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Nasacort HFA (Triamcinolone Acetonide) - Warnings and Precautions

 
 



WARNINGS

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.

The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.

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 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.

Avoid spraying in eyes.

PRECAUTIONS

General

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS: Pediatric Use).

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.

Rarely, immediate hypersensitivity reactions or contact dermatitis occur after the administration of Nasacort HFA Nasal Aerosol. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including triamcinolone acetonide. 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.

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 or systemic therapy and discontinuance of treatment with Nasacort HFA Nasal Aerosol. As with any long-term topical treatment of the nasal cavity, patients using Nasacort HFA Nasal Aerosol over several months or longer should be examined periodically for evidence of Candida infection or other adverse effects on the nasal mucosa.

Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract or in patients with untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.

When used at higher than recommended doses or in rare individuals at recommended doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. Therefore, larger than recommended doses of Nasacort HFA Nasal Aerosol should be avoided. If signs or symptoms of hypercorticism and/or suppression of HPA function occur, Nasacort HFA Nasal Aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

Information for Patients

Patients being treated with Nasacort HFA Nasal Aerosol should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

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 HFA Nasal Aerosol at regular intervals since its effectiveness depends on regular use (see DOSAGE AND ADMINISTRATION). Individual patients will experience a variable time to onset and degree of symptom relief, and generally takes 1 week of treatment to reach maximum benefit. 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 by a reasonable time, or if the condition worsens. Nasal irritation occurred in 6.2% of adults who used 440 mcg/day, the maximum recommended daily intranasal dose. The patient should contact the physician if nasal irritation occurs. It is advisable for patients who experience nasal septum discomfort to re-evaluate their technique in the application of Nasacort HFA Nasal Aerosol to minimize deposition of drug onto the septum.

For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully. Spraying Nasacort HFA Nasal Aerosol directly into the eyes or onto the nasal septum should be avoided. It is important to shake the canister well prior to each actuation to insure that a consistent amount is dispensed per actuation. The canister should be discarded after 100 actuations.

Drug-Drug Interactions

No drug interaction studies with triamcinolone acetonide have been performed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year study in rats, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 1.0 mcg/kg (approximately 1/50 of the maximum recommended daily intranasal dose in adults and children on a mcg/m2 basis). In a 2-year study in mice, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 3.0 mcg/kg (approximately 1/30 of the maximum recommended daily intranasal dose in adults and children on a mcg/m2 basis).

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 mcg/kg (approximately 1/3 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 1/10 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). At 1.0 mcg/kg (approximately 1/50 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 2/5 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). In rabbits, triamcinolone acetonide was also teratogenic at inhalation doses of 20 mcg/kg and above (approximately 4/5 of 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 20 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 monkeys were cranial malformations.

There are no adequate and well-controlled studies in pregnant women. Therefore, Nasacort HFA Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction 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 an increase in corticosteroid 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 monitored.

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 this product is administered to nursing women.

Pediatric Use

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

A placebo-controlled clinical growth study in children has not been conducted with Nasacort HFA Nasal Aerosol. Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Nasacort HFA Nasal Aerosol, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Nasacort HFA Nasal Aerosol, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Geriatric Use

Clinical studies of Nasacort HFA Nasal Aerosol 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.

Page last updated: 2007-05-18

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