Tablets - 5 mg

Dermosolon contains the active substance prednisolone which is a glucocorticoid (adrenal cortex hormone) that affects metabolism, electrolyte balance and functioning of tissues.

Dermosolon 5 mg is indicated in diseases which require systemic therapy with glucocorticoids.

Depending on the presentation and severity of the disease, these include:

Hormone replacement therapy in:

• impaired adrenal function or insufficiency of adrenal gland of any cause (e.g., Addison’s disease, adrenogenital syndrome, surgical removal of adrenal gland (pituitary insufficiency) beyond the growth age (in such cases cortisone and hydrocortisone are the first choice);
• stress disorders caused by long-term corticosteroid therapy.

 Rheumatic disorders:

• during active phases of vascular inflammation:

• polyarteritis nodosa (if the patient has hepatitis B, treatment duration should be limited to two weeks);
• giant cell arteritis, muscle pain and stiffness (polymialgia rheumatica);
• inflamation of temporal arteries (arteritis), in acute visual loss, initial high endovenous loading doses of glucocorticoids are given, and then, chronic treatment is continued keeping under control erythrocyte sedimentation;

 Diseases of bronchi and lungs:

• asthma, concomitant bronchodilator treatment is recommended;
• acute exacerbation of existing chronic obstructive respiratory airway disease, recommended treatment duration: up to 10 days
• specific lung disease such as: acute inflammation of alveoli (alveolitis), stiffness and rimodeling of the lung tissue (pulmonary fibrosis), as maintenance treatment of chronic forms of sarcoidosis in stages II and III (accompanied with dyspnea, cough and pulmonary insufficiency);
• as preventive treatment of respiratory distress syndrom in preterm infants

Upper respiratory airways diseases:

• severe forms of drug fever and allergic rhinitis when glucocorticoids given as nasal spray have not been effective;
• acute narrowing of the larynx or trachea: angioedema, obstructive laryngitis (pseudo – croup).

Skin diseases:

• diseases of skin and mucous membranes that due to severity of the disease and / or involvement of certain organs can not be treated locally with glucocorticoids.

These include:

• allergic reactions or reactions similar to them, allergic reactions associated with infections: such as acute urticaria, anaphylactoid reactions;
• severe skin diseases that partially destroy the skin, rash caused by drugs, exudative erythema multiforme, toxic epidermal necrolysis (Lyell’s syndrome), pustulosis acuta generalisata, erythema nodosum, acute neutrophilic dermatosis associated with fever (Sweet’s syndrome), allergic contact dermatitis;
• rash: e.g., rash caused by an allergic reaction such as atopic dermatitis or contact dermatitis, rash caused by pathogens (nummular eczema);
• diseases associated with presentation of patches on the skin: e.g., sarcoidosis, inflammation of lips (granulomatous cheilitis);
• severe disease associated with presentation of skin blisters: e.g., pemphigus vulgaris, bullous pemphigoid, benign mucous membrane pemphigoid, linerar IgA dermatosis ;
• vasculitis: e.g., allergic vasculitis, polyarteritis nodosa;
• immune system disorders (autoimmune disease): e.g., dermatomyositis, systemic scleroderma (indurative phase), chronic discoid and subacute cutaneous lupus erythematosus;
• severe skin diseases during pregnancy (see also “Pregnancy and breast – feeding”): e.g., herpes gestationis, impetigo herpetiformis;
• severe skin diseases associated with erythema, skin peeling, e.g, pustular psoriasis, pityriasis rubra pilaris, parapsoriasis group; erythroderma, also associated with Sezary syndrome;
• other severe diseases: e.g., Jarisch – Herxheimer reaction to penicillin treatment of syphilis, quickly growing cavernous hemangioma, Behçet’s disease, pyoderma gangrenosum, eosinophilic fasciitis, lichen planus exanthematicus, inherited epidermolysis bullosa.

Blood diseases / Neoplastic diseases:

• autoimmune blood disease:

anemia caused by the destruction of red blood cells by the body itself (autoimmune hemolytic anemia);

idiopathic thrombocytopenic purpura (Werlhof’s disease), acute phase of platelet count decrease (inttermittent thrombocytopenia;

• malign disease, e. g.:

acute lymphocytic leukemia;

Hodgkin’s disease;

non-Hodkgin’s lymphoma;

chronic lymphocytic leukemia;

Waldenstrom's macroglobulinemia;

multiple myeloma;

high blood calcium levels as a result of an existing malignant disease;

• prevention and treatment of vomiting due to chemotherapy.

 Note:

Dermosolon 5 mg may be used in the advanced stages of malignant disease for the relief of symptoms such as loss of apetite, loss of weight and general weakness, when other specific treatment options have not been successful.

Central nervous system disease

• certain forms of paralysis (myasthenia gravis), azathioprine is the first choice, chronic Gullain-Barré syndrome, Tolosa-Hunt syndrome, polyneuropathy as a result of monoclonal gammopathy, multiple sclerosis (for gradual decrease of dose after administration of perfusions with high glucocorticoid doses for the treatment of an acute atack), certain epileptic forms in infants (BNS cramps).

Specific progressive forms of infectious diseases:

• toxic states in severe infectious diseases (in combination with antibiotics / chemotherapy), such as tuberculous meningitis, severe forms of pulmonary tuberculosis.

Eye diseases:

• diseases and inflamatory processes that involve the eye and the orbit of the eye: diseases that involve the optic nerve (optic neuropathy, e.g., giant cell arteritis due to problems of blood circulation or injuries), Behçet’s syndrome, sarcoidosis, endocrine orbitopathy, visible swelling of the orbit, transplant rejection reaction and certain choroid diseases such as Harada disease and sympathetic ophtalmia.

In the following diseases, Dermosolon may be used only when local treatment has not been effective:

• inflammation of different parts of the eye:

Gastrointestinal disorder / liver disease:

• colitis ulecerosa;
• Crohn’s disease;
• autoimmune liver disease (autoimmune hepatitis);
• corrosion of the esophagus.

Kidney disease

• Kidney autoimmune disease: glomerulonephritis with minimal change, extracapillary proliferative glomerulonephritis (rapid progressive glomerulonephritis) (dosage: loading doses, usually in combination with cytostatics), in reduction and termination of treatment in Goodpasture syndrome, for continuation of long – term treatment of all other forms;
• spread of connective tissue in the area between kidneys and pelvis with no defined cause (retroperitoneal fibrosis).