NDC 0003-0293 Kenalog-40

Triamcinolone Acetonide

NDC Product Code 0003-0293

NDC CODE: 0003-0293

Proprietary Name: Kenalog-40 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Triamcinolone Acetonide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Triamcinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium- to strong-potency corticosteroid. The potency depends on the strength and the form that you use. For details on the potency of your product, ask your pharmacist.

NDC Code Structure

NDC 0003-0293-05

Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON > 1 mL in 1 VIAL, SINGLE-DOSE

NDC 0003-0293-20

Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON > 5 mL in 1 VIAL, MULTI-DOSE

NDC 0003-0293-28

Package Description: 1 VIAL, MULTI-DOSE in 1 CARTON > 10 mL in 1 VIAL, MULTI-DOSE

NDC Product Information

Kenalog-40 with NDC 0003-0293 is a a human prescription drug product labeled by E.r. Squibb & Sons, L.l.c.. The generic name of Kenalog-40 is triamcinolone acetonide. The product's dosage form is injection, suspension and is administered via intra-articular; intramuscular form.

Labeler Name: E.r. Squibb & Sons, L.l.c.

Dosage Form: Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Kenalog-40 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TRIAMCINOLONE ACETONIDE 40 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intra-articular - Administration within a joint.
  • Intramuscular - Administration within a muscle.
  • Intra-articular - Administration within a joint.
  • Intramuscular - Administration within a muscle.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: E.r. Squibb & Sons, L.l.c.
Labeler Code: 0003
FDA Application Number: NDA014901 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Triamcinolone Topical

Triamcinolone Topical is pronounced as (trye am sin' oh lone)

Why is triamcinolone topical medication prescribed?
Triamcinolone is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions. It is also used to relieve the d...
[Read More]

* Please review the disclaimer below.

Kenalog-40 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

-------------------- Kenalog®-40 Injection (Triamcinolone Acetonide Injectable Suspension, Usp) --------------------

NOT FOR USE IN NEONATESCONTAINS BENZYL ALCOHOLFor Intramuscular or Intra-articular Use OnlyNOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE

Description

Kenalog


®-40 Injection (triamcinolone
acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid
with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR
AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION.


Each mL of the sterile aqueous suspension provides 40 mg triamcinolone
acetonide, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol
as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate
80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5.
At the time of manufacture, the air in the container is replaced by nitrogen.The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione
cyclic 16,17-acetal with acetone. Its structural formula is:Triamcinolone acetonide occurs as a white to cream-colored, crystalline
powder having not more than a slight odor and is practically insoluble in
water and very soluble in alcohol.

Clinical Pharmacology

Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are readily absorbed from the gastrointestinal tract.Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining properties, are used as replacement
therapy in adrenocortical deficiency states. Synthetic analogs such as triamcinolone
are primarily used for their anti-inflammatory effects in disorders of many
organ systems.Kenalog-40 Injection has an extended duration of effect which may be sustained over a period
of several weeks. Studies indicate that following a single intramuscular dose
of 60 mg to 100 mg of triamcinolone acetonide, adrenal suppression occurs within
24 to 48 hours and then gradually returns to normal, usually in 30 to 40 days.
This finding correlates closely with the extended duration of therapeutic
action achieved with the drug.

Intramuscular

Where oral therapy is not feasible, injectable corticosteroid therapy,
including Kenalog-40 Injection (triamcinolone acetonide injectable suspension,
USP) is indicated


for intramuscular use as follows:


Allergic states: Control of severe or incapacitating
allergic conditions intractable to adequate trials of conventional treatment
in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions,
perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.


Dermatologic diseases: Bullous dermatitis herpetiformis,
exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme
(Stevens-Johnson syndrome).


Endocrine disorders: Primary or secondary adrenocortical
insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic
analogs may be used in conjunction with mineralocorticoids where applicable;
in infancy, mineralocorticoid supplementation is of particular importance),
congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative
thyroiditis.


Gastrointestinal diseases: To tide the patient
over a critical period of the disease in regional enteritis and ulcerative
colitis.


Hematologic disorders: Acquired (autoimmune) hemolytic
anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of
secondary thrombocytopenia.


Miscellaneous: Trichinosis with neurologic or
myocardial involvement, tuberculous meningitis with subarachnoid block or
impending block when used with appropriate antituberculous chemotherapy.


