TRIACORT 40 mg /1 Ml Инъекционная Суспензия

Содержание инструкции

1. TRIACORT 40 mg/1 ml injectable suspension, 80 mg/2 ml injectable suspension

TRIACORT 40 mg/1 ml injectable suspension, 80 mg/2 ml injectable suspension

(triamcinolone acetonide)

PHARMACOTHERAPEUTIC CATEGORY
Systemic corticosteroid

THERAPEUTIC INDICATIONS
Intramuscular administration of TRIACORT(triamcinolone acetonide injectable suspension) is indicated for systemic corticosteroid therapy in conditions such as allergic syndromes (to control severe or debilitating conditions not treatable by conventional means), dermatoses, generalized rheumatoid arthritis and other connective tissue diseases. Intramuscular administration is particularly useful in these diseases when oral corticosteroid therapy is not feasible.

TRIACORTcan also be administered by intra-articular or intra-bursal route and directly into tendon sheaths and cystic tendon formations.
These routes of administration allow for effective short-term local therapy for pain, swelling and joint stiffness resulting from traumatic or rheumatoid arthritis, osteoarthritis, synovitis, bursitis and tenosynovitis.
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 disease processes such as traumatic arthritis or bursitis may represent typical indications for therapy conducted exclusively via the intra-articular route.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient (triamcinolone acetonide) or to any of the excipients. Corticosteroids are contraindicated in patients with systemic infections and in children under two years of age. Intramuscular administration of corticosteroids is contraindicated in the presence of idiopathic thrombocytopenic purpura.

PRECAUTIONS FOR USE
Secondary adrenal insufficiency may occur following treatment with corticosteroids and may persist for months after discontinuation of therapy. Therefore, in any stressful condition (such as trauma, surgery or serious illness) that occurs during this period, hormone therapy should be resumed. Since the secretion of mineralocorticoids may be impaired, sodium chloride and/or mineralocorticoids should be administered concurrently.
In patients with hypothyroidism or liver cirrhosis, the response to corticosteroids may be increased.
Caution is advised in patients with herpes simplex keratitis, as corneal perforation is possible.
During corticosteroid therapy, various psychiatric disturbances may occur: euphoria, insomnia, mood and personality changes, severe depression or symptoms of true psychosis. Pre-existing emotional instability or psychotic tendencies may be exacerbated by corticosteroids. The use of antidepressant drugs does not relieve these disorders and may exacerbate mental disorders induced by corticosteroid therapy.
Corticosteroids should be administered with caution in the following cases: nonspecific ulcerative colitis with a risk of perforation, abscesses and pyogenic infections in general, diverticulitis, recent intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, acute glomerulonephritis, chronic nephritis, hypertension, congestive heart failure, thrombophlebitis, thromboembolic episodes, osteoporosis, rash, metastatic carcinoma, myasthenia gravis.
Although TRIACORTmay improve the symptoms of inflammation, its cause should be investigated and treated.
Intra-articular administration of a corticosteroid can produce systemic as well as local effects. Even accidental injection of the suspension into periarticular soft tissues can cause systemic effects and is the most common cause of local therapeutic failure. Patients undergoing intra-articular treatment should not subject the joints in which improvement has been obtained to excessive stress, otherwise deterioration of the joint may increase. On the occasion of intra-articular administration, avoid overdistension of the joint capsule and leakage of the steroid along the needle track, 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 some particular cases, especially after repeated administrations, a radiographic examination is recommended.
Intra-articular injection rarely causes discomfort in the joint. An increase in pain accompanied by local swelling, further limitation of joint mobility, fever, and malaise should raise suspicion of a septic joint process. If confirmed, discontinue the corticosteroid and immediately initiate appropriate antibacterial therapy for 7 to 10 days after the disappearance of any evidence of infection.
Avoid intra-articular injection into joints that have been the site of infectious processes.
Repeated injections into inflamed tendons have been followed by tendon rupture, and therefore this practice should also be avoided.
Edema may occur in the presence of renal dysfunction with a reduced glomerular filtration rate.
During prolonged therapy, adequate protein intake is essential to counteract the tendency to gradual weight loss sometimes associated with a negative nitrogen balance, wasting and skeletal muscle weakness.
Menstrual irregularities may occur in women treated with corticosteroids.
In peptic ulcer, recurrence may remain asymptomatic until perforation or bleeding occurs.
Prolonged corticosurrenal therapy can cause hyperacidity or peptic ulcer; therefore, the administration of an antacid is recommended.
It is essential to monitor patients even after discontinuation of therapy with triamcinolone acetonide, as a sudden recurrence of the main symptoms of the disease for which the patient was treated may occur.

