Sinakten Depot - Instructions For Use, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sinakten depot

Sinakten depot: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Synacthen depot

ATX code: H01AA02

Active ingredient: tetracosactide (Tetracosactide)

Manufacturer: Nycomed Austria (Austria); Ciba-Geigy (Switzerland)

Description and photo update: 2019-26-08

Sinakten depot is a drug with anti-inflammatory, anti-allergic and immunosuppressive effects, affecting fat, carbohydrate, mineral and protein metabolism.

Release form and composition

The dosage form of Synacthen depot is a suspension for intramuscular administration (in 1 ml ampoules, 1 or 10 ampoules in a cardboard box).

Active ingredient in 1 ml of suspension: tetracosactide hexaacetate - 1 mg.

Pharmacological properties

Pharmacodynamics

Tetracosactide - the active substance of the Synacthen depot, consists of the first 24 amino acids, which are part of the natural ACTH (adrenocorticotropic hormone). Tetracosactide, like ACTH, stimulates the production of mineralocorticosteroids and glucocorticosteroids by the adrenal cortex, and, to a lesser extent, androgens. This ensures the therapeutic effect of Synacthen depot in diseases that are usually treatable with glucocorticosteroids.

Tetracosactide has immunosuppressive, anti-allergic and anti-inflammatory effects, affects carbohydrate, fat, protein, mineral metabolism and inhibits the development of connective tissue.

The pharmacological activity of tetracosactide with the activity of glucocorticosteroids cannot be compared, since under the influence of ACGG, in contrast to treatment with glucocorticosteroids alone, tissues are exposed to the physiological spectrum of corticosteroids.

The pharmacodynamic response does not increase with the use of high doses of Synacthen depot, however, prolongation of its action is observed. With a longer course, there is minimal suppression of the hypothalamic-pituitary-adrenal system compared with prolonged use of glucocorticosteroids.

During therapy, ACTH binds to a specific receptor in the membrane of the adrenal cortex cells. The resulting hormone-receptor complex leads to the activation of adenylate cyclase, which takes part in the formation of cyclic AMP (adenosine monophosphate).

After intramuscular injection of Synacthen depot in a dose of 1 mg, the concentration of cortisol increases, its maximum values are recorded for 8-12 hours after injection. For 24 hours, the increased concentration of cortisol persists, then after about 36–48 hours, the value returns to its original value. The long-term effect of Synacthen depot is due to the delayed release of tetracosactide.

Pharmacokinetics

After intramuscular injection of 1 mg of Synacthen Depot, the plasma concentration of tetracosactide varies in the range of 200-300 pg / ml, it is maintained for 12 hours. Delayed release of the active ingredient is provided by the adsorption of tetracosactide on zinc phosphate.

The apparent volume of distribution of the substance is approximately 0.4 l / kg.

Tetracosactide in blood plasma under the action of enzymatic hydrolysis rapidly decomposes first into inactive oligopeptides, and then into free amino acids. The terminal half-life of the substance is approximately 3 hours.

Excretion of tetracosactide occurs mainly by the kidneys. The substance does not penetrate the placental barrier. No data confirming or refuting the penetration of tetracosactide into breast milk.

Indications for use

• rheumatic diseases: psoriatic arthritis, spondyloarthritis, gout, acute rheumatic arthritis, rheumatoid arthritis, nonspecific infectious polyarthritis;
• neurological diseases: generalized cryptogenic forms of epilepsy with hypsarrhythmia (forms of epilepsy with myoclonic-astatic seizures or myoclonic absences, West, Lennox-Gastaut syndromes), multiple sclerosis (with exacerbation), generalized indefinite forms of epilepsy with continuous epilepsy wave complexes slow wave sleep, Landau-Kleffner syndrome, other indeterminate forms of epilepsy);
• connective tissue diseases (collagenosis): psoriatic arthritis, dermatomyositis, rheumatism, periarteritis nodosa, systemic lupus erythematosus, primary reticulosis, sarcoidosis, scleroderma;
• diseases of the digestive system: regional enteritis, ulcerative colitis;
• diseases / conditions in which glucocorticoids are usually indicated (short-term therapy): diseases of the gastrointestinal tract in patients who do not tolerate oral administration of glucocorticoids; cases when the use of usual doses of glucocorticoids does not lead to an adequate effect;
• oncological diseases (as an additional drug to improve the tolerance of chemotherapy);
• skin diseases: exudative erythema multiforme, contact dermatitis, psoriatic erythroderma and psoriasis, widespread eczema, true pemphigus, disseminated erythematous lupus, lichen planus, toxicoderma, prurigo (prurigo), true eczema, neurodermatitis;
• eye diseases of rheumatic, allergic and inflammatory genesis;
• respiratory diseases: bronchial asthma and diseases of allergic etiology;
• conditions in which the prevention of adrenal insufficiency is required: interstitial pituitary insufficiency, against the background of prolonged use of large doses of corticosteroids, stimulation of the adrenal cortex when switching to maintenance doses of corticosteroid drugs.

