Composition, form of production and packaging
Tablets for implantation of white color with a yellowish shade, cylindrical, odorless.
1 tab.
naltrexone hydrochloride 1 g
triamcinolone acetonide 100 mg
Excipients: magnesium stearate.
1 PC. - semi-syringes (1) - bags (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Competitive opioid receptor antagonist.
Protexoxone is a combination drug that lasts for up to 8-10 weeks, contains an antagonist of opioid receptors naltrexone and corticosteroid triamcinolone, designed to prevent a local inflammatory reaction in the implantation area.
Due to the main active substance of naltrexone, the drug competitively blocks binding of agonists or displaces them from opioid receptors, affects opioid receptors of all types and prevents or eliminates the effect of exogenous opioid drugs - opioid analgesics and their surrogates (including morphine, heroin). Reduces or removes symptoms caused by the use of opioids.
Long-term use does not cause increased tolerance and dependence.
PHARMACOKINETICS
Suction and distribution
After n / c implantation of a dose of naltrexone 1 g, the therapeutic concentration of naltrexone and 6 -? - naltrexol persists to 2 months.
Metabolism and excretion
Metabolized in the liver with the formation of active metabolites, incl. 6 -? - Naltrexol. It is excreted mainly with urine and with bile.
INDICATIONS
- Treatment of opioid dependence outside the withdrawal syndrome;
- rehabilitation and prevention of relapse of opioid dependence.
DOSING MODE
Prodetoxone tablets are intended for implantation.
Treatment with opioid dependence Prodetoxone should be started after 7-10 days of abstinence from the use of opioids and preparations containing them, or after another method of opioid detoxification with confirmation of withdrawal from the withdrawal syndrome: absence of opioids in the urine and negative provocative test with naloxone.
S / implantation is preferably performed in the subcutaneous fat of the anterior abdominal wall. After infiltration anesthesia with observance of rules of asepsis and antiseptics in the place where the implant is supposed to be placed, 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. The syringe container is inserted into the canal until it reaches its distal end. With the help of the piston, the implant is pushed out of the container and placed in the subcutaneous fat tissue, after which 1-2 dermal seams are inserted from the non-absorbable material. The seam is treated with an antiseptic solution, a sterile sticker is applied.
In the future, the change of the label is made every other day with the treatment of the joint site with antiseptic solutions. Sutures are removed 7-8 days after implantation.
If necessary, repeated implantation is possible. The duration of treatment and the number of repeated implantations is determined by the attending physician.
SIDE EFFECT
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.
On the part of the reproductive system: perhaps - slowing of ejaculation, decreased potency; rarely - increased or decreased libido.
Dermatological reactions: redness of the skin, acne, itching, local aseptic inflammation.
Other: chills, tremors, joint pains, enlarged lymph nodes, exacerbation of hemorrhoids.
CONTRAINDICATIONS
- opioid withdrawal syndrome;
- lack of data on provocation with naloxone testifying to withdrawal from abstinence syndrome;
- positive test for the presence of opioids in urine;
acute hepatitis;
- liver failure;
- Itenko-Cushing syndrome;
- systemic fungal infections;
- glaucoma;
- Osteoporosis;
- Pregnancy;
- the period of breastfeeding;
- children's age till 6 years;
- hypersensitivity to opioid receptor blockers (naloxone and naltrexone preparations) in the anamnesis and other components of the drug, in particular, to triamcinolone.
PREGNANCY AND LACTATION
Contraindicated use of the drug during pregnancy and during breastfeeding.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated use of the drug in acute hepatitis, liver failure.
APPLICATION FOR CHILDREN
Contraindication: children under 6 years.
SPECIAL INSTRUCTIONS
The drug should be used in specialized medical institutions under the supervision of a doctor.
Before use, liver failure should be ruled out, and the level of transaminases should be monitored periodically during treatment.
During treatment with Prodetoxone, if necessary, anesthesia for medical reasons (surgery, trauma) is preferably using non-opioid analgesics. In case of emergency analgesia, opioid analgesics should be cautious and prescribe opioids at a higher dose to overcome antagonism.
Patients should be warned:
- when seeking medical help, the patient is obliged to inform medical workers about treatment with Prodetoxone;
- If there are pains in the abdomen, darkening of the urine, yellowing of the sclera should 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 a fatal outcome as a result of stopping breathing.
OVERDOSE
Data on drug overdose are not provided.
DRUG INTERACTION
The combined use of prodecoxone with hepatotoxic drugs increases the risk of liver damage.
Possible increased drowsiness with the simultaneous use of Prodetoxone with thioridazine.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of 15 В° to 25 В° C. Shelf life - 2 years.