Neoplastic diseases: For the palliative management
of leukemias and lymphomas.


Nervous system: Acute exacerbations of multiple
sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.


Ophthalmic diseases: Sympathetic ophthalmia, temporal
arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical
corticosteroids.


Renal diseases: To induce diuresis or remission
of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.


Respiratory diseases: Berylliosis, fulminating
or disseminated pulmonary tuberculosis when used concurrently with appropriate
antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic
sarcoidosis.


Rheumatic disorders: As adjunctive therapy for
short-term administration (to tide the patient over an acute episode or exacerbation)
in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis;
psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low-dose maintenance therapy). For the treatment
of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Intra-Articular

The intra-articular or soft tissue administration of
Kenalog-40 Injection is indicated as adjunctive therapy for short-term administration (to tide
the patient over an acute episode or exacerbation) in acute gouty arthritis,
acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis,
rheumatoid arthritis, synovitis, or osteoarthritis.

Contraindications

Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components
of this product (see


WARNINGS: General).


Intramuscular corticosteroid preparations are contraindicated for
idiopathic thrombocytopenic purpura.

General

Exposure to excessive amounts of benzyl alcohol has been associated
with toxicity (hypotension, metabolic acidosis), particularly in neonates,
and an increased incidence of kernicterus, particularly in small preterm infants.
There have been rare reports of deaths, primarily in preterm infants, associated
with exposure to excessive amounts of benzyl alcohol. The amount of benzyl
alcohol from medications is usually considered negligible compared to that
received in flush solutions containing benzyl alcohol. Administration of high
dosages of medications containing this preservative must take into account
the total amount of benzyl alcohol administered. The amount of benzyl alcohol
at which toxicity may occur is not known. If the patient requires more than
the recommended dosages or other medications containing this preservative,
the practitioner must consider the daily metabolic load of benzyl alcohol
from these combined sources (see


PRECAUTIONS: Pediatric Use).


Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see


ADVERSE REACTIONS). Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.


Because Kenalog-40 Injection (triamcinolone acetonide injectable
suspension, USP) is a suspension, it should


not be administered
intravenously.


Unless a


deep intramuscular injection is given, local
atrophy is likely to occur. (For recommendations on injection techniques,
see


DOSAGE AND ADMINISTRATION.) Due to
the significantly higher incidence of local atrophy when the material is injected
into the deltoid area, this injection site should be avoided in favor of the
gluteal area.


Increased dosage of rapidly acting corticosteroids is indicated
in patients on corticosteroid therapy subjected to any unusual stress before,
during, and after the stressful situation. Kenalog-40 Injection is a long-acting preparation, and is
not suitable for use in acute stress situations. To avoid drug-induced adrenal
insufficiency, supportive dosage may be required in times of stress (such
as trauma, surgery, or severe illness) both during treatment with Kenalog-40
Injection and for a year afterwards.Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including Kenalog-40 Injection, should not be used for the treatment of traumatic brain injury.

Patients who are on corticosteroids are more susceptible to infections
than are healthy individuals. There may be decreased resistance and inability
to localize infection when corticosteroids are used. Infection with any pathogen
(viral, bacterial, fungal, protozoan, or helminthic) in any location of the
body may be associated with the use of corticosteroids alone or in combination
with other immunosuppressive agents. These infections may be mild to severe.
With increasing doses of corticosteroids, the rate of occurrence of infectious
complications increases. Corticosteroids may also mask some signs of current
infection.

This product, like many other steroid formulations, is sensitive
to heat. Therefore, it should not be autoclaved when it is desirable to sterilize
the exterior of the vial.The lowest possible dose of corticosteroid should be used to control
the condition under treatment. When reduction in dosage is possible, the reduction
should be gradual.Since complications of treatment with glucocorticoids are dependent
on the size of the dose and the duration of treatment, a risk/benefit decision
must be made in each individual case as to dose and duration of treatment
and as to whether daily or intermittent therapy should be used.Kaposi’s sarcoma has been reported to occur in patients
receiving corticosteroid therapy, most often for chronic conditions. Discontinuation
of corticosteroids may result in clinical improvement.

NOTE: CONTAINS BENZYL ALCOHOL (see


PRECAUTIONS).


