Nasacort

Indications : Anemia, acquired hemolytic; Anemia, congenital hypoplastic; Ankylosing spondylitis; Arthritis, gouty; Arthritis, post-traumatic; Arthritis, psoriatic; Arthritis, rheumatoid; Asthma; Berylliosis; Bursitis; Carditis, rheumatic; Chorioretinitis; Choroiditis; Colitis, ulcerative; Conjunctivitis, allergic; Dermatitis herpetiformis; Dermatitis, atopic; Dermatitis, contact; Dermatitis, exfoliative; Dermatitis, seborrheic; Enteritis, regional; Epicondylitis; Erythema multiforme; Erythroblastopenia; Herpes zoster ophthalmicus; Hypercalcemia, secondary to neoplasia; Hyperplasia, congenital adrenal; Hypersensitivity reactions, secondary to drugs; Iridocyclitis; Iritis; Keratitis; Leukemia; Loffler’s syndrome; Lupus erythematosus, systemic; Lymphoma; Meningitis, tuberculous; Multiple sclerosis; Mycosis fungoides; Nephrotic syndrome; Neuritis, optic; Ophthalmia, sympathetic; Pemphigus; Pneumonitis, aspiration; Psoriasis; Rhinitis, perennial allergic; Rhinitis, seasonal allergic; Sarcoidosis; Serum sickness; Stevens-Johnson syndrome; Synovitis, secondary to osteoarthritis; Tenosynovitis; Thrombocytopenia, secondary; Thrombocytopenic purpura, idiopathic; Thyroiditis, nonsuppurative; Trichinosis; Tuberculosis, disseminated; Tuberculosis, fulminating; Ulcer, allergic corneal marginal; Uveitis

Pregnancy Category C

Top 200 Drugs

FDA Approved 1958 Oct

DRUG CLASS : Corticosteroids; Antiasthmatics; Corticosteroids-Inhalation/Nasal; Dental Preparations; Ocular Anti-Inflammatory; Sulfonamides/Related Compounds; Topical Steroids

BRAND NAMES : Acetocot (US); Adcortyl (England, Israel); Adcortyl in Orabase (England); Aftab (Germany); Albicort (Belgium); Aricin (US); Aristcort ^*; Aristocort (Bahamas, Barbados, Belize, Bermuda, Curacao, Guyana, Jamaica, Netherland-Antilles, Surinam, Trinidad); Aristocort A (Hong-Kong, Malaysia, Thailand); Aristocort Topical (US); Aristogel (US); Azmacort (US); Cenocort A-40 (US); Cinalog (US); Cinolar (US); Cinonide 40 (US); Delphi Creme (Netherlands); Delphicort (Germany, Austria); Delta-Tritex (US); Denkacort Forte (Hong-Kong); Dermacort (Hong-Kong, Malaysia); Facort (Thailand); Flutex (US); Ftorocort (Bahamas, Barbados, Belize, Bermuda, Curacao, Guyana, Jamaica, Netherland-Antilles, Surinam, Trinidad); Gemicort (Korea); Generlog (Thailand); Kena-Plex 40 (US); Kenac (US); Kenacort (India); Kenacort A (Switzerland, Philippines, Colombia, Netherlands, Belgium); Kenacort A I.A.-I.D. (Costa-Rica, El-Salvador, Guatemala, Honduras, Nicaragua, Panama, Ecuador); Kenacort A I.M. (Bahrain, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, Ecuador, Costa-Rica, El-Salvador, Guatemala, Honduras, Nicaragua, Panama, Indonesia, Malaysia); Kenacort A in Orabase (Switzerland); Kenacort-A (Australia, New-Zealand, Indonesia, Malaysia, Taiwan, Peru, Hong-Kong, Bahrain, Egypt, Kenya, Tanzania, Uganda); Kenacort-A IM (Hong-Kong, Taiwan, Thailand); Kenacort-A in Orabase (Netherlands); Kenacort-A Intra-articular Intra-dermal (Philippines); Kenacort-A IA ID (Hong-Kong, Indonesia, Taiwan, Thailand); Kenacort A IA ID (Malaysia, Bahrain, Jordan); Kenacort E (Peru); Kenacort IM (Colombia, Mexico); Kenacort Retard (France); Kenacort T (Finland, Norway); Kenacort T Munnsalve (Norway); Kenaject-40 (US); Kenalog (US); Kenalog-10 ^*; Kenalog-40 (Canada); Kenalog Dental (Mexico); Kenalog in Orabase (Australia, New-Zealand; Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South-Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe, Canada, Indonesia, Malaysia, Thailand); Kenalone ^*; Kenonel (US); Ledercort (Bahrain, Cyprus, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, South-Africa, England, India); Ledercort A (Taiwan, Philippines); Nasacort (US); Nasacort AQ (Mexico); Nincort (Taiwan); Oracort (US); Oralog (Indonesia); Oralone (US); Oramedy (Korea); Shincort (Malaysia, Thailand); Sholog K (US); Steronase AQ (Israel); Tac (US); Tramacort 40 (US); Tri-Kort (US); Triacet (US); Triacort (US); Triaderm (Canada); Triam-A (US); Triamcinair (US); Triamcot (US); Triamonide 40 (US); Trianide (US); Triatex (US); Tricort (Finland); Tricot (Korea); Triderm (US); Trigon (Spain); Trilog (US); Trylone A (US); Trymex (US); Unif (Thailand); Volon A (Austria); Volon A Antibiotikafrei (Austria, Germany); Volon A 10 (Germany); Volon A 40 (Germany); Volon A Spray (Austria);
(International brand names outside U.S. in italics)
^* Indicates foreign drugs without region specification at time of publication.

HCFA JCODES : J3301 per 10 mg IM

DESCRIPTION :

Nasal and Oral Inhalers and AQ Nasal Spray : Triamcinolone acetonide, nasal inhaler, is a glucocorticosteroid with a molecular weight of 434.51 and with the chemical designation 9-Fluoro-11beta, 16alpha, 17,21-tetrahydroxypregna-1, 4-diene-3,20-dione cyclic 16,17-acetal with acetone. (C₂₄H₃₁FO₆).

Oral Inhaler : Triamcinolone acetonide Oral Inhaler is a metered-dose aerosol unit containing a microcrystalline suspension of Triamcinolone acetonide in the propellant dichlorodifluoromethane and dehydrated alcohol 1% w/w. Each canister contains 60 mg Triamcinolone acetonide. Each actuation releases approximately 200 mcg Triamcinolone acetonide, of which approximately 100 mcg are delivered from the unit (in vitro testing). There are at least 240 actuations in one Triamcinolone acetonide aerosol canister. After 240 actuations, the amount delivered per actuation may not be consistent and the unit should be discarded.

