What Trica is and what it is used for
Trica is given as an injection containing medicine that is a corticosteroid. Corticosteroids are similar to a type of hormone produced naturally in the body by the adrenal glands. Corticosteroid one in Trica is called triamcinolone hexacetonide.
Trica is injected into or around joints. It is given to adults and young people as a treatment against pain, swelling, and stiffness in joints in subacute and chronic inflammatory joint disease, i.a.
- rheumatoid arthritis (joint inflammation)
- juvenile idiopathic arthritis (JIA, arthritis in children)
- osteoarthritis (a joint disease caused by wear and tear) and post-traumatic arthritis (caused by external injury)
- synovitis (mild swelling of tissue around the joint), tendinitis ( inflammation of a tendon), bursitis ( inflammation of one or more bursae (small fluid-filled cavities) with synovial fluid in the body), epicondylitis (longitudinal pain in the elbow, also called tennis elbow).
Trica can also be used intra-articularly (as an injection into the joint) in children aged 3–12 years with juvenile idiopathic arthritis.
Triamcinolone hexacetonide found in Trica may also be approved to treat other conditions not listed in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you receive Trica
Do not use Trica
- if you are allergic to triamcinolone hexacetonide or any of the other ingredients of this medicine (listed in section 6).
- Must not be given to newborn or premature infants or children up to 3 years of age.
- if you have active tuberculosis, herpes simplex infection of the eye, acute psychosis, or a generalized fungal and parasitic infection.
- if you have an infection in the joint or near the joint be treated
- to relieve joint pain caused by arthritis due to tuberculosis or gonorrhea
- if you have recently had a broken bone or have an unhealed broken bone.
Warnings and precautions
Trica contains a powerful corticosteroid and should therefore be used with caution if you have any of the following diseases.
You must therefore inform your doctor before receiving Trica if you have any of the following conditions:
- heart failure, acute coronary artery disease
- hypertension (high blood pressure )
- thrombophlebitis (blood clot), thromboembolism (a blood clot that breaks loose and is carried with the blood to another vessel that it blocks)
- myasthenia gravis (muscle weakness)
- osteoporosis _
- peptic ulcer (stomach ulcer), diverticulitis ( inflammation of a small bulge in the wall of the large intestine), ulcerative colitis ( chronic inflammation of the large intestine), recent intestinal anastomosis ( surgery after the removal of parts of the intestine)
- any skin disease such as eczema
- psychosis (mental health problems with hallucinations or delusions)
- “full moon face” and fat accumulation on the trunk (Cushing’s syndrome)
- diabetes mellitus
- underactive thyroid ( hypothyroidism )
- reduced kidney function, acute glomerulonephritis (damage to the small filters inside the kidney), chronic nephritis (long-term inflammation of the kidney)
- liver cirrhosis (cirrhosis)
- infection that cannot be treated with antibiotics
- cancer metastases (cancer that spreads from one organ or part of an organ to another organ or part of an organ
- active tuberculosis
- herpes simplex infection of the eye
- fungal and parasitic infection
Contact a doctor if you experience blurred vision or other visual disturbances.
The medicine must not be given intravenously (into a vein), intradermally, (into the skin), subcutaneously (under the skin), intramuscularly (into a muscle), intraocularly (into the eye), epidurally (into the spinal canal), or intrathecally (into the brain or spinal cord).
Be careful not to overuse a joint that feels better after receiving a Trica injection. The joint must recover from the inflammation that caused the symptoms. Repeated injections can damage the joint.
You should not be vaccinated or immunized with live vaccines if you are treated with medium or high-dose corticosteroids for more than 2 weeks, as a possible lack of antibody response may cause medical complications, especially neurological ones.
If you experience a serious reaction or acute infection, treatment must be discontinued and appropriate treatment instituted.
Corticosteroid drugs suppress the body’s natural immune response. If you come into contact with someone who has an infectious disease, e.g. chickenpox, shingles, or measles, you should contact a doctor as soon as possible.
Children and young people
Growth and development in children receiving long-term treatment with corticosteroids should be monitored.
Other medicines and Trica
Tell your doctor if you are taking, have recently taken, or might be taking any other medicines, even those without a prescription.
Some medicines can increase the effects of Trica and your doctor may want to monitor you closely if you are taking these medicines (eg some anti-HIV medicines: ritonavir, cobicistat).
