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Nasacort (Triamcinolone Acetonide Nasal) - Warnings and Precautions

 
 



WARNINGS

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, e.g., 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 Nasacort 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, Nasacort Nasal Inhaler should be used with caution in patients already receiving alternate-day prednisone treatment for any disease.

PRECAUTIONS

General

In clinical studies with triamcinolone acetonide administered intranasally, 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 therapy and discontinuance of treatment with Nasacort 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. Nasacort 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 CLINICAL TRIALS section).

Nasacort Nasal Inhaler should be used with caution, if at all, in patients with active or quiescent tuberculous infections 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 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, Nasacort Nasal Inhaler should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

Information for Patients

Patients being treated with Nasacort 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 Nasacort 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/m2 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/m2 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/m2 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/m2 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/m2 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/m2 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/m2 basis, respectively) and rabbits (approximately 0.75, 1.5 and 3.0 times the recommended dose on a mcg/m2 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/m2 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 Nasacort 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.

Page last updated: 2007-09-11

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