COMPOSITION
HISONE -5
Each uncoated tablet contains:
Hydrocortisone IP 5 mg
HISONE-10
Each uncoated tablet contains:
Hydrocortisone IP 10 mg
HISONE
Each uncoated tablet contains:
Hydrocortisone IP 20 mg
DESCRIPTION
The chemical name for Hydrocortisone is pre-4-ene-3, 20-dione, 11,17,21-trihydroxy-, (11â).
Its molecular weight is 362.
CLINICAL PHARMACOLOGY
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
This hormone mimics the effects of the body's natural corticosteroids. It depresses the synthesis, release, and activity of inflammation producing body chemicals. It also suppresses the activity of the immune system. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
Onset of Effect: Varies widely depending on the form of the drug used.
INDICATIONS AND USAGE
HISONE tablets are indicated in the following conditions:
ENDOCRINE DISORDERS: Primary or secondary adrenocortical insufficiency (Hydrocortisone and cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia, hypercalcemia associated with cancer, and Nonsuppurative thyroiditis.
RHEUMATIC DISORDERS: As adjuvant therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis, Acute and subacute bursitis, Acute nonspecific tenosynovitis, Acute gouty arthritis, Post-traumatic osteoarthritis, Synovitis of osteoarthritis and Epicondylitis.
COLLAGEN DISEASES: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus, Systemic dermatomyositis(polymyositis), and Acute rheumatic carditis.
DERMATOLOGIC DISEASES: Pemphigus, Bullous dermatitis herpetiformis, Severe erythema multiforme (Stevens-Johnson syndrome), Exfoliative dermatitis, Mycosis fungoides, Severe psoriasis, and Severe seborrheic dermatitis,
CONTRAINDICATIONS
Systemic fungal infections.
WARNINGS
In patients on corticosteroids therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation of indicated. Corticosteroids may mask some sign of infection and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. While on corticosteroid therapy patients should not be vaccinated against smallpox. 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.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
PRECAUTIONS
ORAL TABLET : Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during a period; hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual. Psychic derangement may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency hypertension; osteoporosis; and myasthenia gravis.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Pregnancy Category C: Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Chronic corticosteroid therapy may interfere with the growth and development of children.
Food Interactions: Avoid excess sodium.
ADVERSE REACTIONS
ORAL TABLETS:
FLUID AND ELECTROLYTE DISTURBANCES: Sodium retention, Fluid retention, Congestive heart failure in susceptible patients, Potassium loss, Hypokalemic alkalosis & Hypertension.
MUSCULOSKELETAL: Muscle weakness, Steroid myopathy, Loss of muscle mass, Osteoporosis, Vertebral compression fractures, Aseptic necrosis of femoral and humeral heads & Pathologic fracture of long bones.
ALLERGIC STATES: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis, Serum sickness, Bronchial asthma, Contact dermatitis, Atopic dermatitis and Drug hypersensitivity reactions.
OPHTHALMIC DISEASES: Severe acute and chronic allergic processes involving the eye and its adnexa 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 used concurrently with appropriate antituberculous chemotherapy, and Aspiration pneumonitis.
HEMATOLOGIC DISEASES: Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia in adults, Acquired (autoimmune) hemolytic anemia Erythroblastopenia and, Congenital (erythroid) hypoplastic anemia.
NEOPLASTIC DISEASES: For palliative management of: Leukemias and lymphomas in adults and Acute leukemia of childhood.
EDEMATOUS STATES: To induce a diuresis or remission of proteinuria in the nephritic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
GASTROINTESTINAL DISEASES : To tide that patient over a critical period of the disease in: Ulcerative colitis, and Regional enteritis.
MISCELLANEOUS: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, and Trichinosis with neurologic or myocardial involvement.
DOSAGE AND ADMINISTRATION
The initial dosage of HISONE (Hydrocortisone) may vary from 20 mg to 240 mg per day depending on the specific disease entity being treated. In situations of less 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 response, HISONE should be discontinued and the patient should be 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. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial dosage in small decrements at appropriate time intervals until the lowest dosage, which will maintain an adequate clinical response is reached. Constant monitoring is needed regarding to drug dosage. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
IF YOU MISS ADOSE:
If you take several doses a day and it is close to the next dose, double the next dose. If you take 1 dose a day and you do not remember until the next day, skip the missed dose and do not double the next dose.
OVERDOSE
Symptoms: Fever, muscle or joint pain, nausea, dizziness, fainting, difficulty breathing. Prolonged overuse: Moon face, obesity, unusual hair growth, acne, loss of sexual function, muscle wasting.
GASTROINTESTINAL : Peptic ulcer with possible perforation and hemorrhage, Pancreatitis, Abdominal distention & Ulcerative esophagitis.
DERMATOLOGIC : Impaired wound healing, Thin fragile skin, Petechiae and ecchymoses, Facial erythema, Increased sweating & may suppress reactions to skin tests.
NEUROLOGICAL : Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, Convulsions, Vertigo & Headache.
ENDOCRINE: Development of Cushingoid state, Suppression of growth in children, Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness, Menstrual irregularities, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus & increased requirements for insulin or oral hypoglycemic agents in diabetics.
OPHTHALMIC : Posterior subcapsular cataracts, increased intraocular pressure, Glaucoma & Exophthalmos
METABOLIC : Negative nitrogen balance due to protein catabolism.
DISEASE INTERACTIONS
Consult your doctor if you have a history of bone disease, chicken pox, measles, gastrointestinal disorders, diabetes, recent serious infection, tuberculosis, glaucoma, heart disease, hypertension, liver or kidney disorders, high blood cholesterol, overactive or underactive thyroid, myasthenia gravis, or lupus.
DRUG INTERACTIONS
Consult your doctor for specific advice if you are taking aminoglutethimide, antacids, barbiturates, carbamazepine, griseofulvin, mitotane, phenylbutazone, phenytoin, primidone, rifampin, injectable amphotericin B, oral antidiabetic agents, insulin, digitalis drugs, diuretics, or medications containing potassium or sodium.
STORAGE
Store at a temperature not exceeding 25°C. Protect from light & moisture.
PRESENTATION
HISONE - 5 : Each box contains 20 strips of 10 tablets.
HISONE - 10 : Each box contains 20 strips of 10 tablets.
HISONE : Each box contains 5 strips of 10 tablets.
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