• SINAKTEN ® DEPOT suspozitorii for injection. 1 mg amp. 1 ml

SINAKTEN ® DEPOT suspozitorii for injection. 1 mg amp. 1 ml

Description for SINAKTEN ® DEPOT suspozitorii for injection. 1 mg amp. 1 ml


Sinakten Depot

Sinakten depot stimulates the production of the adrenal cortex of glucocorticoids and mineralocorticoids. Effective for diseases treatable by glucocorticoids. Is used to treat neurological diseases (multiple sclerosis), rheumatic diseases (in which glucocorticoids are shown), skin diseases (pemphigus, severe eczema and psoriasis), diseases of the gastrointestinal tract (ulcerative colitis, enteritis), cancer (in order to improve tolerability of chemotherapy ).

Latin name:
SINAKTEN DEPOT / SYNACTHEN DEPOT.

Structure and Composition:
Sinakten depot suspension for injection in ampoules of 1 ml of 10 pieces. in the package.
1 ml suspension Sinakten depot contains 1 mg tetrakozaktida.

Active-active substance:
Tetrakozaktid / Tetrakozaktid geksaatsetat / Tetracosactide.

Properties / Action:
Tetrakozaktid - the active ingredient of the drug Sinakten Depot - consists of the first 24 amino acids that make up the natural kortikotropnogo hormone - ACTH. As well as ACTH, tetrakozaktid stimulates the production of the adrenal cortex of glucocorticoids and mineralocorticoids, and to a lesser degree, androgens.
All this explains the therapeutic effect Sinaktena depot in diseases can usually be treated with glucocorticoids. However, the pharmacological activity Sinaktena depot can not be compared with the activity of glucocorticoids, as influenced by ACTH, in contrast to treatment with glucocorticoids alone, tissues exposed to physiological spectrum of corticosteroids.
ACTH binds to specific receptor cell membranes of the adrenal cortex. The resulting hormone-receptor complex activates adenylate cyclase, which is involved in the formation of cyclic AMP (adenosine monophosphate), which in turn activates the protein kinase that provides the synthesis of pregnenolone from cholesterol. Through various enzymatic reactions of pregnenolone synthesized a variety of corticosteroids.
Delayed release of tetrakozaktida Sinaktena Depot provides long-term effect of the drug. Thus, increased levels of cortisol in plasma after intramuscular injection of 1 mg Sinaktena depot lasts for 24-32 hours.

Pharmacokinetics:
After intramuscular injection of 1 mg Sinaktena Depot tetrakozaktida concentration in plasma determined by radioimmunoassay, ranged from 200 to 300 pg / ml and maintained for 12 hours.
Slow release of active substances from the site of intramuscular injections is provided by adsorption tetrakozaktida on zinc phosphate.
The apparent volume of distribution tetrakozaktida is about 0.4 L / kg. Serum tetrakozaktid quickly dissolves under the action of the enzymatic hydrolysis of the first on the inactive oligopeptides, then - on the free amino acids.
After intravenous injection of corticotropin-labeled 131I, excretion of radiolabel in urine for 24 hours amounted to 95-100%.

Indications:
Neurological disorders:
# Multiple sclerosis, an exacerbation;
# Infantile myoclonic encephalopathy with gipsaritmiey;
Rheumatic diseases:
# Short-term treatment of diseases and conditions that are usually shown glucocorticoids;
# Patients with diseases of the gastrointestinal tract, which not tolerate taking steroids by mouth;
# Instances where the use of conventional doses of glucocorticoids does not lead to adequate effect.
Skin diseases:
# Long-term treatment of skin diseases, usually respond to therapy with glucocorticoids - for example, pemphigus, severe chronic eczema, eritrodermicheskoy or pustular psoriasis.
Gastro-intestinal tract:
# Ulcerative colitis;
# Regionarny enteritis;
Oncology:
# As an additional treatment to improve the tolerability of chemotherapy.

