Trilac

Triamcinolone acetonide.

Each mL contains: Triamcinolone acetonide, BP 10 mg.

Pharmacology: Pharmacodynamics: Triamcinolone acetonide is a synthetic glucocorticoid with marked anti-inflammatory and anti-allergic actions. Following local injection, relief of pain and swelling and greater freedom of movement are usually obtained within a few hours; such administration avoids the more severe systemic side-effects which may accompany parenteral or oral corticosteroid administration.
Pharmacokinetics: Triamcinolone acetonide may be absorbed into the systemic circulation from synovial spaces. However clinically significant systemic levels after intra-articular injection are unlikely to occur except perhaps following treatment of large joints with high doses. Systemic effects do not ordinarily occur with intra-articular injections when the proper techniques of administration and the recommended dosage regimens are observed.
The systemic effects of intradermally administered triamcinolone acetonide have not been extensively studied. The risk of systemic absorption, though minimal, should be taken into consideration especially when repeated intralesional administrations may be necessary.
In common with other corticosteroids, triamcinolone is metabolised largely hepatically but also by the kidney and is excreted in urine. The main metabolic route is 6-beta-hydroxylation; no significant hydrolytic cleavage of the acetonide occurs. In view of the hepatic metabolism and renal excretion of triamcinolone acetonide, functional impairments of the liver or kidney may affect the pharmacokinetics of the drug. This may become clinically significant if large or frequent doses of intradermal or intra-articular triamcinolone acetonide are given.

Intra-articular: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.
Intradermal: for lichen simplex chronicus (neuro-dermatitis), granuloma annulare, lichen planus, keloids, alopecia areata and hypertrophic scars.

Triamcinolone acetonide (Trilac) 10 mg/mL Injection is for intra-articular or intra-dermal injection ONLY. The safety and efficacy of administration by other routes has yet to be established (see sections Contraindications and Precautions). Strict aseptic precautions should be observed. Since the duration of effect is variable, subsequent doses should be given when symptoms recur and not at set intervals.
Adults: The dose for intra-articular administration, and injection into tendon sheaths and bursae, is dependent on the size of the joint to be treated and on the severity of the condition. Doses of 2.5-5 mg (0.25-0.5 mL) for smaller joints and 5-15 mg (0.5-1.5 mL) for larger joints usually alleviate the symptoms.
Intradermal dosage is usually 2-3 mg (0.2-0.3 mL), depending on the size of the lesion. No more than 5 mg (0.5 mL) should be injected at any one site. If several sites are injected the total dosage administered should not exceed 30 mg (3 mL). The injection may be repeated if necessary, at one or two weeks intervals.
Elderly: Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close supervision is required to avoid life-threatening reactions.
Children: Not recommended in children under 6 years. Intra-articular/intradermal may be used in older children in suitably adjusted dosages. Growth and development of children on prolonged corticosteroid therapy should be carefully observed. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases (see Precautions).

Chronic: The symptoms of glucocorticoid corticosteroid overdose may include confusion, anxiety, depression, gastrointestinal cramping or bleeding, ecchymosis, moon face and hypertension. After long-term use, rapid withdrawal can result in acute adrenal insufficiency (which also may occur in times of stress). Cushingoid changes can result from continued use of large doses.
Acute: There is no specific treatment for overdose, but supportive therapy should be instituted and, if gastrointestinal bleeding occurs, it should be managed.

Hypersensitivity to any of the ingredients.
Systemic infections unless specific anti-infective therapy is employed.
Administration by intravenous, intrathecal, epidural or intraocular injection.

Intra-Articular Injection: Corticosteroids should not be injected into unstable joints.
Patients should be specifically warned to avoid over-use of joints in which symptomatic benefit has been obtained. Severe joint destruction with necrosis of bone may occur if repeated intra-articular injections are given over a long period of time. Care should be taken if injections are given into tendon sheaths to avoid injection into the tendon itself. Repeated injection into inflamed tendons should be avoided as it has been shown to cause tendon rupture.
Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with depot corticosteroids.