The initial dose of Kenalog-40 Injection may vary from 2.5 mg to 100 mg per day depending
on the specific disease entity being treated (see


Dosage section
below). However, in certain overwhelming, acute, life-threatening situations,
administration in dosages exceeding the usual dosages may be justified and
may be in multiples of the oral dosages.


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 decrements at appropriate time intervals until the lowest
dosage which will maintain an adequate clinical response is reached. 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 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 the corticosteroid
for a period of time consistent with the patient’s condition. If after long-term
therapy the drug is to be stopped, it is recommended that it be withdrawn
gradually rather than abruptly.

STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should
be shaken before use to ensure a uniform suspension. Prior to withdrawal,
the suspension should be inspected for clumping or granular appearance (agglomeration).
An agglomerated product results from exposure to freezing temperatures and
should not be used. After withdrawal, Kenalog-40 Injection should be injected 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.

Cardio-Renal

Average and large doses of corticosteroids can cause elevation
of blood pressure, salt and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives except
when they are used in large doses. Dietary salt restriction and potassium
supplementation may be necessary (see


PRECAUTIONS).
All corticosteroids increase calcium excretion.


Literature reports suggest an apparent association between use
of corticosteroids and left ventricular free wall rupture after a recent myocardial
infarction; therefore, therapy with corticosteroids should be used with great
caution in these patients.

As sodium retention with resultant edema and potassium loss may
occur in patients receiving corticosteroids, these agents should be used with
caution in patients with congestive heart failure, hypertension, or renal
insufficiency.

Endocrine

Corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency
after withdrawal of treatment.Metabolic clearance of corticosteroids is decreased in hypothyroid
patients and increased in hyperthyroid patients. Changes in thyroid status
of the patient may necessitate adjustment in dosage.

Drug-induced secondary adrenocortical insufficiency may be minimized
by gradual reduction of dosage. This type of relative insufficiency may persist
for months after discontinuation of therapy; therefore, in any situation of
stress occurring during that period, hormone therapy should be reinstituted.
Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid
should be administered concurrently.

Fungal Infections

Corticosteroids may exacerbate systemic fungal infections and therefore
should not be used in the presence of such infections unless they are needed
to control drug reactions. There have been cases reported in which concomitant
use of amphotericin B and hydrocortisone was followed by cardiac enlargement
and congestive heart failure (see


PRECAUTIONS: Drug Interactions: Amphotericin B injection and potassium-depleting agents).

Special Pathogens

Latent disease may be activated or there may be an exacerbation
of intercurrent infections due to pathogens, including those caused by


Amoeba,


Candida,


Cryptococcus,


Mycobacterium,


Nocardia,


Pneumocystis, or


Toxoplasma.


It is recommended that latent amebiasis or active amebiasis be
ruled out before initiating corticosteroid therapy in any patient who has
spent time in the tropics or in any patient with unexplained diarrhea.Similarly, corticosteroids should be used with great care in patients
with known or suspected


Strongyloides (threadworm) infestation.
In such patients, corticosteroid-induced immunosuppression may lead to


Strongyloides hyperinfection
and dissemination with widespread larval migration, often accompanied by severe
enterocolitis and potentially fatal gram-negative septicemia.


Corticosteroids should not be used in cerebral malaria.

Tuberculosis

The use of corticosteroids in patients with active tuberculosis
should be restricted to those cases of fulminating or disseminated tuberculosis
in which the corticosteroid is used for the management of the disease in conjunction
with an appropriate anti-tuberculosis regimen. If corticosteroids are indicated
in patients with latent tuberculosis or tuberculin reactivity, close observation
is necessary as reactivation of the disease may occur. During prolonged corticosteroid
therapy, these patients should receive chemoprophylaxis.

Vaccination

Administration of live or live, attenuated vaccines is contraindicated
in patients receiving immunosuppressive doses of corticosteroids. Killed or
inactivated vaccines may be administered. However, the response to such vaccines
cannot be predicted. Immunization procedures may be undertaken in patients
who are receiving corticosteroids as replacement therapy, eg, for Addison’s
disease.

Viral Infections

Chicken pox and measles can have a more serious or even fatal course
in pediatric and adult patients on corticosteroids. In pediatric and adult
patients who have not had these diseases, particular care should be taken
to avoid exposure. The contribution of the underlying disease and/or prior
corticosteroid treatment to the risk is also not known. If exposed to chicken
pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated.
(See the respective package inserts for complete VZIG and IG prescribing information.)
If chicken pox develops, treatment with antiviral agents should be considered.

