Package leaflet: Information for the patient

KENACORT 40 mg/ml injectable suspension

Triamcinolone Acetonide
Please read this leaflet carefully before using/giving this medicine to the child because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What KENACORT is and what it is used for
What you need to know before using/giving KENACORT to the child
How to use/give KENACORT to the child
Possible side effects
How to store KENACORT
Contents of the pack and other information

1. What KENACORT is and what it is used for

KENACORT contains the active substance triamcinolone acetonide and belongs to a group of medicines called systemic corticosteroids, which act against inflammation.
KENACORT is used in adults and children over 6 years of age, and is administered
➢ by intramuscular route (injection given directly into the muscles) when oral therapy is not possible, to treat:

allergies, particularly in cases of severe or debilitating conditions that cannot be treated with conventional therapies
dermatoses, skin diseases characterized by the appearance of pale pink spots that tend to desquamate
generalized rheumatoid arthritis, a disease affecting the joints causing pain, swelling, and stiffness
other connective tissue diseases (the tissue that connects parts of the body).
➢ by intra-articular route (injection given directly into the joint) or by intrabursal route (injection given directly into the fluid-filled sacs located where a tendon or ligament rubs against other tissue within the joints, known as bursae), for short-term treatment of:
pain, swelling, and stiffness occurring locally in the joints due to certain inflammatory diseases (e.g. traumatic arthritis, rheumatoid arthritis, osteoarthritis, synovitis, bursitis). In the case of generalized arthritic diseases, KENACORT is used as an adjunct to treatment with other medicines, especially through injection into a joint.

2. What you need to know before using/giving KENACORT to a child

Do not use/give KENACORT to a child

if he/she is allergic to triamcinolone acetonide or to any of the other ingredients of this medicine (listed in section 6)
if he/she has an ongoing infection spreading from the site of infection throughout the body (systemic infection)
if the child is under two years of age (see also section Children and adolescents)
in case of intramuscular administration, if he/she suffers from a blood coagulation disorder that may lead to easy bruising and excessive bleeding (idiopathic thrombocytopenic purpura).

Warnings and precautions
Talk to your doctor or pharmacist before using KENACORT if you/the child:

have thyroid problems (a gland in the neck) causing lower hormone production than normal (hypothyroidism), or if you suffer from liver disease (hepatic cirrhosis). In these cases, the response to the medicine may be increased
suffer from an eye infection caused by the herpes simplex virus, as corneal perforation (a transparent membrane located in the front part of the eye) may occur. Prolonged use may lead to serious eye problems (posterior subcapsular cataract or glaucoma) and increase the risk of eye infections
suffer from depression or a mental illness. The use of this medicine may worsen pre-existing instability. The use of antidepressant drugs does not relieve such disorders and may worsen mental disturbances induced by the medicine, which may include euphoria, insomnia, mood and personality changes, severe depression, or symptoms of actual psychiatric disorders
suffer from intestinal inflammation (non-specific ulcerative colitis) with risk of perforation
have accumulations of pus forming within a tissue (abscesses) and infections caused by pyogenic organisms (germs that penetrate tissues and produce pus)
suffer from inflammation of one or more diverticula (pouches forming in the intestine at the level of the colon)
have recently undergone surgery to connect two sections of the intestine (intestinal anastomosis)
have an active or latent (i.e., without symptom manifestation) peptic ulcer (lesion of the stomach or intestinal mucosa); in case of prolonged therapy, an antacid may be prescribed
suffer from kidney disease (renal insufficiency, acute glomerulonephritis, or chronic nephritis), as fluid retention (edema) may occur
suffer from high blood pressure (hypertension). Your doctor may prescribe a low-salt diet and potassium supplements
have a heart that does not pump enough blood to meet the body's needs (congestive heart failure)
suffer from vein inflammation (thrombophlebitis)
suffer from blood clot formation within veins (thromboembolic episodes)
suffer from reduced bone mass (osteoporosis)
have skin rashes (exanthema)
suffer from a condition characterized by weight gain, fluid retention, skin striae, and abnormal hair growth due to excess corticosteroids (Cushing's syndrome)
have diabetes mellitus
suffer from seizure disorders
have a malignant tumor with metastases (cells detaching from the original tumor and spreading to other organs)
suffer from a disease affecting muscles, progressively causing loss of tone and strength (myasthenia gravis)
are elderly. Your doctor will monitor you during treatment with KENACORT, as some adverse effects such as osteoporosis (reduced bone mass) or hypertension (high blood pressure), common during corticosteroid therapy, may have more serious consequences in elderly patients
have a history of allergic reactions to drugs, as this medicine may rarely cause severe allergic reactions
are under particular stress (such as trauma, surgery, or serious illness); in such cases, your doctor may prescribe additional appropriate therapy. During prolonged treatment, adequate protein intake is essential to avoid excessive weight loss and weakness.

