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 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, 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.

General: 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 discontinuance of treatment with Nasacort AQ Nasal Spray.

Nasacort AQ Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract or in patients with untreated fungal, bacterial, or systemic viral infections or ocular herpes simplex.

Because of the inhibitory effect of corticosteroids, 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, Nasacort AQ Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

Information for Patients: Patients being treated with Nasacort AQ Nasal Spray 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 Nasacort AQ Nasal Spray at regular intervals since its effectiveness depends on its regular use. (See DOSAGE AND ADMINISTRATION.)

An improvement in some patient symptoms may be seen within the first day of treatment, and generally, it takes one week of treatment to reach maximum benefit. Initial assessment for response should be made during this time frame and periodically until the patient's symptoms are stabilized.

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. Patients who experience recurrent episodes of epistaxis (nose bleeds) or nasal septum discomfort while taking this medication should contact their physician. For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully.

It is important to shake the bottle well before each use. Also, the bottle should be discarded after either 30 actuations or 120 actuations since the amount of triamcinolone acetonide delivered thereafter per actuation may be substantially less than 55 mcg of drug. Do not transfer any remaining suspension to another bottle.

Carcinogenesis, Mutagenesis, and Impairment Of Fertility: In a two-year study in rats, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 1.0 mcg/kg (approximately 1/30 and 1/50 of the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis, respectively). In a two-year study in mice, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 3.0 mcg/kg (approximately 1/12 and 1/30 of the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis, respectively).

No evidence of mutagenicity was detected from in vitro tests (a reverse mutation test in Salmonella bacteria and a forward mutation test in Chinese hamster ovary cells) conducted with triamcinolone acetonide.

In male and female rats, triamcinolone acetonide caused no change in pregnancy rate at oral doses up to 15.0 mcg/kg (approximately ½ of the maximum recommended daily intranasal dose in adults on a mcg/m² basis).

Triamcinolone acetonide caused increased fetal resorptions and stillbirths and decreases in pup weight and survival at doses of 5.0 mcg/kg and above (approximately 1/5 of the maximum recommended daily intranasal dose in adults on a mcg/m² basis). At 1.0 mcg/kg (approximately 1/30 of the maximum recommended daily intranasal dose in adults on a mcg/m² basis), it did not induce the above mentioned effects.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. In rats, triamcinolone acetonide was teratogenic at inhalation doses of 20 mcg/kg and above (approximately 7/10 of the maximum recommended daily intranasal dose in adults on a mcg/m² basis). In rabbits, triamcinolone acetonide was teratogenic at inhalation doses of 20 mcg/kg and above (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis). In monkeys, triamcinolone acetonide was teratogenic at an inhalation dose of 500 mcg/kg (approximately 37 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis). Dose-related teratogenic effects in rats and rabbits included cleft palate and/or internal hydrocephaly and axial skeletal defects, whereas the effects observed in the monkey were cranial malformations.

There are no adequate and well-controlled studies in pregnant women. Nasacort AQ Nasal Spray, like other corticosteroids, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Since their introduction, experience with oral corticosteroids in pharmacologic as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid 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 Nasacort AQ Nasal Spray is administered to nursing women.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

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 corticosteroids should be considered.

Geriatric Use: Clinical studies of Nasacort AQ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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