Neurologic

Epidural and intrathecal administration of this product is not recommended. Reports of serious medical events, including death, have been associated with epidural and intrathecal routes of corticosteroid administration (see


ADVERSE REACTIONS: Gastrointestinal and


Neurologic/Psychiatric).

Ophthalmic

Use of corticosteroids may produce posterior subcapsular cataracts,
glaucoma with possible damage to the optic nerves, and may enhance the establishment
of secondary ocular infections due to bacteria, fungi, or viruses. The use
of oral corticosteroids is not recommended in the treatment of optic neuritis
and may lead to an increase in the risk of new episodes. Corticosteroids should
not be used in active ocular herpes simplex.Adequate studies to demonstrate the safety of Kenalog Injection
use by intraturbinal, subconjunctival, sub-Tenons, retrobulbar, and intraocular
(intravitreal) injections have not been performed. Endophthalmitis, eye inflammation,
increased intraocular pressure, and visual disturbances including vision loss
have been reported with intravitreal administration. Administration
of Kenalog Injection intraocularly or into the nasal turbinates is not recommended.Intraocular injection of corticosteroid formulations containing benzyl alcohol, such as Kenalog Injection, is not recommended because of potential toxicity from the benzyl alcohol.

Intraocular pressure may become elevated in some individuals. If
steroid therapy is continued for more than 6 weeks, intraocular pressure should
be monitored.

Gastrointestinal

Steroids should be used with caution in active or latent peptic
ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative
colitis, since they may increase the risk of a perforation.Signs of peritoneal irritation following gastrointestinal perforation
in patients receiving corticosteroids may be minimal or absent.There is an enhanced effect of corticosteroids in patients with
cirrhosis.

Intra-Articular And Soft Tissue Administration

Intra-articularly injected corticosteroids may be systemically
absorbed.Appropriate examination of any joint fluid present is necessary
to exclude a septic process.A marked increase in pain accompanied by local swelling, further
restriction of joint motion, fever, and malaise are suggestive of septic arthritis.
If this complication occurs and the diagnosis of sepsis is confirmed, appropriate
antimicrobial therapy should be instituted.Injection of a steroid into an infected site is to be avoided.
Local injection of a steroid into a previously infected joint is not usually
recommended.Corticosteroid injection into unstable joints is generally not
recommended.Intra-articular injection may result in damage to joint tissues
(see


ADVERSE REACTIONS: Musculoskeletal).

Musculoskeletal

Corticosteroids decrease bone formation and increase bone resorption
both through their effect on calcium regulation (ie, decreasing absorption
and increasing excretion) and inhibition of osteoblast function. This, together
with a decrease in the protein matrix of the bone secondary to an increase
in protein catabolism, and reduced sex hormone production, may lead to inhibition
of bone growth in pediatric patients and the development of osteoporosis at
any age. Special consideration should be given to patients at increased risk
of osteoporosis (ie, postmenopausal women) before initiating corticosteroid
therapy.

Neuro-Psychiatric

Although controlled clinical trials have shown corticosteroids
to be effective in speeding the resolution of acute exacerbations of multiple
sclerosis, they do not show that they affect the ultimate outcome or natural
history of the disease. The studies do show that relatively high doses of
corticosteroids are necessary to demonstrate a significant effect. (See


DOSAGE AND ADMINISTRATION.)


An acute myopathy has been observed with the use of high doses
of corticosteroids, most often occurring in patients with disorders of neuromuscular
transmission (eg, myasthenia gravis), or in patients receiving concomitant
therapy with neuromuscular blocking drugs (eg, pancuronium). This acute
myopathy is generalized, may involve ocular and respiratory muscles, and may
result in quadriparesis. Elevation of creatinine kinase may occur. Clinical
improvement or recovery after stopping corticosteroids may require weeks to
years.Psychiatric derangements may appear when corticosteroids are used,
ranging from euphoria, insomnia, mood swings, personality changes, and severe
depression to frank psychotic manifestations. Also, existing emotional instability
or psychotic tendencies may be aggravated by corticosteroids.