Contact your doctor if blurred vision or other visual disturbances occur.
Female patients should be informed that menstrual irregularities may occur, and vaginal bleeding may occur in post-menopausal women. If deemed appropriate by the doctor, suitable diagnostic tests will be recommended.
In case of intra-articular administration
In case of intra-articular administration, you/the child should pay particular attention:

not to overuse the treated joints for which symptom improvement has been achieved, as they could further deteriorate
if an increase in pain associated with local swelling, greater difficulty moving the joint, fever, and malaise occurs. These could be signs of an ongoing joint infection (see section 4. Possible side effects). In such a case, consult your doctor immediately, who will decide whether to discontinue treatment with KENACORT and initiate an alternative appropriate therapy.

KENACORT and other diseases
Corticosteroid medicines may mask infection symptoms and infections may occur simultaneously during their use. During corticosteroid therapy, the body's defense capabilities may be reduced, and it may be difficult to identify the site of infection. Moreover, if you are taking medicines that suppress the body's defenses, including corticosteroids, you are more susceptible to infections than those not taking these drugs.
Therefore, inform your doctor if you/the child:

have chickenpox or measles in progress. These infectious diseases may worsen or even lead to death. Avoid exposure to these diseases for yourself and the child during corticosteroid treatment if you have not previously had them. If exposure occurs, inform your doctor, as appropriate therapy will need to be initiated
have an ongoing pinworm infestation (a disease caused by a very small worm capable of penetrating intact skin). You may develop intestinal inflammation and severe infections that could even lead to death
are about to receive a vaccine, as due to lowered defenses you may be more prone to complications
suffer from active tuberculosis (an infectious disease caused by the bacterium Mycobacterium tuberculosis, which usually develops in the lungs). Your doctor may prescribe appropriate anti-tuberculosis therapy in addition to KENACORT
suffer from latent tuberculosis or have a positive tuberculin reaction (bacterial extracts used for disease diagnosis). Your doctor will prescribe preventive therapy (chemoprophylaxis) with drugs to prevent possible infection.

For those engaged in sports
Using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
KENACORT contains 9.9 mg/ml of benzyl alcohol; therefore, this medicine must not be given to premature infants or newborns. KENACORT is contraindicated in children under two years of age and may cause toxic and allergic reactions in children up to 3 years of age.
Benzyl alcohol, if taken in excessive amounts, may cause a condition called "gasping syndrome," characterized by effects such as:

depression of the nervous system
gasping respiration
uncontrolled body movements (convulsions)
bleeding in the head
hypotension (low blood pressure), especially in newborns
metabolic acidosis (increased levels of acid in the blood), especially in newborns
slow heartbeat (bradycardia). Additionally, due to the presence of benzyl alcohol, the child may experience:
an increased risk of kernicterus (yellowish discoloration of the skin, sclera, and mucous membranes caused by excessive elevation of bilirubin levels in the blood), especially in premature infants
rare cases of death, particularly in premature infants.

KENACORT is not recommended in children under 6 years of age.
If the child is undergoing long-term corticosteroid treatment, the doctor must carefully monitor his/her development, as corticosteroids may slow growth (see section 4. Additional side effects in children).
Children must not be vaccinated or immunized during corticosteroid therapy, as these substances may affect the body's steroid production.
Other medicines and KENACORT
Inform your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you/the child are taking any of the following medicines:

