Ректодельт 100

General characteristics. Structure:

Acting substance: prednisone; 1 suppository - 100 mg of Prednisonum;

Excipients: solid fat.

Pharmacological properties:

Pharmacodynamics. Prednisonum — not fluorinated GKS for system use.

Prednisonum has dozozavisimy effect on metabolism practically of all fabrics. At the physiological levels its action is necessary for maintenance of a homeostasis of an organism at rest and an exercise stress, and also for regulation of activity of immune system.

At exceeding of the dose applied with the replaceable purpose, Prednisonum has bystry antiinflammatory effect (anti-exudative and anti-proliferative action) and the slowed-down immunosuppressive effect. It inhibits a chemotaxis and activity of cells of immune system, release and effect of a mediator of an inflammation and immune responses, for example, lizosomalny enzymes, prostaglandins, leukotrienes.

At a bronchospasm Prednisonum increases action of β-adrenomimetik with bronkhodilatiruyushchy effect (permissive action).

Prolonged treatment by high doses leads to involution of immune system and bark of adrenal glands.

Mineralokortikoidny action (considerable for a hydrocortisone, sensitive for Prednisonum) can demand control of electrolytes of serum.

Influence of Prednisonum on disturbance of passability of respiratory tracts is based on reduction of inflammatory process, decrease or prevention of hypostasis of a mucous membrane, braking of a bronchial stenosis, oppression or reduction of a myxopoiesis and decrease in viscosity of slime. The following mechanism is the cornerstone of this effect: decrease in permeability of vessels and stabilization of membranes, normalization of sensitivity of muscles of bronchial tubes to action β2-симпатомиметиков (in case of decrease in sensitivity at their prolonged constant use), oppression of reaction like I, since 2nd week of treatment.

Pharmacokinetics. Absorption: the GKS level in a blood plasma is defined already soon after administration of drug.

Metabolism: after introduction Prednisonum is quickly metabolized in Prednisolonum. Generally, Prednisonum and Prednisolonum in an organism mutually turn each other, at the same time the most part is made by Prednisolonum. Absolute bioavailability makes about 29%.

Distribution: Prednisolonum contacts transcortinum and proteins of plasma. The volume of distribution makes about 1,5 ml/min.

Removal: about 2-5% of the absorbed dose are allocated with urine in the form of Prednisonum, about 11-24% — in the form of Prednisolonum, the rest — in the form of other metabolites.

Indications to use:

Suppositories of Rektodelt 100 are appointed to children for an intensive care of a pseudocroup, a croup, spastic bronchitis.

Route of administration and doses:

To children 6 months are more senior appoint 1 suppository a day that corresponds to 100 mg of Prednisonum. Duration of use depends on the course of a disease. At acute conditions of generally rather short-term therapy. If necessary treatment is repeated once. Further use is not recommended. Treatment by suppositories of Rektodelt 100 should not exceed 2 days (that corresponds to 200 mg of Prednisonum).

Suppositories need to be entered deeply into a rectum.

Rectal use is especially recommended to small children when in/in, in oil or peroral introduction of GKS creates difficulties and an additional stress at children.

It is inadmissible to exceed the recommended dose of drug and duration of its use. In case of non-compliance with recommendations development of heavy side reactions is possible (see. Side REACTIONS).

Features of use:

Drug of Rektodelt 100 is recommended to be used first of all at acute states. As well as concerning other GKS, Rektodelt's use 100 is possible only in the careful analysis of a ratio risk/advantage. Prolonged use (more than 2 days) is possible only under constant observation of the doctor.

Period of pregnancy and feeding by a breast. There are no sufficient data concerning Rektodelt's use 100 during pregnancy. In researches system use of Prednisonum has embriotoksichesky and teratogenic effect on animals. A wolf mouth, anomalies of a skeletogeny, delay of pre-natal development, death of an embryo were typical embriotoksichesky and teratogenic effects which were observed in researches on animals using other GKS except Prednisonum.

