Prokto-Glivenol

General characteristics. Structure:

Active agents: Tribenozidum of 400 mg; lidocaine of 40 mg

Excipients: витепсол E85 (suppozitorny mass of n°1) - 305 mg, витепсол W35 (suppozitorny mass of n°2) - 1255 mg.

Pharmacological properties:

Prokto-Glivenol — the combined drug for topical treatment of outside and internal hemorrhoids.
Tribenozidum reduces permeability of capillaries, improves microcirculation, raises a tone of vessels, has antiinflammatory properties. Antagonistic effect of drug is directed to some endogenous substances which play a role of mediators at development of an inflammation and pain. Lidocaine is local anesthetic, weakens the itch, burning and pain caused by hemorrhoids.
About 2-20% of Tribenozidum which is contained in cream are absorbed through skin.
System bioavailability of Tribenozidum makes 30% of the quantity getting to a system blood stream at drug use orally or in / century of suppositories.
Cmax in a blood plasma making about 1 mkg/ml (Tribenozidum and metabolites) are observed in 2 h after rectal administration of suppository (400 mg of Tribenozidum).
Tribenozidum is intensively metabolized by an organism. After administration of 1 suppository of 20-27% of a dose it is removed with urine in the form of metabolites.
Lidocaine is quickly absorbed from a mucous membrane and it is bad — from the unimpaired skin. Its bioavailability makes about 50% after rectal use. Cmax in a blood plasma, about 0,70 mkg/ml, was observed in 112 min. after use of 1 suppository that makes 300 mg of lidocaine.
Metabolism takes place in a liver quickly, metabolites are removed with urine and make less than 10% of lidocaine in not changed look.

Indications to use:

Topical treatment of outside and internal hemorrhoids.

Route of administration and doses:

Appoint on 1 suppository or 1 portion of cream in the morning and in the evening. At disappearance of acute symptoms the dose is reduced to 1 suppository or 1 application of cream a day. In the presence of internal hemorrhoidal nodes cream can be entered by means of a nozzle. Duration of treatment depends on disease severity.
30 g of cream (1 tuba) are enough for 20–30 applications.

Features of use:

Drug should be used with care at patients who have severe damages of a liver.
Due to the availability of cetyl alcohol rectal cream can cause emergence of local skin reactions (for example contact dermatitis). Some allergic reactions which can be shown with delay can be caused by availability of methylparahydroxybenzoate and a propilparagidroksibenzoat.
Capacity with rectal cream contains latex rubber which can cause allergic reactions.
Considering that lidocaine is quickly absorbed from a mucous membrane, manifestations of systemic action are possible.
Use during pregnancy and feeding by a breast. Drug should not be used throughout the I trimester of pregnancy.
Prokto-Glivenol it is possible to apply from 4th month of pregnancy and to the women nursing with observance of the recommended dosing, considering possible risk both for mother, and for the child.
Children. Data relatively of use of drug for children are absent.
Ability to influence speed of response at control of vehicles or work with other mechanisms. It is unknown.

Side effects:

Seldom (> 1/10 000, <1/1000). Drug in a zone of introduction can cause a feeling of slight discomfort and pain, burning, rash, an itch and urticaria, fever, hemorrhoidal hemorrhages; very seldom (<1/10 000) — anaphylactic reactions, including a Quincke's disease, a face edema, a bronchospasm and frustration from cardiovascular system.

Interaction with other medicines:

It is unknown.

Contraindications:

Hypersensitivity to any component of drug, including to amide mestnoanesteziruyushchy medicines.
Drug is contraindicated in the presence of the injured sites of a mucous membrane.
Drug should not be used throughout the I trimester of pregnancy.
Drug do not appoint to children due to the lack of experience its use in pediatrics.

Overdose:

There are no data on overdose of the drug Prokto-Glivenol. At accidental intake it is necessary to wash out a stomach quickly. Treatment has to be symptomatic with the general supporting measures.

Storage conditions:

At a temperature not above 30 °C.
To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

1 rectal suppository contains Tribenozidum 400 mg and lidocaine of 40 mg; in the blister of 5 pieces, in a box 2 blisters.