Nasacort AQ

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• weakness, tired feeling, nausea, loss of appetite, weight loss;
• fever, chills, body aches, flu symptoms;
• easy bruising or bleeding, unusual weakness;
• white patches or sores inside your nose or mouth, or on your lips; or
• blurred vision, eye pain, or seeing halos around lights.

Less serious side effects may include:

• stinging, burning, or bleeding in your nose;
• sneezing after use of the medicine;
• sore throat, cough, stuffy nose;
• watery eyes;
• headache;
• nausea, vomiting; or
• an unpleasant taste or smell.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not use this medication in a child under 2 years old without the advice of a doctor. Some brands of triamcinolone nasal are not made for use in children.

Do not use this medication if you are allergic to triamcinolone.

Before using triamcinolone nasal, tell your doctor if you are allergic to any drugs, or if you have tuberculosis, asthma, a history of glaucoma or cataracts, any type of infection, or if you have had recent surgery or injury to your nose.

It may take up to a week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment, or if they get worse any time during treatment.

Triamcinolone nasal can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Do not stop using triamcinolone nasal suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the medication before stopping completely.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

• It is used to ease allergy signs.
• It is used to treat nose stuffiness.

• Tell all of your health care providers that you take Nasacort AQ. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Talk with your doctor if you come into contact with anyone who has chickenpox or measles and you have not had chickenpox, measles, or the vaccines for them.
• If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Nasacort AQ as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to take this medicine as you have been told by your doctor. Do not use more than you were told to use.
• Do not take Nasacort AQ by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• Prime pump before first use by shaking and spraying it 5 times into the air or if not used for more than 2 weeks by spraying 1 time into the air.
• Shake well before use.
• Blow your nose before use.
• Spray up the nose only. Do not spray onto the wall joining the two nostrils.
• Close 1 nostril.
• Tilt your head forward a little.
• Put nose spray tube into other nostril.
• While breathing in through the nose, press down once to release spray.
• Breathe out from your mouth.
• Do not blow your nose for 15 minutes after you use this medicine.
• Check your spray use with your doctor at each visit. Read and follow the facts on how to use the spray. Make sure you use the spray the right way.
• Keep using Nasacort AQ as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Bad nose irritation.
• Bad nosebleeds.
• Nose sores.
• Whistling sound when you breathe.
• Redness or white patches in mouth or throat.
• Change in eyesight.

Nasacort AQ should not be administered to patients with a history of hypersensitivity to triamcinolone acetonide or to any of the other ingredients of this preparation.

Systemic and local corticosteroid use may result in the following:

• Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing [see Warnings and Precautions (5.1)]
• Glaucoma and Cataracts [see Warnings and Precautions (5.2)]
• Immunosuppression [see Warnings and Precautions (5.3)]
• Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.4, 5.5), Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In placebo-controlled, double-blind, and open-label clinical studies, 1483 adults and children 12 years and older received treatment with Nasacort AQ Nasal Spray. These patients were treated for an average duration of 51 days. In the controlled trials (2–5 weeks duration) from which the following adverse reaction data are derived, 1394 patients were treated with Nasacort AQ Nasal Spray for an average of 19 days. In a long-term, open-label study, 172 patients received treatment for an average duration of 286 days. Adverse reactions from 12 studies in adults and adolescent patients 12 to 17 years of age receiving Nasacort AQ Nasal Spray 27.5 mcg to 440 mcg once daily are summarized in Table 1.

In clinical trials, nasal septum perforation was reported in one adult patient who received Nasacort AQ Nasal Spray.

A total of 602 children 6 to 12 years of age were studied in 3 double-blind, placebo-controlled clinical trials. Of these, 172 received 110 mcg/day and 207 received 220 mcg/day of Nasacort AQ Nasal Spray for two, six, or twelve weeks. The longest average durations of treatment for patients receiving 110 mcg/day and 220 mcg/day were 76 days and 80 days, respectively. One percent of patients treated with Nasacort AQ were discontinued due to adverse experiences. No patient receiving 110 mcg/day and one patient receiving 220mcg/day discontinued due to a serious adverse event. A similar adverse reaction profile was observed in pediatric patients 6–12 years of age as compared to adolescents and adults with the exception of epistaxis which occurred in less than 2% of the children studied. Adverse reactions from 2 studies in children 4 to 12 years of age receiving Nasacort AQ Nasal Spray 110 mcg once daily are summarized in Table 2.

A total of 474 children 2 to 5 years of age were studied in a 4-week double-blind, placebo-controlled clinical trial. Of these, 236 received 110 mcg/day of Nasacort AQ Nasal Spray for a mean duration of 28 days. No patient discontinued due to a serious adverse event. Adverse reactions from the single placebo-controlled study in children 2 to 5 years of age receiving Nasacort AQ Nasal Spray 110 mcg once daily are summarized in Table 3.

In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but acute systemic adverse experiences are unlikely [see Overdosage (10)].

Post-Marketing Experience

In addition to the adverse drug reactions reported during clinical studies and listed above, the following adverse reactions have been identified during post-approval use of Nasacort AQ Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reactions that have been reported during post-marketing experience include: nasal discomfort and congestion, sneezing, alterations of taste and smell, nausea, insomnia, dizziness, fatigue, dyspnea, decreased blood cortisol, cataract, glaucoma, increased ocular pressure, pruritus, rash, and hypersensitivity.

Mechanism of Action

Triamcinolone acetonide is a synthetic fluorinated corticosteroid with approximately 8 times the potency of prednisone in animal models of inflammation.

Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

Pharmacodynamics

In order to determine if systemic absorption plays a role in the effect of Nasacort AQ Nasal Spray on allergic rhinitis symptoms, a two week double-blind, placebo-controlled clinical study was conducted comparing Nasacort AQ, orally ingested triamcinolone acetonide, and placebo in 297 adult patients with seasonal allergic rhinitis. The study demonstrated that the therapeutic efficacy of Nasacort AQ Nasal Spray can be attributed to the topical effects of triamcinolone acetonide.

Adrenal Function: In order to evaluate the effects of systemic absorption on the Hypothalamic-Pituitary-Adrenal (HPA) axis, 4 clinical studies, one each in adults and in children 6–12 years of age, 2–5 years of age, and 2–11 years of age, were conducted.

The adult clinical study compared 220 mcg or 440 mcg Nasacort AQ per day, or 10 mg prednisone per day with placebo for 42 days. Adrenal response to a six-hour 250 mcg cosyntropin stimulation test showed that Nasacort AQ administered at doses of 220 mcg and 440 mcg had no statistically significant effect on HPA activity versus placebo. Conversely, oral prednisone at 10 mg/day significantly reduced the response to ACTH.

A study evaluating plasma cortisol response thirty and sixty minutes after 250 mcg cosyntropin stimulation in 80 pediatric patients 6 to 12 years of age who received 220 mcg or 440 mcg (twice the maximum recommended daily dose) daily for six weeks was conducted. No abnormal response to cosyntropin infusion (peak serum cortisol <18 mcg/dL) was observed in any pediatric patient after six weeks of dosing with Nasacort AQ at 440 mcg per day.

In pediatric patients 2 to 5 years of age (n = 61) receiving Nasacort AQ 110 mcg per day intranasally, HPA axis function was assessed by cosyntropin stimulation test; however, the results were inconclusive.

An effect of Nasacort AQ Nasal Spray on adrenal function in children 2 to 5 years of age cannot be ruled out.

In a 6-week trial in 140 children 2 to 11 years of age with allergic rhinitis, a daily dose of 110 or 220 mcg of Nasacort AQ Nasal Spray was compared to placebo nasal spray. A subset of 24 children 6 to 11 years of age received a higher dose of 220 mcg of Nasacort AQ Nasal Spray. A positive control was not included in this trial. Adrenal function was assessed by measurement of 24 hour serum cortisol levels before and after the treatment. The difference from placebo in the change from baseline in LS mean serum cortisol AUC (0–24 hr) at the end of week 6 for the Nasacort AQ Nasal Spray treatment groups (110 mcg and 220 mcg) was -4.2 mcg∙hour/dL (95% CI: -14.7, 6.4).

Pharmacokinetics

Based upon intravenous dosing of triamcinolone acetonide phosphate ester in adults, the half-life of triamcinolone acetonide was reported to be 88 minutes. The volume of distribution (Vd) reported was 99.5 L (SD ± 27.5) and clearance was 45.2 L/hour (SD ± 9.1) for triamcinolone acetonide. The plasma half-life of corticosteroids does not correlate well with the biologic half-life.

Pharmacokinetic characterization of the Nasacort AQ Nasal Spray formulation was determined in both normal adult subjects and patients with allergic rhinitis. Single dose intranasal administration of 220 mcg of Nasacort AQ Nasal Spray in normal adult subjects and patients demonstrated minimal absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5 ng/mL (range: 0.1 to 1.0 ng/mL) and occurred at 1.5 hours post dose. The mean plasma drug concentration was less than 0.06 ng/mL at 12 hours, and below the assay detection limit (the minimum LOQ of the assay was 0.025 ng/ml) at 24 hours. The average terminal half-life was 3.1 hours. The range of mean AUC0–∞ values was 1.4 ng∙hr/mL to 4.7 ng∙hr/mL between doses of 110 mcg to 440 mcg in both patients and healthy volunteers. Dose proportionality was demonstrated in both normal adult subjects and in allergic rhinitis patients following single intranasal doses of 110 mcg or 220 mcg Nasacort AQ Nasal Spray. The Cmax and AUC0–∞ of the 440 mcg dose increased less than proportionally when compared to 110 and 220 mcg doses.

Following multiple dose administration of Nasacort AQ 440 mcg once daily in pediatric patients 6 to 12 years of age, plasma drug concentrations, AUC0–∞, Cmax and Tmax were similar to those values observed in adult patients receiving the same dose. Intranasal administration of Nasacort AQ 110 mcg once daily in pediatric patients 2 to 5 years of age exhibited similar systemic exposure to that achieved in adult patients 20 to 49 years of age with intranasal administration of Nasacort AQ at a dose of 220 mcg once daily. Based on the population pharmacokinetic modeling, the apparent clearance and volume of distribution following intranasal administration of Nasacort AQ in pediatric patients 2 to 5 years of age were found to be approximately half of that in adults.

In animal studies using rats and dogs, three metabolites of triamcinolone acetonide have been identified. They are 6β-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6β-hydroxytriamcinolone acetonide. All three metabolites are expected to be substantially less active than the parent compound due to (a) the dependence of anti-inflammatory activity on the presence of a 21-hydroxyl group, (b) the decreased activity observed upon 6-hydroxylation, and (c) the markedly increased water solubility favoring rapid elimination. There appeared to be some quantitative differences in the metabolites among species. No differences were detected in metabolic pattern as a function of route of administration.