TRIAMCINOLONE ACETONIDE- triamcinolone acetonide spray, metered
Teva Pharmaceuticals USA Inc
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Triamcinolone Acetonide Nasal Spray safely and effectively. See full prescribing information for Triamcinolone Acetonide Nasal Spray.
Triamcinolone Acetonide Nasal Spray For intranasal use only. Shake Well Before Using. Initial U.S. Approval: 1957 INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONSTriamcinolone acetonide should be used during pregnancy only if potential benefit justifies potential risk to fetus. (8.1) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 6/2015 |
Triamcinolone Acetonide Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.
Adverse reactions | Placebo
(N=962) | Triamcinolone Acetonide
220 mcg (N=857) |
---|---|---|
% | % | |
Pharyngitis |
3.6 |
5.1 |
Epistaxis |
0.8 |
2.7 |
Cough increased |
1.5 |
2.1 |
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART). |
Adverse reactions | Placebo
(N=202) | Triamcinolone Acetonide
110 mcg (N=179) |
---|---|---|
% | % | |
Flu syndrome |
7.4 |
8.9 |
Cough increased |
6.4 |
8.4 |
Pharyngitis |
6.4 |
7.8 |
Bronchitis |
1 |
3.4 |
Dyspepsia |
1 |
3.4 |
Tooth disorder |
1 |
3.4 |
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART). |
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 triamcinolone acetonide 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 triamcinolone acetonide nasal spray 110 mcg once daily are summarized in Table 3.
Adverse reactions | Placebo
(N=238) | Triamcinolone Acetonide
110 mcg (N=236) |
---|---|---|
% | % | |
Headache |
4.2 |
5.5 |
Pharyngolaryngeal pain |
4.2 |
5.5 |
Epistaxis |
5.0 |
5.1 |
Nasopharyngitis |
3.8 |
5.1 |
Abdominal upper pain |
0.8 |
4.7 |
Diarrhea |
1.3 |
3.0 |
Asthma |
2.1 |
2.5 |
Rash |
1.7 |
2.5 |
Excoriation |
0.0 |
2.5 |
Rhinorrhea |
1.7 |
2.1 |
Coding dictionary for adverse events is Medical Dictionary for Regulatory Activities terminology (MedDRA) Version 8.1 |
C24H31FO6Molecular Weight: 434.51
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
See FDA-Approved Patient Labeling accompanying the product.
IMPORTANT: Please read these instructions carefully before using your triamcinolone acetonide nasal spray.
Manufactured in Israel by:
Perrigo Israel Pharmaceuticals Ltd.
Industrial Zone, Yeruham 80500, Israel
Manufactured for:
TEVA Pharmaceuticals USA
Sellersville, PA 18960
Rev. A 9/2012
Patient Information
These instructions provide important information about triamcinolone acetonide. Ask your healthcare provider or pharmacist if you have any questions.
Important: For use as a nasal spray only.
What is Triamcinolone Acetonide?
Triamcinolone acetonide nasal spray is a prescription medicine called a corticosteroid used to treat nasal symptoms of seasonal and year around allergies in adults and children 2 years of age and older. When triamcinolone acetonide is sprayed in your nose, this medicine helps to lessen the symptoms of sneezing, runny nose, nasal itching and stuffy nose.
Triamcinolone acetonide is not for children under the age of 2 years.
Who should use Triamcinolone Acetonide?
Do not use triamcinolone acetonide if you have had a reaction to triamcinolone acetonide or to any of the other ingredients in triamcinolone acetonide. See the end of this leaflet for a complete list of ingredients in triamcinolone acetonide.
What should I tell my healthcare provider before using Triamcinolone Acetonide?
Tell your healthcare provider if you are:
Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
How do I use Triamcinolone Acetonide?
Do not stop taking triamcinolone acetonide without telling your healthcare provider. Before you throw away triamcinolone acetonide, talk to your healthcare provider to see if you need another prescription. If your healthcare provider tells you to continue using triamcinolone acetonide, throw away the empty or expired bottle and use a new bottle of triamcinolone acetonide.
What are the possible side effects of Triamcinolone Acetonide?
Common side effects of triamcinolone acetonide include:
Sore throat, headache, and nosebleeds. If you have an increase in nosebleeds after using triamcinolone acetonide or the inside of your nose hurts, contact your healthcare provider.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Patient Instructions for Use
Read these instructions carefully before using your triamcinolone acetonide.
Before using the spray pump bottle:
Priming the Spray Pump Bottle
Using the spray:
Cleaning the spray pump bottle:
If the spray bottle does not work:
The hole in the tip of the nozzle may be blocked. Never try to unblock the spray hole or enlarge it with a pin or other sharp object. This will make the spray mechanism not work correctly. Changing the size of the opening can change the amount of medicine you or your child will receive. This could cause an overdose of the medicine. To clean nasal spray pump bottle, refer to Step 15.
Important information
Repriming the spray pump is only necessary when it has not been used for more than 2 weeks. To reprime, shake the bottle and only pump the spray bottle one time. Do not reprime if you use the spray more often than every two weeks.
Each triamcinolone acetonide bottle contains 120 doses of medicine plus a little extra for priming the pump. A check-off chart is included with your triamcinolone acetonide to help you keep track of the number of sprays. This will help make sure that you receive 120 sprays of triamcinolone acetonide.
How should I store Triamcinolone Acetonide?
Keep triamcinolone acetonide and all medicines out of the reach of children.
General information about the safe and effective use of triamcinolone acetonide.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information. Do not use triamcinolone acetonide for a condition for which it was not prescribed. Do not give triamcinolone acetonide to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about triamcinolone acetonide. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about triamcinolone acetonide that is written for health professionals.
For more information, call 1-800-227-7522.
What are the ingredients in Triamcinolone Acetonide Nasal Spray?
Active ingredient: triamcinolone acetonide
Inactive ingredients: benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium dihydrate, microcrystalline cellulose and polysorbate 80 in purified water. Hydrochloric acid or sodium hydroxide may be added to adjust the pH to a target of 5.0 within a range of 4.5 and 6.0.
Manufactured in Israel by:
Perrigo Israel Pharmaceuticals Ltd.
Industrial Zone, Yeruham 80500, Israel
Manufactured for:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. A 9/2012
NDC 0093-2085-17
TRIAMCINOLONE
ACETONIDE
Nasal Spray
0.055 mg/spray
FOR INTRANASAL USE ONLY
SHAKE WELL BEFORE USING
Attention Pharmacist: DISPENSE WITH
INFORMATION FOR THE PATIENT.
Rx only
One 16.5g Spray Bottle
120 Metered Actuations
TEVA
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide spray, metered |
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Labeler - Teva Pharmaceuticals USA Inc (001627975) |