Also increase in risk of development of a wolf mouth in an embryo of the person as a result of system use of GKS in the period of the I trimester was noted. Animal experiments also showed that use of subteratogenic doses during pregnancy increases risk of emergence of a delay of pre-natal development, cardiovascular diseases and metabolic disturbances at adults, and also long change of density of receptors to a glucocorticoid, transfer of nervous impulses and reactions.

If GKS are applied in the III trimester, there is a risk of development of an atrophy of bark of adrenal glands. In this case it is necessary to carry out replacement therapy for the newborn.

Thus, Rektodelt 100 can be applied during pregnancy only after the careful analysis of a ratio risk/advantage.

Prednisonum and Prednisolonum gets into breast milk. Data on a negative impact on the child are absent. In need of use of higher doses feeding by a breast needs to be stopped.

Children. Drug is used at children aged 6 months are more senior.

Influence on ability to manage vehicles and to work with mechanisms. Does not influence.

Side effects:

In case of emergency treatment reaction from immune system — hypersensitivity to Rektodelt 100 can be the only possible side effect. Prolonged use of GKS can cause such side reactions:

from endocrine system: Itsenko's syndrome — Cushing of different intensity with such manifestations as a crescent-shaped face, obesity, development of a diabetic metabolic syndrome, a hyperglycemia up to development of steroid diabetes is possible, exhaustion (up to an atrophy) functions of bark of adrenal glands, a growth inhibition at children, disturbance of secretion of a sex hormone, a hirsutism, changes of a gemogramma.

From a metabolism: a hypopotassemia, a delay of sodium and liquid in an organism, negative nitrogenous balance.

From cardiovascular system: AG.

From system of blood: increase in coagulability of blood.

From a musculoskeletal system: aseptic necrosis of bones, osteoporosis, atrophy of muscles.

From a GIT: gastric or intestinal ulcers (owing to ulcerogenic action on a GIT and increases in acidity of a gastric juice), pancreatitis.

From skin: changes of skin (atrophy of skin, telangiectasia, striya, acne rashes; hematomas, bruises, skin discoloration).

From cardiovascular system: increase in permeability of vessels.

From an organ of sight: steroid cataract, manifesting latentno current glaucoma.

From TsNS: mental disturbances.

The effects caused by an immunodepressive effect: decrease in resilience to infections, delay of healing of wounds.

Interaction with other medicines:

Enzymatic inductors, such as barbiturates, Phenytoinum, Primidonum, rifampicin, can weaken Rektodelt's effects 100.

Estrogen can strengthen clinical action of Rektodelt 100.

At simultaneous use of Rektodelt 100 and atropine or other anticholinergic drugs increase in intraocular pressure can develop.

Combined use with salicylates or NPVP can increase risk of development of gastrointestinal bleedings.

Effects of anti-diabetic means, insulin and derivatives of coumarin can be weakened at combined use with Rektodelt 100.

The concomitant use of cardiac glycosides can increase glikozidny activity that is connected with steroidindutsirovanny loss of potassium.

At simultaneous use of saluretichesky means increase in removal of potassium is possible.

Corticosteroids can lead to decrease in concentration of a prazikvantel in a blood plasma.

At combined use with APF inhibitors the risk of changes of a gemogramma increases.

Hlorokin, гидрохлорокин and мефлокин can increase risk of emergence of a myopathy, cardiomyopathy.

The effect of Somatotropinum can decrease.

TTG — the raising effect of a protirelin can decrease.

Cyclosporine level in a blood plasma increases, the risk of development of spasms of cerebral genesis increases.

Contraindications:

The known hypersensitivity to Prednisonum or other ingredient of drug. At short-term use of Prednisonum for treatment of acute, potentially life-threatening and urgentny states, other contraindications is not present.

Overdose:

Acute intoxication is not described by Prednisonum or other GKS.

In case of overdose it is necessary to consider a possibility of manifestation of side effects mainly from endocrine system, disturbances of metabolism and electrolytic balance. The antidote is unknown.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

One packaging contains 2, 4 or 6 suppositories.