Adequate studies to demonstrate the safety of Triamcinolone acetonide (Trilac) 10 mg/mL Injection use by intra-turbinal, subconjunctival, sub-tenons, retrobulbar and intraocular (intravitreal) injections have not been performed. Endophthalmitis, eye inflammation, increased intraocular pressure and visual disturbances including vision loss have been reported with intravitreal administration. Several instances of blindness have been reported following injection of corticosteroid suspensions into the nasal turbinates and intralesional injection about the head.
Cases of serious anaphylactic reactions and anaphylactic shock, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.
Intra-articular injection should not be carried out in the presence of active infection in or near joints. The preparation should not be used to alleviate joint pain arising from infectious states such as gonococcal or tubercular arthritis.
Undesirable effects may be minimised using the lowest effective dose for the minimum period, and by administering the daily requirement, whenever possible, as a single morning dose on alternate days. Frequent patient review is required to titrate the dose appropriately against disease activity (see Dosage & Administration).
Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily. Patients should carry steroid treatment cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.
Chickenpox and measles are of particular concern since these normally minor illnesses may be fatal in immunosuppressed patients.
Unless they have had chickenpox, patients receiving parenteral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature.
Passive immunisation with varicella-zoster immunoglobulin is needed for exposed non-immune patients receiving systemic corticosteroids or for those who have used them within the previous 3 months; varicella-zoster immunoglobulin should preferably be given within 3 days of exposure and not later than 10 days. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and dosage may need to be increased.
Patients should be advised to avoid exposure to measles and to seek medical advice without delay if exposure occurs. Prophylaxis with normal immunoglobulin may be needed.
During corticosteroid therapy antibody response will be reduced and therefore affect the patient's response to vaccines. Live vaccines should not be administered.
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see Adverse Reactions).
Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see Interactions), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.
Special Precautions: Particular care is required when considering use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.
Recent intestinal anastomoses, diverticulitis, thrombophlebitis, existing or previous history of severe affective disorders (especially previous steroid psychosis), exanthematous disease, chronic nephritis, or renal insufficiency, metastatic carcinoma, osteoporosis (post-menopausal females are particularly at risk); in patients with an active peptic ulcer (or a history of peptic ulcer). Myasthenia gravis. Latent or healed tuberculosis; in the presence of local or systemic viral infection, systemic fungal infections or in active infections not controlled by antibiotics. In acute psychoses; in acute glomerulonephritis. Hypertension; congestive heart failure; glaucoma (or a family history of glaucoma), previous steroid myopathy or epilepsy. Liver
failure.
During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, caution is advised in co-administration of triamcinolone acetonide and ritonavir (see Interactions).
Corticosteroid effects may be enhanced in patients with hypothyroidism or cirrhosis and decreased in hyperthyroid patients.
Diabetes may be aggravated, necessitating a higher insulin dosage. Latent diabetes mellitus may be precipitated.
Menstrual irregularities may occur and in postmenopausal women vaginal bleeding has been observed. This possibility should be mentioned to female patients but should not deter appropriate investigations as indicated.
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of drug allergies.
All corticosteroids increase calcium excretion.
Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.
This product contains benzyl alcohol and must not be given to premature babies or neonates. Benzyl Alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Use in Pregnancy & Lactation: The ability of corticosteroids to cross the placenta varies between individual drugs, however triamcinolone does cross the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non gravid state.
Corticosteroids may pass into breast milk, although no data are available for triamcinolone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.

Use in Pregnancy: The ability of corticosteroids to cross the placenta varies between individual drugs, however triamcinolone does cross the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important.
As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non gravid state.
Use in Lactation: Corticosteroids may pass into breast milk, although no data are available for triamcinolone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression.

Following intra-articular administration: Undesirable reactions have included post injection flare, transient pain, occasional irritation at the injection site, sterile abscess formation, hyperpigmentation and hypopigmentation, charcot-like arthropathy and occasional brief increase in joint discomfort.
Following intradermal administration: Rare instances of blindness associated with intralesional therapy around the face and head, transient local discomfort, sterile abscesses, hyper- and hypopigmentation and subcutaneous and cutaneous atrophy (which usually disappears, unless the basic disease process is itself atrophic) have occurred.

Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalemia.
Anticholinesterases: Effects of the anticholinesterase agent may be antagonised.
Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should be closely monitored.
Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.
Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.
Antitubercular drugs: Isoniazid serum concentrations may be decreased.
Cyclosporine: Monitor for evidence of increased toxicity of cyclosporine when the two are used concurrently.
Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.
Estrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.
Hepatic Enzyme Inducers (eg. barbiturates, phenytoin, carbamazepine, rifampin): There may be increased metabolic clearance of Triamcinolone acetonide (Trilac) 10 mg / mL Injection. Patients should be carefully observed for possible diminished effect of steroid, and the dosage of Triamcinolone acetonide (Trilac) 10 mg/mL Injection should be adjusted accordingly.
Human growth hormone (eg. Somatrem): The growth-promoting effect may be inhibited.
CYP 3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Caution is advised in co-administration with strong CYP3A4 inhibitors (eg,ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with triamcinolone because increased systemic corticosteroid adverse effects may occur.
Nondepolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.
Nonsteroidal anti-inflammatory agents (NSAIDS): Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDS. Also, corticosteroids can reduce serum salicylate levels and therefore decrease their effectiveness. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.
Thyroid drugs: metabolic clearance of adrenocorticoids is decreased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid drugs.
Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated (see Precautions).

Store at temperatures not exceeding 30°C.

Corticosteroid Hormones

H02AB08 - triamcinolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.

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