| MUSCULOSKELETAL SYSTEM | ||||
| Myalgia | 2.5% | 3.3% | 3.0% | 2.6% |
What should I look out for while using AllerNaze?
AllerNaze
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint or muscular pain, or both, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions which require long-term corticosteroid treatment, too rapid a decrease in systemic corticosteroid may cause a severe exacerbation of their symptoms.
Patients who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults on immunosuppressant doses of corticosteroids. In children, or 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.
What might happen if I take too much AllerNaze?
Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. In the event that the entire contents of the bottle were administered all at once, via oral or nasal application, clinically significant adverse events would likely not result. The patient may experience some gastrointestinal upset. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism (see ).
How should I store and handle AllerNaze?
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.Each 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal SprayEach 15 mL bottle of (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.Keep out of reach of children.Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.Use within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.Rx onlyLupin PharmaAllerNaze [AL-er-nāz](triamcinolone acetonide, USP)Nasal Spray
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Triamcinolone acetonide is a more potent derivative of triamcinolone. Triamcinolone acetonide is approximately eight times more potent than prednisone in animal models of inflammation. The clinical significance of this is unclear.
Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g. mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g. histamines, eicosanoids, leukotrienes, and cytokines) involved in inflammation.
Non-Clinical Toxicology
AllerNazeThe replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint or muscular pain, or both, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions which require long-term corticosteroid treatment, too rapid a decrease in systemic corticosteroid may cause a severe exacerbation of their symptoms.
Patients who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults on immunosuppressant doses of corticosteroids. In children, or 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.
Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see section).
In clinical studies with triamcinolone acetonide nasal spray, 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 .
AllerNaze
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, should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
Systemic Availability and HPA Axis Suppression:
In adequate, well-controlled and uncontrolled studies, 1187 patients have received triamcinolone acetonide solution. The adverse reactions summarized below, are based upon seven placebo controlled clinical trials of 2-6 weeks duration in 847 patients with seasonal or perennial allergic rhinitis (504 patients received 200 mcg or 400 mcg per day of triamcinolone acetonide solution and 343 patients received vehicle placebo). Adverse events reported by 2% or more of patients (regardless of relationship to treatment) who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with triamcinolone acetonide solution than with placebo are displayed in the table below. Overall, the incidence and nature of adverse events with triamcinolone acetonide solution 400 mcg was comparable to that seen with triamcinolone acetonide solution 200 mcg and with vehicle placebo.
Adverse events reported by 2% or more of patients who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with placebo than with triamcinolone acetonide solution included: application site reaction (e.g. transient nasal burning and stinging), rhinitis, dysmenorrhea, pain (unspecified) and allergic reaction.
The adverse effects related to the irritation of nasal mucous membranes (i.e. application site reaction) did not usually interfere with treatment. In the controlled and uncontrolled studies, approximately 0.3% of patients discontinued because of irritation of nasal mucous membranes.
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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