amphotericin B (a drug used to treat fungal infections) or other substances that cause a decrease in blood potassium levels
anticholinesterases (medicines that inhibit acetylcholine breakdown, used for certain gastrointestinal and respiratory disorders, postoperative vomiting, vomiting during pregnancy, etc.)
oral anticoagulants (medicines to make blood less viscous)
antidiabetics (medicines used to treat diabetes, characterized by high blood glucose levels)
antituberculosis medicines (medicines used to treat tuberculosis, an infectious disease caused by Mycobacterium tuberculosis, usually developing in the lungs)
cyclosporine (a medicine that suppresses the immune system, used to prevent organ transplant rejection)
digitalis glycosides (drugs used to increase the heart's contraction force)
estrogens (female sex hormones), including oral contraceptives (the pill)
liver enzyme inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampicin), medicines that affect liver function
human growth hormone (e.g., somatrem), a hormone promoting height growth
muscle relaxants (drugs capable of reducing muscle tone)
NSAIDs, non-steroidal anti-inflammatory drugs (used to treat inflammation, pain, and fever)
thyroid drugs (medicines used to treat thyroid disorders)
vaccines (products that stimulate patients' immune systems to build specific resistance to infections)
acetylsalicylic acid (a drug used to make blood less viscous or to treat inflammation, pain, and fever), as if you suffer from low prothrombin levels (a protein involved in blood clotting processes) in the blood, your doctor will carefully evaluate whether to prescribe KENACORT
drugs that inhibit an enzyme in the body (cytochrome P450 3A4) such as ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Your doctor will evaluate the benefit-risk ratio for you and/or the fetus, breastfeeding newborn, or child.
If you have used high doses of KENACORT during pregnancy, your baby must be carefully monitored, as he/she may develop impaired adrenal gland function (glands located above the kidneys) with reduced production of one or more hormones (adrenal insufficiency).
Driving and using machines
During KENACORT treatment, you may experience adverse effects such as dizziness. If these symptoms occur, do not drive or operate machinery.
KENACORT contains benzyl alcohol and sodium
KENACORT contains 9.9 mg/ml of benzyl alcohol. Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems (gasping syndrome), in young children.
Do not administer to newborns up to 4 weeks of age unless otherwise recommended by a doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist.
Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
KENACORT contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially "sodium-free".

3. How to use/administer KENACORT to the child

Use/administer this medicine to the child exactly as directed by the doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
The doctor will determine the most appropriate dose for the child based on the condition being treated, the route of administration, age, and response to treatment.
The recommended initial dose may range from 2.5 to 60 mg per day, depending on the specific condition being treated.

Intramuscular administration
Adults and children over 12 years
The recommended initial dose is 60 mg.
The maintenance dose is generally between 40 and 80 mg, depending on the response to treatment and the time required for symptom improvement. In some cases, lower doses of 20 mg or less may be sufficient.
If you/the child suffer from hay fever (an allergic reaction of the mucous membranes of the eyes, nose, and respiratory tract to seasonal pollen) or pollen-induced asthma (generally reversible obstruction of the lower airways caused by exposure to pollen), a single injection of 40–100 mg of KENACORT may be sufficient to achieve symptom remission lasting throughout the entire pollen season.

Children aged 6 to 12 years
The recommended initial dose is 40 mg.
The doctor will determine the most appropriate dose for the child based on age, condition being treated, route of administration, and response to treatment.

Intra-articular or intrabursal administration
The doctor will determine the most appropriate dose for you based on the condition being treated, the route of administration, age, and response. See the information provided at the end of this leaflet.

Method of administration

Use the product under strictly sterile conditions.
Shake the vial well before use to ensure uniformity of the preparation and absence of aggregates. Do not expose the product to low temperatures, as this may cause aggregation; if this occurs, do not use the product.
Withdraw the suspension from the vial using a syringe.
Administer the injection immediately after withdrawal to prevent deposits forming in the syringe. Take all necessary precautions to avoid the risk of infection or accidental intravascular needle insertion.

In case of intramuscular administration
For intramuscular administration, inject deeply into the gluteal muscles. Otherwise, moderate to marked thinning of the subcutaneous fat may occur. The gluteal site is preferred over the deltoid (shoulder muscle), as local atrophy (reduction in muscle mass) occurs more frequently at the deltoid site.
For adults, it is recommended to use a needle of at least 4 cm in length, or longer in obese individuals, and to change the injection site with each subsequent dose.

In case of intra-articular or intrabursal administration
The medicine will be administered by an experienced physician. See the information provided at the end of this leaflet.

Use in children
KENACORT must not be administered to children under 2 years of age (see section 2 “Children and adolescents”) and its administration is not recommended in children under 6 years of age.