AQ Nasal Spray : Triamcinolone acetonide AQ nasal spray is an unscented, thixotropic, water-based metered-dose pump spray formulation unit containing a microcrystalline suspension of triamconolone acetonide in an aqueous medium. Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride, and edetate disodium are contained in this aqueous medium; 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.

Each bottle contains 9.075 mg Triamcinolone acetonide. Each actuation delivers 55 mcg Triamcinolone acetonide from the nasal actuator to the patient (estimated from in vitro testing) after an initial priming of 5 sprays. It will remain adequately primed for 2 weeks. If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray. There are at least 120 actuations in one Triamcinolone acetonide AQ nasal spray bottle. After 120 actuations, the amount of Triamcinolone acetonide delivered per actuation may not be consistent and the unit should be discarded. In the manufacturer’s original package insert, patients are provided with a check-off form to track usage in the Information for Patients tear-off sheet.

Nasal Inhaler : Triamcinolone acetonide Nasal Inhaler is a metered-dose aerosol unit containing a microcrystalline suspension of Triamcinolone acetonide in dichlorodifluoromethane and dehydrated alcohol 0.7% w/w. Each canister contains 15 mg Triamcinolone acetonide. Each actuation releases approximately 55 mcg Triamcinolone acetonide from the nasal actuator to the patient (estimated from in vitro testing). There are at least 100 actuations in one Triamcinolone acetonide Nasal Inhaler canister. After 100 actuations, the amount delivered per actuation may not be consistent and the unit should be discarded. Patients are provided with a check-off card to track usage as part of the Information for Patients tear-off sheet.

Dental Paste : Each gram of Triamcinolone acetonide in Orabase provides 1 mg (0.1%) Triamcinolone acetonide in emollient dental paste containing gelatin, pectin, and carboxymethylcellulose sodium is a plastibase (plasticized Hydrocarbon Gel), a polyethylene and mineral oil gel base.

Injection-10 : (For Intra-articular, Intrabursal or Intradermal Use)

Triamcinolone acetonide (sterile Triamcinolone acetonide suspension) provides Triamcinolone acetonide, a synthetic corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intradermal, intra-articular, and intrabursal injection into tendon sheaths. The preparation is NOT suitable for IV or IM use. Each ml of the sterile aqueous suspension provides 10 mg Triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as preservative, 0.75% carboxymethylcellulose sodium, and 0.04%, polysorbate 80; sodium hydroxide or hydrochloric may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name is 9-fluoro- 11beta,16alpha,17,21-tetrahyroxypregna-1,4-diene -3,20- dione cyclic 16,17- acetal with- acetone.

Injection-40 : Not for IV or intradermal use.

Triamcinolone acetonide (sterile Triamcinolone acetonide suspension) provides Triamcinolone acetonide, a synthetic corticosteroid with marked anti-inflammatory action. Each ml of the sterile aqueous suspension provides 40 mg Triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as preservative, 0.75% carboxymethylcellulose sodium, and 0.04%, polysorbate 80. Sodium hydroxide or hydrochloric may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

Aerosol Spray, Cream, and Ointment : For dermatologic use only.

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in the class include Triamcinolone acetonide. The chemical name is 9- Fluoro-11beta,16beta,17, 21- tetrahyroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.

Aerosol Spray: A two-second application which covers an area approximately the size of the hand, delivers an amount of Triamcinolone acetonide not exceeding 0.2. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% Triamcinolone acetonide. Each gram of spray provides 0.147 mg Triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%) and isobutane propellant.

Cream: (All Strengths.) Each gram of 0.025%, 0.1% and 0.5% Triamcinolone acetonide cream provides 0.25% mg, 1 mg or 5 mg Triamcinolone acetonide, respectively, in a vanishing cream base containing propylene glycol, cetearyl alcohol (and) ceteareth-20 white petrolatum, sorbitol solution, glyceryl monostearate, polyethylene glycol monostearate, simethicone, sorbic acid, and purified water.

Ointment: (All Strengths.) Each gram of 0.025%, 0.1%, and 0.5% Triamcinolone acetonide ointment provides 0.25 mg, 1 mg, or 5 mg Triamcinolone acetonide, respectively in Plastibase (plasticized hydrocarbon gel), a polyethylene and mineral oil gel base.

CLINICAL PHARMACOLOGY :

Oral Inhaler: The precise mechanism of the action of the inhaled drug is unknown. However, use of the inhaler makes it possible to provide effective local steroid activity with minimal systemic effect.

Triamcinolone acetonide is a more potent derivative of triamcinolone. Although triamcinolone itself is approximately one to two times as potent as prednisone in animal models of inflammation, Triamcinolone acetonide is approximately 8 times more potent than prednisone.

Pharmacokinetic studies with radiolabeled Triamcinolone acetonide have been carried out by the oral route and intravenous route in several species. The pharmacokinetic behavior of the Triamcinolone acetonide was similar in all species within each route of administration. The major portion of the dose was eliminated in the feces irrespective of route of administration with only one species (rabbit) showing significant urinary excretion of radioactivity.

The results of studies in which Triamcinolone acetonide was administered as an aerosol showed rapid disappearance of radioactivity from the lungs comparable to that observed following oral administration with peak blood levels occurring in one to two hours. Virtually no radioactivity was present in the lung and trachea 24 hours after dosing.

Based upon intravenous dosing of Triamcinolone acetonide phosphate ester, 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 corticoids does not correlate well with the biologic half-life.

Three metabolites of Triamcinolone acetonide have been identified. They are 6beta-hydroxyTriamcinolone acetonide, 21-carboxyTriamcinolone acetonide and 21-carboxy-6beta-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 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.

Nasal Inhaler and AQ Nasal Spray: Triamcinolone acetonide is a more potent derivative of triamcinolone. Although triamcinolone itself is approximately one to two times as potent as prednisone in animal models of inflammation, Triamcinolone acetonide is approximately 8 times more potent than prednisone.

Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids are very effective. However, they do not have an immediate effect on allergic signs and symptoms. When allergic symptoms are very severe, local treatment with recommended doses (microgram) of any available topical corticosteroids are not as effective as treatment with larger doses (milligram) of oral or parenteral formulations. When corticosteroids are prematurely discontinued symptoms may not recur for several days.

