Nasacort

Triamcinolone is a medication available in both prescription and non-prescription forms. It is used to treat inflammation caused by a variety of diseases, conditions, and allergies.

The prescription forms are used to treat inflammation due to arthritis and disorders of the skin, blood, kidney, lungs, eye, thyroid, and intestines. This medication page refers to the prescription form of triamcinolone.

Triamcinolone belongs to a group of drugs called corticosteroids. These work by mimicking the action of steroids normally produced by your body.

Triamcinolone is available as a topical cream, ointment, lotion, spray for use on the skin, and as a paste for use in the mouth. It is also available in injectable forms to be given directly into a muscle (IM), a joint (intra-articular) and the eye (intravitreal) by a healthcare professional.

Common side effects of triamcinolone include upset stomach, headache, insomnia, anxiety, depression, acne, increased hair growth, easy bruising, and irregular menstrual cycles.

Triamcinolone can also cause dizziness. Do not drive or operate heavy machinery until you know how triamcinolone affects you.

• Aventis Pharmaceuticals, Inc.

• DHS, Inc.

• DispenseXpress, Inc.

• Dispensing Solutions, Inc.

• Palmetto State Pharmaceuticals

• Quality Care Products, LLC

• Sanofi-Aventis U.S. LLC

• Vibranta, Inc.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of triamcinolone, there are no specific foods that you must exclude from your diet when receiving this medication.

This section provides information on the proper use of a number of products that contain triamcinolone. It may not be specific to Nasacort. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get this medicine in your eyes or mouth. If it does get on these areas, rinse it off right away with water and call your doctor right away.

Do not use this medicine for any other nose problem without checking with your doctor first.

To use the spray:

• Shake the bottle gently before each use.
• When you use the triamcinolone nasal spray for the first time, you must prime the spray. Press down fully on the top of the pump 5 times or until a fine spray comes out. Prime the spray if it has not been used for 14 days or more.
• Gently blow your nose before using the spray if needed. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
• Close the opposite nostril with a finger. Release 1 spray and at the same time, breathe in gently through the nostril.
• Hold your breath for a few seconds then breathe out slowly through your mouth.
• Spray the opposite nostril using the same steps.
• Do not blow your nose for 15 minutes after using the spray.
• Wipe the tip of the spray bottle with a clean, dry tissue or cloth and put the cap back on.
• Use the check-off chart that is included in the package to help you monitor the number of sprays you used.
• Throw this medicine away after you use 120 sprays.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For treatment of seasonal and perennial allergic rhinitis
    • Adults and teenagers—Two sprays in each nostril once a day. Your doctor may adjust your dose if needed. Each spray contains 55 micrograms (mcg) of triamcinolone.
    • Children 6 to 12 years of age—One spray in each nostril once a day. Some children may need two sprays in each nostril once a day. Your doctor may adjust your dose if needed.
    • Children 2 to 5 years of age—One spray in each nostril once a day.
    • Children younger than 2 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• chills
• congestion
• diarrhea
• dryness or soreness of the throat
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• increased cough
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny nose
• shivering
• sweating
• tender, swollen glands in the neck
• trouble sleeping
• trouble with swallowing
• unexplained nosebleeds
• unusual tiredness or weakness
• voice changes
• vomiting

• Cough producing mucus
• difficulty with breathing
• noisy breathing
• shortness of breath
• tightness in the chest

• Blindness
• bloody mucus
• blurred vision
• changes in vision
• darkening of the skin
• decreased vision
• eye pain
• fainting
• fast heartbeat
• hives
• irritation
• itching
• joint stiffness or swelling
• loss of appetite
• lower back or side pain
• mental depression
• painful or difficult urination
• rash
• redness of the skin
• slowing of normal growth in children
• swelling of the eyelids, face, lips, hands, or feet
• tearing
• trouble healing
• white patches in the throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain
• tooth problems
• upper abdominal or stomach pain

• Change in sense of smell or taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In double-blind, parallel, placebo-controlled clinical trials of seasonal and perennial allergic rhinitis, in adults and adolescents in fixed total daily doses of 110, 220 and 440 mcg per day, the responses to aerosolized triamcinolone acetonide demonstrated a statistically significant improvement over placebo. In open label trials where the doses were sometimes adjusted according to patients' signs and symptoms, the daily doses and regimens varied. The most commonly used dose was 110 mcg per day.

Nasacort Nasal Inhaler, at a dose of 220 mcg once daily, has also been studied in two double-blind, placebo-controlled trials of two and four weeks duration in children ages 6 through 11 years with seasonal and perennial allergic rhinitis. These trials included 162 males and 91 females. Nasacort administered at a fixed dose of 220 mcg once daily resulted in consistent and statistically significant reductions of allergic rhinitis symptoms over vehicle placebo.

