Brand name: TriamHexal

Active ingredient (generic name): Triamcinolone acetonide

Manufacturer: Hexal

Importer: Behestan Darou

Pharmacotherapeutic group: Antineoplastic agents

Pharmaceutical form: 40mg/1ml ampoule

Pharmacodynamic:  

Triamcinolone acetonide is a synthetic glucocorticoid with marked anti-inflammatory and anti-allergic actions.

Intra-Articular Injection: Following local injection, relief of pain and swelling and greater freedom of movement are usually obtained within a few hours.

Intramuscular Injection: Provides an extended duration of therapeutic effect and fewer side effects of the kind associated with oral corticosteroid therapy, particularly gastro-intestinal reactions such as peptic ulceration. Studies indicate that, following a single intramuscular dose of 80mg triamcinolone acetonide, adrenal suppression occurs within 24 - 48 hours and then gradually returns to normal, usually in approximately three weeks. This finding correlates closely with the extended duration of therapeutic action of triamcinolone acetonide.

 

Pharmacokinetic:

Triamcinolone acetonide is absorbed slowly, though almost completely, following depot administration by deep intramuscular injection; biologically active levels are achieved systemically for prolonged periods (weeks to months). Half life is about 2 to 5 hours.  In common with other corticosteroids, triamcinolone is metabolised largely hepatically but also by the kidney and is excreted in urine.

 

Therapeutic indication:

Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.

Intramuscular use: Where sustained systemic corticosteroid treatment is required: Allergic states, e.g. bronchial asthma, seasonal or perennial allergic rhinitis. In seasonal allergies, patients who do not respond to conventional therapy may achieve a remission of symptoms over the entire period with a single intramuscular injection (see Dosage); Endocrine disorders, e.g. primary or secondary adrenocortical insufficiency. Collagen disorders, e.g. during an exacerbation of maintenance therapy of selected cases of SLE or acute rheumatic carditis; Dermatological diseases, e.g. pemphigus, severe dermatitis and Stevens Johnson Syndrome; Rheumatic, Gastrointestinal or Respiratory disorders - as an adjunctive, short-term therapy; Haematological disorders, e.g. acquired (autoimmune) haemolytic anaemia; Neoplastic diseases, e.g. palliative management of leukaemia and lymphomas; Renal disease, such as acute interstitial nephritis, minimal change nephrotic syndrome or lupus nephritis.

 

Dosage and administration:

 

Intra-Articular Injection: For intra-articular administration or injection into tendon sheaths and bursae, 2.5 to 15mg, subcutaneous or direct  Injection  up to 40mg (1.0ml) for larger joints, depending on the specific disease entity being treated. Single injections into several sites for multiple joint involvement, up to a total of 80mg, have been given without undue reactions.

Adults and Children over 12 Years: The suggested initial dose is 40mg (1.0ml) injected deeply into the upper, outer quadrant of the gluteal muscle. Subsequent dosage depends on the patient's response and period of relief. Patients with hay fever or pollen asthma who do not respond to conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single dose of 40-100mg given when allergic symptoms appear.

Children from 6-12 Years of Age: 2.5 to 15 ml which might be repeated if needed.

 

Adverse reaction:

Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis in long period treatments. High dosage administration may cause a wide range of psychiatric reactions including affective disorders, peptic ulcer, hypertension and thrombophlebitis.

Pharmacokinetic interactions:

Aminoglutethimide, Amphotericin B injection and potassium-depleting agents, Antidiabetics, Insulin, Digitalis glycosides, diuretics, hepatic enzyme inducers, Ritodrin, Sodium containing food or medicaments, Sumatrom, Sumatropin and live vaccines cause contraindications.

Special warnings:

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 treatment with Triamhexal, Sodium intake should be limited and Potassium containing supplements should be increased.

During long term therapy with Tramhexal, regular ophthalmic monitoring is indicated.

Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible, therefore growth and development of children on prolonged corticosteroid therapy should be carefully observed.

 

Pregnancy and lactation:

The ability of corticosteroids to cross the placenta varies between individual drugs, however triamcinolone does cross the placenta. Triamhexal is in group C. 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, therefore not recommended while lactation.

 

Storage temperature:  

Do not store above 25°C. Protect from light and frost.

 

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