Based upon intravenous dosing of Triamcinolone acetonide phosphate ester, 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 Triamcinolone acetonide AQ nasal spray formulation was determined in both normal subjects and in patients with allergic rhinitis. Single dose intranasal administration of 220 mcg of the AQ nasal spray in normal subjects and patients demonstrated minimal absorption of Triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5ng/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 at 24 hours. The average terminal half-life was 3.1 hours. The range of mean AUC _{0 –} values was 1.4 ng·hr/mL between doses of 110 mcg to 440 mcg in both patients and healthy volunteers. Dose proportionality was demonstrated in both normal subjects and in allergic rhinitis patients following single intranasal doses of 110 mcg or 220 mcg Triamcinolone acetonide AQ nasal spray. The C_max and AUC of the 440 mcg dose increased less than proportionally when compared to 110 and 220 mcg doses.

When administered intranasally to humans at 440 mcg/day dose, the peak plasma concentration was <1 ng/ml and occurred on average at 3.4 hours (range 0.5 – 8.0 hours) post dosing. The apparent half-life was 4.0 hours (range 1.0 – 7.0 hours); however, this value probably reflects lingering absorption. Intranasal doses below 440 mcg/day gave sparse data and did not allow for the calibration of meaningful pharmacokinetic parameters.

In animal studies using rats and dogs, three metabolites of Triamcinolone acetonide have been identified. They are 6beta-hydroxyTriamcinolone acetonide, 21-carboxyTriamcinolone acetonide and 21-carboxy-6beta-Triamcinolone 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 21-hydroxyl group, (b) the decreased activity observed upon –hydroxylation, and (c) the markedly increased water solublity 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 adminstration.

Individualization Of Dosage

Nasal Inhaler: Individual patients will experience a variable time to onset and degree of symptom relief when using Triamcinolone acetonide. It is recommended that dosing be started at 220 mcg once a day and the effect be assessed in four to seven days.

Adults and Children 12 Years of Age and Older: Some relief can be expected in approximately two-thirds of patients within four to seven days. If greater effect is desired an increase of dose to 440 mcg once a day can be tried. If adequate relief has not been obtained by the third week of Triamcinolone acetonide treatment, consideration to alternate forms of treatment should be considered.

A dose-response between 110 mcg/day (one spray/nostril/day) and 440 mcg/day (four sprays/nostril/day) is not clearly discernible. In general, in the clinical trials the highest dose tended to provide relief sooner. This suggests an alternative approach to starting therapy with Triamcinolone acetonide (e.g., starting treatment with 440 mcg (four sprays/nostril/day) and then, depending on the patient’s response, decreasing the dose by one spray per day every four to seven days).

Although Triamcinolone acetonide may be used at 220 mcg/day or 440 mcg/day divided into two or four times a day, the degree of relief does not seem to be significantly different compared to once-a-day dosing. As with other nasal corticosteroids, the vehicle used to deliver the corticosteroid may cause symptoms that are difficult to distinguish from the patient’s rhinitis symptoms. Thus, depending upon the balance between these vehicle side effects and the benefits of treatment, in determining the optimal dose for the relief of symptoms, individual patients may need to have a trial of high and low doses.

Children 6 Through 11 Years of Age: In children 6 through 11 years of age, it is recommended that dosing be started at 220 mcg as two sprays (55 mcg/spray) in each nostril once a day. In clinical trials, significant relief of rhinitis symptoms in children was observed as early as the fourth day of treatment and generally, it took one to two weeks to achieve maximum benefit. If adequate relief has not been obtained by the third week of treatment, alternate forms of treatment should be considered.

In general, it is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. In clinical trials, after symptoms have been brought under control at the recommended starting doses, reducing the daily dose to 110 mcg (one spray in each nostril oncer per day) has been shown to be effective in controlling symptoms in approximatley one-half of adult patients being treated long-term for allergic rhinitis. (See PRECAUTIONS, WARNINGS, Information for the Patient, and ADVERSE REACTIONS).

AQ Nasal Spray: It is recommended that dosing be started at 220 mcg as 2 sprays in each nostril once daily for adults and children 12 years and older.

An improvement in some patient symptoms may be seen within the first day 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. If adequate relief of symptoms has not been obtained after 3 weeks of treatment, Triamcinolone acetonide AQ nasal spary should be discontinued.

It is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. Therefore, when the maximum benefit has been achieved and symptoms have been controlled, reducing the dose to 110 mcg (one spray in each nostril once per day) has been shown to be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled at 220 mcg/day. (See PRECAUTIONS, WARNINGS, Information for the Patient, and ADVERSE REACTIONS.)

Aerosol Spray, Cream, and Ointment: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

CLINICAL STUDIES :

Nasal Inhaler In double-blind, parallel, placebo-controlled clinical trials of seasonal and perennial allergic rhinitis, in adults and adolescentes 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.

The 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. The nasal inhaler, 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 Triamcinolone acetonide, 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 Triamcinolone acetonide 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 Triamcinolone acetonide application resulted in daily peak and trough concentrations, the mean of which was 3.5 times below the Kenalog plasma levels. Both topical Triamcinolone acetonide and intramuscular Kenalog-40 were clinically effective. In addition, in some studies there was evidence of improvement of eye symptoms. This suggests that Triamcinolone acetonide, 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, Triamcinolone acetonide 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 Triamcinolone acetonide 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 Triamcinolone acetonide nasal inhaler.

AQ Nasal Spray: The safety and efficacy of Triamcinolone acetonide AQ nasal spray has been evaluated in 10 double-blind, placebo-controlled clinical trials of two to four weeks in duration in adults and children 12 years and older with seasonal or perennial allergic rhinitis. The number of patients treated with the AQ nasal spray in these studies was 1266; of these patients, 675 were male and 591 were female.

Overall, the results of these clinical trials showed that Triamcinolone acetonide AQ nasal spray 220 mcg once daily (2 sprays in each nostril) when compared to placebo provides statistically significant relief of nasal symptoms including sneezing, stuffiness, discharge, and itching.

INDICATIONS AND USAGE:

Oral Inhaler: Triamcinolone acetonide Oral Inhaler is indicated only for patients who require chronic treatment with corticosteroids for the control of the symptoms of bronchial asthma. Such patients would include those already receiving systemic corticosteroids and selected patients who are inadequately controlled on a non-steroid regimen and in whom steroid therapy has been withheld because of concern over potential adverse effects.

Triamcinolone acetonide oral inhaler is NOT indicated:

AQ Nasal Spray: Triamcinolone acetonide AQ nasal spray is indicated for the treatment of seasonal and perennial allergic rhinitis symptoms.