It is especially important to tell your doctor if you are also taking:
amphotericin B injection and potassium-lowering agents: a combination of these with Trica can cause too low levels of potassium in the blood
cholinesterase inhibitors: as they may become less effective
anticholinergics (eg atropine): as the pressure in the eye may increase
blood thinners (oral anticoagulants ): Corticosteroids can enhance or reduce the blood thinning ( anticoagulant ) effect.
Blood sugar-lowering agents (antidiabetics, eg sulphonylurea derivatives, and insulin ): Corticosteroids can increase blood sugar levels
blood pressure lowering agents (antihypertensive agents, including diuretics ): may become less effective
medicines against tuberculosis, e.g. isoniazid: the concentration of isoniazid in the blood may decrease
immunosuppressive agents (cyclosporine): When used concurrently, cyclosporine may cause increased cyclosporine and corticosteroid activities
medicines against heart failure ( digitalis glycosides ): Concomitant treatment with Trica may increase the risk of digitalis toxicity
medicines that increase the number of certain liver enzymes (eg barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): may reduce the effect of Trica
human growth hormone (somatropin): The growth-promoting effect may be reduced during long-term treatment with Trica
drugs against fungal infections ( ketoconazole ): Corticosteroid effects of Trica may increase
protease inhibitors for HIV infection (ritonavir): Corticosteroid effects may be increased or prolonged
neuromuscular nondepolarizing agents: Steroids may decrease or increase neuromuscular blockade
Nonsteroidal anti-inflammatory drugs ( NSAIDs ): Corticosteroids may increase the incidence and severity of gastrointestinal bleeding and peptic ulcers associated with NSAIDs. Corticosteroids can lead to reduced salicylate concentrations in serum and thus reduce its effect. If treatment with corticosteroids is discontinued during simultaneous treatment with high doses of salicylates, it can cause salicylate poisoning. If you are using aspirin and have low prothrombin levels in your blood, tell your doctor or nurse
the hormone that prevents pregnancy, including birth control pills (oral contraceptives): The corticosteroid effect of Trica may be longer
Thyroid medication: If you have an underactive thyroid gland ( hypothyroidism ) or an overactive thyroid gland ( hyperthyroidism ), inform your doctor or nurse as the dose may need to be adjusted
vaccines: Neurological complications and a reduced antibody response can occur in special situations when patients taking corticosteroids are vaccinated. (See section 2 Warnings and precautions)
drugs that prolong the QT interval et or induce torsades de pointes (a form of cardiac arrhythmia ): Use of Trica and class IA antiarrhythmics such as disopyramide, quinidine, and procainamide or other class II antiarrhythmics such as amiodarone, bepridil, and sotalol is not recommended.
The greatest caution is required when Trica is used with phenothiazines, tricyclic antidepressants, terfenadine and astemizole, vincamine, intravenous erythromycin, halofantrine, pentamidine, and sultopride.
Combination with agents that cause electrolyte disturbances such as hypokalemia (potassium-depleting diuretics, intravenous amphotericin B, and some laxatives ), low magnesium levels, and severely decreased blood calcium levels is not recommended.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you are pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Trica is not expected to affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Trica contains benzyl alcohol and sorbitol (E420)
Benzyl alcohol can cause toxic and severe allergic reactions in infants and children up to 3 years of age.
Trica contains sorbitol. If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to get Trica
A doctor (or nurse on a doctor’s prescription ) gives you an injection with Trica. The dose is determined by the doctor.
This medicine is intended for intra-articular, peri-articular, and intrasynovial use (in and around a joint). This medicine must not be used intravenously (into a vein), intradermally, (into the skin), subcutaneously (under the skin), intramuscularly (into a muscle), intraocularly (into the eye), epidurally (into the spinal canal), or intrathecally (into the brain or spinal cord ).
The doctor prescribes the dose that is most suitable for you.
For intra-articular use ( injection into the joint, dosage for adults and adolescents) for all indications
The dose is determined individually and can vary from 2 to 20 mg depending on the size of the joint and the amount of fluid in the joint. Usually, 10-20 mg (0.5-1 ml) is used in large joints (eg hip, knee, and shoulder), 5-10 mg (0.25-0.5 ml) in medium-sized joints (eg . elbow and wrist), and 2‑6 mg (0.1‑0.3 ml) in small joints (eg hands and feet). If there is a lot of fluid in the joint, this can be removed before injection. The subsequent dose and number of injections depend on how the disease responds. Since Trica is long-acting, no joint should be treated more than once every 3-4 weeks.
Control of pain after treatment: The pain in a joint caused by intra-articular injection can be prevented or alleviated by avoiding unnecessary movement for 12 hours after injection.
