Pharmacort

PACKAGE LEAFLET

PHARMACORT “40mg/ml Injectable Suspension” 3 Vials of 1 ml, “80mg/2ml Injectable Suspension” 3 Vials of 2 ml, “80mg/2ml Injectable Suspension” 5 Ampoules of 2 ml

Triamcinolone acetonide
PHARMACOTHERAPEUTIC CATEGORY
Systemic corticosteroid
THERAPEUTIC INDICATIONS
Intramuscular administration of PHARMACORT (injectable suspension of Triamcinolone Acetonide)
is indicated for systemic corticosteroid therapy in disease 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 of administration is
particularly useful in the above-mentioned diseases when oral corticosteroid therapy is not feasible.
PHARMACORT may also be administered intra-articularly or intrabursally, and directly into tendon sheaths and tendon cystic formations.
These routes of administration allow effective short-term local therapy of pain, swelling, and joint stiffness resulting from traumatic or rheumatoid arthritis, osteoarthritis, synovitis, bursitis, and tendinitis.
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 substance (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
A state of secondary adrenal insufficiency may occur following corticosteroid therapy and may persist for months after discontinuation of treatment. Therefore, in any stressful condition (such as trauma,
surgery, or severe illness) occurring during this period, corticosteroid therapy should be reinstated. Since mineralocorticoid secretion may be impaired, concomitant administration of sodium chloride and/or mineralocorticoids may be necessary.
In patients with hypothyroidism or hepatic cirrhosis, the response to corticosteroids may be enhanced.
Caution is advised in patients with ocular herpes simplex, as corneal perforation may occur.
During corticosteroid therapy, various types of psychiatric disturbances may occur: euphoria, insomnia, mood and personality changes, severe depression, or symptoms of frank psychosis. Pre-existing emotional instability or psychotic tendencies may be exacerbated by corticosteroids. Use of antidepressant drugs
does not alleviate these disturbances and may exacerbate corticosteroid-induced mental disorders.
Corticosteroids should be administered with caution in the following conditions: non-specific ulcerative colitis with 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 PHARMACORT may improve inflammatory symptoms, the underlying cause should be investigated 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 produce systemic effects and is the most frequent 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 certain specific cases, especially after repeated administrations, radiographic examination 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 should be discontinued and appropriate antibacterial therapy initiated immediately, continuing for 7 to 10 days after all signs of infection have disappeared.
Avoid intra-articular injection in joints previously affected by infectious processes.
Repeated injections into inflamed tendons have been followed by tendon rupture, and this practice should therefore be avoided.
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.
Menstrual irregularities may occur in women undergoing corticosteroid treatment.
In peptic ulcer disease, recurrence may remain asymptomatic until perforation or hemorrhage occurs. Prolonged corticosteroid therapy may cause hyperacidity or peptic ulcer; therefore, administration of an antacid is recommended.
Monitoring of patients is essential even after discontinuation of triamcinolone acetonide therapy, as a sudden recurrence of the main symptoms of the disease for which the patient was treated may occur.
Menstrual irregularities may occur, and vaginal bleeding has been observed in postmenopausal women. Female patients should be informed of this risk but should still undergo appropriate diagnostic evaluations.
Use in children
Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of nuclear jaundice, especially in premature infants. There have been rare reports of death, particularly in premature infants, associated with exposure to excessive amounts of benzyl alcohol (see also section SPECIAL WARNINGS).
PHARMACORT is not recommended for children under 6 years of age.
Children undergoing prolonged corticosteroid therapy should be closely monitored for growth and development, as corticosteroids may 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 corticosteroid therapy. These drugs may affect endogenous steroid production.
Use in the elderly
Adverse effects such as osteoporosis or hypertension, common in systemic corticosteroid therapy, may have more serious consequences in elderly patients.
Close clinical monitoring is therefore recommended.
INTERACTIONS
Amphotericin B injections and agents causing potassium depletion: patients receiving such agents should be monitored for possible hypokalemia.
Anticholinesterase agents: antagonistic reactions with this agent may occur.
Oral anticoagulants: corticosteroids may either increase or decrease anticoagulant effect; therefore, patients receiving both oral anticoagulants and corticosteroids should be closely monitored.
Antidiabetic agents: corticosteroids may increase blood glucose levels; diabetic patients should therefore be closely monitored, especially when starting, stopping, or changing the dose of corticosteroid therapy.
Antituberculosis drugs: serum concentrations of isoniazid may be reduced.
Cyclosporine: increased activity of both corticosteroid drugs and cyclosporine has been observed when administered concurrently.
Digitalis glycosides: possible increased toxicity of digitalis may occur when administered concomitantly with corticosteroids.
Estrogens, including oral contraceptives: an increase in both half-life and concentration of corticosteroids may occur, while clearance may be reduced.
Hepatic enzyme inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampicin): increased metabolic clearance of triamcinolone acetonide has been observed; patients receiving such therapies should be closely monitored and corticosteroid dosage may need to be adjusted.
Human growth hormone (e.g., somatrem): the growth-stimulating effect may be inhibited.
Ketoconazole: decreased clearance of corticosteroid drugs may occur, resulting in increased effects.
Non-depolarizing muscle relaxants: corticosteroids may decrease or increase neuromuscular blocking action.
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, resulting in decreased efficacy.
Conversely, discontinuation of corticosteroids during therapy with high-dose salicylates may lead to salicylate toxicity.
In patients with hypoprothrombinemia, the combination of corticosteroids and aspirin should be administered with caution.
Thyroid drugs: metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Corticosteroid dosage should be re-evaluated in case of changes in thyroid status.
Vaccines: patients receiving corticosteroid therapy who are vaccinated may experience neurological complications and loss of antibody response.
SPECIAL WARNINGS