If you use/administer more KENACORT than you should
If you give the child too much KENACORT, contact your doctor or go to hospital immediately.
If high doses of the medicine are taken for a prolonged period, the following symptoms may occur:

confusion
anxiety
depression
cramps (sudden, severe muscle pains)
stomach and/or intestinal bleeding
bruising
moon-shaped face
increased blood pressure

If you forget to use/administer KENACORT to the child
Do not use a double dose to make up for the missed dose.

If you stop treatment with KENACORT
If you discontinue the medicine after a long period of therapy, gradual withdrawal rather than abrupt cessation is recommended. Sudden discontinuation may result in adrenal insufficiency (inability of the adrenal glands to produce sufficient cortisol, an essential hormone for the body), which may also occur under conditions of stress.
After stopping KENACORT therapy, the symptoms of the disease for which treatment was given may suddenly reappear; therefore, the doctor will monitor you closely even after treatment has ended.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you or the child experience any of the following side effects, STOP treatment with this medicine immediately and contact your doctor straight away, who will advise you on the most appropriate therapy to follow:

severe, rapidly occurring allergic reactions (anaphylaxis) or a serious allergic reaction that may be life-threatening (anaphylactic shock)
increased pain associated with local swelling, greater difficulty moving the joint, fever, and malaise. These could be signs of an ongoing joint infection.

The following side effects may occur during treatment with KENACORT, listed below according to their frequency of occurrence:

Common (may affect up to 1 in 10 people)

infection
headache
clouding of the lens of the eye, which focuses images (cataract)
reactions at the injection site

Uncommon (may affect up to 1 in 100 people)

accumulation of pus at the injection site (sterile abscess), masking of infections
reactions presenting with symptoms similar to allergic reactions but not involving the immune system, the body's defense system (anaphylactoid reaction)
Cushing-like syndrome, characterized by: moon face, buffalo hump, central obesity, increased body hair, irritability (Cushingoid appearance); suppression of adrenal gland function (glands located above the kidneys)
fluid or sodium retention, reduced blood acidity due to potassium deficiency (hypokalemic alkalosis), elevated blood sugar levels (hyperglycemia, diabetes mellitus), which may not respond to treatment (inadequate control of diabetes mellitus)
psychiatric disorders, depression, euphoric mood, mood swings, personality changes, insomnia
uncontrolled body movements (seizures), transient fainting (syncope), increased pressure within the skull without underlying disease (benign intracranial hypertension), nerve inflammation (neuritis), tingling (paresthesia)
blindness, condition characterized by increased pressure of the fluid inside the eye (glaucoma), protruding eyes (exophthalmos), perforation of the transparent membrane of the eye (cornea)
dizziness
weakening of the heart, resulting in insufficient blood flow to meet the body's needs (congestive heart failure), heart rhythm disorders (arrhythmia)
high blood pressure (hypertension), blockage of a blood vessel (embolism), vein inflammation associated with blood clot formation (thrombophlebitis), chronic inflammation of blood vessels (necrotizing vasculitis)
damage to the mucosa of the stomach or intestine (peptic ulcer), possibly accompanied by perforation and bleeding, inflammation of the pancreas (pancreatitis), an organ involved in digestive processes, bloated abdomen, inflammation of the esophageal mucosa (the tube connecting mouth to stomach) associated with ulcer formation (ulcerative esophagitis)
hives, skin rash, dark and light skin patches, thinning of the skin, skin fragility, small hemorrhages caused by blood leakage from small blood vessels (petechiae), bruising (ecchymoses), skin redness (erythema), increased sweating (hyperhidrosis), appearance of spots on the skin of varying sizes and colors ranging from bright red to purple or reddish-brown (purpura), stretch marks (striae cutis), presence in women of coarse, thick hair growth in male-typical areas (hirsutism), skin eruptions resembling boils (acneiform dermatitis), red, raised lesions often localized on the face (cutaneous lupus erythematosus)
loss of bone mass (osteoporosis), bone death (osteonecrosis), fracture of bones weakened by another disease (pathological fracture), delayed fracture healing, musculoskeletal discomfort, muscle weakness, muscle disease (myopathy), loss of muscle mass (muscle atrophy), growth retardation, an inflammatory condition characterized by resorption of foot joint bones (neuropathic arthropathy)
elevated sugar levels in urine (glycosuria)
irregular or absent menstrual periods (amenorrhea), vaginal bleeding after menopause (postmenopausal hemorrhage)
inflammation of the tissue lining the joints (synovitis), pain, irritation at injection site, discomfort at injection site, fatigue, incomplete healing
decreased potassium levels in blood, changes in electrocardiogram (ECG – a graphical recording of the heart's electrical activity), reduced glucose tolerance, negative nitrogen balance (more nitrogen is lost than taken in), increased intraocular pressure, interference with laboratory tests
compression fractures of one or more spinal vertebrae (compressive vertebral fractures)

Frequency not known (frequency cannot be estimated from available data)

hiccups
blurred vision
visual disturbances

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KENACORT

Do not store above 25°C. Do not freeze.
Keep the vials in an upright position.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice the presence of aggregates.

