Stenirol Injection

Composition:

Each vial contain dry powder which contain Methylprednisolone sodium succinate Buferred 3% sterile equivalent with Methylprednisolone   125 mg

 

Pharmacology :

Methylprednisolone is an intermediate corticosteroid that includes glucocorticoids, has anti-inflammatory and immunosuppressant properties.

Glukokortikoid

Anti-inflammation (steroidal).

Glucocorticoids reduce or prevent the tissue response to inflammatory processes, thereby reducing the inflammatory symptoms without being affected by the cause.

Glucocorticoids inhibit the accumulation of inflammatory cells, including macrophages and leukocytes at the site of inflammation. Methylprednisolone also inhibits phagocytosis, release of lysosomal enzymes, synthesis and / or release of some inflammatory chemical mediators. Although definite mechanisms are not yet fully known, their possible effects through blockade macrophage inhibiting factors (MIF), inhibit macrophage localization: reduction or dilation of inflamed capillary permeability and reduced leucocyte attachment to capillary endothelium, inhibit the formation of edema and leukocyte migration; and increase the synthesis of lipomodulin (macrocortin), an inhibitor of phospholipase A2 – mediation of arachidonic acid release from the phospholipid membrane, and subsequent resistance to arachidonic acid synthesis of a derivative inflammatory mediator (prostaglandin, thromboxane and leukotriene). Immunosuppressant work may also affect anti-inflammatory effects.

Immunosuppressants

The mechanism action of immunosuppressants has not been fully understood but is likely to be with the prevention or suppression of mediated cells (delayed hypersensitivity) of immune reactions as well as more specific actions affecting the immune response, glucocorticoids may reduce lymphocyte concentration (T-lymphocytes), monocytes and eosinophils. Methylprednisolone also lowers immunoglobulin binding to cell surface receptors and inhibits the synthesis and / or release of interleukins, resulting in decreased blastogenesis T-lymphocytes and reduced expansion of the primary immune response.

Glucocorticoids may also decrease the trajectory of immune complexes through membrane base, complementary component concentrations and immunoglobulin.

 

Indication :

  • Endocrine disorders:
  • Acute and chronic primary adrenocortical insufficiency:

Hydrocortisone and cortisone are preferred as replacement therapy because of their significant mineralkorticoid activity. Sodium and fluid replacement is also needed. In some patients additional supplemental mineralkorticoid replacement may also be required.

  • Secondary adrenocorticoid insufficiency:

Replacement with glucocorticoids is generally sufficient, mineralkortikoid is not always required.

  • Allergic condition:

Bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, perennial allergic rhinitis or seasonal allergies, drug hypersensitivity reactions, uterine reactions due to transfusion, acute noninfectious laryngeal edema (epinephrine preparation is the first choice).

  • Collagen disorders:

Indicated during acute exacerbation or treatment therapy in cases of acute rheumatic (or non rheumatic) carditis, systemic dermatomyositis (polimyocytis), systemic lupus erythematous.

  • Skin disease:

Pemphigus, severe erythema multiforme (Steven-Johnson syndrome), exfoliative dermatitis, herpetiforme bullous dermatitis, severe seborrhoeic dermatitis, severe psoriasis, mycosis fungioides.

  • Gastrointestinal disorders:

Indicated for cases such as: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy).

  • Blood disorders:

Acquired hemolytic anemia (autoimmune), idiopathic thrombocytopenia purpura in adults (I.V. administration should not be administered by I.M.), secondary thrombocytopenia in adults, erythroblastopenia (red blood cell anemia), congenital hypoplastic anemia).

  • Liver disease:

Alcoholic hepatitis with encephalopathy, chronic active hepatitis, non-alcoholic hepatitis in women, sub acute hepatic necrosis.

  • Hypercalcaemia associated with neoplasm (or sarcoidosis).
  • Non-rheumatic inflammation:

Indicated during acute or exacerbations episodes of disorders such as: acute or sub acute bursitis, epicondylitis, acute non-specific tenosynovitis.

  • Neoplastic disease:

For palliative care in leukemia and lymphoma in adults, acute leukemia on childhood.

  • Nephrotic syndrome:

Indicated for induction of diuresis or reduced symptoms of proteinuria in acquired nephrotic syndrome, long-term therapy may be needed to prevent recurrence.

  • Neurologic disease:
  • Tuberculosis meningitis (additional treatment), indicated for co-administration with anti-tuberculosis chemotherapy in patients with subarachnoid block.
  • Multiple sclerosis, indicated for the treatment of acute exacerbation disease.
  • Neutroma: wound to the spineEye disease:

Severe acute and chronic allergies and inflammatory processes in the eyes such as optical herpes zoster, iritis, iridocyclitis, chorioretinitis, posterior difuse uveitis, optic neuritis, sympathetic opticmia, anterior segment inflammation, allergic corneal conjunctivitis, allergic corneal marginal ulcer, keratitis.

  • Pericarditis: used to remove inflammation and fever.
  • Nasal polyps.
  • Disturbance respiratory tract:

Symptomatic sarcoidosis, berylliosis, pulmonary or fulminant tuberculosis, Loeffler syndrome, aspiration pneumonia.

  • Rheumatic disorders:

As adjunctive therapy, given short-term (in acute episodes or exacerbations), such as: post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthitis including juvenile rheumatoid arthritis (for certain cases can be given low doses as maintenance therapy), acute and subacute bursitis, epicondylitis, non specific acute tendosynovitis, acute gout arthritis, psoriatic arthritis, ankylosing spondylitis.

  • Treatment shock: due to adrenocortical insufficiency.
  • Treatment non suppurative thyroid.
  • Prevention and treatment organ transplant rejection:

Given together with other immunosuppressants such as azathioprine or cyclosporine.

  • Treatment of trichinosis.

 

 

Dosage :

Adult

By I.M .or I.V., 10 – 40 mg ( base ), repeated as needed

  • For high dose (pulse) therapy: I.V., 30 mg (base) per kg body weight is given at least 30 minutes. Dosage can be repeated every 4 – 6 hours as needed.
  • For acute exacerbations in multiple sclerosis: I.M. or I.V., 160 mg (base) per day for a week, followed by 64 mg per day for a month.
  • For treatment acute backbone wounds: I.V., 30 mg (base) per kg body weight is given for 15 minutes, followed by 45 minute infusion; 5.4 mg per kg body weight per hour for 23 hours.

Infant and children

  • Adrenocortical insufficiency: I.M., 0.117 mg (base) per kg of body weight or 3.33 mg (base) per meter square surface body per day (in divided three doses) every third day; or 0.039 – 0.0585 mg (base) per kg body weight or 1.11 – 1.66 mg (base) per meter square surface body once daily.
  • For treatment of acute backbone wounds: I.V., 30 mg (base) per kg of body weight was given for 15 minutes, followed for 45 minutes with infusion of 5.4 mg per kg body weight per hour, for 23 hours.
  • Other indications : I.M., 0,139 – 0,835 mg ( base ) per kg body weight or 4,16 – 25 mg (base) per meter square surface body every 12 to 24 hours.

 

Administration :

For using I.M. or I.V. :

Reconstitute the powder with the supplied solvent (containing 0.9% benzoyl alcohol), shake until completely dissolved. After reconstitution, store it at a temperature below 250C, use it before 48 hours after reconstitution.

 

Presentation and Registration Number :

STENIROL® Powder Injection Box, 1 vial @ 125 mg and 1 ampoule solvent @ 2 ml;  DKL1308019444A1

 

ON MEDICAL PRESCRIPTION ONLY

 

 

Categorised in:

This post was written by admin