Nasal Inhaler: Triamcinolone acetonide 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.

Dental Paste: Triamcinolone acetonide dental paste is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative resulting from trauma.

Injection-10: Intra-Articular: Triamcinolone acetonide Injection-10 is indicated for intra-articular or intrabursal administration, and for injection into tendon sheaths, as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific, tenospecific, and posttraumatic osteoarthritis.

Intradermal: Intralesional administration is indicated for the treatment of keloids, discoid lupus erythematosus, necrobiosis, lipoidica, diabeticorum, alopecia areata, and localized hypertrophic, infiltrated, inflammatory lesions of: licheplanus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). This drug may be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Injection-40: Intramuscular: When oral therapy is not feasible or is temporarily undesirable in the judgement of the physician, Triamcinolone acetonide Injection-40 is indicated for IM use as follows:

1. Endocrine Disorders: Nonsuppurative thyroiditis
2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to side the patient over an acute episode or exacerbation) in: posttraumatic osteoarthritis; synovitis of osteoarthritis; rheumatoid arthritis; acute and subacute bursitis; epicondylitis; acute nonspecific tenosynovitis; acute gouty arthritis; psoriatic arthritis; ankylosing spondylitis; juvenile rheumatoid arthritis.
3. Collagen Disease: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus; acute rheumatic carditis.
4. Dermatologic Diseases: Pemphigus: severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; bullous dermatitis herpetiformis; severe seborrheic dermatitis; severe psoriasis.
5. Allergic States: Controls of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma; contact dermatitis; atopic dermatitis; seasonal or perennial allergic rhinitis.
6. Ophthalmic Diseases: Severe chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus; iritis; iridocyclitis; chorioretinitis; diffuse posterior uveitis and choroiditis; optic neuritis; sympathetic ophthalmia; anterior segment inflammation.
7. Gastrointestinal Diseases: To tide the patient over a critical period of disease in: ulcerative colitis (systemic therapy); regional enteritis (systemic therapy).
8. Respiratory Diseases: Symptomatic sarcoidosis; berylliosis; aspiration pneumonitis.
9. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia.
10. Neoplastic Diseases: For palliative management of: leukemias and lymphomas in adults; acute leukemia of childhood.
11. Edematous State: To induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia, of the idiopathic type or that due to lupus erythematosus.

Intra-Articular: This drug is indicated for the intra-articular or intrabursal administration, and for injections into tendon sheaths as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis; rheumatoid arthritis; epicondylitis; acute nonspecific tenosynovitis; post traumatic osteoarthritis

Aerosol Spray: Triamcinolone acetonide aerosol spray is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Cream: (All Strengths.) Indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Ointment: (All Strengths.) Indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS :

Oral Inhaler: Triamcinolone acetonide Oral Inhaler is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Oral and Nasal Inhalers and AQ Nasal Spray: Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

Aerosol Spray, Cream and Ointment: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

WARNINGS :

Localized infections with Candida albicans have occurred infrequently in the mouth and pharynx. These areas should be examined by the treating physician at each patient visit. The percentage of positive mouth and throat cultures Candida albicans did not change during a year of continuous therapy. The incidence of clinically apparent infection is low (2.5%). These infections may disappear spontaneously or may require treatment with appropriate antifungal therapy or discontinuance of treatment with Triamcinolone acetonide Oral Inhaler.

Triamcinolone acetonide Oral Inhaler is not to be regarded as a bronchodilator and is not indicated for rapid relief of bronchospasm.

Patients should be instructed to contact their physician immediately when episodes of asthma which are not responsive to bronchodilators occur during the course of treatment with Triamcinolone acetonide Oral Inhaler. During such episodes, patients may require therapy with systemic corticosteroids.

There is no evidence that control of asthma can be achieved by the administration of Triamcinolone acetonide Oral Inhaler in amounts greater than the recommended doses, which appear to be the therapeutic equivalent of approximately 10 mg/day of oral prednisone.

Transfer of patients from systemic steroid therapy to Triamcinolone acetonide Oral Inhaler may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g., rhinitis, conjunctivitis, and eczema.

Nasal Inhaler : The replacement of a systemic corticosteroid with a topical corticoid 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 corticoids 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.

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

The use of Triamcinolone acetonide nasal inhaler with alternate-day systemic prednisone could increase the likelihood of hypothalamic-pituitary-adrenal (HPA) suppression compared to a therapeutic dose of either one alone. Therefore, Triamcinolone acetonide nasal inhaler should be used with caution in patients already receiving alternate-day prednisone treatment for any disease.

AQ Nasal Spray : The replacement of a systemic 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.

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

The use of Triamcinolone acetonide AQ nasal spray with alternate day systemic prednisone could increase the likelihood of hypothalamic-pituitary-adrenal (HPA) suppression compared to a therapeutic dose of either one alone. Therefore, Triamcinolone acetonide nasal spray should be used with caution in patients already receiving alternate day prednisone treatment for any disease.

PRECAUTIONS :

General

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 therapy and discontinuance of treatment with Triamcinolone acetonide nasal inhaler or AQ nasal spray.

Triamcinolone acetonide administered intranasally has been shown to be minimally absorbed into the systemic circulation in humans. Patients with active rhinitis showed absorption similar to that found in normal volunteers.

Nasal Inhaler : Triamcinolone acetonide at 440 mcg/day for 42 days did not measurably affect adrenal response to a six hour cosyntropin test. In the same study prednisone 10 mg/day significantly reduced adrenal response to ACTH over the same period (see CLINICAL STUDIES).

AQ Nasal Spray : Daily doses of 220 mcg or 440 mcg Triamcinolone acetonide AQ nasal spray, 10 mg prednisone each was compared to placebo. Adrenal response to six-hour cosyntropin test showed that Triamcinolone acetonide AQ nasal spray in doses of 220 or 440 mcg/day for six weeks had no statistically significant effect on adrenal activity. In the same study prednisolone 10 mg/day significantly reduced adrenal response to synthetic ACTH over the same period.

Either Triamcinolone acetonide Nasal Inhaler or AQ Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections 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 inexcessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, Triamcinolone acetonide nasal inhaler should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

Oral and Nasal Inhalers and AQ Nasal Spray : When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, Triamcinolone acetonide nasal inhaler/AQ nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

Aerosol Spray, Cream and Ointment : Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for the impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique.

