Proximal GLIVENOL

Active material: Lidokain, Tribenozid
When ATH: C05AD01
CCF: The drug with venous, antiinflammatory and Valium action for local application in a proctology
ICD-10 codes (testimony): I84
When CSF: 27.01.02.01.01
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)

Pharmaceutical form, composition and packaging

◊ Rectal cream homogeneous, white, with a faint characteristic odor.

Excipients: tsetomakrohol 1000, cetyl alcohol, isopropyl palmitate, Liquid paraffin, metilparagidroksiʙenzoat, propilparagidroksibenzoat, sorbitan stearate (Arlacel 60), Sorbitol liquid (not crystallized), stearic acid, Purified water.

30 g – aluminum tuba (1) Included with the tip (nozzle-cap) – packs cardboard.

◊ Rectal Suppositories Solid, crack-free, torpedo-shaped, slightly greasy to the touch, yellowish-white, with low specific smell.

Excipients: witepsol E85, витепсол W-35.

5 PC. – strips (2) – packs cardboard.

Pharmacological action

The preparation for the topical treatment of hemorrhoids, therapeutic efficacy is due to a combination of the two components: tribenozida and lidocaine.

Tribenozid has venotonic and anti-inflammatory effect. Venotonic effect is an improvement of vascular tone, reduction of venous stasis, a decrease in the permeability of capillaries and venules and improving microcirculation. The anti-inflammatory effect is inhibiting effect on some endogenous substances, acting as mediators in the development of inflammation and pain.

Lidocaine has a local anesthetic action.

Procto-Glivenol^® reduces symptoms, caused by hemorrhoids (pain, tension of the skin, itch).

Pharmacokinetics

Absorption

After rectal administration of suppositories_max tribenozida in plasma achieved through 2 h and is 1 ug / ml (tribenozid + metabolites). Bioavailability tribenozida with rectal administration of 30% Oral bioavailability (in the form of capsules).

After application of the cream 2-20% tribenozida absorbed through the mucous membrane.

Metabolism

Tribenozid and lidocaine rapidly metabolized in the liver.

Deduction

When administered 1 suppozitoriâ 20-27% the dose is excreted in the urine as metabolites.

Testimony

- External and internal hemorrhoids.

Dosage regimen

The drug is administered rectally in the form of a cream or 1 suppository morning and evening until disappearance of clinical symptoms. If regression of acute symptoms frequency of application may be reduced to 1 times / day.

When internal hemorrhoids cream injected with a nozzle. 30 g cream (1 tuba) sufficient for approximately 20-30 rektalnыh introduced.

Side effect

Local reactions: in a few cases – a slight burning sensation, pain, hypercatharsis.

Other: allergic reactions.

Contraindications

- Liver failure;

- Pregnancy (I trimester);

- Hypersensitivity to the drug.

Pregnancy and lactation

When pregnancy Procto-Glivenol^® not indicated in the I trimester. In applying the drug in the II and III trimester of pregnancy should take into account the potential risk to the fetus.

If necessary, use during lactation should weigh the potential benefits of therapy to the mother and the potential risk for the baby.

Cautions

If during treatment with the drug the patient's condition did not significantly improve or appear unusual symptoms, should verify the diagnosis.

During treatment, the patient should follow the hygiene of the anal region, avoid excessive stress, take measures to maintain a soft stool consistency.

Effects on ability to drive vehicles and management mechanisms

When used in doses, Do not exceed recommended, the preparation has no effect on the ability to do the work, coupled with the need to focus, rapid mental and motor responses.

Overdose

Currently, cases of drug overdose Procto-Glivenol^® not reported.

Drug Interactions

Drug Interactions drug-Glivenol Procto^® not disclosed.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 5 years.