6. Package Contents and Other Information

What KENACORT Contains

The active substance is: triamcinolone acetonide. Each vial contains 40 mg of triamcinolone acetonide.
The other components are: sodium carboxymethylcellulose, sodium chloride, polysorbate 80, benzyl alcohol (see section “KENACORT contains benzyl alcohol”), and water for injections, hydrochloric acid/sodium hydroxide (pH regulators).

Description of the Appearance of KENACORT and Contents of the Package
KENACORT is a parenteral suspension for intramuscular and intra-articular use.
KENACORT is available in packs containing 3 vials of 1 ml injectable suspension.
Marketing Authorization Holder
BRISTOL-MYERS SQUIBB S.r.l.
Piazzale dell’Industria 40/46
Rome - Italy
Manufacturer
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina N. 41
03012 ANAGNI (FR) - Italy
or
Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations,
External Manufacturing Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867, Ireland
The following information is intended for physicians and healthcare professionals:

Therapeutic Indications
Intramuscular administration of KENACORT is indicated for systemic corticosteroid therapy in pathological conditions such as allergic syndromes (to control severe or debilitating conditions not amenable to conventional treatment), dermatoses, generalized rheumatoid arthritis, and other connective tissue disorders. The intramuscular route is particularly useful in the above-mentioned diseases when oral corticosteroid therapy is not feasible.
KENACORT may also be administered by intra-articular or intrabursal injection. These routes allow effective short-term local treatment of pain, swelling, and joint stiffness associated with traumatic or rheumatoid arthritis, osteoarthritis, synovitis, and bursitis.
In the treatment of generalized arthritic diseases, intra-articular injection of triamcinolone acetonide should be considered as an adjunct to other conventional therapeutic measures. Localized pathological processes such as traumatic arthritis or bursitis may represent typical indications for therapy exclusively via the intra-articular route.

Precautions for Use
Although KENACORT may improve symptoms of inflammation, the underlying cause should be identified and treated.
Intra-articular administration of a corticosteroid may produce systemic as well as local effects. Accidental injection of the suspension into periarticular soft tissues may also lead to systemic effects and is the most common cause of local therapeutic failure. Patients undergoing intra-articular treatment should avoid excessive strain on joints that have shown symptomatic improvement, as this may lead to increased joint deterioration.
During intra-articular administration, overdistension of the joint capsule and leakage of steroid along the needle track should be avoided, as subcutaneous atrophy may occur.
Avoid injecting the preparation into unstable joints. In some cases, repeated intra-articular injections may themselves cause joint instability. In selected cases, especially after repeated administrations, radiographic evaluation is recommended. Intra-articular injection rarely causes joint discomfort. An increase in pain accompanied by local swelling, further limitation of joint mobility, fever, or malaise should raise suspicion of septic arthritis. If confirmed, corticosteroid administration must be discontinued and appropriate antibacterial therapy promptly initiated, continuing for 7 to 10 days after resolution of all signs of infection.
Avoid intra-articular injection in joints previously affected by infectious processes. Edema may occur in the presence of renal dysfunction with reduced glomerular filtration rate.
During prolonged therapy, adequate protein intake is essential to counteract the tendency toward gradual weight loss, sometimes associated with negative nitrogen balance, weight loss, and skeletal muscle weakness.
In peptic ulcer disease, recurrence may remain asymptomatic until perforation or hemorrhage occurs.
Prolonged corticosteroid therapy may cause hyperacidity or peptic ulceration; therefore, administration of an antacid is recommended.

