Sinocort Tablet

Triamcinolone.

Each tablet contains: Triamcinolone 4 mg.

Pharmacology: Glucocorticoids cause profound and varied metabolic effects as well as modify the body's immune response to diverse stimuli. Naturally occurring glucocorticoids (Hydrocortisone and Cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Triamcinolone differs from naturally occurring glucocorticoids by having a greater anti-inflammatory and gluconeogenic effect and diminished salt retaining properties.

Endocrine disorders: Primary or secondary adrenocortical insufficiency (Hydrocortisones or Cortisones) are the drugs of choice although synthetic analogs maybe used in conjunction with mineralocorticoids where applicable (mineralocorticoid supplementation is of particular importance when treating this condition in infants), congenital adrenal hyperplasia, nonsuppurative thyroiditis, and hypercalcemia associated with cancer.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in psoriatic arthritis, rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylostenosynovitis, and acute gouty arthritis.
Collagen diseases: For use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis.
Dermatologic diseases: Pemphigus, bullous dermatitis herpentiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, and severe psoriasis.
Allergic states: For the control of seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, angioedema, and urticaria when they are severe or incapacitating and intractable to adequate trials of conventional treatment.
Ophthalmic diseases: Severe, acute, and chronic allergic and inflammatory processes involving the eye and its associated anatomic parts such as allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis, and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, and sympathetic ophthalmia.
Respiratory diseases: Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating, or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculosis chemotherapy, pulmonary emphysema where bronchospasm or bronchial edema plays a significant role, and diffuse interstitial pulmonary fibrosis (Hamman-Rich syndrome).
Hematologic disorders: Idiopathic and secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), and congenital (erythroid) hypoplastic anemia.
Neoplastic diseases: For palliative management of leukemias and lymphomas in adults and acute leukemia in childhood.
Edematous states: To induce a diuresis or remission of proteinuria in the nephrotic syndrome (non uremic, the idiopathic type, or that which is due to lupus erythematosus) and, in conjunction with diuretic agents, to induce a diuresis in refractory congestive heart failure and cirrhosis of the liver with refractory ascites.
Gastrointestinal diseases: To tide the patients over a critical period of the disease in ulcerative colitis, regional enteritis and intractable sprue.
Miscellaneous: Dental postoperative inflammatory reactions and tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate antituberculous chemotherapy.

The initial dosage of SINOCORT tablet may vary from 4-16 mg/day in single or divided doses. When satisfactory response is obtained, the initial dosage should be reduced gradually by 2 mg every two to three days until the smallest dosage is achieved which will adequately maintain the patients. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is lack of satisfactory clinical response, the corticosteroid should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.
For infants and children, the recommended dosage should be governed by the same considerations rather than by strict adherence to the ratio indicated by age or body weight. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage.
Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness and the effect of patient's exposure to stressful situations. It may be necessary to increase the dosage of SINOCORT for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that be withdrawn gradually rather than abruptly. Hormone therapy is an adjunct to, and not a replacement for, conventional therapy.
To transfer patients from other corticosteroids: Substitute SINOCORT (Triamcinolone) 4 mg initially in place of each Cortisone 25 mg; Hydrocortisone 20 mg; Prednisone 5 mg; Prednisolone 5 mg; Methylprednisolone 4 mg; Dexamethasone 0.75 mg; Betamethasone 0.6 mg; and Paramethasone 2 mg. Thereafter, dosage should be adjusted according to individual response.

Pregnant woman.
AIDS patients/HIV infective patients.
Heart disease patient, hypertension, severe renal insufficiency, chicken pox measles, esophagitis, gastritis, peptic ulcer, diabetic.

When patients who are receiving corticosteroid therapy are subjected to unusual stress, increased dosage of rapidly acting corticosteroids is indicated before, during and after the stressful situations. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If an infection occurs during corticosteroid therapy, it should be promptly controlled by suitable antimicrobial therapy. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
The use of Triamcinolone in patients with active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculosis regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Steroid should be used with caution in elderly patients.

As with all corticosteroids, patients should be observed for weight increase, edema, hypertension, and excessive potassium excretion as well as less obvious signs of adrenocortical steroid untoward effects. A liberal protein intake is essential during prolonged therapy.
Drug-induced secondary adrenocortical insufficiency may be minimized by a gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress (such as trauma, surgery, or severe illness) occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
There is an enhanced corticosteroid effect 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.
The lowest possible dose corticosteroid should be used to control the condition being treated. A gradual reduction in dosage should be made when possible.
Psychic derangements may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may also be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinemia.
Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection. Corticosteroids should also be used cautiously in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, acute glomerulonephritis, vaccinia, varicella, exanthema, Cushing's syndrome, antibiotic resistant infections, diabetes mellitus, congestive heart failure, chronic nephritis, thromboembolitic tendencies, thrombophlebitis, convulsive disorders, metastatic carcinoma, and myasthenia gravis.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Menstrual irregularities may occur, and this possibility should be mentioned to female patients past menarche.
Corticosteroids, may aggravate diabetes so that higher dosage of insulin or hypoglycemic agents may become necessary. Triamcinolone may also precipitate the manifestations of latent diabetes mellitus. Continued supervision of the patient after termination of corticosteroid therapy is essential since there may be a sudden reappearance of severe manifestations of the disease for which the patient was treated.
Use in Pregnancy & Lactation: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and the embryo, fetus, or nursing infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Corticosteroids are excreted in small amounts in breast milk and infants of mother taking pharmacological doses of steroids should be monitored for sign of adrenal suppression.

Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and the embryo, fetus, or nursing infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Corticosteroids are excreted in small amounts in breast milk and infants of mother taking pharmacological doses of steroids should be monitored for sign of adrenal suppression.

Patients receiving corticosteroids should be watched closely for the following adverse reactions which may be associated with any corticosteroid therapy: Fluid and electrolyte disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, and hypertension.
Musculoskeletal: Muscle weakness, fatigue, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fractures of long bones, and spontaneous fracture.
Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.
Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation, hirsutism, acneiform eruptions, and suppressed reactions to skin tests.
Neurological: Convulsions, increased intracranial pressure with papilloedema (pseudotumor cerebri) usually after treatment, vertigo, headache, neuritis or parasthesia and aggravation of preexisting.
Endocrine: Menstrual irregularities; development of the Cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness particularly in times of stress (e.g. trauma, surgery, or illness); decreased carbohydrate tolerance, manifestations of latent diabetes mellitus; and increased requirements for insulin or oral hypoglycemic agents in diabetes.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.
Metabolic: Hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism.
Others: Necrotizing angiitis, thrombophlebitis, thromboembolism aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions, Hypersensitivity including anaphylaxis, Leucocytosis and leucopenia, thromboembolism, vertigo, flushing of the face, fatigue and nausea is rare possibility.

Anti diabetic oral and insulin with Triamcinolone increase blood glucose concentration.
Cardiac glycoside.
Diuretics: decrease diuretic drug effects.
Hepatic enzyme inducer: decrease corticosteroid effects.
Drug or food containing sodium: edema and increase blood pressure.

Store below 30°C.

Corticosteroid Hormones

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.

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