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 prone to develop 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 been conducted to demonstrate the safety of PHARMACORT administered via intranasal (turbinates), subconjunctival, sub-tendon, retrobulbar, or intraocular (intravitreal) routes.
Following intravitreal administration, endophthalmitis, ocular 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 nasal turbinates and head lesions. Administration of PHARMACORT (Triamcinolone Acetonide Injectable Suspension) is not recommended and is not indicated for any of these routes of administration.
PHARMACORT is a long-acting preparation and is not advisable in acute situations.
To prevent drug-induced adrenal insufficiency, supportive dosing is recommended in stressful situations (trauma, surgery, or severe illness), both during PHARMACORT therapy and during the year following discontinuation.
Prolonged use of corticosteroids may lead to posterior subcapsular cataracts or glaucoma with potential optic nerve damage and increased risk of secondary ocular infections.
Moderate and high doses of cortisone or hydrocortisone may cause increased 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 and potassium supplementation may be necessary. All corticosteroids increase calcium excretion, which may contribute to or worsen pre-existing osteoporosis.
Corticosteroids may mask some signs of infection, and intercurrent infections may occur during their use. During corticosteroid therapy, defense mechanisms may be impaired, and localization of an injection site may be difficult. Furthermore, patients undergoing 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 receiving corticosteroids. In children or adults receiving corticosteroids who have not had these diseases, particular care should be taken to avoid contagion. If exposure occurs, therapy with varicella-specific immunoglobulins (VZIG) or pooled intravenous immunoglobulins (IVIG) may be indicated. If varicella or herpes zoster develops, antiviral therapy may be considered.
Similarly, corticosteroids must be used with extreme caution in patients with Strongyloides infestation (pinworms), as corticosteroid-induced immunosuppression may lead to Strongyloides superinfection with dissemination and widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
Patients undergoing 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 for treatment of the infection alongside adequate antituberculosis 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 occurred 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.
Pregnancy and lactation
Many corticosteroids used at low doses have shown teratogenic effects in laboratory animals. Since adequate reproductive studies have not been conducted in humans, the use of corticosteroids during pregnancy, lactation, or in women of childbearing potential should be evaluated based on the potential benefit versus the potential risk to the mother, embryo, fetus, or nursing infant.
Neonates born to mothers who received substantial doses of corticosteroids during pregnancy should be closely monitored for signs of adrenal insufficiency.
Effects on ability to drive and use machines
Given the possible occurrence of adverse effects on the central nervous system (e.g., dizziness), patients intending to drive or operate machinery should take this into account.
FOR THOSE ENGAGED IN SPORTING ACTIVITIES: USE OF THE DRUG WITHOUT THERAPEUTIC NEED CONSTITUTES DOPING AND MAY RESULT IN POSITIVE ANTI-DOPING TESTS.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
General
The initial dose of PHARMACORT 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 of drug administered parenterally varies from one-third to one-half of the oral 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, PHARMACORT 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 in question.
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 administration
Adults and children over 12 years: the recommended initial dose is 60 mg. Administer the injection deeply into the gluteal muscles.
If the injection is not performed correctly, atrophy of subcutaneous fat may occur.
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 low doses of around 20 mg or less. Patients with hay fever or pollen asthma who do not respond to desensitizing therapy and other conventional treatments may achieve symptom remission lasting throughout 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 intra-bursal administration and injection into tendon sheaths: 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 type of 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 given without complications.
Administration
General
Administration must be performed under strictly sterile conditions. Before use, shake the container well to ensure uniform suspension of the preparation and check for absence of aggregates. Exposure to low temperatures may cause aggregation, and in such cases the product must not be used. After withdrawal, administer the injection immediately to avoid sedimentation in the syringe. Take all precautions to prevent infection or accidental intravascular injection.
Systemic administration
The injection should be administered deeply into the gluteal muscles. For adults, use of a needle of at least 4 cm in length is recommended; in obese subjects, a longer needle may be required. Alternate the injection site with each subsequent administration.
Local administration
In cases of significant intra-articular effusion, it is advisable to perform preventive aspiration of part of the synovial fluid, without completely emptying the joint; this facilitates symptom remission while avoiding excessive dilution of the injected steroid. Proceed then with intra-articular administration according to standard techniques for joint cavity injections.
For intra-articular or intrabursal administration, and for injection of PHARMACORT into tendon sheaths or tendon cystic formations, concomitant use of a local anesthetic is often advisable.
Maximum care must be taken with this type of injection, especially when administered in the deltoid region or tendon sheaths, to avoid injecting the suspension into surrounding tissues, as this may lead to tissue atrophy. In non-specific acute tenosynovitis, it is important that the injection be administered into the sheath and not into the tendon. In cases of epicondylitis, treatment may be performed by infiltrating the product at the softest point.
Do not use PHARMACORT for intravenous, intradermal, sub-tendon, intranasal (turbinates), subconjunctival, retrobulbar, or intravitreal (intraocular) injection. See 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. After prolonged therapy, abrupt discontinuation of treatment may cause acute adrenal insufficiency. This may also occur during periods of 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, and in case of gastrointestinal bleeding, management should be as for peptic ulcer.
ADVERSE EFFECTS
The list is presented according to the MedDRA organ system classification and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), and not known (frequency cannot be estimated from available data).
Following administration by any route

