ultraprokt

Active material: Цinxokain, Fluocortolone
When ATH: C05AX03
CCF: The drug with anti-inflammatory and Valium action for local application in a proctology
ICD-10 codes (testimony): I84, K60, K62.8
When CSF: 04.04.05
Manufacturer: INTENDIS GmbH (Germany)

Pharmaceutical form, composition and packaging

Ointment colorless or slightly yellowish, translucent.

1 g
fluocortolone 21-pivalate918 g
fluocortolone 21-hexanoate945 g
cinchocaine hydrochloride5 mg

Excipients: 2-octyidodecanol, castor oil, Hydrogenated castor oil, polyethylene glycol 400 monoricinoleate, lemon-pink fragrance PH№65803.

10 g – aluminum tuba (1) complete with plastic tip – packs cardboard.
15 g – aluminum tuba (1) complete with plastic tip – packs cardboard.
30 g – aluminum tuba (1) complete with plastic tip – packs cardboard.
40 g – aluminum tuba (1) complete with plastic tip – packs cardboard.

Suppozitorii white or yellowish white.

1 supp.
fluocortolone 21-pivalate612 g
fluocortolone 21-hexanoate630 g
cinchocaine hydrochloride1 mg

Excipients: tallow (vitepsol W35).

5 PC. – strips (2) – packs cardboard.
6 PC. – strips (2) – packs cardboard.

 

Pharmacological action

Combined preparation for local use in proctology. Anti-inflammatory, protivozudnoe, antiallergic, antihistamine, local anesthetic effect.

Fluocortolone in two forms, part of the drug, ensures rapid onset of action and long duration.

When applied topically, fluocortolone prevents the marginal accumulation of neutrophils, which leads to a decrease in inflammatory exudate and lymphokine production, inhibition of macrophage migration, reduction of infiltration and granulation processes. Cinchocaine has a local anesthetic effect.

 

Pharmacokinetics

Pharmacokinetic data not available.

 

Testimony

- Hemorrhoids;

- superficial anal fissures;

- Proctitis.

 

Dosage regimen

Before using Ultraproct, you should thoroughly clean the anal area.. It is most preferable to use Ultraproct after defecation.. There is usually rapid improvement, however, to avoid relapses, treatment should be continued, at least, during 1 of the week, but with less frequency of use (ointment - 1 time / day or 1 suppository every other day), even with complete disappearance of symptoms. Length of treatment, possibly, should not exceed 4 of the week.

Ointment, usually, apply 2 times / day; on the first day for rapid relief of symptoms - up to 4 time / day.

A small amount of ointment (about the size of a pea) should be distributed around the anus and inserted into the anus. Apply the ointment with your fingertip, to overcome sphincter resistance. Before introducing the ointment into the rectum, you must screw the supplied tip onto the tube.. If there is severe inflammation with acute pain, it is recommended to first insert the ointment into the anus with your finger.. Protruding hemorrhoids (bumps) should be thickly lubricated with ointment and carefully pressed back with your finger.

Suppozitorii inserted deep into the rectum, usually, by 1 PC. daily. At severe disease in 1 day is entered according to 1 suppozitoriû 2-3 times / day.

If the candles have softened due to heat, then they should be placed in cold water, without removing the packaging, then they will return to their previous form.

 

Side effect

Dermatological reactions: in the field of application of the drug – burning, itching, xerosis. With prolonged use (more 4 weeks) possible skin atrophy, teleangiэktazii, gipopigmentatsiya.

Allergic reactions: seldom-skin manifestations.

 

Contraindications

- manifestations of tuberculosis, syphilis in the area where the drug is applied;

— manifestations of viral diseases in the area of ​​application of the drug;

- I trimester of pregnancy;

- Hypersensitivity to the drug.

 

Pregnancy and lactation

The drug is contraindicated for use in the I trimester of pregnancy.

Unlikely, what is the amount of fluocortolone, which is excreted in breast milk, enough, to cause some action.

 

Cautions

If fungal infections are present, additional appropriate treatment is necessary.

Avoid accidental contact of Ultraproct with the eyes..

After use, it is recommended to wash your hands thoroughly.

 

Overdose

In accordance with the results of studies of the acute toxicity of fluocortolone esters and cinchocaine hydrochloride, acute intoxication is unlikely to occur with a single rectal or perianal use of Ultraproct, even with an accidental overdose.

If you accidentally taking the drug orally (eg, when swallowing several grams of ointment or several suppositories) it is possible to develop predominantly symptoms of side effects of cinchocaine hydrochloride of a somatic nature, which, depending on the dose, can manifest as severe cardiovascular disorders (decrease until cardiac arrest) and disorders of the central nervous system (convulsions, up to cessation of breathing).

 

Drug Interactions

During clinical trials and use of the drug in medical practice, no interactions or incompatibility with other drugs were identified..

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The ointment should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 4 year.

Suppositories should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 2 year.

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