Triamcinolone 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

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 triamcinolone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to triamcinolone 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 triamcinolone'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 triamcinolone, 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 triamcinolone 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 triamcinolone 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 triamcinolone 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 triamcinolone. 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 triamcinolone.

A nurse or other trained health professional will give you triamcinolone. You may also be taught how to give your medicine at home. triamcinolone is given as a shot into one of your muscles, a joint, or a spot on your skin called a lesion.

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

triamcinolone 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.

triamcinolone 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 triamcinolone.

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.

triamcinolone 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 triamcinolone 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 triamcinolone: 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 triamcinolone.

Talk with your doctor before getting flu shots or other vaccines while you or your child are receiving triamcinolone 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 triamcinolone. The results of some tests may be affected by triamcinolone.

Do not stop using triamcinolone 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

triamcinolone may cause slow growth. If your child is using triamcinolone, 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.

Triamcinolone acetonide injectable suspension, USP is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. THIS FORMULATION IS SUITABLE FOR INTRA-ARTICULAR AND INTRALESIONAL USE ONLY.

Each mL of the sterile aqueous suspension provides 10 mg triamcinolone acetonide, with sodium chloride for isotonicity, 0.94% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80; sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 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:

M.W. 434.5

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).

Because triamcinolone acetonide injectable suspension is a suspension, it should not be administered intravenously. Strict aseptic technique is mandatory.

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.

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.

Triamcinolone acetonide injectable suspension is a long-acting preparation, and is not suitable for use in acute stress situations.

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 triamcinolone acetonide injectable suspension should not be used for the treatment of traumatic brain injury.

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. 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.

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.

Infections

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.

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).

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 Strongyloideshyperinfection 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.

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.

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, e.g., for Addison’s disease.

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 triamcinolone acetonide injectable suspension 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 triamcinolone acetonide injectable suspension, USP intraocularly or into the nasal turbinates is not recommended.

Intraocular injection of corticosteroid formulations containing benzyl alcohol such as triamcinolone acetonide injectable suspension, USP, is not recommended because of potential toxicity from the benzyl alcohol.