Recovery of HPA axis function and thermal homostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Oral Inhaler: During withdrawal from oral steroids, some patients may experience symptoms of systemically active steroid withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement of respiratory function (see DOSAGE AND ADMINISTRATION for details). Although steroid withdrawal effects are usually transient and not severe, severe and even fatal exacerbation of asthma can occur if the previous daily oral corticosteroid requirement had significantly exceeded 10 mg/day of prednisone or equivalent.

In responsive patients, inhaled corticosteroids will often permit control of asthmatic symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since Triamcinolone acetonide is absorbed into the circulation and can be systemically active, the beneficial effects of Triamcinolone acetonide Oral Inhaler in minimizing or preventing HPA dysfunction may be expected only when recommended dosages are not exceeded.

Suppression of HPA function has been reported in volunteers who received 400 mcg daily of Triamcinolone acetonide. In addition, suppression of HPA function has been reported in some patients who have received recommended doses for as little as 6 to 12 weeks. Since the response of HPA function to inhaled corticosteroids is highly individualized, the physician should consider this information when treating patients.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effects including suppression of growth in children. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of a decrease in adrenal function.

The long-term effects of Triamcinolone acetonide inhaler in human subjects are not completely known, although patients have received Triamcinolone acetonide Oral Inhaler on a continuous basis for periods of two years or longer. While there has been no clinical evidence of adverse experiences, the local effects of the agent on developmental or immunologic processes in the mouth, pharynx, trachea and lung are also unknown.

Triamcinolone acetonide Oral Inhaler should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract or in patients with untreated fungal, bacterial, or systemic viral infections or ocular herpes simplex. The potential effects of long-term administration of Triamcinolone acetonide Oral Inhaler on lung or other tissues are unknown. However, pulmonary infiltrates with eosinophilia have occurred in patients receiving other inhaled corticosteroids.

Information for the Patient

Patients being treated with Triamcinolone acetonide nasal inhaler or AQ 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 Triamcinolone acetonide nasal inhaler/AQ nasal spray at regular intervals since its effectiveness depends on its regular use. 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. 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. Nasal irritation and/or burning or stinging after use of the spray occur only rarely with this product. The patient should contact the physician if they occur.

Nasal Inhaler : For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully. Spraying Triamcinolone acetonide directly onto the nasal septum should be avoided. Because the amount dispensed per puff may not be consistent, it is important to shake the canister well. Also, the canister should be discarded after 100 actuations.

AQ Nasal Spray : For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully. It is important to shake the bottle well before each use. Also, the bottle should be discarded after 120 actuations since the amount of Triamcinolone acetonide delivered thereafter per actuation may be substantially less than 55 mcg of drug. Do not transfer any remaining suspension to another bottle.

Oral and Nasal Inhalers and AQ Nasal Spray : 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.

Aerosol Spray, Cream and Ointment : Patients using topical corticosteroids should receive the following information and instructions:

• This medication is to be used as directed by the physician. It is for external use only; avoid contact with the eyes and inhalation of the spray.
• Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
• The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
• Patients should report any signs of local adverse reactions especially under occlusive dressing.
• Parents of pediatric patients should be advised not to use tight- fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

Aerosol Spray, Cream and Ointment : A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Oral and Nasal Inhalers: No evidence of treatment-related carcinogenicity was demonstrated after two years of once daily oral administration of Triamcinolone acetonide at a maximum daily dose of 1.0 mcg/kg/day (6.1 mcg/m²/day) in male or female rats and 3.0 mcg/kg/day (12.9 mcg/m²/day in male or female mice.

Male and female rats which were administered oral Triamcinolone acetonide at doses as high as 15 mcg/kg/day (110 mcg/m²/day, as calculated on a surface area basis) exhibited no evidence of impaired fertility. The maximum human dose, for comparison, is 6.3 mcg/kg/day (240 mcg/m²/day). However, a few female rats which received maternally toxic doses of 8 or 15 mcg/kg/day (60 mcg/m²/day or 110 mcg/m²/day, respectively, as calculated on a surface area basis) exhibited dystocia and prolonged delivery. Developmental toxicity, which included increases in fetal resorptions and stillbirths and decreases in pup body weight and survival, also occurred at the maternally toxic doses (2.5 – 15.0 mcg/kg/day or 20 – 110 mcg/m²/day, as calculated on a surface area basis). Reproductive performance of female rats and effects on fetuses and offspring were comparable between groups that received placebo and non-toxic or marginally toxic doses (0.5 and 1.0 mcg/kg/day or 3.8 mcg/m²/day and 7.0 mcg/m²/day).

AQ Nasal Spray : No evidence of treatment-related carcinogenicity was demonstrated after two years of once daily gavage of Triamcinolone acetonide at doses of 0.05, 0.2, and 1.0 mcg/kg (approximately 0.2. 0.7, and 4.0% of the recommended clinical dose on a mcg/m² basis) in the mouse. Mutagenesis studies with Triamcinolone acetonide have not been carried out.

No evidence of impaired fertility was manifested when oral doses of up to 15.0 mcg/kg (55.0% of the recommended clinical dose on a mcg/m²basis) were administered to female and male rats. However, triamconolone acetonide at oral doses of 8.0 mcg/kg (approximately 30.0% of the recommended clinical dose on a mcg/m² basis) caused dystocia and prolonged delivery and at oral doses of 5.0 mcg/kg (approximately 20.0 % of the recommended clinical dose on a mcg/m² basis) and above caused increases in fetal resorptions and stillbirths and decreases in pup body weight and survival. At a lower dose of 1.0 mcg/kg (approximately 4.0% of the recommended clinical dose on a mcg/m² basis), it did not induce the aforementioned effects.

Aerosol Spray, Cream and Ointment: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results.

Pregnancy Category C

Oral and Nasal Inhalers: Like other corticoids, Triamcinolone acetonide has been shown to be teratogenic in rats and rabbits. Teratogenic effects, which occurred in both species at 0.02, 0.04 and 0.08 mg/kg/day (approximately 135, 270 and 540 mcg/m²/day in the rat and 320, 640 and 1280 mcg/m²/day in the rabbit, as calculated on a surface area basis), included a low incidence of cleft palate and/or internal hydrocephaly and axial skeletal defects. Teratogenic effects, including CNS and cranial malformations, have also been observed in non-human primates at 0.5 mg/kg/day (approximately 6.7 mg/m²/day). The doses of 0.02, 0.04, 0.08, and 0.5 mg/kg/day used in these toxicology studies are approximately 12.8, 25.5, 51, and 318.7 times the minimum recommended dose of 110 mcg of Triamcinolone acetonide per day and 3.2, 6.4, 12.7, and 80 times the maximum recommended dose of 440 mcg of Triamcinolone acetonide per day based on a patient body weight of 70 kg. Administration of aerosol by inhalation to pregnant rats and rabbits produced embryotoxic and fetotoxic effects which were comparable to those produced by administration by other routes. There are no adequate and well-controlled studies in pregnant women. Triamcinolone acetonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Experience with oral corticoids since their introduction in pharmacologic as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from corticoids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous steroid dose and many will not need corticoid treatment during pregnancy.