In attempting to determine if systemic absorption played a role in the response to Nasacort, a clinical study comparing intranasal and depot intramuscular triamcinolone acetonide was conducted. The doses used were based on bioavailability studies of each formulation. The final doses of Nasacort 440 mcg once a day and Kenalog®-40, 4 mg intramuscularly once a week, were chosen to deliver comparable total amounts of weekly triamcinolone acetonide. However, the weekly injection yielded sustained plasma levels throughout the dosing interval while the daily Nasacort application resulted in daily peak and trough concentrations, the mean of which was 3.5 times below the Kenalog plasma levels. Both topical Nasacort and intramuscular Kenalog-40 were clinically effective. In addition, in some studies there was evidence of improvement of eye symptoms. This suggests that Nasacort, at least to some degree is acting by a systemic mechanism.

In order to evaluate the effects of systemic absorption on the Hypothalamic-Pituitary-Adrenal (HPA) axis, Nasacort administered to adults in doses of 440 mcg once a day was compared to placebo and 42 days of a single morning dose of prednisone 10 mg. Adrenal response to a six-hour cosyntropin stimulation test suggests that intranasal Nasacort 440 mcg/day for six weeks did not measurably affect adrenal activity. Conversely, oral prednisone at 10 mg/day significantly reduced the response to ACTH.

No evidence of adrenal axis suppression was observed in 26 pediatric patients exposed for 6 weeks to systemic levels of triamcinolone acetonide higher than the systemic levels observed following administration of the maximum recommended dose of Nasacort Nasal Inhaler.

Nasacort Nasal Inhaler is indicated for the nasal treatment of seasonal and perennial allergic rhinitis symptoms in adults and children 6 years of age and older.

Adults and Children 12 years of age and older

In controlled and uncontrolled studies, 1257 adult and adolescent patients received treatment with intranasal triamcinolone acetonide. Adverse reactions are based on the 567 patients who received a product similar to the marketed Nasacort canister.

These patients were treated for an average of 48 days (range 1 to 117 days). The 145 patients enrolled in uncontrolled studies received treatment from 1 to 820 days (average 332 days). The most prevalent adverse experience was headache, being reported by approximately 18% of the patients who received Nasacort. Nasal irritation was reported by 2.8% of the patients receiving Nasacort. Other nasopharyngeal side effects were reported by fewer than 5% of the patients who received Nasacort and included: dry mucous membranes, naso-sinus congestion, throat discomfort, sneezing, and epistaxis. The complaints do not usually interfere with treatment and in the controlled and uncontrolled studies approximately 1% of patients have discontinued because of these nasal adverse effects. In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely (see OVERDOSAGE section).

Children 6 through 11 years of age

Adverse event data in children 6 through 11 years of age are derived from two controlled clinical trials of two and four weeks duration. In these trials, 127 patients received fixed doses of 220 mcg/day of triamcinolone acetonide for an average of 22 days (range 8 to 33 days).

Adverse events occurring at an incidence of 3% or greater and more common among children treated with 220 mcg triamcinolone acetonide daily than vehicle placebo were:

Adverse events occurring at a rate of 3% or greater that were more common in the placebo group were upper respiratory tract infection, headache and concurrent infection.

Only 1.6% of patients discontinued due to adverse experiences. No patient discontinued due to a serious adverse event related to Nasacort therapy.

Though not observed in controlled clinical trials of Nasacort Nasal Inhaler in children, cases of nasal septum perforation among pediatric users have been reported in post-marketing surveillance of this product.

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.

If improvement is not evident after 2 to 3 weeks, the patient should be re-evaluated. (See INDIVIDUALIZATION OF DOSAGE section).

Adults and Children 12 years of age and older

The recommended starting dose of Nasacort Nasal Inhaler is 220 mcg per day given as two sprays (55 mcg/spray) in each nostril once a day. If needed, the dose may be increased to 440 mcg per day (55 mcg/spray) either as once-a-day dosage or divided up to four times a day, i.e., twice a day (two sprays/nostril), or four times a day (one spray/nostril). After the desired effect is obtained, some patients may be maintained on a dose of as little as one spray (55 mcg) in each nostril once a day (total daily dose 110 mcg per day).

Children 6 through 11 years of age

The recommended starting dose of Nasacort Nasal Inhaler is 220 mcg per day given as two sprays (55 mcg/spray) in each nostril once a day. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose.

Nasacort Nasal Inhaler is not recommended for children below 6 years of age since adequate numbers of patients have not been studied in this age group.

Directions for Use

Illustrated Patient's Instructions for use accompany each package of Nasacort Nasal Inhaler.

Nasacort Nasal Inhaler is supplied as an aerosol canister which will provide 100 metered dose actuations. Each actuation delivers 55 mcg triamcinolone acetonide through the nasal actuator. The Nasacort Nasal Inhaler canister and accompanying nasal actuator are designed to be used together. The Nasacort Nasal Inhaler canister should not be used with other nasal actuators and the supplied nasal actuator should not be used with other products' canisters. Nasacort Nasal Inhaler is supplied with a white plastic nasal actuator and patient instructions. Net weight of the canister contents is 10 grams.

NDC 0075-1505-43.