Use in children
Exposure to an excessive amount of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), especially in neonates, and an increased incidence of kernicterus, particularly in premature infants. Rare reports of death, especially in premature infants, have been associated with exposure to an excessive amount of benzyl alcohol (see also SPECIAL WARNINGS).
TRIACORTis not recommended in children under 6 years of age.
Children undergoing prolonged corticosteroid therapy should be carefully monitored for growth and development, as corticosteroids can suppress growth.
Caution should be exercised in case of exposure to varicella, measles or other infectious diseases.
Children should not be vaccinated or immunized during therapy with corticosteroids.
These can affect the production of endogenous steroids.

Use in the elderly
Side effects such as osteoporosis or hypertension, common in systemic corticosteroid therapy, may have more serious consequences in the elderly.
Therefore, close clinical monitoring is recommended.
Menstrual irregularities may occur and vaginal bleeding has been observed in postmenopausal women. Female patients should be informed of the risk but should still be advised to undergo appropriate investigations.

Interactions with other medicines and other forms of interaction
Injections of Amphotericin B and agents that cause a decrease in potassium: subjects taking these agents should be monitored for possible hypokalemia.
Anticholinesterases: antagonistic reactions with this agent may occur.
Oral anticoagulants: corticosteroids can both increase and decrease anticoagulant action; therefore, strict monitoring of subjects taking both oral anticoagulants and corticosteroids is necessary.
Antidiabetics: corticosteroids can increase blood glucose; strict monitoring of diabetic subjects is necessary, especially when starting, stopping or changing the dosage of corticosteroid therapy.
Antituberculosis drugs: serum concentrations of isoniazid may be decreased.
Cyclosporine: increased activity of both corticosteroid drugs and cyclosporine has been noted when taken simultaneously.
Digitalis glycosides: a possible increase in digitalis toxicity may occur when administered simultaneously with corticosteroid drugs.
Estrogens, including oral contraceptives: both the half-life and concentration of corticosteroids may be increased, while clearance may be decreased.
Hepatic enzyme inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin): increased metabolic clearance of triamcinolone acetonide has been noted; subjects taking these therapies should be monitored closely and the dosage of corticosteroids may need to be adjusted.
Human growth hormone (e.g. somatrem): the growth-stimulating effect may be inhibited.
Ketoconazole: a decrease in the clearance of corticosteroid drugs may occur with a consequent increase in effects.
Non-depolarizing muscle relaxants: corticosteroids can decrease or increase the neuromuscular blocking action.
Non-steroidal anti-inflammatory drugs (NSAIDs): corticosteroids can increase the incidence and/or severity of gastrointestinal bleeding and ulceration caused by NSAIDs. In addition, corticosteroids can reduce serum salicylate levels with a consequent decrease in efficacy. Conversely, stopping the administration of corticosteroids during therapy with high doses of salicylate could cause salicylate toxicity.
The association between corticosteroids and aspirin should be administered with caution in subjects with hypoprothrombinemia.
Thyroid drugs: the metabolic clearance of corticosteroids is decreased in hypothyroid subjects and increased in hyperthyroid subjects. The dosage of corticosteroids should be rebalanced in case of changes in thyroid status.
Vaccines: subjects undergoing corticosteroid therapy who are vaccinated may experience neurological complications and loss of antibody response. Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.

SPECIAL WARNINGS
This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death, especially in pediatric patients. “Gasping syndrome” has been associated with benzyl alcohol. Although normal therapeutic dosages of this product release amounts of benzyl alcohol that are substantially lower than those reported in association with “gasping syndrome”, the minimum dose of benzyl alcohol that can cause toxicity is not known.
Premature and low-birth-weight infants, as well as patients receiving high dosages, may more easily develop toxicity.