AQ Nasal Spray : Triamcinolone acetonide has been shown to be teratogenic at inhalational doses of 20, 40, and 80 mcg/kg in rats (approximately 0.75, 1.5, and 3.0 times the recommended clinical dose on a mcg/m² basis, respectively), in rabbits at the same doses (approximately 1.5, 3.0, and 6.0 the recommended clinical dose on a mcg/m² basis, respectively) and in monkeys, at an inhalational dose of 500 mcg/kg (approximately 37.0 times the recommended clinical dose on a mcg/m² basis.) Dose-related teratogenic effects in rats and rabbits included cleft palate and/or internal hydrocephaly and axial skeltal defects whereas the effects observed in the monkey were CNS and/or cranial malformations. There are no adequate and well-contolled studies in pregnant women. Triamcinolone acetonide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Experience with oral corticoids since their introduction in pharmacologic as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from corticoids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous steroid dose and many will not need corticoid treatment during pregnancy.

Oral and Nasal Inhalers and AQ Nasal Spray : Nonteratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.

Aerosol Spray, Cream and Ointment : Category C. Teratogenic Effects: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well- controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for long periods of time.

Nursing Mothers

Nasal Inhaler/AQ Nasal Spray : 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 Triamcinolone acetonide nasal inhaler/AQ nasal spray is administered to nursing women.

Aerosol Spray, Cream and Ointment: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Safety and effectiveness have not been established in children below the age of 6. Oral corticosteroids have been shown to cause growth suppression in children and teenagers, particularly with higher doses over extended periods. If a child or teenager on any corticosteroid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of steroids should be considered.

Aerosol Spray, Cream and Ointment: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestation of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Oral Inhaler : Safety and effectiveness have not been established in children below the age of 6. Oral corticoids have been shown to cause growth suppression in children and teenagers, particularly with higher doses over extended periods. If a child or teenager on any corticoid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of steroids should be considered.

ADVERSE REACTIONS :

Oral Inhaler : A few cases of oral candidiasis have been reported (see WARNINGS). In addition, some patients receiving Triamcinolone acetonide Oral Inhaler have experienced hoarseness, dry throat, irritated throat and dry mouth. Increased wheezing and cough have been reported infrequently as has facial edema. These adverse effects have generally been mild and transient.

Nasal Inhaler : Adults and Children 12 Years of Age and Older: In controlled and uncontrolled studies, 1257 patients received treatment with intranasal Triamcinolone acetonide. Adverse reactions are based on the 567 patients who received a product similar to the marketed Triamcinolone acetonide 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 Triamcinolone acetonide nasal inhaler irritation was reported by 2.8% of the patients receiving Triamcinolone acetonide. Other nasopharyngeal side effects were reported by fewer than 5% of the patients who received Triamcinolone acetonide 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).

Children Ages 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 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 reated 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 Triamcinolone acetonide nasal inhaler therapy.

Though not observed in controlled clinical trials of Triamcinolone acetonide nasal inhaler in children, cases of nasal septum perforation among pediatric users have been reported in post marketing surveillance of this product.

AQ Nasal Spray: In placebo-controlled, double-blind and open-label clinical studies, 1483 patients received treatment with Triamcinolone acetonide aqeous nasal spray. These patients were treated for an average duration of 50.7 days. In the controlled trials (2-5 weeks duration) from which the following adverse reaction data is derived, 1394 patients were treated with the Triamcinolone acetonide AQ nasal spray for an average of 18.7 days. In the long-term, open-label study, the 172 patients received treatment for an average duration of 286 days.

Also, these adverse events occurring at an incidence of 2% or greater and more common among patients treated with placebo than 220 mcg Triamcinolone acetonide daily were: Headache and Rhinitis.

Nasal septum perforation was reported in one patient although relationship to Triamcinolone acetonide AQ nasal spray has not been established.

In the event of accidental overdosage, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely. (See OVERDOSAGE.)

Aerosol Spray, Cream and Ointment: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressing (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

OVERDOSAGE :

Nasal Inhaler: Acute overdosage with this dosage form is unlikely. The acute topical application of the entire 15 mg of the canister would most likely cause nasal irritation and headache. It would be unlikely to see acute systemic adverse effects if the nasal application of the 15 mg of Triamcinolone acetonide was administered all at once.

AQ Nasal Spray: 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 either oral or nasal application, clinically significant systemic adverse events would most likely not result. The patient may experience some gastrointestinal upset.

Aerosol Spray, Cream and Ointment: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see General).

DOSAGE AND ADMINISTRATION :

Oral Inhaler : All patients should be instructed that the Triamcinolone acetonide oral inhaler must be used on a regular daily basis rather than prn . Reliable dosage delivery cannot be assured after 240 actuations and patients should be cautioned against longer use of individual canisters.

Good oral hygiene including rinsing of the mouth after inhalation is recommended.

Adults : The usual dosage is two inhalations (approximately 200 mcg) given three to four times a day. The maximum daily intake should not exceed 16 inhalations (1600 mcg) in adults. Higher initial doses (12 to 16 inhalations per day) may be advisable in patients with more severe asthma, the dosage then being adjusted downward according to the response of the patient. In some patients maintenance can be accomplished when the total daily dose is given on a twice a day schedule.

Children 6 to 12 Years of Age : The usual dosage is two inhalations (100 to 200 mcg) given three or four times a day according to the response of the patient. The maximal daily intake should not exceed 12 inhalations (1200 mcg) in children 6 to 12 years of age. Insufficient clinical data exist with respect to the administration of Triamcinolone acetonide oral inhaler in children below the age of 6. The long-term effects of inhaled steroids on growth are still under evaluation.

Patients receiving bronchodilators by inhalation should be advised to use the bronchodilator before Triamcinolone acetonide Oral Inhaler in order to enhance penetration of Triamcinolone acetonide into the bronchial tree. After use of an aerosol bronchodilator, several minutes should elapse before use of the Triamcinolone acetonide Oral Inhaler to reduce the potential toxicity from the inhaled fluorocarbon propellants in the two aerosols.

