Kenalog-10 injection

(listed alphabetically under each subsection)

The following adverse reactions may be associated with corticosteroid therapy:

Allergic reactions: Anaphylactoid reaction, anaphylaxis including anaphylactic reactions and anaphylactic shock, 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.

Your doctor or pharmacist can provide more information about triamcinolone injection.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• Allergy Drugs: Prescription and OTC
• Pain Management Medication Types
• Psoriatic Arthritis
• Reactive Arthritis
• Rheumatoid Arthritis (RA)
• Septic Arthritis

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

Triamcinolone injection is used to treat many different types of inflammatory conditions, including severe allergic reactions, severe colitis, blood cell disorders, inflammatory eye disorders, lung disorders, acute gouty arthritis, rheumatic arthritis, and problems caused by low adrenal gland hormones.

Triamcinolone injection is also used to treat inflammation of the joints or tendons to treat arthritis, bursitis, or epicondylitis (tennis elbow). It is usually given in these conditions only as a short-term treatment of a severe or aggravated episode.

Triamcinolone is also used to treat certain skin disorders caused by autoimmune conditions such as lupus, psoriasis, lichen planus, and others.

Triamcinolone injection may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss an appointment for a scheduled triamcinolone injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

An overdose of triamcinolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• (after injection into a joint space) increased pain or swelling, joint stiffness, fever, and general ill feeling;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• unusual changes in mood or behavior;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• stomach cramps, vomiting, diarrhea, bloody or tarry stools, rectal irritation;

• fast or slow heartbeats;

• sudden numbness or weakness (especially on one side of the body);

• a seizure (convulsions);

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety;

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or

• signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, joint or muscle pain, craving salty foods, irritability, nausea, vomiting, loss of appetite, diarrhea, and weight loss.

Common side effects may include:

• skin changes (acne, dryness, redness, discoloration);

• increased hair growth, or thinning hair;

• nausea, bloating, appetite changes;

• stomach or side pain;

• headache, sleep problems (insomnia);

• a wound that is slow to heal;

• sweating more than usual; or

• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 Kenalog-10) 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 Kenalog-10 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.