Naltrexone 50 mg, 10 pcs.

One capsule contains: 

Active substance: 

naltrexone hydrochloride in terms of 100% substance - 50.0 mg.

Excipients: 

lactose monohydrate - 98.5 mg;

magnesium stearate - 1.5 mg.

Hard gelatin capsule No. 4  - 38.0 mg.

Capsule body:

titanium dioxide (E 171) - 2%;

gelatin up to 100%.

Capsule cap:

iron dye yellow oxide (E 172) - 1.7143%, titanium dioxide (E 171) - 1%;

dye indigo carmine (E 132) - 0.3%;

gelatin up to 100%.

Treatment of opioid addiction with the aim of maintaining the patient in a state in which opioids cannot have a characteristic effect (as part of complex therapy).

The drug is prescribed only after the relief of withdrawal symptoms.

Treatment of chronic alcoholism (as part of complex therapy / including with maintenance therapy in the same doses as with heroin addiction against the background of psychotherapy /).

• Concomitant use of opioid analgesics;

• A positive urine test for opioids;

• Lack of data on a provocative test with naloxone;

• Acute hepatitis;

• Liver failure;

• Hypersensitivity to naltrexone.

From the side of the central nervous system : sleep disturbances, anxiety, dizziness, headache; in isolated cases - depression, confusion, hallucinations.

From the digestive system : decreased appetite, nausea, vomiting, diarrhea, constipation, abdominal pain; when using the drug in a daily dose of more than 200 mg, there is a hepatotoxic effect, an increase in the activity of hepatic transaminases.

Others : lymphocytosis, weakness, myalgia, arthralgia, decreased or increased libido.

When Naltrexone VWF was used according to indications in therapeutic doses in patients whose bodies do not contain opioids, the development of serious side effects was not observed.

With the simultaneous use of VWF with Naltrexone, the effectiveness of drugs containing opioids (antitussives, opioid analgesics, anti-inflammatory drugs) decreases.

In these cases, opioid-free alternative analgesics should be used.

Clinically significant drug interactions with other drugs have not been described.

The use of Naltrexone VF is possible in specialized narcological departments or on an outpatient basis under the supervision of a physician. The patient must have a positive attitude towards drug addiction treatment.

In case of heroin addiction, treatment with Naltrexone VWF can be started no earlier than 7-10 days after the last drug intake and provided there are no signs of withdrawal symptoms after a negative naloxone test or after a negative urine test for opioid content.

Treatment is not started until a challenge test with intravenous administration of 500 mcg of naloxone becomes negative. The naloxone test is not performed on patients with withdrawal symptoms or if opioids are found in the urine. A repeat naloxone test can be performed after 24 hours.

The introductory phase of therapy with Naltrexone VWF The

recommended initial single dose of Naltrexone VWF is 20 mg, after which the patient should be monitored for 1 hour. In the absence of signs of withdrawal symptoms, the patient can be given the remainder of the daily dose (30 mg). The doctor should control the swallowing of the drug by the patient.

Supportive therapy with Naltrexone EF

After the end of the introductory phase, the drug is prescribed at a dose of 50 mg every 24 hours (this dose will be sufficient to block the effect of 25 mg of heroin administered intravenously).

You can use other treatment regimens:

   - 50 mg of Naltrexone VWF is prescribed daily for the first 5 days of the week and 100 mg on Saturday;
   - 100 mg of Naltrexone VWF is prescribed 1 time in 2 days or 150 mg 1 time in 3 days;
   - 100 mg of Naltrexone VWF is prescribed on Monday and Tuesday and 150 mg on Friday. 

This regimen is convenient for patients with a long-term opioid deprivation mindset.

The minimum course of treatment is 3 months, the standard course is 6 months.

In the treatment of chronic alcoholism, the drug is prescribed in a dose of 50 mg 1 time / day. The minimum course of treatment is 3 months.

Treatment is not started until a naloxone test has been performed to rule out the presence of opioids in the body.

Currently, there is no data on the possibility of an overdose of the drug Naltrexone VWF. If necessary, symptomatic therapy is carried out and observation is provided in a specialized hospital.

Naltrexone FV is intended for inpatient and outpatient treatment under the supervision of a narcologist. Drug treatment is recommended to be accompanied by a course of psychotherapy.

During the treatment period, the patient should have a Naltrexone EF prescription card with him to inform other health workers in case of emergency.

If it is necessary to overcome the blockade of opioid receptors (induction anesthesia, pain relief in emergency situations), it is necessary to use short-acting opioid analgesics in high doses, which reduces the risk of respiratory depression and vascular collapse.

The drug does not cause the formation of physical and mental dependence.

Hard gelatin capsules No. 4, the body of the capsule is white, the cap is dark green.

Capsule contents: white or off-white powder.