Triamcinolone Acetonide

TRIAMCINOLONE ACETONIDE- triamcinolone acetonide spray, metered
Teva Pharmaceuticals USA Inc

1 INDICATIONS AND USAGE

Triamcinolone Acetonide Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.

2 DOSAGE AND ADMINISTRATION

Administer Triamcinolone Acetonide Nasal Spray by the intranasal route only. Shake Triamcinolone Acetonide Nasal Spray well before each use.

2.1 Adults and Adolescents 12 Years of Age and Older

The recommended starting and maximum dose is 220 mcg per day as two sprays in each nostril once daily. Titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dose to 110 mcg per day (one spray in each nostril once a day) has been shown to be effective in maintaining control of the allergic rhinitis symptoms.

2.2 Children 2 to 12 Years of Age

Children 6 to 12 years of Age
The recommended starting dose is 110 mcg per day given as one spray in each nostril once daily. Children not responding adequately to 110 mcg per day may use 220 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, the dosage may be decreased to 110 mcg once daily.
Children 2 to 5 years of age:
The recommended and maximum dose is 110 mcg per day given as one spray in each nostril once daily.
Triamcinolone Acetonide Nasal Spray is not recommended for children under 2 years of age.

2.3 Administration Information

Priming
Prime Triamcinolone Acetonide Nasal Spray before using for the first time by shaking the contents well and releasing 5 sprays into the air away from the face. It will remain adequately primed for two weeks. If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray. Shake Triamcinolone Acetonide Nasal Spray well before each use.
If adequate relief of symptoms has not been obtained after 3 weeks of treatment, Triamcinolone Acetonide Nasal Spray should be discontinued. [see Warnings and Precautions (5), Patient Counseling Information (17), and Adverse Reactions (6)]

3 DOSAGE FORMS AND STRENGTHS

Triamcinolone acetonide nasal spray is a metered-dose pump spray containing the active ingredient triamcinolone acetonide. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays. Each 16.5 gram bottle (120 actuations) contains 9.075 mg of triamcinolone acetonide. The bottle should be discarded when the labeled-number of actuations have been reached even though the bottle is not completely empty.

4 CONTRAINDICATIONS

Triamcinolone acetonide should not be administered to patients with a history of hypersensitivity to triamcinolone acetonide or to any of the other ingredients of this preparation.

5 WARNINGS AND PRECAUTIONS

5.1 Local Nasal Effects

Epistaxis
In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in patients treated with triamcinolone acetonide nasal spray than those who received placebo [see Adverse Reactions (6) ].
Nasal Septal Perforation
In clinical trials, nasal septum perforation was reported in one adult patient treated with triamcinolone acetonide nasal spray.
Candida Infection
In clinical studies with triamcinolone acetonide nasal spray, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local or systemic therapy and discontinuation of triamcinolone acetonide nasal spray. Therefore, patients using triamcinolone acetonide nasal spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.
Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, surgery, or trauma should not use triamcinolone acetonide nasal spray until healing has occurred.

5.2 Glaucoma and Cataracts

Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.

5.3 Immunosuppression

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or have not been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.

5.4 Hypothalamic-Pituitary-Adrenal Axis Effects

Hypercorticism and Adrenal Suppression
When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of triamcinolone acetonide nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, 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 requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

5.5 Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving triamcinolone acetonide nasal spray. To minimize the systemic effects of intranasal corticosteroids, including triamcinolone acetonide nasal spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4) ].

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