Description
Release form
Tablets
Packing
10 pcs.
Pharmacological action of
Naltrexone competitively blocks the binding of agonists or displaces them from opiate receptors. Reduces or alleviates the symptoms caused by intravenous opiate administration. It has the highest affinity for mu and kappa receptors.
Indications
– Prevention of the pharmacological effects of exogenous opioids and maintaining an opioid-free state in patients with opioid dependence.
– Comprehensive treatment for alcohol addiction.
Contraindications
– Hypersensitivity (including to naloxone).
– Receive opiates.
– A positive test for the presence of opioids in the urine.
– Withdrawal Syndrome.
– Acute hepatitis.
– Liver failure.
– Pregnancy.
– Breastfeeding (excluded during treatment).
– Children and adolescents (under 18 years).
Use during pregnancy STI and breastfeeding is contraindicated
Special instructions
Before use, subclinical liver failure must be excluded, during treatment transaminases should be monitored periodically, cannot be combined with drugs that have hepatotoxic properties.
To prevent the development of acute withdrawal symptoms, patients should stop taking opioids and preparations containing them at least 7-10 days in advance, it is necessary to determine the opioids in the urine and conduct a provocative test with naloxone if these requirements are not met, withdrawal symptoms may appear 5 minutes after taking the drug and last for 48 hours.
Naltrexone must be discontinued at least 48 hours before surgery, which will require the use of opioid analgesics.
If emergency analgesia is necessary, opiates should be used with caution in an increased dosage (to overcome antagonism), since respiratory depression will be deeper and longer.
Persistent loss of appetite and progressive weight loss require discontinuation of therapy.
Ineffective in the treatment of cocaine as well as non-opioid drug dependence.
Patients should be warned that:
When seeking medical help, they are required to inform health workers about treatment with naltrexone.
In case of abdominal pain, dark urine, yellowing of the sclera, stop taking it and consult a doctor.
If you use heroin and other drugs in small doses on your own, there will be no effect from their use, and a further increase in the dose of drugs will lead to death (respiratory arrest).
Composition of
1 tablet contains: Naltrexone hydrochloride – 50 mg
Dosage and Administration
Inside.
The drug is prescribed only after the relief of withdrawal symptoms and after a preliminary detoxification.
The use of naltrexone begins in specialized drug treatment units 7-10 days after the last opioid drug. In the future, the patient should be under strict medical supervision, a positive attitude towards the treatment of drug addiction in the patient is necessary.
Treatment of alcoholism: Inside 50 mg once a day, a 12-week course of treatment prevents relapse for 6 months (the success of treatment depends on the consent of the patient).
Drug dependence treatment: Start only after 7-10 days of abstinence from opioid use, confirmed by a provocative test and urinalysis for the content of opioids. The patient should have no “withdrawal” syndrome and signs of withdrawal. Treatment does not begin until a provocative test with an intravenous administration of 0.5 mg of naloxone is negative. The initial dose of 25 mg, the patient’s condition should be monitored for 1 hour, in the absence of withdrawal syndrome, 50 mg once a day should be prescribed, this dose blocks 25 mg of intravenous heroin. Alternative treatment regimens: 1. 50 mg every weekday and 100 mg on Saturday.
2.100 mg every other day.
3.150 mg after 2 days.
4.100 mg (Monday), 100 mg (Wednesday) and 150 mg (Friday). It should be borne in mind that the use of these treatment regimens increases the risk of hepatotoxicity. The course of treatment is determined individually.
Side effects of the digestive system
: Rarely – increased appetite, dry mouth, flatulence, aggravated hemorrhoid symptoms, erosive and ulcerative lesions of the gastrointestinal tract, abdominal pain, increased activity of liver enzymes .
From the nervous system: and sensory organs More often – extraordinary fatigue. Rarely – blurred visual perception, confusion, hallucinations, depression of the central nervous system, ringing and a feeling of stuffiness in the ears, pain and burning sensation in the eyes, photophobia, irritability, drowsiness, disorientation in time and space.
From the respiratory system: Rarely – hoarseness, nasal congestion (hyperemia of the vessels of the nasal cavity), sneezing, shortness of breath, dry throat, increased sputum mucosa, sinusitis.
From the cardiovascular system: Rarely – chest pain, nonspecific ECG changes.
From the genitourinary system: Discomfort during urination, increased urination.
Allergic reactions: Less common is a skin rash. Rarely – hyperthermia, skin itching, increased secretion of the sebaceous glands.
Other: Rarely – thirst, increase or loss of body weight, pain in the inguinal region, swollen lymph nodes, lymphocytosis. In one case, the development of idiopathic thrombocytopenic purpura against the background of preliminary sensitization to the drug is described.
Opioid withdrawal syndrome: Abdominal pain, epigastric spasms, anxiety, nervousness, fatigue, irritability, diarrhea, tachycardia, hyperthermia, rhinorrhea, sneezing, goose bumps, sweating, yawning, arthralgia, myalgia, anorexia, or vomiting, tremors, general weakness.
Drug Interactions
Increases (mutually) the risk of liver damage when combined with hepatotoxic drugs.
Possible lethargy or increased drowsiness when combined with thioridazine.
Reduces the effectiveness of drugs containing opioids (antitussive drugs, analgesics).
Accelerates the onset of symptoms of “withdrawal syndrome” against the background of drug dependence (symptoms may appear as early as 5 minutes after administration of the drug, last for 48 hours, are characterized by persistence and difficulty in eliminating them).
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Expiration
See packaging
active substance
naltrexone
Terms leave through pharmacies
In retseptu
lekarstvennaja form
kapsul
Moscow Pharmaceutical Factory CJSC, Russia