Dosage and administration:
Treatment is initiated with daily use Sinaktena Depot. After about 3 days of treatment continues intermittently mode. Sinakten Depot is administered intramuscularly.
Adults Sinakten depot is administered in an initial dose of 1 mg daily. In severe cases, and in oncology practice treated Sinaktenom depot can be initiated with a dose of 1 mg, applied every 12 hours. After the acute manifestations subside Sinakten depot is usually administered at a dose of 1 mg every 2-3 days. In cases where the observed good effects, the dose Sinaktena depot may be reduced to a minimum - 0.5 mg every 2-3 days or 1 mg once a week.
For infants (under 1), the initial dose Sinaktena depot 0.25 mg daily, maintenance dose is 0.25 mg every 2-8 days.
For younger children (from 1 to 6 years), the initial dose Sinaktena depot is 0.25-0.5 mg daily, maintenance dose - 0.25-0.5 mg every 2-8 days.
For school-age children (6 to 15 years), the initial dose is 0.25-1 mg daily, maintenance dose - 0.25-1 mg every 2-8 days.

Overdose:
In that case, if the developing fluid retention (weight gain) or excessive adrenocorticotropic activity (Cushing's syndrome), Sinakten Depot should be abolished or appointed in a smaller dose (either by reducing the daily dose in half, either by lengthening the intervals between injections, for example, to 5-7 days).
Treatment: There is no antidote. Showing symptomatic treatment.

Contraindications:
Hypersensitivity to tetrakozaktidu and / or ACTH, acute psychosis, infectious diseases, peptic ulcer, refractory heart failure, treatment of Cushing's syndrome, treatment of primary adrenal insufficiency, adrenogenital syndrome, pregnancy and lactation.
Due to the increased risk of anaphylactic reactions Sinakten Depot should not be used for the treatment of asthma or other allergic diseases.
Since Sinakten Depot contains benzyl alcohol, the drug is contraindicated in neonates (especially preterm), in which benzyl alcohol can cause severe poisoning.

Use during pregnancy and lactation:
Sinakten Depot is contraindicated during pregnancy and lactation.

Side effects:
Since Sinakten Depot causes an increase in production of glucocorticoids and mineralocorticoids in the adrenal cortex can be observed side effects typical of these steroids.
Hypersensitivity reactions: Sinakten Depot may provoke the development of hypersensitivity reactions, which are more severe (anaphylaxis) in patients predisposed to allergies (especially asthma). Hypersensitivity reactions may be such phenomena as changes in the skin at the injection site, dizziness, nausea, vomiting, hives, itching, feeling of fever, weakness, shortness of breath, angioedema (angioedema).
From the musculo-skeletal system: osteoporosis, muscle weakness, steroid myopathy, reduced muscle mass, vertebral compression fractures, aseptic necrosis of the femoral head and shoulder bones, pathologic fractures of long (tubular) bones, tendon rupture.
From the gastrointestinal tract: peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis.
From the skin and its appendages: a violation of wound healing, thin, vulnerable skin, petechiae and ecchymosis, erythema face, increased sweating, suppression of reactions to intradermal introduction of diagnostic products, acne and skin pigmentation.
From the central and peripheral nervous system: convulsions; increased intracranial pressure with optic nerve papilla edema (pseudotumor of the brain, usually after treatment), dizziness, headache, mental changes.
From the endocrine system: sodium retention, water retention, potassium loss, alkalosis gipokaliemichesky, loss of calcium, irregular menstrual cycle, Cushing syndrome, growth suppression in children, secondary adrenocortical insufficiency and the pituitary gland, especially during times of stress, such as after trauma, surgical interventions or disease, decrease carbohydrate tolerance, hyperglycemia, development of clinical manifestations of latent diabetes mellitus, hirsutism.
On the part of the vision: the rear subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
From the exchange processes: negative nitrogen balance due to protein catabolism.
With the cardiovascular system: hypertension, necrotizing vasculitis, congestive heart failure. In some cases, infants and toddlers with long-term treatment of drug at high doses may develop reversible myocardial hypertrophy.
Other: increased susceptibility to infections, abscess, thromboembolism, weight gain, increased appetite, leukocytosis.

Precautions and special instructions:
Sinakten Depot should be used only under medical supervision.
Sinakten Depot should not be given intravenously.

SINAKTEN ® DEPOT suspozitorii for injection. 1 mg amp. 1 ml

  • Product Code: 17
  • Availability: In Stock
  • $90.00

  • Ex Tax: $90.00

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