Relief® Pro (Relief® Pro)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFluocortolone + LidocaineFluocortolone + Lidocaine
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  • Relief® Pro
    suppositories rect. 
    BAYER, AO     Russia
  • Relief® Pro
    cream rect. 
    BAYER, AO     Russia
    • Dosage form: & nbspRectal cream.
    Composition:
    1 g of cream contains:
    active substances: fluorocortolone pivalate 1 mg, lidocaine hydrochloride in terms of anhydrous substance 20 mg;
    Excipients: sodium hydrogen phosphate dodecahydrate 0.7 mg, disodium edetate 1 mg, sodium dihydrogen phosphate dihydrate 4.5 mg, benzyl alcohol 5 mg, sorbitan stearate 10 mg, polysorbate 60 35 mg, cetostearyl alcohol 60 mg, paraffin liquid 90 mg, white petrolatum 100 mg, purified water 672.8 mg.
    Description:
    White, opaque cream.
    Pharmacotherapeutic group:glucocorticosteroid for topical application combined
    ATX: & nbsp

    C.05.A.X.03   Preparations for the treatment of hemorrhoids and anal fissures in combination

    Pharmacodynamics:
    Fluocortolone
    Fluocortolone when exposed to the skin prevents the accumulation of neutrophils, leads to a decrease in lymphokines and inhibition of migration of macrophages, contributing to a reduction in the processes of infiltration, exudation and granulation.
    Fluocortolone suppresses inflammatory and allergic skin reactions and relieves itching, burning and pain; reduces dilatation of capillaries, interstitial edema and tissue infiltration.
    Lidocaine
    Lidocaine 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:
    Local therapeutic effect is achieved with a low level of active components in the blood plasma.
    Fluorocortolone pivalate
    After a single rectal application of 1 g of cream or the administration of a single suppository, the absorption of glucocorticosteroid was as much as 5% of the amount of drug applied or administered.
    During the daily administration of 2 suppositories 3 times a day for 4 weeks, the content of fluocortolone in the blood plasma did not reach the level that exerts systemic influence.
    Fluorocortolone pivalate is hydrolyzed by esterases, enzymes of the inflammation focus, with the formation of fluocortolone, 11-ketofluocortolone and trimethylacetic acid.
    The half-lives from the plasma of fluocortolone and its metabolites after rectal administration were approximately 1.3 and 4 hours, respectively. Fluocortolone is excreted from the body in the form of metabolites mainly along with urine.
    Lidocaine
    Absorption and bioavailability of lidocaine after rectal administration of the cream and suppository is about 30% and 24%, respectively.
    The half-life of lidocaine from the blood plasma is 1-2 hours. In the human body lidocaine metabolized by oxidative N-dealkylation, hydrolysis of the amide bond and hydroxylation of the aromatic ring to form 4-hydroxy-2,6-xylidine, which is the main metabolite and 70% of the drug is recovered with this urine as this metabolite.
    Indications:
    - Hemorrhoids;
    - proctitis;
    - eczema in the anus (rectal cream).
    Contraindications:
    - Ttuberculosis and syphilitic processes in the application area;
    - viral diseases (eg, chicken pox, vaccination reaction, shingles) in the area of ​​application of the drug;
    - 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.

    Relief® Pro cream and suppositories should be administered with caution in pregnant women. 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:

    Relief® Pro is recommended after defecation. Before using the drug should be hygiene anus (anus).

    Duration of treatment should not exceed 2 weeks.

    - Rectal cream

    Rectal cream should be applied twice a day: morning and evening. In the first days of treatment, the cream can be applied three times a day. As relief of symptoms often enough, one application per day is enough.

    Pressing on the finger a small amount of cream (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, you need to apply the cream with the tip of your finger.

    To inject the cream into the rectum, the attached applicator should be screwed onto the tube and inserted into the anus. Then, lightly pressing the tube, squeeze a small amount of cream into the rectum.

    Side effects:

    With prolonged treatment with both cream and suppositories Relief® Pro (more than four weeks), there is a risk of developing local skin changes, such as atrophy, striae or telangiectasia.

    Rectal cream:

    burning: 1-10%, rarely - irritation and allergic reactions.
    Overdose:

    In case of accidental ingestion of the drug inside (for example, if several grams of cream or more than one suppository are swallowed), the most severe symptoms can arise from the cardiovascular system (depression of heart function, cardiac arrest) and CNS (convulsions, respiratory depression, respiratory arrest) in dose dependence.

    Interaction:

    Patients receiving antiarrhythmic drugs should apply lidocaine carefully. With the simultaneous use of lidocaine with antiarrhythmic drugs, the lengthening of the interval QT and, in very rare cases, the development of AV blockade or ventricular fibrillation is possible.

    Special instructions:

    In the presence of fungal infections, in addition to Relief® Pro, appropriate antifungal therapy is required.

    It is necessary to avoid getting Relief ® Pro inside or contact with the eyes.

    After applying the cream, we recommend that you wash your hands thoroughly.

    Effect on the ability to drive transp. cf. and fur:

    Not found.

    Form release / dosage:
    Rectal cream, 1 mg + 20 mg / g.
    Packaging:

    By 10, 15, 30 or 50 g in an aluminum tube sealed with a membrane, with a screw cap.

    A tube with an applicator and instruction for use is placed in a cardboard box.

    Storage conditions:At a temperature of no higher than 30 ° C.
    Shelf life:3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005202/09
    Date of registration:29.06.2009 / 27.06.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp21.11.2016
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