Prodetoxone® (Prodetoxon)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceNaltrexone + TriamcinoloneNaltrexone + Triamcinolone
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  • Prodetoxone®
    pills д / импл. 
       
    • Dosage form: & nbsptablets for implantation
    Composition:

    Naltrexone hydrochloride - 1 g, triamcinolone acetonide - 0.1 g, magnesium stearate - 0.011 g.

    Description:

    Tablets of cylindrical form of white color with a yellowish tinge, odorless, 18.0 +/- 0.5 mm in length, with a diameter of 8.5 +/- 0.5 mm.

    Pharmacotherapeutic group:Opioid receptor antagonist
    ATX: & nbsp

    V.03.A.B   Antidotes

    Pharmacodynamics:

    Protexoxone® is a long-acting (up to 8-10 weeks) combined preparation containing an opioid receptor antagonist naltrexone, as well as glucocorticoid triamcinolone.

    intended for the prevention of local inflammatory reaction in the field of implantation Due to the main active substance-antantecoxone - the drug competitively blocks the binding of agonists or displaces them with opioid receptors of all types and prevents or eliminates the effect of exogenous opioid preparations of narcotic analgesics and their surrogates (morphine, heroin and other opioids.) Reduces or alleviates the symptoms caused by the use of opioids.

    When alcoholism is associated with opioid receptors and blocks the effects of endorphins.Reduces the need for alcohol and prevents relapses within 6 months after single-entry implantation Protexone ®. Long-term use of ns caused an increase in tolerance and the formation of dependence.

    Pharmacokinetics:

    Metabolised in the liver with the formation of active metabolites, including 6-beta-naltrexol. It is excreted mostly by the kidneys and with bile. After subcutaneous implantation of a dose of naltrexone 1 g, the therapeutic concentration of naltrexone and 6-beta-naltrexol persists to 2 months.

    Indications:Treatment of patients with opioid drug addiction (dependence) outside the withdrawal syndrome, and also for rehabilitation and relapse.
    Treatment of patients alcohol dependence: stabilization remission and profgalaxy relapsecenturies.
    Contraindications:

    Hypersensitivity to opioid receptor blockers in a patient's history (naloxone and naltrexone preparations) and other components of the drug, in particular, to triamcinolone.

    Opioid withdrawal syndrome.

    Absence of data on provocation with naloxone testifying to withdrawal from the withdrawal syndrome.

    Positive test for the presence of opiates in urine.

    Acute hepatitis, hepatic failure, Itenko-Cushing syndrome, systemic mycoses, glaucoma, osteoporosis, pregnancy, breast-feeding, children under 6 years.

    Carefully:
    Pregnancy and lactation:
    Dosing and Administration:
    Treatment of drug dependence drug Protexoxone should be started only after at least 7-10 days of abstinence from the use of opioids and preparations containing them, or after another method of opiate detoxification with confirmation of withdrawal from the withdrawal syndrome - the absence of opioids in the urine and a negative provocative test with naloxone.

    Treatment of patients with alcohol dependence with Prodetoxone® is advisable to start not in a state of intoxication, the implantation procedure can be conduct after detoxification or at least a short period of abstinence from alcohol intake.

    Subcutaneous implantation tablets Prodegoxone® is preferred in subcutaneous fatty tissue the front of the abdominal wall. After infiltration anesthesia with observance of rules of asepsis and antiseptics in the place where it is presumed placement of the implant, a cut of skin about 1.5 cm long is made.In a blunt way (using the "Bilroth" clamp), a channel is created to insert an implant about 5 cm long. Syringe- The container is inserted into the canal until it reaches its distal end. With the aid of the piston, the implant is pushed out of the container and placed in the subcutaneous fat; after which 1-2 dermal The seam of non-absorbable material. The seam is treated with an antiseptic solution, a sterile sticker is applied. AT Further, the change of the sticker is made every other day with the processing of the joint site with solutions antiseptics. Sutures are removed after 7-8 days after implantation.

    If necessary, repeated implantation.
    The duration of treatment and the number of repeated implantations is determined by the attending physician.

    Side effects:

    On the part of the digestive system - decreased appetite, nausea, vomiting, diarrhea or constipation, abdominal pain, impaired liver function.

    From the cardiovascular system - tachycardia, increased blood pressure, phlebitis.

    From the side of the central nervous system - headache, weakness, sleep disorder, anxiety, dizziness, decreased mood, dysphoric reactions.

    On the part of the respiratory system - nasal congestion, coughing, difficulty breathing.

    From the skin - redness of the skin, acne, itching.

    On the part of the genitourinary system - possibly slowing of ejaculation, decreased potency, rarely increased or decreased libido.

    Others - chills, tremors, joint pains, local aseptic inflammation, enlarged lymph nodes, exacerbation of hemorrhoids.

    Overdose:
    Interaction:

    Increases the risk of liver damage when combined with hepatotoxic drugs. Possible increased drowsiness when combined with thioridazine.

    Special instructions:

    It is used in specialized medical institutions under the supervision of a doctor.

    Before use, liver failure should be ruled out, during the treatment should periodically monitor the activity of transaminases.

    During treatment with Prodetoxone ®, if necessary, anesthesia for medical reasons (surgery, trauma) preferably using non-narcotic analgesics; In the case of emergency analgesia with narcotic drugs, caution should be used to administer opioids in an increased dosage (to overcome antagonism).Patients should be warned that:

    - when seeking medical care, they should inform health workers about treatment with a long-acting drug containing naltrexone;

    - in case of abdominal pain, darkening of the urine, yellowing of the sclera, it is necessary to consult a doctor;

    - when using heroin and other opioid drugs in small doses, the effect of their use will not be, and further increase in the dose of narcotic drugs can lead to death (stopping breathing).

    Effect on the ability to drive transp. cf. and fur:
    Form release / dosage:

    Pills.

    Packaging:A tablet for implantation is placed in aseptic conditions in a semi-syringe made from a polymer mass and in a sterile combined sealed packet of thick paper and polyethylene film. Packages are placed in packs of cardboard together with instructions for use.
    Storage conditions:

    List B.

    Protected from light and moisture, out of reach of children at a temperature of 15 ° C to 25 ° C.

    Shelf life:

    2 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N003877 / 01
    Date of registration:11.01.2010
    Manufacturer: & nbsp
    Information update date: & nbsp07.07.2010
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