Azmacort

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. The following are medications that may interact with Azmacort since it contains triamcinolone:

• arthritis medications
• aspirin
• digoxin (Lanoxin)
• diuretics ('water pills')
• estrogen (Premarin)
• ketoconazole (Nizoral)
• oral contraceptives
• phenobarbital
• phenytoin (Dilantin)
• rifampin (Rifadin)
• theophylline (Theo-Dur)
• vitamins

This is not a complete list of Azmacort drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Azmacort fall into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether Azmacort crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Azmacort.

Triamcinolone acetonide, USP, the active ingredient in Azmacort® Inhalation Aerosol, is a corticosteroid with a molecular weight of 434.5 and with the chemical designation 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. (C24H31FO6).

Azmacort Inhalation Aerosol is a metered-dose aerosol unit containing a microcrystalline suspension of triamcinolone acetonide in the propellant dichlorodifluoromethane and dehydrated alcohol USP 1% w/w. Each canister contains 60 mg triamcinolone acetonide. The canister must be primed prior to the first use. After an initial priming of 2 actuations, each actuation delivers 200 mcg triamcinolone acetonide from the valve and 75 mcg from the spacer-mouthpiece under defined in vitro test conditions. The canister will remain primed for 3 days. If the canister is not used for more than 3 days, then it should be reprimed with 2 actuations. There are at least 240 actuations in one Azmacort Inhalation Aerosol canister. After 240 actuations, the amount delivered per actuation may not be consistent and the unit should be discarded.

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.

The precise mechanism of the action of glucocorticoids in asthma is unknown. However, the inhaled route makes it possible to provide effective local anti-inflammatory activity with reduced systemic corticosteroid effects. Though highly effective for asthma, glucocorticoids do not affect asthma symptoms immediately. While improvement in asthma may occur as soon as one week after initiation of Azmacort Inhalation Aerosol therapy, maximum improvement may not be achieved for 2 weeks or longer.

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 glucocorticoids does not correlate well with the biologic half-life.

The pharmacokinetics of radiolabeled triamcinolone acetonide [14C] were evaluated following a single oral dose of 800 mcg to healthy male volunteers. Radiolabeled triamcinolone acetonide was found to undergo relatively rapid absorption following oral administration with maximum plasma triamcinolone acetonide and [14C]-derived radioactivity occurring between 1.5 and 2 hours. Plasma protein binding of triamcinolone acetonide appears to be relatively low and consistent over a wide plasma triamcinolone acetonide concentration range as a function of time. The overall mean percent fraction bound was approximately 68%.

The metabolism and excretion of triamcinolone acetonide were both rapid and extensive with no parent compound being detected in the plasma after 24 hours post-dose and a low ratio (10.6%) of parent compound AUC0-∞ to total [14C] radioactivity AUC0-∞. Greater than 90% of the oral [14C]-radioactive dose was recovered within 5 days after administration in 5 out of the 6 subjects in the study. Of the recovered [14C]-radioactivity, approximately 40% and 60% were found in the urine and feces, respectively.

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

Adults: The usual recommended dosage is two inhalations (150 mcg) given three to four times a day or four inhalations (300 mcg) given twice daily. The maximal daily intake should not exceed 16 inhalations (1200 mcg) in adults. Higher initial doses (12 to 16 inhalations per day) may be considered in patients with more severe asthma.

Children 6 to 12 Years of Age: The usual recommended dosage is one or two inhalations (75 to 150 mcg) given three to four times a day or two to four inhalations (150 to 300 mcg) given twice daily. The maximal daily intake should not exceed 12 inhalations (900 mcg) in children 6 to 12 years of age. Insufficient clinical data exist with respect to the safety and efficacy of the administration of Azmacort Inhalation Aerosol to children below the age of 6. The long-term effects of inhaled steroids, including Azmacort Inhalation Aerosol, on growth are still not fully known.

Rinsing the mouth after inhalation is advised.