Per la presenza di alcool benzilico, pertanto il prodotto non deve essere somministrato ai
bambini al di sotto dei due anni.
Do not inject intravenously, as it is a suspension.
No studies have been conducted to demonstrate the safety of therapy with TRIACORT
administered via endonasal (turbinates), subconjunctival, subtendinous,
retrobulbar and intraocular (intravitreal) routes.
Following intravitreal administration, endophthalmitis, eye inflammation, increased intraocular pressure, and visual disturbances including vision loss have been reported. Numerous cases of blindness have also been reported following injections of
corticosteroid suspensions into the nasal turbinates and into head lesions. The administration of
TRIACORT (Triamcinolone Acetonide Injectable Suspension) is not recommended, nor is it
indicated for any of these routes of administration.
The administration of TRIACORT via epidural or intrathecal route must not be used. Cases
of serious adverse events have been associated with administration via epidural or
intrathecal route.
Cases of severe anaphylactic reactions and anaphylactic shock, including death, have been reported
in subjects who received a triamcinolone acetonide injection,
regardless of the route of administration.
TRIACORT is a long-acting preparation and is not advisable in acute situations.
To avoid drug-induced adrenal insufficiency, a supporting dosage is indicated
in stressful situations (trauma, surgery or serious illness), both during
treatment with TRIACORTand in the following year.
Prolonged use of corticosteroids can lead to posterior subcapsular cataract or
glaucoma with possible damage to the optic nerves and increase the likelihood of secondary ocular
infections.
Moderate and high doses of cortisone or hydrocortisone can cause increased blood
pressure, fluid and salt retention, and increased potassium excretion. These effects
are less likely with synthetic derivatives, unless they are used at high doses.
A low-salt diet and potassium supplementation may be necessary. All corticosteroids increase the excretion of
calcium, which may therefore be associated with or exacerbate pre-existing osteoporosis.
Corticosteroids can mask some signs of infection and infections may occur during their use. During corticosteroid therapy, defense capabilities may be reduced and it may be difficult to locate a possible site of
infection. In addition, subjects undergoing immunosuppressive therapy including corticosteroids,
are more susceptible to infections than those who do not use these
drugs.
Chickenpox and measles can have a more severe or even fatal course in patients
treated with corticosteroids. In children or adults treated with corticosteroids who
have not had these diseases, particular care should be taken to avoid
contagion. If this occurs, specific varicella (VZIG) or intravenous immunoglobulin (IVIG) therapy may be indicated. If
chickenpox or herpes zoster develops, antiviral therapy may be considered.
Similarly, corticosteroid drugs must be used with extreme caution in
subjects with Strongyloides (pinworm) infestation, as the immunosuppression induced by
corticosteroids can cause a superinfection with Strongyloides with widespread dissemination and
larval migration, often accompanied by severe enterocolitis and gram-negative septicemia
potentially fatal.
Patients undergoing corticosteroid treatment, especially at high doses, should not be
vaccinated or immunized because of loss of antibody response they are predisposed
to clinical, especially neurological, complications.
The use of triamcinolone acetonide in active tuberculosis should be limited to cases of fulminant or disseminated disease in which the corticosteroid is used for the treatment of the infection
along with adequate antituberculosis therapy. If corticosteroids are administered to
patients with latent tuberculosis or with a positive tuberculin response, chemoprophylaxis is necessary.
Since rare cases of anaphylactic reactions have occurred in patients undergoing
parenteral corticosteroid therapy, appropriate precautions should be taken before
administration, especially when the patient's history reveals an allergy to drugs.
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 this area.

Pregnancy and breastfeeding
Many corticosteroids used at low doses have shown teratogenic effects in
laboratory animals. Because adequate reproduction studies in humans have not been conducted, the use of corticosteroids during pregnancy, breastfeeding or in women of childbearing potential should be
evaluated in light of the possible benefit versus the potential risk to the mother,
embryo, fetus or breastfeeding infant.
Newborns from mothers who received substantial doses of corticosteroids during pregnancy
should be carefully monitored for signs of hypoadrenalism. Ask
your doctor or pharmacist before taking any medication.

Effects on the ability to drive and operate machinery
Given the possible occurrence of adverse effects on the Central Nervous System (for
example, dizziness), it is advisable that the patient who is about to drive or use
machinery take this possibility into account.
FOR THOSE WHO PRACTICE SPORTS: THE USE OF THE DRUG WITHOUT THERAPEUTIC NECESSITY
CONSTITUTES DOPING AND MAY IN ANY CASE RESULT IN POSITIVE ANTI-DOPING TESTS.