For periarticular use (an injection around the joint, dosing for adults and adolescents only)
Bursitis/epicondylitis: Usually 10‑20 mg (0.5‑1 ml) depending on the size of the bursa and the severity of the disease. In most cases, one treatment session is sufficient.
Use for children and adolescents
Use in children aged 3-12 years with juvenile idiopathic arthritis
The dosage schedule for triamcinolone hexacetonide as an intra-articular injection for the treatment of JIA in children is 1 mg/kg for large joints (knee, hip, shoulder) and 0.5 mg/kg for smaller joints (wrist, ankle, and elbow). For hands and feet, 1-2 mg/joint for metacarpophalangeal/metatarsophalangeal joints (MCP/MTP joints) and 0.6-1 mg/joint for proximal interphalangeal joints (PIP joints) can be used.
If you have been given too much Trica
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice. Show them the Trica package if possible.
Overdose can cause changes in the skin around the injection site, such as when the time between injections at the same site is too short. If this occurs, healing may take several months due to the long-term effects of the drug.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects depend on the dose and duration of treatment. Side effects that affect the whole body are rare but can occur as a result of repeated treatment in and around joints. As with other intra-articular steroid treatments, transient inhibition of adrenocortical function has been observed during the first week after injection. This effect is enhanced by the simultaneous use of corticotropin or oral steroids.
Common side effects (may affect up to 1 in 10 people)
- local reactions at the injection site such as collections, redness, pain, swelling, and tissue damage
Rare side effects (may affect up to 1 in 1,000 people)
- injections with too high a dose or too often in the same place can cause local thinning of the skin’s top two layers, the dermis, and subcutaneous tissue, causing thin skin. Due to Trica’s long-term effects, it takes several months for the skin to return to normal.
- vertigo (dizziness or a feeling that everything is “spinning”).
Very rare side effects (may affect up to 1 in 10,000 people)
- thromboembolism (a blood clot that breaks loose and is carried with the blood to another vessel that becomes blocked)
- formation of calcium deposits in and around the treated joint, tendon rupture (tearing of the tendon)
- the skin becomes lighter or darker
- severe allergic reaction causing difficulty breathing or dizziness
Frequency not known (cannot be estimated from available data)
- heart failure, abnormal heart rhythm
- high blood pressure
- loss of muscle mass, osteoporosis (bone fragility), death of bone tissue due to poor blood supply to the joint head of the upper arm or femur, spontaneous fractures, symptoms similar to neurogenic joint disease
- peptic ulcer possibly followed by perforation and bleeding, pancreatitis ( inflammation of the pancreas)
- impaired wound healing, skin fragility, skin bruising and bruising, facial redness and/or rash, increased sweating, red or purple skin discoloration, stretch marks, acne-like skin rash, hives
- increased blood pressure in the brain without any known cause usually after treatment, headache
- insomnia (sleeplessness), depression (sometimes severe), euphoria, mood swings, hallucinations, and delusions
- irregular menstruation, bleeding in postmenopausal women, abnormal hair growth, Cushing-like symptoms (full moon face, fat accumulation on the trunk), impaired adrenal cortex function, or partially shrunken adrenal glands especially during periods of stress (eg, trauma, surgery, or illness) reduced tolerance to sugars, activation of underlying diabetes mellitus
- cataract, excessive pressure in the eye ( glaucoma ), blurred vision
- high levels of nitrogen in the blood due to the breakdown of proteins
- worsening or masking of infection er
Rare cases of a hypersensitivity reaction may occur.
Additional side effects in children and adolescents
There is a risk of reduced growth in children.
How to store Trica
The doctor, nurse, or pharmacist knows how to properly store the medicine.
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the ampoule label and the outer carton after “Expiry date”. The expiration date is the last day of the specified month.
Do not use this medicine if you notice any visible signs that the appearance of the medicine has changed.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is triamcinolone hexacetonide 20 mg/ml.
- 1 ampoule with 1 ml solution for injection, the suspension contains 20 mg triamcinolone hexacetonide.
- Other ingredients per 1 ml are sorbitol (E420) 455 g, polysorbate 80 4 mg, benzyl alcohol 9 mg, and water for injections.
Appearance and package sizes of the medicine
Trica is a milky, white suspension
Trica is available in packs of 1, 10, 12, and 50 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Esteve Pharmaceuticals GmbH
RIEMSER Pharma GmbH
This medicine is approved in the European Economic Area under the names:
Finland, Denmark, Sweden, and Norway: Trica