Contraindications

Absolute:

• combined use with antibiotics in the treatment of infectious diseases;
• Itsenko-Cushing's syndrome;
• peptic ulcer of the stomach and duodenum (with exacerbation);
• adrenogenital syndrome;
• acute psychoses;
• refractory chronic heart failure;
• newborns, premature babies (due to the benzyl alcohol depot, which is a part of Synakten, which can lead to severe poisoning);
• pregnancy;
• lactation period;
• children under 3 years old;
• hypersensitivity to the components of the drug.

Relative (Sinakten depot is prescribed with caution in cases of the following diseases / conditions):

• chronic renal failure;
• intestinal anastomosis;
• diabetes;
• bronchial asthma (due to the increased risk of developing anaphylactic reactions);
• tendency to thromboembolism;
• arterial hypertension;
• myasthenia gravis;
• diverticulitis;
• osteoporosis;
• nonspecific ulcerative colitis.

Instructions for the use of Synacthen depot: method and dosage

Sinakten depot should be administered intramuscularly only. At the beginning of therapy, the drug is used daily. After about 3 days, they switch to intermittent mode.

For adults, Sinakten depot is prescribed in an initial single dose of 1 mg (1 time per day). In oncological practice and in acute cases, a single dose can be applied once every 12 hours. After improvement of the condition, they usually switch to the introduction of a single dose 1 time in 2-3 days. With the development of a good therapeutic effect, the dose can be reduced to the minimum - every 2-3 days, 0.5 mg, or once a week, 1 mg.

Recommended dosage regimen for children:

• young children 3–6 years old: initial dose - 0.25–0.5 mg daily; supporting - 0.25-0.5 mg 1 time in 2-8 days;
• school-age children 6–15 years old: initial dose - 0.25–1 mg daily; supporting - 0.25-1 mg 1 time in 2-8 days.

Diagnostic test

Plasma concentration of hydroxycorticosteroids is determined before and 30 minutes after intramuscular injection of 0.25 mg of Synacthen depot. If the concentration increases by at least 200 nmol / L (70 μg / L) and 30 minutes after injection is higher than 500 nmol / L (180 μg / L), the adrenal cortex function is considered normal.

Infusion test

In the case of an indefinite result of a short-term test and in order to determine the functional reserve of the adrenal cortex, 0.25 mg of the drug is injected intravenously by drop, after which the dynamics of changes in the plasma concentration of hydroxycorticosteroids is determined (additionally, if necessary, the concentration of 17-ketosteroids and 17-hydroxycorticosteroids in daily urine is determined).

Side effects

Possible side effects: edema, allergic reactions, water and Na + retention, Itsenko-Cushing's syndrome, increased blood pressure, hypokalemia, "steroid" myopathy, hyperglycemia, myasthenia gravis, osteoporosis, decreased resistance to infections, mental disorders, erosive and ulcerative gastrointestinal lesions. intestinal tract, skin pigmentation;

Itching, hyperemia, rash (local reactions) may appear at the injection site of the suspension.

Children who receive Synakten depot for a long time in doses exceeding the recommended ones may develop myocardial hypertrophy and growth retardation.

Overdose

The main symptoms: fluid retention, the development of Cushing's syndrome.