DOSAGE, METHOD AND TIME OF ADMINISTRATION
General:
The initial dose of TRIACORTmay vary from 2.5 to 60 mg/day depending on the specific
pathology to be treated.
In less severe cases, lower doses may be sufficient, while higher initial doses may be necessary in other
patients. Generally, the amount of
drug administered parenterally varies from one-third to one-half of the dose
administered orally every 12 hours. Higher dosages may be justified in cases that may endanger the patient's life. The initial dosage should be
maintained or adjusted until a satisfactory clinical response is achieved.
If this is not achieved after a reasonable period of time, TRIACORT should be
gradually discontinued and the patient should be treated with other therapy.
THE POSOLOGY SCHEME IS VARIABLE AND MUST BE INDIVIDUALIZED BASED ON
THE PATHOLOGY TO BE TREATED AND THE PATIENT'S RESPONSE.
It is recommended to use the minimum dose useful for the pathology in question.
Once a positive response to therapy has been achieved, the appropriate maintenance dose
should be determined by gradually decreasing the initial dose until the minimum dose useful for maintaining the desired therapeutic response is reached. If the
product is to be discontinued after long-term therapy, gradual and not abrupt discontinuation is recommended.

Dosage
For systemic use
Adults and children over 12 years of age
the recommended initial dose is 60 mg. Practice the injection deeply into the muscles
of the gluteal region.
If the injection is not performed correctly, atrophy of the subcutaneous fat may occur.
The dosage is generally adjusted between 40 and 80 mg, depending on the patient's response and
the duration of remission. In some patients, the symptoms may, however, be well
controlled with low doses of the order of 20 mg or less. Patients with hay fever
or pollen asthma who do not respond to desensitization therapy and other conventional therapies may experience remission of symptoms throughout the pollen season with a single injection of 40-100 mg.
Children from 6 to 12 years: the recommended initial dose is 40 mg, although the dosage
depends more on the severity of the symptoms than on age or body weight.
Infants or premature babies: this preparation contains benzyl alcohol. Do not use in infants
or premature babies (see also PRECAUTIONS FOR USE, Use in children and
SPECIAL WARNINGS).

For local administration
Intra-articular or intra-bursal administration and injection into tendon sheaths: a
single injection of triamcinolone acetonide is often sufficient, but several may be needed to adequately relieve symptoms.
Initial dose: 2.5-5 mg for small joints, 5 to 15 mg for larger ones, a
depending on the type of pathology to be treated. In adults, doses up to 10 mg for the more
restricted areas and up to 40 mg for the more extensive ones are usually sufficient. Doses up to a total of 80 mg have been administered
without complications by single injections.

Administration
General:

STERILE CONDITIONS ARE REQUIRED FOR ADMINISTRATION.Shake the bottle well before use to ensure uniform suspension of the preparation and make sure that no
agglomerates have formed. Exposure to low temperatures causes agglomerates and in
this case the product should not be used. After withdrawal, immediately
perform the injection to avoid deposits in the syringe. Use all precautions to prevent
the risk of infection or the penetration of the needle into a blood vessel.

For systemic use
The injection should be performed deeply into the muscles of the gluteal region. For adults, use a needle at least 4 cm long is recommended, in obese subjects, a longer needle may be
necessary. Alternate the site with each subsequent injection.

Local administration
In cases of significant intra-articular effusion, it is advisable to aspirate part of the synovial fluid preventively,
without however completely emptying the collection; this precaution helps to facilitate the remission of symptoms, avoiding
at the same time an excessive dilution of the steroid injected in situ. Then proceed to
intra-articular administration according to the prescribed technical rules for injections in
joint cavity.
With intra-articular or intra-bursal administration, and with the injection of TRIACORTinto
tendon sheaths or cystic formations, the use of
a local anesthetic may often be appropriate.
Maximum care must be taken with this type of injection, especially if
performed in the deltoid region and in tendon sheaths, to avoid injection of
the suspension into the surrounding tissue, as this can lead to tissue atrophy.
In non-specific acute tenosynovitis, it is important that the injection is performed
inside the sheath and not into the tendon. In the case of epicondylitis, treatment can be
carried out by infiltrating the product into the softest point.

