Ultraproject® (Ultraproct®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspointment rectal
Composition:

Ointment (g / 100 g):

active substances: fluocortolone hexonate 0.0945 g, fluocortolone pivalate 0.0918 g, cinchocaine hydrochloride 0.5000 g;

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

Description:

Ointment rectal: colorless or slightly yellow translucent ointment.

Pharmacotherapeutic group:glucocorticosteroid for topical application + local anesthetic
ATX: & nbsp
  • Preparations for the treatment of hemorrhoids and anal fissures in combination
    • Pharmacodynamics:

    Combination drug, anti-inflammatory; antipruritic, antiallergic, local anesthetic effect.

    - Fluocortolone

    The structure includes fluocortolone in two forms, which provides a quick start to the action and its long duration. Fluocortolone with local effects prevents the accumulation of neutrophils, which leads to a decrease in inflammatory exudate and production of lymphokines, inhibition of migration of macrophages, a reduction in the processes of infiltration and granulation.

    - Tsinghokain

    Tsinghokain is a local anesthetic; anesthesia is achieved by suppressing the formation and carrying out of nerve impulses along afferent nerve fibers by depolarizing the sodium channels.

    Pharmacokinetics:

    Fluorocortolone pivalate and fluocortolone hexonate having different lipophilicity and molecular weights diffuse at different rates and as a result, a faster effect is achieved on one side, and on the other, its longer duration.

    Fluorocortolone is hydrolyzed by esterases, enzymes of the inflammatory focus, with the formation of fluocortolone, 11-ketofluocortolone and trimethylacetic acid.

    The half-life of the plasma of fluocortolone and its metabolites after rectal administration was approximately 1.3 and 4 hours, respectively. Fluocortolone is excreted from the body in the form of metabolites mainly by the kidneys.

    Indications:Hemorrhoids, superficial anal fissures, proctitis.
    Contraindications:

    - Tuberculosis or syphilitic processes in the field of application of the drug;

    - viral diseases (eg chicken pox, vaccine response) in the area of ​​drug application;

    - treatment of children and adolescents is not recommended due to the lack of data on clinical trials;

    - I trimester of pregnancy;

    - hypersensitivity to the components of the drug.

    Pregnancy and lactation:

    A number of epidemiological studies suggest a possible increased risk of developing the wolf mouth in newborns whose mothers received glucocorticosteroids by mouth in the first trimester of pregnancy.

    Data on the use of local glucocorticosteroids during pregnancy have not been accumulated enough, but in this case the likelihood of adverse effects is very low due to the minimal bioavailability of glucocorticosteroids in topical application.

    Ultraproct® ointment and suppositories should be administered with caution in pregnant women in the second and third trimester.

    When appointing pregnant and lactating women, it is necessary to compare the expected benefit of treatment for the mother with a possible risk to the fetus and the baby.

    When a doctor prescribes a drug during pregnancy and lactation, it should be used for a short time.

    Dosing and Administration:

    Ultraprotect is recommended after defecation. Before using the drug should be hygiene anus (anus).

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

    Pressing on the finger a small amount of ointment (about the size of a pea), you need to lubricate the area around the anus and inside the anal ring. To overcome the resistance of the sphincter, it is necessary to apply the ointment with the tip of the finger. Before the introduction of the ointment into the rectum, the attached applicator must be screwed onto the tube and inserted into the anus. Then, lightly pressing the tube, squeeze a small amount of ointment into the rectum.

    Usually, there is a rapid improvement, but this should not serve as a reason for too rapid cessation of treatment. To avoid recurrence, you should continue to use Ultraproduct® for at least another week, although with a lower frequency (ointment - once a day or 1 suppository every other day), even with complete disappearance of symptoms. However, the duration of treatment should not exceed 4 weeks.

    Side effects:

    Burning, itching, dry skin.

    With prolonged (more than 4 weeks) use of Ultraprotect, it is impossible to exclude the appearance of telangiectasia, hypopigmentation and skin atrophy.

    In rare cases, allergic reactions may occur.

    Overdose:

    In accordance with the results of studies on the acute toxicity of estersfluocortolone and cinchocaine is unlikely to manifest acute intoxication with a single rectal or perianal application of Ultraprotect® even in case of accidental overdose.

    In case of accidental oral administration of the drug (for example, if several grams of ointment or several suppositories are swallowed) is likely mainly a manifestation of the side effects of the somnestic cynchocaine, which, depending on the dose, may manifest as severe cardiovascular symptoms (decreased cardiac activity up to cardiac arrest ), and symptoms of impaired central nervous system (convulsions, inhibition of respiratory function until the stopping of breathing).

    Interaction:Clinical trials and use of the drug in medical practice have not revealed incompatibility or interaction with other drugs.
    Special instructions:

    In the presence of fungal infections in addition to Ultraprot® requires the appropriate antifungal therapy.

    Avoid ingestion of Ultraproctate® or eye contact.

    After applying the ointment is recommended to wash your hands thoroughly.

    Effect on the ability to drive transp. cf. and fur:Not found.
    Form release / dosage:Ointment rectal.
    Packaging:

    By 10, 15, 30 or 40 g in an aluminum tube with a laminated coating.

    A tube with instructions for use and a special plastic tip is placed in a cardboard box.

    Storage conditions:

    Store the ointment at a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014591 / 02
    Date of registration:21.11.2008 / 14.10.2014
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp16.02.2016
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