Therapy: cancellation of Synacthen depot, dose reduction; symptomatic treatment. The antidote is unknown.

special instructions

Sinakten Depot should be used only when indicated and under medical supervision.

Do not administer the drug intravenously.

Before starting therapy, you should make sure that there are no allergic reactions and diseases (especially bronchial asthma). Also important is information about whether the patient has previously been treated with ACTH drugs, and whether he has had any hypersensitivity reactions to these drugs. If, during the injection or after the administration of the drug, local / systemic allergic reactions develop (for example, in the form of severe erythema and soreness at the injection site, urticaria, itching, a feeling of heat, shortness of breath or severe weakness), the therapy is discontinued. In the future, the use of any ACTH drugs must be abandoned.

Patients who have undergone trauma or surgery during the period of use of Synacthen depot or within one year after the end of therapy are shown to increase the dose of tetracosactide or resume treatment with this drug. In some cases, fast-acting glucocorticoids are additionally prescribed.

The minimum effective dose of tetracosactide should be used during therapy. The dose is reduced gradually. A long course can cause the development of a relative insufficiency of the pituitary-adrenal system, which can persist for several months after the withdrawal of Synacthen depot. In such cases, they decide on the appointment of appropriate substitution therapy.

An increase in the action of tetracosactide can be observed in patients with liver cirrhosis or hypothyroidism.

During the period of therapy, mental disorders may develop (for example, in the form of euphoria, insomnia, mood swings and severe depression or psychotic phenomena). Already existing psychotic tendencies and emotional lability may also increase.

Care should be taken to treat eye lesions associated with herpes simplex, as this can cause corneal perforation. With prolonged use of Synacthen Depot, glaucoma or posterior subcapsular cataract may appear.

Tetracosactide therapy can activate latent amoebiasis, therefore, latent / active amebiasis should be excluded before starting the drug.

In cases where therapy is prescribed to patients with a positive Mantoux reaction or latent tuberculosis, the patient's condition should be monitored. With long-term use of Synakten depot, such patients are shown preventive chemotherapy.

When carrying out vaccination or any other immunization procedure, it should be taken into account that the formation of antibodies decreases against the background of the use of tetracosactide.

In most cases, hypersensitivity reactions appear within the first 30 minutes after the administration of the suspension.

With prolonged use of Synacthen Depot, it may be necessary to carry out replacement therapy with K + drugs.

Water and Na + retention in the body can usually be controlled / prevented with a salt-free diet.

When prescribing a long course, children should monitor their growth. Due to the likelihood of developing myocardial hypertrophy, during the period of treatment in children under 7 years of age, it is necessary to regularly carry out ECG monitoring.

Influence on the ability to drive vehicles and complex mechanisms

When driving vehicles, patients should take into account the likelihood of the effect of Synacthen depot on the central nervous system, which requires increased precautions.

Application during pregnancy and lactation

According to the instructions, Sinakten depot is not prescribed during pregnancy / lactation.

Pediatric use

Sinakten depot therapy is contraindicated in children under 3 years of age due to the benzyl alcohol contained in the suspension, due to the high risk of toxic / allergic reactions, up to and including death.

With long-term treatment in children, regular growth monitoring is required.

Young children should have regular echocardiography.

With impaired renal function

In chronic renal failure, Sinakten Depot should be used with caution.

Drug interactions

There are no data on the significant interaction of Synacthen depot with other drugs / substances.

During the period of therapy, an increase in the dose of drugs with hypoglycemic and hypotensive effects may be required.

Analogs

Synacthen depot analogues are: Norditropin NordiLet, Humatrop, Somatropin, Dinatrop, Biosome, Genotropin, Saizen, Jintropin, Rastan, Omnitrop.

Terms and conditions of storage

Store in a dark place, out of reach of children, at a temperature of 2-8 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sinakten depot

There are not many reviews of the Sinakten depot. Most of them relate to the use of the drug in children as an anticonvulsant. Most often, there is a positive trend, although the effect does not develop immediately. There are reviews indicating the development of adverse reactions. Also, some users note insufficient therapeutic effect.

Price for Sinakten depot in pharmacies

The approximate price for the Sinakten depot (1 ampoule) is 2250–2400 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!