Different considerations must be given to the following groups of patients in order to obtain the full therapeutic benefit of Triamcinolone acetonide Oral Inhaler :

Patients not Receiving Systemic Steroids : The use of Triamcinolone acetonide Oral Inhaler is straightforward in patients who are inadequately controlled with non-steroid medications but in whom systemic steroid therapy has been withheld because of concern over potential adverse reactions. In patients who respond to Triamcinolone acetonide, an improvement in pulmonary function is usually apparent within one to two weeks after the start of Triamcinolone acetonide Oral Inhaler.

Patients Receiving Systemic Steroids : In those patients dependent on systemic steroids, transfer to Triamcinolone acetonide Oral Inhaler and subsequent management may be more difficult because recovery from impaired adrenal function is usually slow. Such suppression has been known to last up to 12 months or longer. Clinical studies, however, have demonstrated that Triamcinolone acetonide Oral Inhaler may be effective in the management of these asthmatic patients and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

The patient’s asthma should be reasonably stable before treatment with Triamcinolone acetonide Oral Inhaler is started. Initially, the inhaler should be used concurrently with the patient’s usual maintenance dose of systemic steroid. After approximately one week, gradual withdrawal of the systemic steroid is started by reducing the dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. A slow rate of withdrawal cannot be overemphasized. During withdrawal, some patients may experience symptoms of systemically active steroid withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement of respiratory function. Such patients should be encouraged to continue with the inhaler but should be watched carefully for objective signs of adrenal insufficiency, such as hypotension and weight loss. If evidence of adrenal insufficiency occurs, the systemic steroid dose should be boosted temporarily and thereafter further withdrawal should continue more slowly. No clinical studies have been conducted evaluating Triamcinolone acetonide with alternate day prednisone regimens. However, based on the results of such a study with another inhaled corticosteroid, inhaled corticosteroids generally are not recommended for chronic use with alternate day prednisone regimens (see WARNINGS).

During periods of stress or a severe asthma attack, transfer patients will require supplementary treatment with systemic steroids. Exacerbations of asthma which occur during the course of treatment with Triamcinolone acetonide Oral Inhaler should be treated with a short course of systemic steroid which is gradually tapered as these symptoms subside. There is no evidence that control of asthma can be achieved by administration of Triamcinolone acetonide Oral Inhaler in amounts greater than the recommended doses.

Contents under pressure. Do not puncture. Do not use or store near heat or an open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children.

Store at room temperature.

Nasal Inhaler and AQ Nasal Spray : 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 2-3 weeks, the patient should be re-evaluated or discontinue treatment. (See CLINICAL PHARMACOLOGY, Individualization Of Dosage).

Adults and Children 12 years of Age and Older : The recommended starting dose of Triamcinolone acetonide Nasal Inhaler is 220 mcg per day given as two sprays (approximately 55 mcg/spray) in each nostril once a day. If needed, the dose may be increased to 440 mcg per day (approximately 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 (approximately 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 Triamcinolone acetonide nasal ihaler 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 always desirable to titrate the patient to the minimum effective dose.

Triamcinolone acetonide 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 Triamcinolone acetonide Nasal Inhaler.

Contents under pressure. Do not puncture. Avoid spraying in eyes. Do not use or store near heat or open flame. Exposure to temperatures above 120° F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children.

Note: The following statement is required by the Federal government’s Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC’s):

Dental Paste

Press a small dab (about 1/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in a granular, gritty sensation, however, a smooth slippery film develops.

The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.

Injection-10

Dosage: The initial dose for intra-articular or intrabursal administration and for injection into tendon sheaths may vary from 2.5 to 5 mg for smaller joints and from 5 to 15 mg for larger joints depending on the specific disease entity being treated. Single injections into several joints for multiple locus involvement, up to 20 mg or more, have been given without incident. For intradermal administration, the initial dose of Triamcinolone acetonide will vary depending upon the specific disease entity being treated but should be limited to 1.0 mg (0.1 ml) per injection site, since larger volumes are more likely to produce cutaneous atrophy. Multiple sites (separated by one centimeter or more) may be injected, keeping in mind that the greater the total volume employed the more corticosteroids become available for possible systemic absorption and subsequent corticosteroid effects. Such injections may be repeated, if necessary, at weekly or less frequent intervals.

The lower dosages in the initial dosage range of Triamcinolone acetonide may produce the desired effect when the corticosteroid is administered to provide a localized concentration. The site of the injection and the volume of the injection should be carefully considered when Triamcinolone acetonide is administered for this purpose. The initial dosage should be maintained for this purpose. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, this drug should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of the patient’s individual drug responsiveness,a nd the effect of the patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of this drug for a period of time consistent with the patients’s condition. If the drug is to be stopped after long-term therapy, it is recommended that it be withdrawn gradually rather than abruptly.

Administration

Shake the vial before use to insure a uniform suspension. Prior to withdraw, inspect suspension for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdraw, inject without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.

Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest x-ray should be made at regular intervals during prolonged therapy. Upper GI x-rays are desirable with an ulcer history or significant dyspepsia.

For treatment of joints, the usual intra-articular Injection technique as described in standard textbooks, should be followed. If excessive amount of synovial fluid is present in the joint, some but not all, should be aspirated to aid in the relief of pain and to prevent undue dilation of the steroid.

With intra-articular or intrabursal administration, and with injection of this drug into tendon sheaths, the use of a local anesthetic is used, its package insert should be read with care and all the precautions connected with its use should be observed. It should be injected into the surrounding soft tissues prior to the injection of the injection of the corticosteroid. A small amount of the anesthetic solution may be instilled into the joint.

In treating acute nonspecific tenosynovitis, care should be taken to insure that the injection of this drug is made into the tendon sheath rather than the tendon substance. Epicondylitis (tennis elbow) may be treated by infiltrating the preparation into the area of greatest tenderness.

For treatment of dermal lesions, inject this drug directly into the lesion, i.e, intradermally or sometimes subcutaneously. For accuracy of dosage measurement and ease of administration, it is preferable to employ a tuberculin syringe and a small-bore needle (23 to 25 gauge). Ethyl chloride spray may be used to alleviate the discomfort of the injection.

Injection-40 : The initial dose may vary from 2.5 to 60 mg per day. Depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Usually the parenteral dosage ranges are about 1/3 to 1/2 of the oral dose given every 12 hours. However in certain overwhelming, acute, life-threatening situations, administrations of dosages exceeding the usual dosages may be justified and may be in multiples of the usual dosages.

The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, this drug should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of the patient’s individual drug responsiveness,a nd the effect of the patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of this drug for a period of time consistent with the patients’s condition. If the drug is to be stopped after long-term therapy, it is recommended that it be withdrawn gradually rather than abruptly.

Dosage

Systemic: Although this drug may be administered for most initial therapy, most physicians’s prefer to adjust the dose orally until adequate control is attained. IM administration provides a sustained or depot action which can be used to supplement or reduce initial oral therapy. With IM therapy, greater supervision of the amount of steroid used is made possible in the patient who is inconsistent in following an oral dosage schedule. In maintenance therapy, the patient-to-patient response is not uniform and, therefore, the dose must be individualized for optimal control.

For Adults and Children Over 12 Years of Age: The suggested initial dose is 60 mg, injected deeply into the gluteal muscle. Subcutaneous fat atrophy may occur if care is not taken to inject the preparation intramuscularly. Dosage is usually adjusted within the range of 40 to 80 mg depending upon the patient response and duration of relief. However, some patients may be well controlled on dosages as low as 20 mg or less patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after one injection of 40 to 100 mg.

For Children from 6 to 12 Years of Age: The suggested initial dose is 40 mg, although dosage depends more upon the severity of symptoms than on age or weight. There is insufficient clinical experience with this drug to recommend its use in children under six years of age.

Local

For intra-articular or intra-bursal administration and for injection into tendon sheaths, the initial dose of this drug may vary from 2.5 to 5 mg for smaller joints and from 5 to 15 mg for larger joints depending on the specific disease entity being treated, (A more dilute form of sterile Triamcinolone acetonide suspension is available). For adults, doses of up to 10 mg for smaller areas and up to 40 mg for larger areas have usually been sufficient to alleviate symptoms. Single injections into several joints for multiple locus involvement, up to a total of 80 mg, have been given without undue reactions. A single local infection of Triamcinolone acetonide is frequently sufficient, but several injections may be needed for adequate relief of symptoms. The lower dosages in the initial dosage range of Triamcinolone acetonide may produce the desired effect when the corticosteroid is administered to provide a localized concentration. The site of injection and the volume of the injection should be carefully considered when Triamcinolone acetonide is administered for this purpose.

Administration

General : Shake the vial before use to insure a uniform suspension. Prior to withdraw, inspect suspension for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdraw, inject without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.

Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest x-ray should be made at regular intervals during prolonged therapy. Upper GI x-rays are desirable with an ulcer history or significant dyspepsia.

Systemic : For systemic therapy, injection should be made deeply into the gluteal muscles to insure IM delivery. For adults, a minimum needle length of 1 1/2 inches is recommended. In obese patients, a longer needle may be required. Use alternate sites for subsequent injections.

Local : For treatment of joints, the usual intra-articular Injection technique as described in standard textbooks, should be followed. If excessive amount of synovial fluid is present in the joint, some but not all, should be aspirated to aid in the relief of pain and to prevent undue dilation of the corticosteroid.

With intra-articular or intrabursal administration, and with injection of this drug into tendon sheaths, the use of a local anesthetic is used, its package insert should be read with care and all the precautions connected with its use should be observed. It should be injected into the surrounding soft tissues prior to the injection of the injection of the corticosteroid. A small amount of the anesthetic solution may be instilled into the joint.

In treating acute nonspecific tenosynovitis, care should be taken to insure that the injection of this drug is made into the tendon sheath rather than the tendon substance. Epicondylitis (tennis elbow) may be treated by infiltrating the preparation into the area of greatest tenderness.

Aerosol Spray

Directions for use of the spray can are provided on the label. The preparation may be applied to any surface area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided.

Three or four applications daily of Triamcinolone acetonide aerosol spray are generally adequate.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Spray a small amount of the preparation onto the lesion, cover a small amount of the preparation onto the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected the area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply the spray under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional spray should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Cream : (All Strengths) Apply Triamcinolone acetonide cream, 0.025% to the affected area two to four times daily. Rub in gently.

Apply the 0.1% or the 0.5% strength as appropriate, to the affected area two or three times daily. Rub gently.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Spray a small amount of the preparation onto the lesion, cover a small amount of the preparation onto the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected the area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply the spray under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional spray should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Cream : (All Strengths.) Apply Triamcinolone acetonide cream, 0.025% to the affected area two to four times daily. Rub in gently.

Apply the 0.1% or the 0.5% strength as appropriate, to the affected area two or three times daily. Rub gently.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Spray a small amount of the preparation onto the lesion, cover a small amount of the preparation onto the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected the area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply the spray under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional spray should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Ointment : (All Strengths) Apply a thin film of Triamcinolone acetonide 0.225% to the affected area two or four times daily.

Apply a thin film of the 0.1% or the 0.5% Triamcinolone acetonide ointment as appropriate, to the affected areas tow or three times daily.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Spray a small amount of the preparation onto the lesion, cover a small amount of the preparation onto the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected the area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply the spray under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional spray should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Storage : Store at controlled room temperature, 15-30°C (59-86°F). Protect from light; freezing, and heat.

PATIENT INFORMATION :

Triamcinolone acetonide is a corticosteroid product used primarily for its ability to decrease inflammation and relieve irritation. It is available as a nasal inhaler or an oral inhaler to decrease inflammation in the lungs of those with asthma or allergies. Proper technique for using an oral inhaler or a nasal inhaler is important to getting maximum effectiveness from the drug. Your pharmacist or physician can evaluate your technique. Inhalers should be shaken prior to use. The plastic inhaler should be washed regularly and allowed to dry. You should rinse your mouth with water after taking puffs from your oral inhaler. A cream, lotion and ointment are used to relieve itching and inflammation on the skin. The skin should not be tightly bandaged where the medication is applied. This includes diapers on babies being treated for rash. This medication should not be stopped abruptly but should be slowly discontinued. If you notice any signs of infection, or lack of cuts healing please contact your physician immediately. This medication works slowly and should not be used to treat conditions requiring quick relief of symptoms. For example, the inhalers should not be used to treat immediate breathing difficulties. This medication should be taken exactly as prescribed by your physician.

HOW SUPPLIED :

AQ Nasal Spray

Nasacort (triamcinolone acetonide AQ nasal spray is a nonchlorofluorocarbon (CFC) containing metered-dose pump spray which will provide 120 actuations. Net weight of the bottle contents is 16.5 grams.

It is supplied in a high-density polyethylene container with a metered-dose pump unit, nasal adapter, and patient instructions

Storage: Store at controlled room temperature, 15-30°C (59-86°F).