Rectodel - instructions for use, dose, side effects, contraindications

Active substancePrednisonePrednisone

Similar drugsTo uncover

Rectodel®

suppositories rect.

Trommsdorff GmbH & Co. KG Artscaimittel Germany

Dosage form: & nbsprectal suppositories

Composition:

1 suppository contains:

active substance: Prednizone 100 mg;

adjuvant: solid fat 1041 mg.

Description:

Suppositories torpedo-shaped, white or almost white with a smooth surface.

Pharmacotherapeutic group:glucocorticosteroid

ATX: & nbsp

H.02.A.B.07 Prednisone

Pharmacodynamics:

Rectodel® has anti-inflammatory, anti-allergic, anti-shock and immunosuppressive effects. Stabilizes cell membranes, incl. lysosomal, reduces the yield of proteolytic enzymes from lysosomes (inhibition of the alteration phase and restriction of the inflammation focus), inhibits phospholipase A₂, violates the liberation of arachidonic acid and, as a result, inhibits the synthesis of prostaglandins, hydroxy acids and leukotrienes, inhibits the activity of hyaluronidase and reduces the permeability of capillaries (suppression of the exudation phase), fibroblast activity (oppression of the proliferation phase).

Antiallergic properties are due to the violation of degranulation of mast cells, a decrease in the synthesis of leukotrienes and suppression of the production of antibodies, anti-shock - by the delay of sodium and water,increased vascular response to endo- and exogenous vasoconstrictor substances and stimulating effect on cardiac activity, antitoxic - acceleration of the inactivation of toxic substances in the liver, a decrease in the permeability of cell membranes.

Immunosuppressive effect is due to inhibition of the release of cytokines (interleukin-1, interleukin-2, interferon gamma) from lymphocytes and macrophages.

Suppresses the synthesis and secretion of adrenocorticotropic hormone and, secondarily, the synthesis of endogenous glucocorticosteroids. Affects carbohydrate, protein, fat and water-salt metabolism.

Pharmacokinetics:

With rectal administration, more than 20% of the drug is absorbed, although this amount may increase if there is inflammation or damage to the rectal mucosa. It is an inactive drug that is metabolized in the liver with the formation of an active metabolite - prednisolone, which exhibits pharmacological activity. In plasma, most (up to 90%) of prednisolone is in combination with proteins. Prednisolone undergoes further transformations in the liver, kidneys, bronchi to oxidized forms that form conjugates with glucuronic and sulfuric acids. It is excreted by the kidneys mainly in an inactive form.

With increasing dose, the half-life, total clearance, volume of distribution and degree of binding to proteins increase.

Indications:

False groats (viral croup) in children with the inability to use other ways of introducing prednisone.

Contraindications:

For short-term use (1-2 days) for "vital" indications, the only contraindication is hypersensitivity.

Dosing and Administration:

Rectodelta® in children is used rectally (injected into the rectum).

Wash your hands, remove the suppository from the contoured package, cut the package with scissors along the contour, and insert into the anus with a pointed end, as deep as possible. For more convenient introduction of the suppository, it is recommended to bend the child or squat it.

Children to stop coughing and suffocation one suppository Rectodel® is administered per day (corresponding to 100 mg of prednisone). If necessary, another introduction is possible on this day or on the second day. Further continuation of treatment is not recommended. The total dose should not exceed two suppositories (corresponding to 200 mg of prednisone).

The duration of Rectodelt® treatment should not exceed 2 days.Exceeding the dose, as well as increasing the duration of treatment can cause serious undesirable side effects, including the Itenko-Cushing syndrome.

The drug is not intended for permanent or curative treatment.

Side effects:

With short-term therapy, the only expected side effects may be itching, burning, irritation at the injection site. Allergic reactions are possible.

Overdose:

When an overdose increases the likelihood of side effects from the endocrine system, the metabolic system and water-salt balance.

Interaction:

The action of insulin, oral hypoglycemic and hypotensive drugs, as well as oral anticoagulants (coumarin derivatives) may be weakened by the simultaneous use of prednisone.

Glucocorticosteroids can reduce the concentration of salicylates and praziquantel in the blood.

Inductors of enzymes (barbiturates, phenytoin, primidon, rifampicin) can reduce the effect of glucocorticosteroids.

Hormonal contraceptives, estrogens can enhance the clinical effect of prednisone.

With simultaneous use of prednisone and atropine or other M-holinoblokatorov, as well as antihistamines, tricyclic antidepressants and nitrates may increase intraocular pressure.

Increase the risk of side effects of glucocorticosteroids:

- non-steroidal anti-inflammatory drugs (erosive-ulcerative lesions and bleeding from the gastrointestinal tract);

- androgens, estrogens, oral contraceptives, steroid anabolics (hirsutism, acne);

- antipsychotic drugs, carbutamide, azathioprine (cataract);

- Diuretics and laxatives (hypokalemia);

- cardiac glycosides (digitalis intoxication).

In the case of simultaneous use with ACE inhibitors, changes in the blood formula are possible.

Possible weakening of the action of growth hormone.

Chlorokhin, hydroxychloroquine, mefloquine - increased risk of myopathies and cardiomyopathies.

Cyclosporine is an increased risk of cerebral cramps.

Special instructions:

Dose and duration of treatment with suppositories Rectodel^® can not be exceeded. Otherwise, serious undesirable side effects may develop.The drug is not intended for permanent or curative treatment.

The expected therapeutic benefit needs to be assessed against potential adverse effects.

Form release / dosage:

Suppositories rectal, 100 mg.

Packaging:

For 2, 4 or 6 suppositories in a polyvinyl chloride strip.

Each strip, together with the instruction for use, is placed in a cardboard box.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009890/09

Date of registration:04.12.2009

The owner of the registration certificate:Trommsdorff GmbH & Co. KG ArtscaimittelTrommsdorff GmbH & Co. KG Artscaimittel Germany

Manufacturer: & nbsp

TROMMSDORFF GmbH & Co.KG Germany

Representation: & nbspVEYNS CJSCVEYNS CJSCRussia

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Rectodel® (Rectodelt®)