Information For Patients

Patients should be warned not to discontinue the use of corticosteroids
abruptly or without medical supervision, to advise any medical attendants
that they are taking corticosteroids, and to seek medical advice at once should
they develop fever or other signs of infection.Persons who are on corticosteroids should be warned to avoid exposure
to chicken pox or measles. Patients should also be advised that if they are
exposed, medical advice should be sought without delay.

Drug Interactions

Aminoglutethimide: Aminoglutethimide may lead
to a loss of corticosteroid-induced adrenal suppression.


Amphotericin B injection and potassium-depleting agents: When
corticosteroids are administered concomitantly with potassium-depleting agents
(ie, amphotericin B, diuretics), patients should be observed closely for
development of hypokalemia. There have been cases reported in which concomitant
use of amphotericin B and hydrocortisone was followed by cardiac enlargement
and congestive heart failure.


Antibiotics: Macrolide antibiotics have been reported
to cause a significant decrease in corticosteroid clearance.


Anticholinesterases: Concomitant use of anticholinesterase
agents and corticosteroids may produce severe weakness in patients with myasthenia
gravis. If possible, anticholinesterase agents should be withdrawn at least
24 hours before initiating corticosteroid therapy.


Anticoagulants, oral: Coadministration of corticosteroids
and warfarin usually results in inhibition of response to warfarin, although
there have been some conflicting reports. Therefore, coagulation indices should
be monitored frequently to maintain the desired anticoagulant effect.


Antidiabetics: Because corticosteroids may increase
blood glucose concentrations, dosage adjustments of antidiabetic agents may
be required.


Antitubercular drugs: Serum concentrations of
isoniazid may be decreased.


Cholestyramine: Cholestyramine may increase the
clearance of corticosteroids.


Cyclosporine: Increased activity of both cyclosporine
and corticosteroids may occur when the two are used concurrently. Convulsions
have been reported with this concurrent use.


Digitalis glycosides: Patients on digitalis glycosides
may be at increased risk of arrhythmias due to hypokalemia.


Estrogens, including oral contraceptives: Estrogens
may decrease the hepatic metabolism of certain corticosteroids, thereby increasing
their effect.


Hepatic enzyme inducers (eg, barbiturates, phenytoin,
carbamazepine, rifampin): Drugs which induce hepatic microsomal drug
metabolizing enzyme activity may enhance the metabolism of corticosteroids
and require that the dosage of the corticosteroid be increased.


Ketoconazole: Ketoconazole has been reported to
decrease the metabolism of certain corticosteroids by up to 60%, leading to
an increased risk of corticosteroid side effects.


Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant
use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids
increases the risk of gastrointestinal side effects. Aspirin should be used
cautiously in conjunction with corticosteroids in hypoprothrombinemia. The
clearance of salicylates may be increased with concurrent use of corticosteroids.


Skin tests: Corticosteroids may suppress reactions
to skin tests.


Vaccines: Patients on prolonged corticosteroid
therapy may exhibit a diminished response to toxoids and live or inactivated
vaccines due to inhibition of antibody response. Corticosteroids may also
potentiate the replication of some organisms contained in live attenuated
vaccines. Routine administration of vaccines or toxoids should be deferred
until corticosteroid therapy is discontinued if possible (see


WARNINGS: Infections: Vaccination).

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies have been conducted in animals to determine
whether corticosteroids have a potential for carcinogenesis or mutagenesis.Steroids may increase or decrease motility and number of spermatozoa
in some patients.

Teratogenic Effects: Pregnancy Category C

Corticosteroids have been shown to be teratogenic in many species
when given in doses equivalent to the human dose. Animal studies in which
corticosteroids have been given to pregnant mice, rats, and rabbits have yielded
an increased incidence of cleft palate in the offspring. There are no adequate
and well-controlled studies in pregnant women. Corticosteroids should be used
during pregnancy only if the potential benefit justifies the potential risk
to the fetus. Infants born to mothers who have received corticosteroids during
pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk
and could suppress growth, interfere with endogenous corticosteroid production,
or cause other untoward effects. Caution should be exercised when corticosteroids
are administered to a nursing woman.

Pediatric Use

This product contains benzyl alcohol as a preservative. Benzyl
alcohol, a component of this product, has been associated with serious adverse
events and death, particularly in pediatric patients. The “gasping
syndrome” (characterized by central nervous system depression, metabolic
acidosis, gasping respirations, and high levels of benzyl alcohol and its
metabolites found in the blood and urine) has been associated with benzyl
alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional
symptoms may include gradual neurological deterioration, seizures, intracranial
hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure,
hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic
doses of this product deliver amounts of benzyl alcohol that are substantially
lower than those reported in association with the “gasping syndrome,”
the minimum amount of benzyl alcohol at which toxicity may occur is not known.
Premature and low-birth-weight infants, as well as patients receiving high
dosages, may be more likely to develop toxicity. Practitioners administering
this and other medications containing benzyl alcohol should consider the combined
daily metabolic load of benzyl alcohol from all sources.The efficacy and safety of corticosteroids in the pediatric population
are based on the well-established course of effect of corticosteroids which
is similar in pediatric and adult populations. Published studies provide evidence
of efficacy and safety in pediatric patients for the treatment of nephrotic
syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month
of age). Other indications for pediatric use of corticosteroids, eg, severe
asthma and wheezing, are based on adequate and well-controlled trials conducted
in adults, on the premises that the course of the diseases and their pathophysiology
are considered to be substantially similar in both populations.The adverse effects of corticosteroids in pediatric patients are
similar to those in adults (see


ADVERSE REACTIONS).
Like adults, pediatric patients should be carefully observed with frequent
measurements of blood pressure, weight, height, intraocular pressure, and
clinical evaluation for the presence of infection, psychosocial disturbances,
thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients
who are treated with corticosteroids by any route, including systemically
administered corticosteroids, may experience a decrease in their growth velocity.
This negative impact of corticosteroids on growth has been observed at low
systemic doses and in the absence of laboratory evidence of HPA axis suppression
(ie, cosyntropin stimulation and basal cortisol plasma levels). Growth velocity
may therefore be a more sensitive indicator of systemic corticosteroid exposure
in pediatric patients than some commonly used tests of HPA axis function.
The linear growth of pediatric patients treated with corticosteroids should
be monitored, and the potential growth effects of prolonged treatment should
be weighed against clinical benefits obtained and the availability of treatment
alternatives. In order to minimize the potential growth effects of corticosteroids,
pediatric patients should be


titrated to the lowest effective
dose.

Geriatric Use

No overall differences in safety or effectiveness were observed
between elderly subjects and younger subjects, and other reported clinical
experience has not identified differences in responses between the elderly
and younger patients, but greater sensitivity of some older individuals cannot
be ruled out.

Adverse Reactions

(listed alphabetically under each subsection)The following adverse reactions may be associated with corticosteroid
therapy:Allergic reactions: Anaphylaxis including death, angioedema.


Cardiovascular: Bradycardia, cardiac arrest, cardiac
arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure,
fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants,
myocardial rupture following recent myocardial infarction (see


WARNINGS), pulmonary edema, syncope, tachycardia,
thromboembolism, thrombophlebitis, vasculitis.


Dermatologic: Acne, allergic dermatitis, cutaneous
and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema,
erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased
sweating, lupus erythematosus-like lesions, purpura, rash, sterile abscess,
striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp
hair, urticaria.


Endocrine: Decreased carbohydrate and glucose
tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis,
increased requirements for insulin or oral hypoglycemic agents in diabetes,
manifestations of latent diabetes mellitus, menstrual irregularities, secondary
adrenocortical and pituitary unresponsiveness (particularly in times of stress,
as in trauma, surgery, or illness), suppression of growth in pediatric patients.


Fluid and electrolyte disturbances: Congestive
heart failure in susceptible patients, fluid retention, hypokalemic alkalosis,
potassium loss, sodium retention.


Gastrointestinal: Abdominal distention, bowel/bladder
dysfunction (after intrathecal administration [see


WARNINGS: Neurologic]), elevation in serum liver enzyme
levels (usually reversible upon discontinuation), hepatomegaly, increased
appetite, nausea, pancreatitis, peptic ulcer with possible perforation and
hemorrhage, perforation of the small and large intestine (particularly in
patients with inflammatory bowel disease), ulcerative esophagitis.


Metabolic: Negative nitrogen balance due to protein
catabolism.


