Expiration date: 08/2025

The composition and form of issue:

Rectal ointment 100 g contains:

fluocortolone hexonet 0,0945 g

fluocortolone pivalate 0,0918 g

the qinhokain hydrochloride 0.5 g

auxiliary substances: 2-octyldodecanol castor oil, hydrogenated castor oil, macrogol-400-monoricinoleate (polyethylene glycol-400-monoricinoleate) fragrance lemon-pink PH No. 65803 

the aluminum tubes of 10 g in a cardboard bundle 1 tuba.

Rectal suppositories weighing 1.8 g 1 supp.  contains:

fluocortolone hexonet 0,630 mg

fluocortolone pivalate 0,612 mg

the qinhokain hydrochloride 1 mg

excipients: hard fat (Witepsol W35) — 1797,758 mg 

the aluminum strip 5 PCs. in cardboard pack 2 strip.

Description pharmaceutical form:

Ointment rectally: colorless or slightly yellowish, translucent.

Rectal suppositories: white or yellowish-white, with a smooth surface.

Pharmacokinetics:

Pivalate fluocortolone and fluocortolone hexonet having different lipophilicity and molecular weight, diffuse at different speeds. The result is, on the one hand, a more rapid effect, but its long duration.

Fluocortolone hydrolyzed by serum esterases, enzymes of inflammation with the formation of fluocortolone, 11-cytofluorometry and trimethylhexanoic acid. T1/2 of plasma fluocortolone and its metabolites after rectal be approximately 1.3 and 4 h respectively.

Fluocortolone excreted as metabolites primarily by the kidneys.

Description pharmacological action:

Combined medication, anti-inflammatory, pruritic, anti-allergic, mestnoanesteziruyuschy effect.

Fluocortolone

The preparation consists of two forms fluocortolone, which provides quick onset of action and greater duration. Fluocortolone local influence warns boundary accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, and the inhibition of migration of macrophages, reduces the processes of infiltration and granulation.

Qinhokain

Qinhokain — local anesthetic. Analgesia is achieved through the suppression of the formation and conduct nerve impulses along afferent nerve fibers by depolarization sodium channels.

Indications:

Hemorrhoids, superficial anal fissures, proctitis.

Contraindications:

• tuberculous or syphilitic processes in the area of application of the drug
  
• viral diseases (e.g., chickenpox, reactions to vaccination) in the field of application of the drug
  
• the treatment of children and adolescents is not recommended in the absence of data on clinical trials
  
• The first trimester of pregnancy
  
• hypersensitivity to the drug.
  

Application of pregnancy and breast-feeding:

A number of epidemiological studies suggests a possible increased risk of cleft palate in infants whose mothers received corticosteroids orally in the first trimester of pregnancy. Data on the use of local corticosteroids during pregnancy might not have enough, but in this case, the probability of adverse effects is very low due to the minimal bioavailability of GCS in the local application.

Ultraproct ointment and suppositories should be administered with caution in pregnant women in II and III trimester. In appointing pregnant and lactating women, you must map the potential benefits of treatment for mother and possible risk for the fetus and infant.

In the appointment of a physician during pregnancy and lactation the drug should be used for a short time.

Side effects:

Burning, itching, dryness of the skin.

With prolonged (more than 4 weeks) use Ultraproct we can not exclude the appearance of telangiectasia, hypopigmentation and skin atrophy.

In rare cases may experience allergic reactions.

Drug interactions:

Clinical trials and the use of the drug in medical practice did not reveal incompatibilities or interactions with other drugs.

Method of application and dose:

Ultraproct it is recommended to apply after defecation. Before using the drug should carry out the hygiene of the anus (back passage).

Ointment rectal

Usually the ointment should be applied 2 times a day, the first day for speedy relief of symptoms — up to 4 times.

Squeezing on the finger a small amount of ointment (about the size of a pea), it is necessary to lubricate the area around the anus and inside the anal ring. To overcome the resistance of the sphincter need to apply ointment with finger tip. Before the introduction of the ointment into the rectum it is necessary to wind the tube on the supplied applicator and put it in the anus. Then, by pressing gently on the tube, squeeze a small amount of ointment into the rectum.

Rectal suppositories

Usually should daily use 1 supp., inserting it deep into the rectum. In severe form in the first day 2 or 3 times enter 1 supp.

When heavily inflamed and therefore, painful hemorrhoids, it is recommended to start treatment with ointment.

Protruding hemorrhoids should be abundantly lubricated with ointment gently by setting back the finger.

If under the influence of heat suppositories softened they should be placed in cold water, removing it from the packaging, then they will again take the same form.

Usually there is a rapid improvement, but this should not serve as the basis for too soon the end of treatment. To prevent recurrence should continue to apply Ultraproct else, at least for 1 week, though less frequently (ointment once a day 1 or 1 supp. — a day), even with full disappearance of the symptoms. However, the duration of treatment should not exceed 4 weeks.

Overdose:

In accordance with the results of studies of acute toxicity of esters of fluocortolone and qinhokain unlikely a manifestation of acute intoxication after a single rectal or perianal use Ultraproct even in case of accidental overdose. In case of accidental oral intake of the preparation (e.g. ingestion of a few grams of the ointment or several suppositories) is probably primarily a manifestation of the side effects of qinhokain somatic nature, which, depending on the dose may manifest as severe cardiovascular symptoms (decrease in cardiac activity until the heart failure) and symptoms of dysfunction of the Central nervous system (convulsions, inhibition of respiratory function until you stop breathing).

Special instructions:

In the presence of fungal infections in addition to Ultraproct requires the implementation of appropriate antifungal therapy. You should avoid getting Ultraproct inside or contact with the eyes. After application of the ointment should carefully wash their hands.

Effects on ability to drive and use mechanisms

It is not revealed.