FORMULATION COMPOSITION of GIMTAFORT Medicine

Active ingredient: Hydrocortisone … 10 mg.
Excipients: Pregelatinized corn starch, Mannitol, Microcrystalline cellulose, Crospovidone, Magnesium stearate, Talc … sufficient for 1 tablet.

Description: White, round tablets with intact edges and surfaces.

INDICATIONS of GIMTAFORT Medicine

– Endocrine disorders
Adrenal insufficiency (primary and secondary adrenal insufficiency, congenital adrenal hyperplasia, adrenal sex steroid syndrome): Hydrocortisone or cortisone is the first-line treatment. Synthetic glucocorticoids may be used in combination with mineralocorticoids, with mineralocorticoid supplementation being particularly important in newborns. Replacement therapy is indicated for the treatment of adrenal insufficiency in children, adolescents, and adults (under 18 years of age).
Non-infectious thyroiditis
Hypercalcemia associated with cancer

– Rheumatic disorders

Short-term supportive treatment (to help patients through acute or severe episodes) in
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (some cases may require maintenance treatment with low doses)
Ankylosing spondylitis
Non-specific bursitis
Acute and subacute rhinitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Osteoarthritis-related arthritis
Meningitis
Collagen disorders
Maintenance therapy or during acute exacerbations in
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatoid arthritis

– Dermatological disorders
Pemphigus
Herpetiform dermatitis
Severe polycythemia (Stevens-Johnson syndrome)
Exfoliative dermatitis
Cutaneous T-cell lymphoma
Severe psoriasis
Severe seborrheic dermatitis

– Allergy
Control of severe allergic conditions or those unresponsive to conventional treatments
Seasonal or perennial allergic rhinitis
Serum sickness
Asthma
Contact dermatitis
Allergic dermatitis
Drug-induced hypersensitivity reactions

– Ophthalmic disorders
Allergic conjunctivitis
Allergic corneal ulcer
Uveitis
Iritis and cyclitis
Scleritis
Anterior eye inflammation
Diffuse choroiditis and scleritis
Optic neuritis
Sympathetic ophthalmia

– Respiratory disorders
Symptomatic granulomatous disease
Loeffler’s syndrome not manageable by other therapies
Beryllium poisoning
Acute or disseminated pulmonary tuberculosis when used concurrently with chemotherapy
Lung injury due to inhalation

– Hematologic disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Autoimmune hemolytic anemia
Erythrocyte reduction (anemia)
Congenital aplastic anemia

– Neoplastic disorders
Palliative treatment
Leukemia and lymphoma in adults
Acute leukemia in children

– Edema
Inducing diuresis or reducing proteinuria in nephrotic syndrome (without uremia) due to idiopathic causes or lupus erythematosus

– Gastrointestinal disorders
To help patients through acute exacerbations of:
Ulcerative colitis
Enteritis

– General
Tuberculous meningitis in the subarachnoid space when used concurrently with appropriate anti-infective chemotherapy
Trichinosis with cardiovascular and neurological complications

DOSAGE AND ADMINISTRATION of GIMTAFORT Medicine

Administration
Take with a glass of water. If used for a prolonged period, do not discontinue abruptly; the dose should be tapered gradually.

Dosage
The initial dose may range from 20–240 mg of hydrocortisone per day, depending on the specific condition being treated.
The initial dose should be maintained or adjusted until the desired response is achieved. If there is no clinical response within a reasonable period, GIMTAFORT should be discontinued, and the patient should be switched to an appropriate alternative therapy.

Dosing should be individualized based on the patient’s therapeutic response.
Once the desired response is achieved, the appropriate maintenance dose should be determined by gradually reducing from the initial dose over an appropriate period until the lowest effective dose is reached. Continuous monitoring of the patient’s condition is required.
If the patient’s condition worsens, the GIMTAFORT dose may need to be increased for an appropriate period based on the patient’s status. After long-term treatment, the dose should be tapered gradually rather than stopped abruptly.

CONTRAINDICATIONS

Systemic fungal infections
Patients receiving live vaccines
Hypersensitivity to any component of the medicine

WARNINGS AND PRECAUTIONS FOR USE

Warnings

In patients receiving corticosteroid therapy who experience unusual stress, the corticosteroid dose should be rapidly increased before, during, and after the stressful event. Corticosteroids may mask certain signs of infection, and new infections can occur during use. Infections with any pathogen—including viral, bacterial, fungal, protozoal, or helminthic—at any site of the body may be associated with corticosteroid use alone or in combination with other immunosuppressive drugs, affecting cellular and systemic immunity. These infections may be mild but can also be severe and sometimes fatal. The risk of infection complications increases with higher corticosteroid doses. Corticosteroid use may reduce resistance and impair the localization of infection.
Prolonged corticosteroid use may cause posterior subcapsular cataracts, glaucoma that can damage optic nerves, and may increase the risk of opportunistic eye infections caused by fungi or viruses.