Musculoskeletal: Aseptic necrosis of femoral and
humeral heads, calcinosis (following intra-articular or intralesional use),
Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis,
pathologic fracture of long bones, post injection flare (following intra-articular
use), steroid myopathy, tendon rupture, vertebral compression fractures.


Neurologic/Psychiatric: Convulsions, depression,
emotional instability, euphoria, headache, increased intracranial pressure
with papilledema (pseudotumor cerebri) usually following discontinuation of
treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality
changes, psychiatric disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia,
and sensory disturbances have occurred after intrathecal administration. Spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke (including brainstem) have been reported after epidural administration of corticosteroids (see


WARNINGS: Neurologic).


Ophthalmic: Exophthalmos, glaucoma, increased
intraocular pressure, posterior subcapsular cataracts, rare instances of blindness
associated with periocular injections.


Other: Abnormal fat deposits, decreased resistance
to infection, hiccups, increased or decreased motility and number of spermatozoa,
malaise, moon face, weight gain.

Overdosage

Treatment of acute overdosage is by supportive and symptomatic
therapy. For chronic overdosage in the face of severe disease requiring continuous
steroid therapy, the dosage of the corticosteroid may be reduced only temporarily,
or alternate day treatment may be introduced.

Systemic

The suggested initial dose is 60 mg,


injected deeply into
the gluteal muscle. Atrophy of subcutaneous fat may occur if the injection
is not properly given. Dosage is usually adjusted within the range of 40 mg to
80 mg, depending upon patient response and duration of relief. However, some
patients may be well controlled on doses as low as 20 mg or less.


Hay fever or pollen asthma: 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
a single injection of 40 mg to 100 mg.In the treatment of acute exacerbations of multiple sclerosis,
daily doses of 160 mg of triamcinolone for a week followed by 64 mg every
other day for one month are recommended (see


PRECAUTIONS:
Neuro-Psychiatric).


In pediatric patients, the initial dose of triamcinolone may vary
depending on the specific disease entity being treated. The range of initial
doses is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 to 48 mg/m


2bsa/day).


For the purpose of comparison, the following is the equivalent
milligram dosage of the various glucocorticoids:Cortisone, 25Triamcinolone, 4Hydrocortisone, 20Paramethasone, 2Prednisolone, 5Betamethasone, 0.75Prednisone, 5Dexamethasone,
0.75Methylprednisolone,
4These dose relationships apply only to oral or intravenous
administration of these compounds. When these substances or their derivatives
are injected intramuscularly or into joint spaces, their relative properties
may be greatly altered.

For systemic therapy, injection should be made


deeply into
the gluteal muscle (see


WARNINGS).
For adults, a minimum needle length of 1½ inches is recommended. In obese
patients, a longer needle may be required. Use alternative sites for subsequent
injections.

Local

Intra-articular administration: A single local injection
of triamcinolone acetonide is frequently sufficient, but several injections
may be needed for adequate relief of symptoms.


Initial dose: 2.5 mg to 5 mg for smaller joints and from
5 mg to 15 mg for larger joints, depending on the specific disease entity being
treated. For adults, doses up to 10 mg for smaller areas and up to 40 mg for
larger areas have usually been sufficient. Single injections into several
joints, up to a total of 80 mg, have been given.

For treatment of joints, the usual intra-articular injection technique
should be followed. If an 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 dilution of the steroid.With intra-articular administration, prior use of a local anesthetic
may often be desirable. Care should be taken with this kind of injection,
particularly in the deltoid region, to avoid injecting the suspension into
the tissues surrounding the site, since this may lead to tissue atrophy.In treating acute nonspecific tenosynovitis, care should be taken
to ensure that the injection of the corticosteroid is made into the tendon
sheath rather than the tendon substance. Epicondylitis may be treated by infiltrating
the preparation into the area of greatest tenderness.

How Supplied

Kenalog


®-40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL.


40 mg/mL, 1 mL vialNDC 0003-0293-0540 mg/mL, 5 mL vialNDC 0003-0293-2040 mg/mL, 10 mL vialNDC 0003-0293-28

Storage

Store at controlled room temperature, 20°–25°C
(68°–77°F), avoid freezing and protect from light. Do not refrigerate.

Other

Bristol-Myers Squibb Company


Princeton, NJ 08543 USA


Product of Italy


1221153A5Rev August 2011

* Please review the disclaimer below.