Special Warnings
KENACORT is a long-acting preparation and is not recommended for acute conditions.
This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. "Gasping syndrome" has been linked to benzyl alcohol. Although normal therapeutic doses of this product release amounts of benzyl alcohol substantially lower than those reported in association with "gasping syndrome," the minimum dose of benzyl alcohol that may cause toxicity is unknown. Premature infants and low-birth-weight neonates, as well as patients receiving high doses, may be more susceptible to toxicity.
Due to the presence of benzyl alcohol, the product must not be administered to children under two years of age.
Do not inject intravenously, as this is a suspension.
No studies have demonstrated the safety of KENACORT administered via intranasal (turbinates), subconjunctival, sub-tendon, retrobulbar, or intraocular (intravitreal) routes.
Following intravitreal administration, endophthalmitis, ocular inflammation, increased intraocular pressure, chorioretinopathy (including crystal deposit maculopathy), viral chorioretinitis/retinitis (primarily cytomegalovirus), and visual disturbances including vision loss have been reported. Numerous cases of blindness have been reported following injections of corticosteroid suspensions into nasal turbinates or into the head region. Administration of KENACORT (Triamcinolone Acetonide Injectable Suspension) is not recommended and is not indicated for any of these routes of administration.
Epidural or intrathecal administration of KENACORT must not be used. Serious adverse events have been associated with epidural or intrathecal administration.
Severe anaphylactic reactions and anaphylactic shock, including fatalities, have been reported in patients receiving triamcinolone acetonide injections, regardless of the route of administration.
To prevent drug-induced adrenal insufficiency, supplemental corticosteroid dosing is recommended during periods of stress (trauma, surgery, or severe illness), both during treatment with KENACORT and during the year following discontinuation.

Visual Disturbances
Visual disturbances may occur with systemic and topical corticosteroid use. If a patient experiences symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which have been reported after systemic and topical corticosteroid use, including triamcinolone acetonide.
Prolonged corticosteroid use may lead to posterior subcapsular cataract or glaucoma, with potential optic nerve damage, and may increase the risk of secondary ocular infections. Moderate to high doses of cortisone or hydrocortisone may cause elevated blood pressure, fluid and sodium retention, and increased potassium excretion. These effects are less likely with synthetic derivatives unless used at high doses. A low-salt diet may be necessary, and potassium supplementation may be required. All corticosteroids increase calcium excretion, which may contribute to or worsen pre-existing osteoporosis.
Corticosteroids may mask signs of infection, and intercurrent infections may occur during their use. During corticosteroid therapy, host defenses may be impaired, making it difficult to localize a potential site of infection. Furthermore, patients receiving immunosuppressive therapy, including corticosteroids, are more susceptible to infections than those not taking these drugs. Varicella and measles may have a more severe or even fatal course in patients on corticosteroid therapy. In children or adults receiving corticosteroids who have not had these diseases, particular care should be taken to avoid exposure. If exposure occurs, therapy with varicella-specific immunoglobulins (VZIG) or intravenous pooled immunoglobulins (IVIG) may be indicated. If varicella or herpes zoster develops, antiviral therapy should be considered.
Similarly, corticosteroids must be used with extreme caution in patients with Strongyloides infestation (pinworms), as corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection with widespread larval dissemination, often accompanied by severe enterocolitis and potentially fatal gram-negative sepsis.
Patients receiving corticosteroid therapy, especially at high doses, should not be vaccinated or immunized, as loss of antibody response predisposes them to clinical complications, particularly neurological ones.
The use of triamcinolone acetonide in active tuberculosis should be limited to cases of fulminant or disseminated disease, where the corticosteroid is used as part of infection treatment alongside adequate antitubercular therapy. If corticosteroids are administered to patients with latent tuberculosis or a positive tuberculin reaction, chemoprophylaxis is required.
Since rare cases of anaphylactic reactions have been reported in patients receiving parenteral corticosteroids, appropriate precautions should be taken before administration, especially in patients with a history of drug allergy.
It is recommended that intramuscular injection be performed deeply, as local atrophy may occur. The gluteal region is preferred over the deltoid, as local atrophy occurs more frequently in the latter.

Interactions
Non-steroidal anti-inflammatory drugs (NSAIDs): corticosteroids may increase the incidence and/or severity of gastrointestinal bleeding and ulceration caused by NSAIDs. Additionally, corticosteroids may reduce serum salicylate levels, leading to decreased efficacy. Conversely, discontinuation of corticosteroids during high-dose salicylate therapy may result in salicylate toxicity.
In patients with hypoprothrombinemia, the combination of corticosteroids and aspirin should be administered with caution.

