Trinolone

Trinolone

triamcinolone

Manufacturer:

Sunward

Distributor:

Antah Pharma
Full Prescribing Info
Contents
Triamcinolone.
Description
Each tablet contains: Triamcinolone 4mg.
Action
Pharmacology: Pharmacodynamics: Triamcinolone is a synthetic glucocorticoid and has potent anti-inflammatory, hormonal and metabolic effects. It is essentially devoid of mineral corticoid activity when administered in therapeutic doses.
a) Promote gluconeogenesis, increase the deposition of glucogen in the liver and inhibit the utilization of glucose.
b) Increase the breakdown of protein. The amino-acid produced are available to support the accelerated glyconeogenesis.
c) Increase the mobilization of fat and stimulate its synthesis and storage.
d) Increase the glomerular filtration rate. The urinary excretion is unaffected.
e) Increase calcium excretion.
f) Depress the production of eosinophils and lymphocytes but stimulate erythropoiesis and the production of polymorphonuclear leucocytes. They inhibit antibody formation and depress the response of tissue to inflammation.
Pharmacokinetics: Triamcinolone is readily and almost completely absorbed after oral administration. About 40% is bound to plasma protein. Its half-life in plasma is about 2 to 5 hours. The metabolic reaction involved consist of 6b-hydroxylation. It is excreted renally, mainly as inactive metabolite.
Indications/Uses
Endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, acute exacerbation of multiple sclerosis, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, oedematous states, gastrointestinal diseases, tuberculous meningitis with subarachnoid block.
Dosage/Direction for Use
Oral administration.
Adult: Adrenocortical insufficiency - 4 to 12mg a day as a single dose or in divided doses, in conjunction with a mineralocorticoid.
Other indications - 4 to 48mg a day as a single dose or in divided doses.
Children: Adrenocortical insufficiency - 117mcg per kg of body weight or 3.3mg per square meter of body surface a day as a single dose or in divided doses, in conjunction with a mineralocorticoid.
Other indications - 416mcg to 1.7mg per kg body weight or 12.5 to 50mg per square meter of body surface a day as a single dose or in divided doses.
Overdosage
Symptoms and Treatment for overdosage and antidote(s): Symptoms are as mentioned in "Side Effects".
The toxic effects of overdosage should be treated symptomatically and dosages reduced or the drug slowly withdrawn. Sodium intake may need to be reduced to less than 1g daily and potassium supplements may be necessary.
Contraindications
It is contraindicated in systemic fungal infections and hypersensitivity to this product.
Special Precautions
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids. Corticosteroids may mask some signs of infection, and new infections may appear during their use. Corticosteroids may affect the nitro blue tetrazolium test for bacterial infection and produce false negative results.
Administration of live virus vaccines is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained.
Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of corticosteroid withdrawal syndrome including fever, myalgia, arthralgia and malaise. There is an enhanced effect of corticosteroid in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
Psychotic derangement may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression. Steroids should be used with caution in nonspecific ulcerative colitis. The use of triamcinolone in active tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, dose observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Use in Children: Chronic use of corticosteroids should be undertaken with caution since prolonged use may suppress growth and development.
Use In Pregnancy & Lactation
Problems in human is not documented, risk/benefit must be considered because it cause teratogenicity in animals and is excreted in breast milk.
Side Effects
Fluid and electrolyte disturbance, congestive heart failure, hypokalaemic alkalosis, hypertension. Muscle weakness, steroid myopathy, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, tendon rupture. Peptic ulcer, perforation of the small and large bowel, pancreatitis, abdominal distention, ulcerative oesophagitis. Impaired wound healing, thin fragile skin, ecchymoses, erythema, increased sweating, allergic dermatitis, urticaria, angioneurotic oedema. Convulsions, increased intracranial pressure with papilloedema, vertigo, headache. Menstrual irregularities, development of cushingoid state. Suppression of growth in children. Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, in trauma, surgery or illness. Decreased carbohydrate tolerance. Manifestations of diabetes mellitus. Increased requirement for insulin or oral hypoglycemic agent in diabetic patients. Hirsutism, posterior subcapsular cataract. Increased intraocular pressure. Glaucoma, exophthalmos, hypersensitivity, thromboembolism, weight gain, increase appetite, nausea, malaise.
Drug Interactions
Acetylsalicylic acid should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Phenytoin (diphenylhydantoin), phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage.
The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies. When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Storage
Store at or below 30°C. Protect from light.
Shelf-life: 3 years.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB08 - triamcinolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
A01AC01 - triamcinolone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
Presentation/Packing
Form
Trinolone tab 4 mg
Packing/Price
10 × 10's;100 × 10's;50 × 10's
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