Allernaze

Allernaze information, interactions and side effects, Triamcinolone acetonide, USP, is a white crystalline powder, with a molecular weight of 434.51. It, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, in chloroform and in methanol. It has a melting point temperature range between 292° and 294°C.

AllerNaze (triamcinolone acetonide nasal spray) is a metered-dose manual spray pump in an amber polyethylene terephthalate (PET) bottle with 0.05% w/v triamcinolone acetonide in a solution containing citric acid, edetate disodium, polyethylene glycol 3350, propylene glycol, purified water, sodium citrate, and 0.01% benzalkonium chloride as a preservative. AllerNaze (triamcinolone acetonide nasal spray) pH is 5.3.

After initial priming (three sprays) of the AllerNaze (triamcinolone acetonide nasal spray) metered pump delivery system, each spray will deliver 50 mcg of triamcinolone acetonide. If the pump was not used for more than 14 days, reprime with 3 sprays or until a fine mist is observed. Each 15 mL bottle contains 7.5 mg of triamcinolone acetonide to deliver 120 metered sprays. After 120 sprays, the amount of triamcinolone acetonide delivered per spray may not be consistent and the bottle should be discarded.

Triamcinolone acetonide, the active ingredient of AllerNaze (triamcinolone acetonide nasal spray) , is a corticosteroid with the chemical name, 9α-Fluoro-11β,16α, 17, 21­tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone (C24 H31 FO6 ). Its structural formula is:

allernaze

INDICATIONS

AllerNaze (triamcinolone acetonide nasal spray) is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 12 years of age or older.

DOSAGE AND ADMINISTRATION

The recommended starting dose of AllerNaze (triamcinolone acetonide nasal spray) for most patients is 200 mcg per day given as 2 sprays (approximately 50 mcg/spray) in each nostril once a day. The maximum dose should not exceed 400 mcg per day. If the 400 mcg dose is used, it may be given either as a once a day dosage (4 sprays in each nostril) or divided into two daily doses of two sprays/nostril twice a day.

The nasal spray pump must be primed before AllerNaze (triamcinolone acetonide nasal spray) is used for the first time. To prime the pump, press down on the shoulder of the white nasal applicator using your forefinger and middle finger while supporting the base of the bottle with your thumb. Press down and release the pump until it sprays 3 times or until a fine mist is observed.

Some patients may obtain relief of symptoms sooner when started on a 400 mcg per day dose of AllerNaze (triamcinolone acetonide nasal spray) than with 200 mcg per day. Onset of significant relief of nasal symptoms was seen within two days after starting treatment at 400 mcg once daily. A starting dose of 400 mcg per day may be considered in patients when starting therapy with AllerNaze (triamcinolone acetonide nasal spray) in cases where a faster onset of relief is desirable. Generally, maximum relief of symptoms may take several days or up to one week to occur.

After symptoms have been brought under control, patients should be titrated to the minimum effective dose to reduce the possibility of adverse effects.

If relief of symptoms is not achieved after 14-21 days of AllerNaze (triamcinolone acetonide nasal spray) therapy given in an adequate dose, AllerNaze (triamcinolone acetonide nasal spray) should be discontinued and alternative diagnosis and therapies considered.

AllerNaze (triamcinolone acetonide nasal spray) is not recommended for use in persons under 12 years of age since its safety and effectiveness have not been established in this age group.

Directions For Use

Illustrated patient instructions for use accompany each package of AllerNaze (triamcinolone acetonide nasal spray) .

HOW SUPPLIED

Each 15 mL bottle of AllerNaze (triamcinolone acetonide nasal spray) (NDC 16781-117-15) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient’ instructions for use leaflet. The bottle should be discarded when the labeled number of actuations have been reached even though the bottle is not completely empty.

Keep out of reach of children.

Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.

Use AllerNaze (triamcinolone acetonide nasal spray) within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.

SIDE EFFECTS

In adequate, well-controlled and uncontrolled studies, 1187 patients have received triamcinolone acetonide solution. The adverse reactions summarized below, are based upon seven placebo controlled clinical trials of 2-6 weeks duration in 847 patients with seasonal or perennial allergic rhinitis (504 patients received 200 mcg or 400 mcg per day of triamcinolone acetonide solution and 343 patients received vehicle placebo). Adverse events reported by 2% or more of patients (regardless of relationship to treatment) who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with triamcinolone acetonide solution than with placebo are displayed in the table below. Overall, the incidence and nature of adverse events with triamcinolone acetonide solution 400 mcg was comparable to that seen with triamcinolone acetonide solution 200 mcg and with vehicle placebo.