Dosage, Route, and Duration of Administration
General
The initial dose of KENACORT may range from 2.5 to 60 mg/day depending on the specific condition being treated.
In milder cases, lower doses may be sufficient, while in others, higher initial doses may be required. Generally, the amount administered parenterally varies from one-third to one-half of the orally administered dose given every 12 hours. In life-threatening cases, higher doses may be justified. The initial dose should be maintained or adjusted until a satisfactory clinical response is achieved. If this is not achieved after a reasonable period, KENACORT should be gradually discontinued and the patient treated with alternative therapy.
THE DOSING REGIMEN IS VARIABLE AND MUST BE INDIVIDUALIZED BASED ON THE CONDITION BEING TREATED AND THE PATIENT'S RESPONSE.
It is recommended to use the lowest effective dose for the condition under consideration.
Once a positive response to therapy is achieved, the appropriate maintenance dose should be determined by gradually reducing the initial dose until the lowest effective dose maintaining the desired therapeutic response is reached. If the product must be discontinued after long-term therapy, gradual, not abrupt, withdrawal is recommended.

Dosage
Systemic Use
Adults and children over 12 years: the recommended initial dose is 60 mg. Administer the injection deeply into the gluteal muscles.
Incorrect injection technique may result in subcutaneous fat atrophy.
The dosage is generally adjusted between 40 and 80 mg, depending on patient response and duration of remission. In some patients, symptoms may be adequately controlled with lower doses of around 20 mg or less. Patients with hay fever or pollen asthma who do not respond to desensitization therapy or other conventional treatments may achieve symptom remission lasting the entire pollen season with a single injection of 40–100 mg.
Children aged 6 to 12 years: the recommended initial dose is 40 mg, although dosing depends more on symptom severity than on age or body weight.
Neonates or premature infants: this preparation contains benzyl alcohol. Do not use in neonates or premature infants (see also sections PRECAUTIONS FOR USE, Use in children, and SPECIAL WARNINGS).

Local Administration
Intra-articular or intrabursal administration: a single injection of triamcinolone acetonide is often sufficient, but multiple injections may be needed to adequately relieve symptoms.
Initial dose: 2.5–5 mg for small joints, 5–15 mg for larger joints, depending on the condition being treated. In adults, doses up to 10 mg for smaller areas and up to 40 mg for larger areas are generally sufficient. Doses up to a total of 80 mg administered via single injections have been used without complications.

Administration
General
Administration must be performed under strictly sterile conditions. Before use, shake the vial well to ensure uniform suspension of the preparation and check for absence of aggregates. Exposure to low temperatures may cause aggregation; in such cases, the product must not be used. After withdrawal, administer the injection immediately to prevent sedimentation in the syringe. Take all precautions to avoid infection or accidental intravascular injection.

Systemic Administration
The injection should be administered deeply into the gluteal muscles. For adults, a needle of at least 4 cm in length is recommended; in obese patients, a longer needle may be required. Alternate the injection site with each subsequent dose.

Local Administration
In cases of significant intra-articular effusion, it is advisable to perform partial aspiration of synovial fluid before injection, without completely emptying the joint. This facilitates symptom relief while avoiding excessive dilution of the injected steroid. Proceed then with intra-articular administration according to standard techniques for joint cavity injections.
The use of a local anesthetic is often advisable during intra-articular or intrabursal administration of KENACORT.
Maximum care must be taken during this type of injection, especially when performed in the deltoid region, to avoid injecting the suspension into surrounding tissues, as this may lead to tissue atrophy.
Do not use KENACORT for intravenous, intradermal, sub-tendon, intranasal (turbinates), subconjunctival, retrobulbar, intravitreal (intraocular), epidural, or intrathecal injection. Refer to the SPECIAL WARNINGS section for further details.

Overdose
Chronic overdose: symptoms of glucocorticoid overdose may include confusion, anxiety, depression, gastrointestinal cramps or bleeding, bruising, moon face, and hypertension. After prolonged therapy, abrupt discontinuation may cause acute adrenal insufficiency, which may also occur during stress. Prolonged high-dose therapy may lead to Cushingoid changes.
Acute overdose: there is no specific treatment for acute corticosteroid overdose; supportive therapy should be instituted. In cases of gastrointestinal bleeding, management should follow that for peptic ulcer disease.

Kenacort