After intramuscular administration

Following intra-articular administration

Following the instructions in this leaflet reduces the risk of adverse effects.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
EXPIRY DATE AND STORAGE
WARNING: DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE STATED ON THE PACKAGE
AVOID FREEZING
Do not store above 25°C.
COMPOSITION
Each 40 mg/ml vial of injectable suspension contains: ACTIVE SUBSTANCE: Triamcinolone acetonide 40.0 mg; EXCIPIENTS: Sodium carmellose; Sodium chloride; Polysorbate; Benzyl alcohol; Water for injections q.s. to 1.0 ml.
Each 80 mg/2 ml vial of injectable suspension contains: ACTIVE SUBSTANCE: Triamcinolone acetonide 80.0 mg; EXCIPIENTS: Sodium carmellose; Sodium chloride; Polysorbate; Benzyl alcohol; Water for injections q.s. to 2.0 ml.
Each 80 mg/2 ml ampoule of injectable suspension contains: ACTIVE SUBSTANCE: Triamcinolone acetonide 80.0 mg; EXCIPIENTS: Sodium carmellose; Sodium chloride; Polysorbate; Benzyl alcohol; Water for injections q.s. to 2.0 ml.
PHARMACEUTICAL FORM AND CONTENT
Injectable suspension for intramuscular and intra-articular use.
Packaging: 40 mg/ml Injectable suspension 3 vials of 1 ml
Packaging: 80 mg/2 ml Injectable suspension 3 vials of 2 ml
Packaging: 80 mg/2 ml Injectable suspension 5 ampoules of 2 ml
MARKETING AUTHORISATION HOLDER
PHARMATEX ITALIA S.r.l.
VIA S. PAOLO 1 - 20121 MILAN (MI) ITALY
MANUFACTURER AND FINAL CONTROLLER
FISIOPHARMA S.R.L.
INDUSTRIAL ESTATE
84020 PALOMONTE (SA) - ITALY
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY