Active ingredients: Triamcinolone (triamcinolone acetonide)
KENACORT 40 mg / ml suspension for injection
Why is Kenacort used? What is it for?
Pharmacotherapeutic group
Systemic corticosteroids, ATC code: H02AB08.
Therapeutic indications
Intramuscular administration of KENACORT is indicated for systemic corticosteroid therapy in morbid conditions such as allergic syndromes (to control severe or debilitating conditions that cannot be treated conventionally), dermatosis, generalized rheumatoid arthritis and other connective tissue diseases. The intramuscular route of administration is particularly useful in the aforementioned diseases when oral corticosteroid therapy is not feasible.
KENACORT can also be administered intra-articularly or intra-borsally. These methods of administration allow to implement a valid local short-term therapy of pain, swelling and joint stiffness resulting from traumatic or rheumatoid arthritis, osteoarthritis, synovitis, bursitis.
In the treatment of generalized arthritic diseases, the intra-articular injection of triamcinolone acetonide is intended as an aid to other conventional therapeutic measures. Circumscribed morbid processes such as traumatic arthritis or bursitis may represent typical indications for a therapy conducted exclusively for intra-articular route.
Contraindications When Kenacort should not be used
Hypersensitivity to the active substance or to any of the excipients (see also section "Special warnings").
Corticosteroids are contraindicated in patients with systemic infections and in children under the age of two. Intramuscular administration of corticosteroids is contraindicated in the presence of idiopathic thrombocytopenic purpura.
Precautions for use What you need to know before taking Kenacort
A state of 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 must be resumed. Since the secretion of mineralocorticoids can be compromised, sodium chloride and / or mineralocorticoids should be administered concomitantly.
In patients with hypothyroidism or with liver cirrhosis, the response to corticosteroids may be increased.
Caution is advised in patients with ocular herpes simplex because corneal perforation is possible.
Psychic alterations of various kinds can occur during corticotherapy: euphoria, insomnia, mood and personality changes, severe depression or symptoms of real psychosis. A pre-existing emotional instability or psychotic tendencies can be aggravated by corticosteroids. Antidepressant medications do not relieve these disorders and can exacerbate the mental disorders induced by corticosteroid therapy.
Corticosteroids should be administered with caution in the following cases: non-specific ulcerative colitis with danger of perforation, abscesses and pyogenic infections in general, diverticulitis, recent intestinal anastomosis, active or latent peptic ulcer, renal insufficiency, acute glomerulonephritis, chronic nephritis, hypertension, insufficiency congestive heart, thrombophlebitis, thromboembolic episodes, osteoporosis, exanthema, metastatic carcinoma, myasthenia gravis.
Although KENACORT can improve the symptoms of inflammation, the cause must be sought and treated.
Intra-articular administration of a corticosteroid can produce systemic as well as local effects. Accidental injection of the suspension into the periarticular soft tissues can also cause systemic effects and is the most frequent cause of local therapeutic failure. Patients undergoing intra-articular treatment should not overstress the joints where improvement has been achieved. symptomatological, otherwise there may be an increase in the deterioration of the joint.
On the occasion of intra-articular administration, over-distension of the joint capsule and the effusion of the steroid along the needle path must be avoided, as subcutaneous atrophy may occur. Avoid injecting the preparation into unstable joints. In some cases, repeated intra-articular injections, they can themselves cause joint instability. In some special cases, especially after repeated administration, it is recommended to perform an X-ray examination.
Intra-articular injection rarely causes joint discomfort. An increase in pain accompanied by local swelling, further impediment of joint motility, fever, malaise, should lead to suspicion of a joint septic process. If confirmed, discontinue administration of the corticosteroid and immediately institute appropriate antibacterial therapy which continues 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.
Edema may occur in the presence of renal dysfunction with a reduced glomerular filtration index. During prolonged therapy, good protein intake is essential to counteract the tendency to gradual weight loss sometimes associated with a negative nitrogen balance, weight loss and skeletal muscle weakness.
Menstrual irregularities may occur and vaginal bleeding has been observed in postmenopausal women. Female patients must be made aware of the risk but appropriate investigations must in any case be recommended.
In the peptic ulcer the recurrence may remain asymptomatic until the moment of perforation or hemorrhage.
Prolonged adrenocortical therapy can cause hyperacidity or peptic ulcer; therefore the administration of an antacid is recommended.
Monitoring of patients is essential even after discontinuation of triamcinolone acetonide therapy as there may be a sudden reappearance of the main symptoms of the disease for which the patient was treated.
Use in children
Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), especially in neonates, and an "increased incidence of nuclear jaundice, particularly in premature babies. There have been rare reports of death, especially in infants. premature babies, associated with exposure to an excessive quantity of benzyl alcohol (see also the section SPECIAL WARNINGS).
KENACORT is not recommended for 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 used in case of exposure to chickenpox, measles or other infectious diseases.
Children should not be vaccinated or immunized during corticosteroid therapy. These can in fact affect the endogenous production of steroids.
Use in the elderly
Side effects such as osteoporosis or hypertension, common in systemic corticosteroid therapy, can have more serious consequences in the elderly.
Close clinical surveillance is therefore recommended.
Pregnancy and Breastfeeding
Many corticosteroids used in low doses have been shown to have a teratogenic effect in laboratory animals. Since adequate reproductive studies in humans have not been conducted, the use of corticosteroids during pregnancy, lactation or childbearing age should be evaluated in the light of the possible benefit against the potential risk to the mother, the embryo, the fetus. or the nursing infant.
Infants of mothers receiving substantial doses of corticosteroids during pregnancy should be carefully monitored for signs of hypoadrenalism.
Ask your doctor or pharmacist for advice before taking any medicine.
Effects on ability to drive and use machines
Given the possible occurrence of undesirable effects affecting the central nervous system (for example vertigo), it is advisable that the patient who is about to drive or use machinery takes this possibility into account.
Interactions Which drugs or foods can modify the effect of Kenacort
Injections of amphotericin B and agents that cause potassium decrease: Subjects taking such agents should be monitored for possible hypokalaemia.
Anticholinesterases: antagonistic reactions with this agent may occur.
Oral anticoagulants: corticosteroids can both increase and decrease the anticoagulant action; it is therefore necessary to closely monitor those who take both oral anticoagulants and corticosteroids.
Antidiabetics: corticosteroids can increase blood sugar; it is necessary to closely monitor diabetic subjects, especially when they start, stop or change the dosage of corticosteroid therapy.
Antituberculosis drugs: Serum concentrations of isoniazid may be decreased.
Ciclosporin: "increased activity of both corticosteroid drugs and cyclosporine has been noted when taken simultaneously.
Digitalis glycosides: a possible increase in digitalis toxicity may occur if administered simultaneously with corticosteroid drugs.
Estrogen, including oral contraceptives: an increase in both the half-life and concentration of corticosteroids may occur, while a decrease in clearance is possible.
Hepatic enzyme inducers (eg barbiturates, phenytoin, carbamazepine, rifampicin): increased metabolic clearance of KENACORT was noted; subjects taking such therapies must be closely monitored and, if necessary, the dosage of corticosteroids must be modified.
Human growth hormone (eg somatrem): the growth stimulating effect may be inhibited. Ketoconazole: a decrease in the clearance of corticosteroid drugs may occur with consequent increase in effects.
Non-depolarizing muscle relaxants: Corticosteroids may decrease or increase neuromuscular blocking action.
Non-steroidal anti-inflammatory agents (NSAIDs): Corticosteroids may increase the incidence and / or severity of gastrointestinal bleeding and ulceration caused by NSAIDs. In addition, corticosteroids can reduce serum salicylate levels resulting in decreased efficacy.
Conversely, discontinuing corticosteroid administration during high-dose salicylate therapy could result in salicylate toxicity. In subjects with hypoprothrombinemia, the combination of corticosteroids and aspirin should be administered with caution.
Thyroid drugs: The metabolic clearance of corticosteroids is decreased in hypothyroid subjects and increased in hyperthyroid subjects. The dosage of corticosteroids must be rebalanced in case of changes in the state of the thyroid.
Vaccines: People on corticosteroid therapy who are vaccinated may have neurological complications and loss of antibody response.
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
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 the "gasping syndrome", the minimum dose of benzyl alcohol that can cause toxicity is not known. Premature and underweight infants, as well as patients receiving high dosages, can more easily develop toxicity.
Due to the presence of benzyl alcohol, therefore the product should not be administered to children under two years of age.
Do not inject intravenously, as it is a suspension.
No studies have been conducted to demonstrate the safety of therapy with KENACORT administered intranasally (turbinates), subconjunctival, subtendinous, retrobulbar and intraocular (intravitreal).
Endophthalmitis, eye inflammation, increased intraocular pressure, visual disturbances including loss of vision have been reported following intravitreal administration. Numerous episodes of blindness have also been reported following injections of corticosteroid suspensions into nasal turbinates and lesions. Administration of KENACORT (Triamcinolone Acetonide Suspension Injectable) is not recommended, nor is it indicated for any of these routes of administration.
Administration of KENACORT by the epidural or intrathecal route should not be used. Cases of serious adverse events have been associated with epidural or intrathecal administration. Cases of severe anaphylactic reactions and anaphylactic shock, including death, have been reported in subjects receiving a "triamcinolone acetonide injection, regardless of route. of administration.
KENACORT is a long-acting preparation and is not recommended in acute situations.
To avoid drug-induced adrenal insufficiency, a supportive dosage is indicated in stressful situations (trauma, surgery or serious illness), both during treatment with KENACORT and in the following year.
Prolonged use of corticosteroids can result in posterior subcapsular cataracts or glaucoma with possible damage to the optic nerves and increase the likelihood of secondary eye infections.
Medium and high doses of cortisone or hydrocortisone can cause increased blood pressure, water and salt retention, and increased potassium excretion. These effects are less likely with synthetic derivatives, unless they are used in high doses. diet low in salt and at the same time administer potassium supplements. All corticosteroids increase the excretion of calcium, which can therefore be associated with or aggravate a pre-existing osteoporosis.
Corticosteroids can mask some signs of infection, and intercurrent infections can occur during their use. In case of corticosteroid therapy, the defense capabilities may be diminished and it may be difficult to locate a possible site of infection. Furthermore, 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 receiving 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, varicella-specific immunoglobulin (VZIG) or pooled immunoglobulin therapy may be indicated. intravenous route (IVIG) If chickenpox or herpes zoster develops, therapy with antiviral agents may be considered.
Similarly, corticosteroid drugs should be used with extreme caution in subjects with Strongyloid infestation (pinworms) as corticosteroid-induced immunosuppression can cause Strongyloid superinfection with widespread larval dissemination and migration, often accompanied by severe enterocolitis and septicemia. from gram-negative potentially fatal.
Patients on corticosteroid treatment, especially at high doses, should not be vaccinated or immunized because due to the loss of antibody response they are predisposed to clinical complications, especially neurological.
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 together with adequate anti-tuberculosis therapy. If corticosteroids are given to patients with latent tuberculosis or with positive response to tuberculin, chemoprophylaxis is required. Since there have been rare cases of anaphylactic reactions in patients undergoing parenteral therapy with corticosteroids, appropriate precautions should be taken prior to administration particularly when the patient's history is allergic to drugs.
It is recommended that intramuscular injection be performed deeply as local atrophy may occur. The gluteal region is preferable to the deltoid region, as there is a higher incidence of local atrophy in this area.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dosage and method of use How to use Kenacort: Dosage
General
The initial dose of KENACORT can vary from 2.5 to 60 mg / day depending on the specific pathology to be treated.
In less severe cases, lower dosages may be sufficient while in other patients higher starting doses may be required. Generally the amount of drug administered parenterally varies from one third to one half of the dose administered orally every 12 hours. In cases that may be life-threatening, higher dosages may be warranted. 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, KENACORT should be gradually discontinued and the patient treated with other therapy.
THE DOSAGE SCHEME IS VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE PATHOLOGY TO BE TREATED AND THE PATIENT'S RESPONSE.
It is recommended to use the lowest useful dose 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. long term, gradual and not sudden discontinuation is recommended.
Dosage
Systemically
Adults and children over 12 years: the recommended starting dose is 60 mg. Inject deeply into the muscles of the gluteal region.
If the injection is not given correctly, subcutaneous fat atrophy can occur.
The dosage usually ranges between 40 and 80 mg, depending on the patient's response and the duration of remission. In some patients, however, symptoms can be well controlled with low doses of the order of 20 mg or less. Patients with hay fever or pollen-induced asthma who do not respond to desensitizing therapy and other conventional therapies may achieve symptom remission. lasting the entire pollen season with a single injection of 40-100 mg.
Children from 6 to 12 years: the recommended starting dose is 40 mg, although the posology depends more on the severity of the symptoms than on age or body weight.
Newborn or premature babies: This preparation contains benzyl alcohol. Do not use in neonates or preterm infants (see also paragraphs PRECAUTIONS FOR USE, Use in children and SPECIAL WARNINGS)
For local administration
Intra-articular or intra-borsal administration: A single injection of triamcinolone acetonide is frequently sufficient, but several may be needed to relieve symptoms adequately.
Initial dose: 2.5-5 mg for small joints, 5 to 15 mg for larger ones, depending on the type of pathology to be treated. In adults, doses of up to 10 mg for smaller areas and up to 40 mg for larger areas are usually sufficient. Doses up to a total of 80 mg have been safely administered by single injections.
Administration
General
Administration under conditions of absolute sterility is necessary.
Before use, shake the bottle well to ensure the uniform suspension of the preparation and make sure that no agglomerations have formed. Exposure to low temperatures causes agglomerations and in this case the product should not be used. After collection, immediately give the injection to avoid deposits in the syringe. Use all precautions to avert the danger of infection or that the needle enters a blood vessel.
Systemically
The injection should be made deeply into the muscles of the gluteal region. For adults we recommend the use of a needle with a minimum length of 4 cm, in obese subjects, a longer needle may be needed. Alternate the site with each subsequent injection.
Local administration
In cases of conspicuous intra-articular effusion, it is advisable to practice the preventive aspiration of part of the synovial fluid, without however reaching the complete emptying of the collection; this measure helps to facilitate the remission of symptoms, while avoiding an "excessive dilution of the steroid injected in situ . Then proceed with intra-articular administration according to the technical standards prescribed for injections in the joint cavity.
With intra-articular or intraborsal administration of KENACORT, the use of a local anesthetic may often be appropriate.
The utmost attention should be paid to this type of injection, especially if performed in the deltoid region to avoid injection of the suspension into the surrounding tissue, since this can lead to tissue atrophy.
Do not use KENACORT for intravenous, intradermal, subtendinous, intrathecal (turbinates), subconjunctival, retrobulbar or intravitreal (intraocular), epidural or intrathecal injection. See the section SPECIAL WARNINGS in this regard.
Overdose What to do if you have taken too much Kenacort
Chronic overdose: Symptoms of glucocorticoid overdose may include confusion, anxiety, depression, gastrointestinal cramps or bleeding, bruising, facies lunaris and hypertension. Following prolonged therapy, abrupt discontinuation of treatment can cause acute adrenal insufficiency. The latter can also occur in stressful situations. Cushingoid-like changes may occur following prolonged therapy with high dosages.
Acute overdose: There is no specific treatment for acute corticosteroid overdose, therefore supportive therapy should be instituted, and in the case of gastrointestinal bleeding, action should be taken as in the case of a peptic ulcer.
If you have any questions about the use of KENACORT, ask your doctor or pharmacist.
Side Effects What are the side effects of Kenacort
Like all medicines, KENACORT can cause side effects, although not everybody gets them.
List of side effects:
Common (may affect up to 1 in 10 people):
- Infection
- Headache
- Cataract
- Injection site reactions
Uncommon (may affect up to 1 in 100 people):
- Sterile injection site abscess, masked infection
- Anaphylactoid reaction, anaphylactic reaction, anaphylactic shock
- Cushingoid, adrenal suppression
- Sodium retention, fluid retention, hypokalaemic alkalosis, hyperglycaemia, diabetes mellitus, inadequate control of diabetes mellitus
- Psychiatric symptom, depression, euphoric mood, mood swings, psychotic disorder, personality change, insomnia
- Convulsions, syncope, benign intracranial hypertension, neuritis, paraesthesia
- Blindness, glaucoma, exophthalmos, corneal perforation
- Vertigo
- Congestive heart failure, arrhythmia
- Hypertension, embolism, thrombophlebitis, necrotizing vasculitis
- Peptic ulcer, peptic ulcer with perforation, peptic ulcer with haemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis
- Urticaria, 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 union, musculoskeletal discomfort, muscle weakness, myopathy, muscle atrophy, growth retardation, neuropathic arthropathy
- Glycosuria
- Irregular menstruation, amenorrhea, postmenopausal haemorrhage
- Synovitis, pain, injection site irritation, injection site discomfort, fatigue, incomplete healing
- Blood potassium decreased, EKG change, carbohydrate tolerance decreased, nitrogen balance negative, intraocular pressure increased, interference in laboratory analysis
- Compressional vertebral fracture
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package
The expiry date refers to the product in intact and correctly stored packaging. Warning: do not use the medicine after the expiry date indicated on the package.
Special precautions for storage: Store at a temperature not exceeding 25 ° C. Do not freeze.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
Composition
KENACORT 40 mg / ml suspension for injection contains: 40 mg triamcinolone acetonide
Excipients: sodium chloride, benzyl alcohol, sodium carboxymethylcellulose, polysorbate 80 and water for injections.
Pharmaceutical form and content
Suspension for injection for intramuscular and intra-articular use. 1 ml vials.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
KENACORT 40 MG / ML INJECTABLE SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 1 ml vial of KENACORT 40 mg / ml contains 40 mg triamcinolone acetonide.
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Suspension for injection.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Intramuscular administration of KENACORT (Triamcinolone acetonide suspension for injection) is indicated for systemic corticosteroid therapy in morbid conditions such as allergic syndromes (to control severe or debilitating conditions that cannot be treated conventionally), dermatosis, generalized rheumatoid arthritis and other connective tissue diseases. . The intramuscular route of administration is particularly useful in the aforementioned diseases when oral corticosteroid therapy is not feasible.
KENACORT can also be administered intra-articularly or intra-borsally. These methods of administration allow to implement a valid local short-term therapy of pain, swelling and joint stiffness resulting from traumatic or rheumatoid arthritis, osteoarthritis, synovitis, bursitis.
In the treatment of generalized arthritic diseases, the intra-articular injection of triamcinolone acetonide is intended as an aid to other conventional therapeutic measures. Circumscribed morbid processes such as traumatic arthritis or bursitis may represent typical indications for a therapy conducted exclusively for intra-articular route.
04.2 Posology and method of administration
General
The initial dose of KENACORT can vary from 2.5 to 60 mg / day according to the specific pathology to be treated.
In less severe cases, lower dosages may be sufficient while in other patients higher starting doses may be required. Generally the amount of drug administered parenterally varies from one third to one half of the dose administered orally every 12 hours. In cases that may be life-threatening, higher dosages may be warranted. 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, KENACORT should be gradually discontinued and the patient treated with other therapy.
THE DOSAGE SCHEME IS VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE PATHOLOGY TO BE TREATED AND THE PATIENT'S RESPONSE.
It is recommended to use the lowest useful dose 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. long term, gradual and not sudden discontinuation is recommended.
DOSAGE
Systemically
Adults and children over 12 years old: the recommended starting dose is 60 mg. Inject deeply into the muscles of the gluteal region.
If the injection is not given correctly, subcutaneous fat atrophy can occur.
The dosage usually ranges between 40 and 80 mg, depending on the patient's response and the duration of remission. In some patients, however, symptoms can be well controlled with low doses of the order of 20 mg or less. Patients with hay fever or pollen-induced asthma who do not respond to desensitizing therapy and other conventional therapies may achieve symptom remission. lasting the entire pollen season with a single injection of 40-100 mg.
Children from 6 to 12 years old: The recommended starting dosage is 40 mg, although the posology depends more on the severity of the symptoms than on age or body weight.
Newborn or premature babies:
This preparation contains benzyl alcohol. Do not use in neonates or premature babies (see section 4.4 and in particular the section "USE IN CHILDREN").
For local administration
Intra-articular or intra-borsal administration: A single injection of triamcinolone acetonide is frequently sufficient, but several may be needed to relieve symptoms adequately.
Initial dose: 2.5-5 mg for small joints, 5 to 15 mg for larger ones, depending on the type of pathology to be treated. In adults, doses of up to 10 mg for smaller areas and up to 40 mg for larger areas are usually sufficient. Doses up to a total of 80 mg have been safely administered by single injections.
METHOD OF ADMINISTRATION
General
Administration under conditions of absolute sterility is necessary. Before use, shake the bottle well to ensure the uniform suspension of the preparation and make sure that no agglomerations have formed. Exposure to low temperatures causes agglomerations and in this case the product should not be used. After collection, immediately give the injection to avoid deposits in the syringe. Use all precautions to avert the danger of infection or that the needle penetrates a blood vessel.
Systemically
The injection should be made deeply into the muscles of the gluteal region. For adults we recommend the use of a needle with a minimum length of 4 cm, in obese subjects, a longer needle may be needed. Alternate the site with each subsequent injection.
Local administration
In cases of conspicuous intra-articular effusion, it is advisable to practice the preventive aspiration of part of the synovial fluid, without however reaching the complete emptying of the collection; this measure helps to facilitate the remission of symptoms, while avoiding an "excessive dilution of the steroid injected in situ . Then proceed with intra-articular administration according to the technical standards prescribed for injections in the joint cavity.
With intra-articular or intra-borsal administration of KENACORT, the use of a local anesthetic may often be appropriate.
The utmost attention should be paid to this type of injection, especially if performed in the deltoid region, to avoid injection of the suspension into the surrounding tissue, since this can lead to tissue atrophy.
Do not use KENACORT for intravenous, intradermal, subtendinous, intrathecal (turbinates), subconjunctival, retrobulbar or intravitreal (intraocular), epidural or intrathecal injection. See Section 4.4 (Special warnings and special precautions for use).
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients (see Section 4.4 "Special warnings and special precautions for use").
Corticosteroids are contraindicated in patients with systemic infections and in children under the age of two. Intramuscular administration of corticosteroids is contraindicated in the presence of idiopathic thrombocytopenic purpura.
04.4 Special warnings and appropriate precautions for use
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 the "gasping syndrome", the minimum dose of benzyl alcohol that can cause toxicity is not known. Premature and underweight infants, as well as patients receiving high dosages, can more easily develop toxicity.
Due to the presence of benzyl alcohol, therefore, the product should not be administered to children under two years of age (see also below, the paragraph "USE IN CHILDREN").
Do not inject intravenously, as it is a suspension.
No studies have been conducted to demonstrate the safety of therapy with KENACORT administered intranasally (turbinates), subconjunctival, subtendinous, retrobulbar and intraocular (intravitreal).
Endophthalmitis, eye inflammation, increased intraocular pressure, visual disturbances including loss of vision have been reported following intravitreal administration. Numerous episodes of blindness have been reported following injections of corticosteroid suspensions into nasal turbinates and lesions of the chief The administration of KENACORT (Triamcinolone Acetonide Suspension Injectable) is not recommended, nor is it indicated for any of these routes of administration.
Administration of KENACORT by the epidural or intrathecal route should not be used. Cases of serious adverse events have been associated with epidural or intrathecal administration.
Cases of severe anaphylactic reactions and anaphylactic shock, including death, have been reported in subjects given an injection of triamcinolone acetonide, regardless of the route of administration.
KENACORT is a long-acting preparation and is not recommended in acute situations.
To avoid drug-induced adrenal insufficiency, a supportive dosage is indicated in stressful situations (trauma, surgery or serious illness), both during treatment with KENACORT and in the following year.
Prolonged use of corticosteroids can result in posterior subcapsular cataracts or glaucoma with possible damage to the optic nerves and increase the likelihood of secondary eye infections.
Medium and high doses of cortisone or hydrocortisone can cause increased blood pressure, water and salt retention, and increased potassium excretion. These effects are less likely with synthetic derivatives, unless they are used in high doses. diet low in salt and at the same time administer potassium supplements. All corticosteroids increase the excretion of calcium, which can therefore be associated with or aggravate a pre-existing osteoporosis
Corticosteroids can mask some signs of infection, and intercurrent infections can occur during their use. In case of corticosteroid therapy, the defense capabilities may be diminished and it may be difficult to locate a possible site of infection. Furthermore, 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 receiving 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, varicella-specific immunoglobulin (VZIG) or pooled immunoglobulin therapy may be indicated. intravenous route (IVIG) If chickenpox or herpes zoster develops, therapy with antiviral agents may be considered.
Similarly, corticosteroid drugs should be used with extreme caution in subjects with Strongyloid infestation (pinworms) as corticosteroid-induced immunosuppression can cause Strongyloid superinfection with widespread larval dissemination and migration, often accompanied by severe enterocolitis and septicemia. from gram-negative potentially fatal.
Patients on corticosteroid treatment, especially at high doses, should not be
vaccinated or immunized because due to the loss of antibody response they are predisposed to clinical complications, especially neurological.
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 together with adequate anti-tuberculosis therapy. If corticosteroids are given to patients with latent tuberculosis or with positive response to tuberculin, chemoprophylaxis is required.
Since there have been rare cases of anaphylactic reactions in patients undergoing parenteral therapy with corticosteroids, appropriate precautions should be taken prior to administration, particularly when the patient's history is allergic to drugs.
It is recommended that intramuscular injection be performed deeply as local atrophy may occur. The gluteal region is preferable to the deltoid region, as there is a higher incidence of local atrophy in this area.
A state of 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 must be resumed. Since the secretion of mineralocorticoids can be compromised, sodium chloride and / or mineralocorticoids should be administered concomitantly.
In patients with hypothyroidism or with liver cirrhosis, the response to corticosteroids may be increased.
Caution is advised in patients with ocular herpes simplex because corneal perforation is possible.
Psychic alterations of various kinds can occur during corticotherapy: euphoria, insomnia, mood and personality changes, severe depression or symptoms of real psychosis. A pre-existing emotional instability or psychotic tendencies can be aggravated by corticosteroids. Antidepressant medications do not relieve these disorders and can exacerbate the mental disorders induced by corticosteroid therapy.
Corticosteroids should be administered with caution in the following cases: non-specific ulcerative colitis with danger of perforation, abscesses and pyogenic infections in general, diverticulitis, recent intestinal anastomosis, active or latent peptic ulcer, renal insufficiency, acute glomerulonephritis, chronic nephritis, hypertension, insufficiency congestive heart, thrombophlebitis, thromboembolic episodes, osteoporosis, exanthema, metastatic carcinoma, myasthenia gravis.
Although KENACORT can improve the symptoms of inflammation, the cause must be sought and treated.
Intra-articular administration of a corticosteroid can produce systemic as well as local effects. Accidental injection of the suspension into the periarticular soft tissues can also cause systemic effects and is the most frequent cause of local therapeutic failure. Patients undergoing intra-articular treatment should not overstress the joints where improvement has been achieved. symptomatological, otherwise there may be an increase in the deterioration of the joint.
On the occasion of intra-articular administration, over-distension of the joint capsule and the effusion of the steroid along the path of the needle should be avoided, as subcutaneous atrophy may occur.
Avoid injecting the preparation into unstable joints. In some cases, repeated intra-articular injections can themselves cause instability of the joint. In some particular cases, especially after repeated administrations, it is advisable to perform an X-ray examination.
Intra-articular injection rarely causes joint discomfort. An increase in pain accompanied by local swelling, further impediment of joint motility, fever, malaise, should lead to suspicion of a joint septic process. If confirmed, discontinue administration of the corticosteroid and immediately institute appropriate antibacterial therapy which continues 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.
Edema may occur in the presence of renal dysfunction with a reduced glomerular filtration index. During prolonged therapy, good protein intake is essential to counteract the tendency to gradual weight loss sometimes associated with negative nitrogen balance, weight loss and skeletal muscle weakness.
Menstrual irregularities may occur and vaginal bleeding has been observed in postmenopausal women. Female patients must be made aware of the risk but appropriate investigations must in any case be recommended.
In the peptic ulcer the recurrence may remain asymptomatic until the moment of perforation or hemorrhage.
Prolonged adrenocortical therapy can cause hyperacidity or peptic ulcer; therefore the administration of an antacid is recommended.
Monitoring of patients is essential even after discontinuation of triamcinolone acetonide therapy as there may be a sudden reappearance of the main symptoms of the disease for which the patient was treated.
Use in children
Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), especially in neonates, and an "increased incidence of nuclear jaundice, particularly in premature babies. There have been rare reports of death, especially in infants. premature, associated with exposure to an excessive amount of benzyl alcohol.
KENACORT is not recommended for 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 used in case of exposure to chickenpox, measles or other infectious diseases.
Children should not be vaccinated or immunized during corticosteroid therapy. These can in fact affect the endogenous production of steroids.
Use in the elderly
Side effects such as osteoporosis or hypertension, common in systemic corticosteroid therapy, can have more serious consequences in the elderly.
Close clinical surveillance is therefore recommended.
04.5 Interactions with other medicinal products and other forms of interaction
Injections of Amphotericin B and agents that cause potassium decrease: Individuals taking these agents should be monitored for possible hypokalaemia.
Anticholinesterases: antagonistic reactions with this agent may occur.
Oral anticoagulants: Corticosteroids can both increase and decrease the anticoagulant action; it is therefore necessary to closely monitor those who take both oral anticoagulants and corticosteroids.
Antidiabetics: corticosteroids can increase blood sugar; it is necessary to closely monitor diabetic subjects, especially when they start, stop or change the dosage of corticosteroid therapy.
Anti-tuberculosis drugs: Serum concentrations of isoniazid may be decreased.
Cyclosporine: an "increased activity of both corticosteroid drugs and cyclosporine was noted when taken simultaneously.
Digitalis glycosides: a possible increase in digitalis toxicity may occur if administered simultaneously with corticosteroid drugs.
Estrogen, including oral contraceptives: an increase in both the half-life and the concentration of corticosteroids may occur, while a decrease in clearance is possible.
Inducers of liver enzymes (e.g. barbiturates, phenytoin, carbamazepine, rifampicin): increased metabolic clearance of KENACORT was noted; strictly monitor the subjects taking such therapies and possibly modify the dosage of corticosteroids.
Human growth hormone (e.g. somatrem): the growth stimulating effect can be inhibited.
Ketoconazole: there may be a decrease in the clearance of corticosteroid drugs with a consequent increase in effects.
Non-depolarizing muscle relaxants: Corticosteroids can decrease or increase neuromuscular blocking action.
Non-steroidal anti-inflammatory agents (NSAIDs): corticosteroids may increase the incidence and / or the severity of gastrointestinal bleeding and ulceration caused by NSAIDs. In addition, corticosteroids can reduce serum salicylate levels resulting in decreased efficacy.
Conversely, discontinuing corticosteroid administration during high-dose salicylate therapy could result in salicylate toxicity.
In subjects with hypoprothrombinemia, the combination of corticosteroids and aspirin should be administered with caution.
Thyroid drugs: the metabolic clearance of corticosteroids is decreased in hypothyroid subjects and increased in hyperthyroid subjects. The dosage of corticosteroids must be rebalanced in case of changes in the state of the thyroid.
Vaccines: Subjects on corticosteroid therapy who are vaccinated may present with neurological complications and loss of antibody response.
04.6 Pregnancy and lactation
Many corticosteroids used in low doses have been shown to have a teratogenic effect in laboratory animals. Since adequate reproductive studies in humans have not been conducted, the use of corticosteroids during pregnancy, lactation or childbearing age should be evaluated in the light of the possible benefit against the potential risk to the mother, the embryo, the fetus. or the nursing infant.
Infants of mothers receiving substantial doses of corticosteroids during pregnancy should be carefully monitored for signs of hypoadrenalism.
04.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed. However, given the possible occurrence of side effects affecting the central nervous system (eg vertigo), it is advisable to inform the patient of this possibility.
04.8 Undesirable effects
Table 1 lists adverse reactions listed by system organ class, MedDRA terminology, and frequency.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100,
Table 1: Adverse Reactions During Kenacort Therapy, by MedDRA System Organ Class
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
ChronicSymptoms of glucocorticoid overdose may include confusion, anxiety, depression, gastrointestinal cramps or bleeding, bruising, facies lunaris and hypertension. Following prolonged therapy, abrupt discontinuation of treatment can cause acute adrenal insufficiency. The latter can also occur in stressful situations. Cushingoid-like changes may occur following prolonged therapy with high dosages.
Acute: There is no specific treatment for acute corticosteroid overdose, therefore supportive therapy should be instituted, and in the case of gastrointestinal bleeding, action should be taken as in the case of a peptic ulcer.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: systemic corticosteroids, ATC code: H02AB08.
KENACORT is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in sterile aqueous suspension, for intramuscular, intra-articular and intra-borsal injectable use. Do not use this formulation for intravenous, intradermal, subtendinous, intrathecal (turbinates), subconjunctival, retrobulbar or intravitreal (intraocular), epidural or intrathecal injection.
KENACORT has a long duration of action which can be permanent or prolonged for a period of several weeks.
Naturally derived glucocorticoids (hydrocortisone), which also cause salt retention, are used as replacement therapy in states of adrenocortical insufficiency. Synthetic analogues, such as triamcinolone, are mainly used for their powerful anti-inflammatory effects in various diseases.
Clinical studies have shown that after a single dose of 60 to -100 mg of triamcinolone acetonide, suppression of adrenal activity occurs between 24 and 48 hours and then returns to normal, usually within 30 to 40 days. These results are closely related to the prolonged therapeutic action achieved with this product.
05.2 Pharmacokinetic properties
Triamcinolone acetonide is absorbed slowly but completely following deep intramuscular administration. Therapeutic levels of product are ensured constantly over a long period (from weeks to months). As with other corticosteroids, triamcinolone is extensively metabolised by the liver but also by the kidney and is excreted in the urine. The main route of metabolism is hydroxylation.
Renal or hepatic dysfunction may affect the pharmacokinetics of the drug.
Following intra-articular administration, unless treatment of large joints with the use at high doses, it is difficult to find clinically significant systemic levels of the product. With the use of appropriate intra-articular doses and methods of administration, no effects are usually observed. systemic.
05.3 Preclinical safety data
The preclinical safety of the product as observed at the time of marketing authorization has been largely superseded by more than thirty years of clinical use and post-marketing pharmacovigilance.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium carboxymethylcellulose, sodium chloride, polysorbate 80, benzyl alcohol, water for injections.
06.2 Incompatibility
see point 4.4.
06.3 Period of validity
3 years
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C. Do not freeze.
06.5 Nature of the immediate packaging and contents of the package
Carton containing 3 vials of 1 ml.
06.6 Instructions for use and handling
see point 4.2.
07.0 MARKETING AUTHORIZATION HOLDER
Bristol-Myers Squibb S.r.l .. Via Virgilio Maroso, 50 - Rome
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. N ° 013972056.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 2010.
10.0 DATE OF REVISION OF THE TEXT
October 2014
