Triamcot Injection

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

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome, low blood pressure, and metabolic acidosis) to newborn or premature infants. Discuss this with your doctor if you are concerned.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

Let your doctor know if you or your child have any events causing unusual stress or anxiety in your life. Your doctor may give you oral corticosteroids.

This medicine may cause fluid retention (edema) in some patients. Carefully follow your doctor's instructions about any special diet (especially on salt intake).

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, pounding, or uneven heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

It may be easier for you to get an infection while you or your child are receiving triamcinolone. Avoid crowded places or being near people who are sick. If you are exposed to chicken pox or measles, tell your doctor right away.

Tell your doctor if you or your child have recently spent time in a tropical climate or have unexplained diarrhea before receiving this medicine.

Talk with your doctor before getting flu shots or other vaccines while you or your child are receiving this medicine because there are certain vaccines that you should not receive.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Before you have any skin tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not stop using this medicine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

Consult your pharmacist.

How to use Triamcot Suspension

Consult your pharmacist.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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