General Precautions

Adrenal insufficiency induced by corticosteroids can be minimized by gradually tapering the dose. This relative adrenal insufficiency may persist for several months after discontinuation; therefore, hormone therapy should be reinstated during any stressful situation occurring in that period.

Corticosteroids may have enhanced effects in patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used with caution in patients with ocular herpes simplex due to the risk of corneal perforation.

The lowest effective corticosteroid dose should be used to control the condition during treatment, and dose reductions should be made gradually whenever possible.

Psychiatric disorders may occur during corticosteroid therapy, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to manifestations of psychosis. Pre-existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Corticosteroids should be used cautiously in nonspecific ulcerative colitis if there is a risk of perforation, abscess, or opportunistic infection; diverticulitis; active or latent peptic ulcer; renal impairment; hypertension; osteoporosis; and myasthenia gravis.

Growth and development in infants and children receiving prolonged corticosteroid treatment should be carefully monitored.

Kaposi’s sarcoma has been reported in patients treated with corticosteroids. Discontinuation of corticosteroids may result in clinical remission. Because the complications of glucocorticoid therapy depend on dose and duration, risk–benefit decisions should be made individually regarding dose, treatment duration, and whether continuous or intermittent therapy is appropriate.

Adrenal medullary tumors, which can be fatal, have been reported following systemic corticosteroid use. In patients suspected of having adrenal medullary tumors, the risk should be carefully considered before initiating corticosteroid therapy.

USE IN PREGNANT AND LACTATING WOMEN
As detailed reproductive studies in humans have not been conducted with corticosteroids, the use of these drugs during pregnancy, lactation, or in women of childbearing potential requires careful consideration of the benefits of therapy against potential risks to the mother and fetus. Newborns of mothers who received significant corticosteroid therapy during pregnancy should be closely monitored for signs of adrenal insufficiency.
Individuals receiving immunosuppressive therapy are more susceptible to infections than healthy individuals. Chickenpox and measles may be more severe or even fatal in corticosteroid-treated children or adults who are not immune. Special precautions should be taken to avoid exposure in these non-immune individuals.
EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINERY
There is no evidence that this medication affects the ability to drive or operate machinery.

DRUG INTERACTIONS AND COMPATIBILITIES

Drugs metabolized by liver enzymes, such as phenobarbital, phenytoin, and rifampin, may increase the clearance of corticosteroids, and a higher corticosteroid dose may be required to achieve the desired response.
Drugs such as troleandomycin and ketoconazole may inhibit corticosteroid metabolism, thereby reducing clearance. Corticosteroid doses should be adjusted to avoid steroid toxicity.
Corticosteroids may increase the clearance of chronic high-dose aspirin. This can lead to reduced serum salicylate levels or an increased risk of salicylate toxicity upon corticosteroid withdrawal. Aspirin should be used with caution when combined with corticosteroids in patients with hypoglycemia.
The effects of corticosteroids on oral anticoagulants vary. There are reports of both enhanced and reduced anticoagulant effects when used concurrently with corticosteroids. Therefore, coagulation parameters should be closely monitored to maintain the desired anticoagulant effect.

ADVERSE DRUG REACTIONS

– Fluid and electrolyte disorders
Sodium and water retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension
– Musculoskeletal
Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, tendon rupture (especially Achilles tendons), vertebral fractures, aseptic necrosis of the femoral head and humerus, long bone fractures
– Gastrointestinal
Gastric ulcers, which may perforate or bleed, pancreatitis, abdominal distension, esophageal ulcers. Increased alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually minor, not associated with any clinical syndrome, and may resolve upon discontinuation.
– Dermatological
Delayed wound healing, fragile skin, petechiae, bruising, facial erythema, increased sweating, possible suppression of skin test reactions
– Neurological
Increased intracranial pressure with papilledema (pseudotumor cerebri) may occur, seizures, dizziness, headache, epidural masses
– Endocrine
Cushing’s syndrome, growth retardation in children, adrenal and pituitary insufficiency (especially during stress, trauma, surgery, or illness), menstrual irregularities, impaired carbohydrate tolerance, manifestations of diabetes mellitus, increased insulin or oral hypoglycemic requirements in diabetic patients
– Ophthalmic
Central serous retinopathy, posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos
– Metabolic
Nitrogen imbalance due to protein catabolism
– Hematologic and lymphatic disorders
Leukocytosis

OVERDOSAGE AND MANAGEMENT

Acute poisoning or fatal overdose is very rare. In cases of overdose, there is no specific antidote; treatment is supportive and symptomatic only.

STORAGE CONDITIONS, SHELF LIFE, AND QUALITY STANDARDS

Storage: Keep below 30°C, protected from moisture and light
Shelf life: 36 months from the date of manufacture

Note	This product is available by prescription only. All information on this website is for reference purposes only.