(triamcinolone)
COMPOSITION
Each Kenacort tablet contains Triamcinolone 4 mg.
DESCRIPTION
Triamcinolone, a potent glucocorticoid, is the 9 alpha fluoro-16 alpha hydroxy derivative of prednisolone. Glucocorticoids are cyclopentanophenanthrene compounds, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
ACTION
Glucocorticoids cause profound and varied metabolic effect as well as modifying the body's immune responses 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 occuring glucocorticoids by having a greater antiinflammatory and gluconeogenic effect and diminished salt-retaining properties.
INDICATIONS
Kenacort (Triamcinolone) tablets are indicated in the treatment of the following conditions:
Endocrine disorders
Primary or secondary adrenocortical insufficiency (hydrocortisones or cortisones are the drugs of choice although synthetic analogs may be used in conjunction with mineralocorticoids where applicable; (mineralocorttooid supplementation is of particular importance when treating this condition in infants); congenital adrenal hyperplasia; nonsuppurativethyroiditis; 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): ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; 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 herpetiformis, severe erythema multiforme (Steven-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, beryllfosis, fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous 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 in cirrhosis of the liver with refractory ascites.
Gastrointestinal diseases
To tide the patients aver 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.
CONTRAINDICATIONS
Corticosteroids are contraindicated in patients with systemic fungal infections.
WARNING
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 situation.
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 viruses.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when they are used in large doses; dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Patients should not be vaccinated against smallpox while on corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.
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 antituberculous 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 patents should receive chemoprophylaxis.
USAGE IN PREGNANCY
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.
PRECAUTIONS
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) occuring during that period, hormonotherapy should be reinstituted.
Since mineralocorticoid secretion may be impaired, salt and/or a mineralocortcoid should be administered concurrently.
There is an enhanced corticosteroid effect in patients with hypothyroidism and in those with cirrhoses.
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.
Triamcinolone, like other glucocorticoids, 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.
ADVERSE REACTIONS
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, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fractures of long bones, and spontaneous fractures.
Gastrointestinal
Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distortion, and ulcerative esophagitis.
Dermatologic
Impaired wound healing, thin fragile skin, petecniae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation, hirsutism, acneform eruptions, and suppressed reactions to skin tests.
Neurological
Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache and aggravation of pre-existing psychiatric conditions.
Endocrine
Menstrual Irregularities; development of the Cushingoid state;
suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particurarly 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 diabetics.
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, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions.
DOSAGE AND ADMINISTRATION
The initial dosage of Kenacort (Triamcinolone) tablets may vary from 4 mg to 48 mg per day depending on the specific disease entity being treated. In situations of lesser severity lower doses will generally suffice while in selected patients higher initial doses may be required. 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 favourable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropiate time intervals until the lowest dosage which will maintain an adequate clinical response te reached. It should be kept in mind that constant monitoringis 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 exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of the tablets 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 it 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 Kenacort (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.
HOW SUPPLIED
Kenacort tablets are available for oral administration in a potency of triamcinolone 4 mg per tablet; each tablet is scored to facilitate flexibility of dosage.
Kenacort foiled tablets are packed in boxes of 100's.
STORAGE
Store at room temperature (25°C - 30 ° C).
HARUS DENGAN RESEP DOKTER
Reg. No.:DKL7824409710A1
Manufactured by
PT Taisho Pharmaceutical Indonesia Tbk.
Bogor-lndonesia
Under authority of
Taisho Pharmaceutical Co., Ltd.
Tokyo, Japan.
Updated: November 2009
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