Different considerations must be given to the following groups of patients in order to obtain the full therapeutic benefit of Azmacort Inhalation Aerosol:

Note : In all patients, it is desirable to titrate to the lowest effective dose once asthma stability has been achieved.

Patients Not Receiving Systemic Corticosteroids: Patients who require maintenance therapy of their asthma may benefit from treatment with Azmacort Inhalation Aerosol at the doses recommended above. In patients who respond to Azmacort Inhalation Aerosol, improvement in pulmonary function is usually apparent within one to two weeks after the initiation of therapy.

Patients Maintained on Systemic Corticosteroids: Clinical studies have shown that Azmacort Inhalation Aerosol may be effective in the management of asthmatics dependent or maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

The patient's asthma should be reasonably stable before treatment with Azmacort Inhalation Aerosol is started. Initially, Azmacort Inhalation Aerosol should be used concurrently with the patient's usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. Inhaled corticosteroids should be used with caution when used chronically in patients receiving prednisone regimens, either daily or alternate day. (See WARNINGS. )

During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

Directions for Use: An illustrated leaflet of patient instructions for proper use accompanies each package of Azmacort Inhalation Aerosol.

Triamcinolone is a steroid. It prevents the release of substances in the body that cause inflammation.

Azmacort is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Azmacort may also be used for other purposes not listed in this medication guide.

• weakness, tired feeling, nausea, loss of appetite, weight loss;

• wheezing or breathing problems after using Azmacort;

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• pain or burning when you urinate;

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);

• worsening asthma symptoms.

Less serious side effects may include:

• nausea, diarrhea, stomach pain;

• joint or muscle pain;

• dryness in your mouth, nose, or throat;

• white patches or sores inside your mouth or on your lips;

• stuffy nose, sinus pain, sore throat, cough; or

• hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

There may be other drugs that can interact with Azmacort. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Applies to triamcinolone: compounding powder, inhalation aerosol, inhalation aerosol with adapter, injectable kit, injectable suspension, oral tablet

Cardiovascular

Cardiovascular side effects have included fluid retention, sodium retention, congestive heart failure, potassium loss, hypokalemic alkalosis, and hypertension.[Ref]

Musculoskeletal

Musculoskeletal side effects have included aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intra-lesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, and vertebral compression fractures. Postmarketing experience has included very rare reports of bone mineral density loss and osteoporosis, especially with prolonged use, which may lead to an increased risk of fractures.[Ref]

Decreases in bone density of the total hip and the trochanter have been reported with the use of inhaled triamcinolone acetonide in a study (n=109) of premenopausal women with asthma. The yearly change in bone density at the total hip and the trochanter showed a greater decline as the number of puffs per day of the inhaled glucocorticoid increased.[Ref]

Gastrointestinal

Gastrointestinal side effects have included peptic ulcer with potential perforation and hemorrhage, perforation of small and large bowel, pancreatitis, abdominal distention, and ulcerative esophagitis.[Ref]

Dermatologic

Dermatologic side effects have included impaired wound healing, thin, fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, and suppressed reactions to skin tests.[Ref]

Nervous system

Nervous system side effects have included convulsions, increased intracranial pressure with papilledema, vertigo, and headache.[Ref]

Endocrine

Endocrine side effects have included development of cushingoid state, menstrual irregularities, suppression of growth in children, manifestations of latent diabetes, increased requirements for insulin or oral hypoglycemic agents in diabetics, decreased carbohydrate tolerance, and secondary adrenocortical and pituitary unresponsiveness.[Ref]

Ocular

Ocular side effects have included posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos. Retinal and choroidal occlusion as a complication after posterior sub-Tenon triamcinolone (the active ingredient contained in Azmacort) injection has been reported.[Ref]

Metabolic

Metabolic side effects have included negative nitrogen balance due to protein catabolism.[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions, anaphylaxis, and angioedema.

Other

Other side effects have included abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, moon face, malaise, and weight gain.

Local

Local side effects have included injection site infections following non-sterile administration.

Some side effects of Azmacort may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.