Tradename

Solopred, Solopred

International non-proprietary name

Methylprednisolone, Methylprednisolone

Compound

Each tablet contains:

active substance: Methylprednisolone USP 4 mg

excipients : Q. S

Each tablet contains:

active substance: Methylprednisolone USP 8 mg

excipients : Q. S

Each tablet contains:

active substance: Methylprednisolone USP 16 mg

excipients : Q. S

Dosage form

Tablets.

Pharmacological properties

Mechanism of action

Methylprednisolone plays an important role in the modern treatment of multiple sclerosis (MS), especially in the acute phase of relapse. It acts in a variety of ways to reduce the inflammatory cycle, including: damping the inflammatory cytokine cascade, inhibiting T cell activation, reducing immune cell extravasation into the central nervous system, facilitating apoptosis of activated immune cells, and indirectly reducing cytotoxic effects. influence of nitric oxide and tumor necrosis factor alpha. This article reviews the most recent observations of these mechanisms, both to understand the mechanism of the disease and to treat it.

Indications for use

Solopred is indicated for conditions requiring glucocorticoid activity, such as:

one.    Endocrine disorders

Primary and secondary adrenal insufficiency Congenital adrenal hyperplasia

2.    Rheumatic diseases Rheumatoid arthritis Juvenile chronic arthritis Ankylosing spondylitis

3.    Collagen   diseases/arteritis Systemic erythematosus   lupus

Systemic dermatomyositis (polymyositis) Rheumatic fever with severe carditis

Giant cell arteritis/polymyalgia rheumatica

four.    Dermatological diseases Vulgaris   pemphigus

5.    Allergic conditions

Severe seasonal and perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness

Allergic contact dermatitis Bronchial asthma

6.    Ophthalmic   diseases Anterior uveitis (iritis, iridocyclitis) Posterior uveitis

Optic neuritis

7.    Respiratory   diseases Pulmonary sarcoid

Fulminant or disseminated TB (with appropriate anti-TB chemotherapy) Gastric aspiration

eight.    Hematological disorders Idiopathic thrombocytopenic purpura Hemolytic anemia   (autoimmune)

9.    Tumor diseases Leukemia (acute and lymphatic) Malignant lymphoma

ten.    Gastrointestinal   disease ulcerative colitis

Crohn's disease

eleven.    Miscellaneous

Tuberculous meningitis (with appropriate anti-tuberculous chemotherapy)

Transplantation

Contraindications

The usual contraindications to systemic or topical use of corticosteroids should be observed:

•        in patients with systemic fungal infections   and   in systemic infections, unless a specific anti-infective agent is used   therapy.

•         in patients with known   hypersensitivity

to methylprednisolone or any of the excipients listed in section 6.1.

•         for intrathecal administration   introductions.

•         for use by the epidural route   introductions.

Special instructions and precautions

Special instructions:

Immunosuppressive effects/increased susceptibility to infections

Corticosteroids   may   raise   susceptibility   to   infections,   may   mask   some   signs   infection,   and   during their use, new infections may occur. With the use of corticosteroids, there may be a decrease in resistance and an inability to localize the infection. Infections caused by any pathogen   including viral, bacterial, fungal, protozoan, or helminthiases anywhere in the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents affecting cellular or humoral immunity or function   neutrophils.

Precautionary measures:

The administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids (see section 4.3). Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, response to such vaccines may be reduced. These immunization procedures may be performed in patients receiving non-immunosuppressive doses of corticosteroids. The use of corticosteroids in active tuberculosis should be limited to those cases of fulminant or disseminated tuberculosis in which corticosteroids are used to treat the disease in combination with an appropriate anti-tuberculosis regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, careful monitoring is necessary, as reactivation of the disease may occur. With long-term corticosteroid therapy, these patients should undergo chemoprophylaxis. Kaposi's sarcoma has been reported in patients receiving corticosteroid therapy. Withdrawal of corticosteroids may lead to clinical remission. The role of corticosteroids in septic shock has been controversial, with early studies reporting both beneficial and harmful effects. More recently, it has been suggested that supplemental corticosteroids are useful in patients who have developed septic shock and who present with adrenal insufficiency. However, their routine use in septic shock is not recommended. A systematic review of a short course of high-dose corticosteroids did not support their use. However, meta-analyses and reviews show that longer courses (5–11 days) of low- dose corticosteroids may reduce mortality, especially in patients with vasopressor-dependent septicemia.   shock.

Side effect

• •         black, tarry   chair,
• •         blindness,
• •         swelling   belly,
• •         bloody   vomit,
• •         pain in   bones
• •         vision change,
• •         pain in   chest,
• •         darkening   skin.

Influence on the ability to drive vehicles and mechanisms

The effect of corticosteroids on the ability to drive or use machines has not been systematically evaluated. After treatment with corticosteroids , undesirable effects such as dizziness, dizziness, visual disturbances and fatigue are possible . When injured, patients   must   to rule   transport   means   or   work with   mechanisms.

Interaction with other drugs

Methylprednisolone is a substrate of the cytochrome P450 ( CYP ) enzyme and is primarily metabolized by CYP 3 A 4. CYP 3 A 4 is the dominant enzyme of the most abundant CYP subfamily in the adult liver. It catalyzes the 6β - hydroxylation of steroids, an important step in phase I metabolism for both endogenous and synthetic corticosteroids. Many other compounds are also CYP 3 A 4 substrates , some of which (as well as other drugs) have been shown to alter glucocorticoid metabolism by inducing (activating) or inhibiting the CYP 3 A 4 enzyme.

Dosage and administration

Oral use

Methylprednisolone: Usual dose range: 2–60 mg/day orally every 6–24 hours.

Overdose

There is no clinical syndrome of acute corticosteroid overdose. Reports of acute toxicity and/or death following an overdose of corticosteroids are rare. In case of overdose, there is no specific antidote; treatment is supportive and symptomatic. After an overdose, the possibility of adrenal suppression should be avoided by gradually reducing the dose level over a period of time. Further traumatic episodes during this period may require special supportive care. Methylprednisolone is undergoing dialysis. Repeated frequent doses (daily or several times a week) over a long period of time can lead to a cushingoid condition.

Storage conditions

Store below 30° C , protect from light and moisture.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Release form

With olopred 4 mg: 3 Alu - Alu Blister of 10 tablets in a carton with insert. those. 3 x 10 tablets

Solopred 8 mg: 3 blisters Alu - Alu , 10 tablets each in a carton with insert. those. 3 x 10 tablets

Solopred 16 mg: 3 blisters Alu - Alu , 10 tablets each in a carton with an insert. those. 3 x 10 tablets