Do not use TRIACORT for intravenous, intradermal, subtendinous, endonasal
(turbinates), subconjunctival, retrobulbar or intravitreal (intraocular), epidural or
intrathecal injection. See the SPECIAL WARNINGS section for details.
Overdose
Chronic overdose: symptoms of glucocorticoid overdose may include
confusion, anxiety, depression, gastrointestinal cramps or bleeding, bruising, moon face and hypertension. Following prolonged therapy, abrupt discontinuation of
treatment may cause acute adrenal insufficiency. The latter can also occur
in case of stress. Following prolonged therapy with high doses, changes of the Cushingoid type may occur.
Acute overdose: there is no specific treatment for acute corticosteroid overdose, therefore supportive therapy should be instituted, and, in case of
gastrointestinal bleeding, intervention should be carried out as in the case of a peptic ulcer.
If you have any doubts about the use of TRIACORT, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, TRIACORT can cause undesirable effects, although not everyone will experience them.
List of undesirable effects :
Common(may affect up to 1 in 10 people) :

• Infection
• Headache
• Cataract
• Reactions at the injection siteUncommon(may affect up to 1 in 100 people):
• Sterile abscess at the injection site, masked infection
• Anaphylactoid reaction, anaphylactic reaction, anaphylactic shock
• Cushingoid, adrenal suppression
• Sodium retention, fluid retention, hypokalemic alkalosis, hyperglycemia, diabetes mellitus, inadequate control of diabetes mellitus
• Psychiatric symptom, depression, euphoric mood, mood swings, psychotic disorder, personality alteration, insomnia
• Convulsions, syncope, benign intracranial hypertension, neuritis, paresthesia
• Blindness, glaucoma, exophthalmos, corneal perforation
• Dizziness
• Congestive heart failure, arrhythmia
• Hypertension, embolism, thrombophlebitis, necrotizing vasculitis
• Peptic ulcer, peptic ulcer with perforation, peptic ulcer with bleeding, pancreatitis, abdominal distension, ulcerative esophagitis
• Urticaria, skin rash, skin hyperpigmentation, skin hypopigmentation, skin atrophy, skin fragility, petechiae, ecchymosis, erythema, hyperhidrosis, purpura, skin striae, hirsutism, acneiform dermatitis, cutaneous lupus erythematosus
• Osteoporosis, osteonecrosis, pathological fracture, delayed fracture consolidation, musculoskeletal discomfort, muscle weakness, myopathy, muscle atrophy, growth retardation, neuropathic arthropathy
• Glycosuria
• Irregular menstruation, amenorrhea, postmenopausal bleeding
• Synovitis, pain, irritation at the injection site, discomfort at the injection site, fatigue, incomplete healing
• Decreased serum potassium, electrocardiogram modification, reduced carbohydrate tolerance, negative nitrogen balance, increased intraocular pressure, interference with laboratory tests
• Vertebral compression fracture

undesirable effects.

Reporting of undesirable effects
If you experience any undesirable effects, including those not listed in this
leaflet, please inform your doctor. You can also report undesirable effects directly
through the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting undesirable effects, you can help provide more information on the
safety of this medicine.
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN

EXPIRY DATE AND STORAGE

Do not store above 25°C

WARNING: DO NOT USE THE MEDICINE AFTER THE EXPIRY DATE INDICATED
ON THE PACKAGING
AVOID FREEZING
COMPOSITION
Each 40 mg/1 ml vial of injectable suspension contains: ACTIVE INGREDIENT:
Triamcinolone acetonide 40.0 mg; EXCIPIENTS: sodium carboxymethylcellulose; sodium chloride; polysorbate;

benzyl alcohol; purified water q.s. to 1.0 ml.
Each 80 mg/2 ml vial of injectable suspension contains: ACTIVE INGREDIENT:
Triamcinolone acetonide 80.0 mg; EXCIPIENTS: sodium carboxymethylcellulose; sodium chloride; polysorbate;

benzyl alcohol; purified water q.s. to 2.0 ml.

PHARMACEUTICAL FORM AND CONTENT
Injectable suspension for intramuscular and intra-articular use.
Pack of 40 mg/1 ml: 3 vials
Pack of 80 mg/2 ml: 3 vials

AIC HOLDER:
PHARMATEX ITALIA SRL
VIA APPIANI ,22
20121 MILAN (ITALY)

MANUFACTURER :
LISAPHARMA SPA
VIA LICINIO 11
22036 ERBA (COMO)

MANUFACTURER AND FINAL CONTROLLER:
FISIOPHARMA SRL
INDUSTRIAL AREA
84020 PALOMONTE (SA)
ITALY