Kenalog-40

In the U.S.

• Aristocort
• Aristocort Forte
• Aristospan
• Clinacort
• Kenalog-10
• Kenalog-40
• Triamcot
• Triam-Forte
• Triesense

Available Dosage Forms:

• Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Triamcinolone injection is used to treat inflammation (swelling), allergic reactions, certain types of arthritis, gout, skin diseases, and many other medical problems. It is given to patients who are not able to take medicines by the mouth. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is to be administered only by or under the immediate supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triamcinolone injection in the pediatric population. However, because of this medicine's toxicity, it should be used with caution especially in premature babies.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triamcinolone injection in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aldesleukin
• Bemiparin
• Ceritinib
• Idelalisib
• Nadroparin
• Pixantrone
• Ritonavir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Aspirin
• Atracurium
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Phenytoin
• Primidone
• Saiboku-To

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (e.g., osteoporosis) or
• Cataracts or
• Cirrhosis (liver problem) or
• Congestive heart failure or
• Depression or
• Emotional problems or
• Glaucoma or
• Heart attack, recent or
• Heart disease or
• Hypertension (high blood pressure) or
• Intracranial hypertension (increased pressure in the head) or
• Kaposi's sarcoma or
• Kidney disease, severe or
• Mental illness or
• Myasthenia gravis (severe muscle weakness) or
• Stomach or bowel problems (e.g., diverticulitis, ulcers, ulcerative colitis) or
• Thyroid problems—Use with caution. May make these conditions worse.

• Brain injury, traumatic or
• Cerebral malaria or
• Herpes infection of the eye or
• Idiopathic thrombocytopenic purpura (low platelet count)—Should not be used in patients with this condition.

• Infection (bacteria, virus, fungus, parasite, or protozoa)—May decrease your body's ability to fight infection.

• Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.

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

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

• Aggression
• agitation
• anxiety
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mental depression
• mood changes
• nervousness
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• shortness of breath
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• Abdominal cramping and/or burning (severe)
• abdominal pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of skin
• decreased vision
• diarrhea
• dry mouth
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fatigue
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn and/or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sleeplessness
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

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

• Blemishes on the skin
• bruising
• dry, scaly skin
• feeling of constant movement of self or surroundings
• full or bloated feeling
• increased appetite
• increased hair growth on the face, forehead, back, arms, and legs
• large, flat, blue, or purplish patches in the skin
• pimples
• pitting or depression of the skin at the injection site
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness of the skin
• redness, swelling, tenderness, or pain at the injection site
• sensation of spinning
• small, red, or purple spots on the skin
• thin, fragile, or shiny skin
• thinning of the scalp hair

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

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

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 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% 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:

MW 434.50

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.

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.

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.

(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: Serious Neurologic Adverse Reactions with Epidural Administration and 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.