ADVERSE EVENTS REPORTED AT A FREQUENCY OF 2% OR GREATER AND MORE COMMON AMONG PATIENTS TREATED WITH triamcinolone acetonide solution THAN PLACEBO REGARDLESS OF RELATIONSHIP TO TREATMENT

 

ADVERSE EVENTS 200 mcg of
triamcinolone
acetonide
once daily
n = 204
400 mcg of
triamcinolone
acetonide
once daily
n = 300
Combined
(200 and 400 mcg)
use of triamcinolone
acetonide
n = 504
Vehicle
Placebo
n = 343
BODY AS A WHOLE
Headache 51.0% 44.3% 47.0% 41.1%
Back Pain 7.8% 4.7% 6.0% 3.5%
RESPIRATORY SYSTEM
Pharyngitis 13.7% 10.3% 11.7% 7.9%
Asthma 5.4% 4.3% 4.8% 2.9%
Cough Increased 2.0% 2.7% 2.4% 2.3%
DIGESTIVE SYSTEM
Dyspepsia 4.9% 2.7% 3.6% 2.0%
Nausea 2.0% 3.0% 2.6% 0.6%
Vomiting 1.5% 2.7% 2.2% 1.5%
SPECIAL SENSES
Taste Perversion 7.8% 5.0% 6.2% 2.9%
Conjunctivitis 4.4% 1.3% 2.6% 1.5%
MUSCULOSKELETAL SYSTEM
Myalgia 2.5% 3.3% 3.0% 2.6%

Adverse events reported by 2% or more of patients who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with placebo than with triamcinolone acetonide solution included: application site reaction (e.g. transient nasal burning and stinging), rhinitis, dysmenorrhea, pain (unspecified) and allergic reaction.

The adverse effects related to the irritation of nasal mucous membranes (i.e. application site reaction) did not usually interfere with treatment. In the controlled and uncontrolled studies, approximately 0.3% of patients discontinued because of irritation of nasal mucous membranes.

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 corticosteroid withdrawal, e.g., joint or muscular pain, or both, 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 which require long-term corticosteroid treatment, too rapid a decrease in systemic corticosteroid may cause a severe exacerbation of their symptoms.

Patients who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults on immunosuppressant doses of corticosteroids. In children, or 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.

PRECAUTIONS

General

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.

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 therapy and discontinuance of treatment with AllerNaze (triamcinolone acetonide nasal spray) .

AllerNaze (triamcinolone acetonide 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 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, AllerNaze (triamcinolone acetonide nasal spray) should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

Systemic Availability and HPA Axis Suppression

Triamcinolone acetonide administered intranasally as triamcinolone acetonide solution has been shown to be absorbed into the systemic circulation in humans. The bioavailability of triamcinolone acetonide when administered as a solution in triamcinolone acetonide solution is approximately 5-fold greater than when administered as a CFC aerosol suspension formulation. While triamcinolone acetonide solution administered to 5 patients with allergic rhinitis at 400 mcg/day for 42 days did not measurably affect adrenal response to a six-hour cosyntropin stimulation test, the 6-hour cosyntropin test is an insensitive assessment for subtle HPA effects of corticosteroids. Doses of 800 and 1600 mcg/day triamcinolone acetonide solution did demonstrate a trend toward dose-related suppression of the HPA response. However, this decrease did not reach statistical significance, whereas 10 mg daily oral prednisone did.

Information for patients

Patients being treated with AllerNaze (triamcinolone acetonide 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 AllerNaze (triamcinolone acetonide nasal spray) at regular intervals since its effectiveness depends on its regular use.

An improvement in some patient symptoms may be seen within the first two days 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. Transient nasal irritation and/or burning or stinging may occur upon instillation with this product. Spraying triamcinolone acetonide directly into the eyes or onto the nasal septum should be avoided. For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully.

The bottle should be discarded after 120 sprays following initial priming since the amount of triamcinolone acetonide delivered thereafter per spray may not be consistent. Do not transfer any remaining solution to another bottle.

Carcinogenesis, Mutagenesis And Impairment Of Fertility

In two-year mouse and Sprague-Dawley rat studies, triamcinolone acetonide did not increase the incidence of tumors at oral doses up to 1 and 3 mcg/kg, respectively (less than the maximum recommended daily intranasal dose on a mcg/m² basis

Triamcinolone acetonide has not been found to be mutagenic in Salmonella/mammalian-microsome reverse mutation assay (Ames test) or the chromosomal aberration test in the Chinese Hamster Ovary Cells.

Triamcinolone acetonide did not impair fertility in Sprague-Dawley rats given oral doses up to 15 mcg/kg (less than the maximum recommended daily intranasal dose on a mcg/m² basis

However, triamcinolone acetonide caused increased fetal resorptions and stillbirths and decreased pup weight and survival at 5 mcg/kg (less than the maximum recommended daily intranasal dose on a mcg/m 2 basis). These effects were not produced at 1 mcg/kg (less than the maximum recommended daily intranasal dose on a mcg/m² basis

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 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 and above (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, or internal hydrocephaly, or both 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. Triamcinolone acetonide, like other corticosteroids, should be used during pregnancy only if the potential benefits justify 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 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 observed.

Nursing Mothers

It is not known whether triamcinolone acetonide is excreted in human breast milk. Because other corticosteroids are excreted in human milk, caution should be exercised when AllerNaze (triamcinolone acetonide nasal spray) is administered to nursing women.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Controlled has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (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 AllerNaze (triamcinolone acetonide nasal spray) should be monitored routinely (e.g. via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including AllerNaze (triamcinolone acetonide nasal spray) , each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Geriatric use

Clinical studies of AllerNaze (triamcinolone acetonide nasal spray) 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

OVERDOSE

Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. In the event that the entire contents of the bottle were administered all at once, via oral or nasal application, clinically significant adverse events would likely not result. The patient may experience some gastrointestinal upset. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism.

CONTRAINDICATIONS

AllerNaze (triamcinolone acetonide nasal spray) is contraindicated in patients with a hypersensitivity to any of its ingredients.

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