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NASACORT
Rhne-Poulenc Rorer
Triamcinolone Acetonide
Corticosteroid
 
Action And Clinical Pharmacology: Triamcinolone is a potent anti-inflammatory steroid with strong topical and weak systemic activity. When administered intranasally in therapeutic doses, it has a direct anti-inflammatory action on the nasal mucosa, the mechanism of which is not yet completely defined. The minute amount absorbed in therapeutic doses has not been shown to exert any apparent clinical systemic effects. tag_IndicationsIndications

Indications And Clinical Uses: For the topical treatment of the symptoms of perennial and seasonal allergic rhinitis unresponsive to conventional treatment.

Contra-Indications: Active or quiescent tuberculosis or untreated fungal, bacterial and viral infection. Hypersensitivity to any of the ingredients. tag_WarningWarnings

Manufacturers' Warnings In Clinical States: In patients previously on prolonged periods or high doses of systemic steroids, the replacement with a topical corticosteroid can be accompanied by symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and depression; in severe cases, adrenal insufficiency may occur, necessitating the temporary resumption of systemic steroid therapy. Careful attention must be given to patients with asthma or other clinical conditions in whom a rapid decrease in systemic steroids may cause a severe exacerbation of their symptoms.

Pregnancy: See Precautions.

Precautions: The replacement of a systemic steroid with Nasacort has to be gradual and carefully supervised by the physician. The guidelines under Dosage should be followed in all such cases.

During long-term therapy pituitary-adrenal function and hematological status should be assessed.

Patients should be informed that the full effect of triamcinolone therapy is not achieved until 2 to 3 days of treatment have been completed. Treatment of seasonal rhinitis should, if possible, start before the exposure to allergens.

Treatment should not be stopped abruptly but tapered off gradually.

Corticosteroids may mask some signs of infection and new infections may appear. A decreased resistance to localized infections has been observed during corticosteroid therapy; this may require treatment with appropriate therapy or stopping the administration of triamcinolone.

The long-term effects of triamcinolone are still unknown, in particular, its local effects; the possibility of atrophic rhinitis and/or pharyngeal candidiasis should be kept in mind.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. ASA should be used cautiously in conjunction with corticosteroids in hypothrombinemia.

Because of the inhibitory effect of corticosteroids on wound healing, in patients who have had recent nasal surgery or trauma, a nasal 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.

Patients should be advised to inform subsequent physicians of prior use of corticosteroids.

Until greater clinical experience has been gained, the continuous, long-term treatment of children under age 12 is not recommended.

Pregnancy: The safety of triamcinolone in pregnancy has not been established. If used, the expected benefits should be weighed against the potential hazard to the fetus, particularly during the first trimester of pregnancy.

Like other glucocorticosteroids, triamcinolone is teratogenic to rodents and nonhuman primates. The relevance of these findings to humans has not yet been established. Infants born of mothers who have received substantial doses of glucocorticosteroids during pregnancy should be carefully observed for hypoadrenalism.

Lactation: Glucocorticosteroids are secreted in human milk. It is not known whether triamcinolone would be secreted in human milk, but it is suspected to be likely. Its use in nursing mothers, requires that the possible benefits of the drug be weighed against the potential hazards to the infant.

Children: Triamcinolone is not presently recommended for children younger than 12 years of age due to limited clinical data in this age group.

Fluorocarbon propellants may be hazardous if they are deliberately abused. Inhalation of high concentrations of aerosol sprays has brought about cardiovascular toxic effects and even death, especially under conditions of hypoxia. Aerosols are safe when used properly and with adequate ventilation, but excessive use should be avoided.

To ensure the proper dosage and administration of the drug, the patient should be instructed by a physician or other health professional in the use of Nasacort (see Information for the Patient).

Adverse Reactions: Adverse reactions reported in both controlled and uncontrolled studies involving 1 148 patients who received intranasal triamcinolone are provided in Table I. N/A

When patients are transferred to Nasacort from a systemic steroid, allergic conditions such as asthma or eczema may be unmasked (see Warnings).

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. However when used chronically in excessive doses or in conjunction with other corticosteroid formulations, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes recur, the dosage of triamcinolone should be discontinued slowly consistent with accepted procedures for discontinuation of chronic steroid therapy.

The restoration of hypothalamic-pituitary axis may be slow; during periods of pronounced physical stress (i.e., severe infections, trauma, surgery) a supplement with systemic steroids may be advisable.

Dosage And Administration: See Warnings.

Nasacort is not recommended for children under 12 years of age.

Careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids when transferred to Nasacort. Initially, Nasacort and the systemic corticosteroid must be given concomitantly, while the dose of the latter is gradually decreased. The usual rate of withdrawal of the systemic steroid is the equivalent of 2.5 mg of prednisone every 4 days if the patient is under close supervision. If continuous supervision is not feasible, the withdrawal of the systemic steroid should be slower, approximately 2.5 mg of prednisone (or equivalent) every 10 days. If withdrawal symptoms appear, the previous dose of the systemic steroid should be resumed for a week before further decrease is attempted.

The therapeutic effects of corticosteroids, unlike those of decongestants, are not immediate. Since the effect of Nasacort depends on its regular use, patients must be instructed to take the nasal inhalations at regular intervals and not as with other nasal sprays, as they feel necessary.

In the presence of excessive nasal mucus secretion or edema of the nasal mucosa, the drug may fail to reach the site of action. In such cases it is advisable to use a nasal vasoconstrictor for 2 to 3 days prior to Nasacort therapy. Patients should be instructed on the correct method of use, which is to blow the nose, then insert the nozzle firmly into the nostril, compress the opposite nostril and actuate the spray while inspiring through the nose, with the mouth closed.

An improvement of symptoms usually becomes apparent within a few days after the start of therapy. However, symptomatic relief may not occur in some patients for as long as 2 weeks. Nasacort should not be continued beyond 3 weeks in the absence of significant symptomatic improvement.

Adults and Children 12 Years of Age and Older: The recommended starting dose is 400 g/day given as 2 sprays (100 g/spray) in each nostril once a day. If needed, the dose may be increased to 800 g/day (100 g/spray) either as once a day dosage or divided up to 4 times a day, i.e., twice a day (2 sprays/nostril), or 4 times a day (1 spray/nostril).

After the desired effect is obtained, patients may be maintained on a dose of 1 spray (100 g) in each nostril once a day (total daily dose: 200 g/day).



Availability And Storage: Each metered-dose aerosol unit contains a microcrystalline suspension of triamcinolone acetonide. Each canister contains: triamcinolone acetonide 15 mg. Each actuation releases approximately 100 g triamcinolone acetonide of which approximately 55 g are delivered from the nasal actuator to the patient (estimated from in vitro testing). Nonmedicinal ingredients: alcohol and dichlorodifluoromethane. There are at least 100 actuations in one canister. The device should not be used after 100 nasal inhalations, since the amount delivered thereafter per actuation may not be consistent. Boxes of 1 with a nasal adapter and patient instructions. (Shown in Product Recognition Section)