Naltrexone capsules 50mg, 10pcs

Composition

One capsule contains:  

Active ingredient:  

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

Auxiliary substances:  

lactose monohydrate – 98.5 mg;

magnesium stearate-1.5 mg.

Solid gelatin capsule No. 4 – 38.0 mg.

Capsule body:

titanium dioxide (E 171) – 2%;

gelatin up to 100%.

Capsule cap:

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

indigo carmine dye (E 132) – 0.3%;

gelatin up to 100%.

Indications

Treatment of opioid addiction in order to maintain the patient’s condition, in which opioids will not be able to have a characteristic effect (as part of complex therapy).

The drug is prescribed only after stopping the withdrawal syndrome.

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

Contraindications

• Simultaneous use of opioid analgesics;

• Positive urinalysis for opioids;

• Lack of data on conducting a provocative test with naloxone;

• Acute hepatitis;

• Liver failure;

• Hypersensitivity to naltrexone.

Side effects

From the central nervoussystem: sleep disorders, 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, increased activity of hepatic transaminases.

Other services:  lymphocytosis, weakness, myalgia, arthralgia, decreased or increased libido.

When using Naltrexone EF as indicated in therapeutic doses in patients who do not contain opioids, the development of serious side effects was not observed.

Interaction

When used concomitantly with Naltrexone, EF reduces the effectiveness of drugs containing opioids (antitussives, opioid analgesics, anti-inflammatory drugs).

In these cases, alternative analgesics that do not contain opioids should be used. Clinically significant drug interactions with other drugs have not been described.

How to take, course of use and dosage

The use of Naltrexone EF is possible in specialized drug treatment departments or on an outpatient basis under the supervision of a doctor. The patient must have a positive attitude towards drug addiction treatment. In the case of heroin addiction, treatment with Naltrexone EF can be initiated no earlier than 7-10 days after the last drug intake and provided that there are no signs of withdrawal syndrome after a negative naloxone test or after a negative urinalysis result for opioid content. Treatment is not initiated until the provocative test with intravenous use of 500 mcg of naloxone becomes negative. The naloxone test is not given to patients with signs of withdrawal symptoms or if opioids are detected in the urine. A second naloxone test can be performed after 24 hours. Introductory phase of therapy with Naltrexone EF The recommended initial single dose of Naltrexone EF is 20 mg, after which the patient’s condition should be monitored for 1 hour. If there are no signs of withdrawal symptoms, the patient can be given the remainder of the daily dose (30 mg). The doctor should monitor the patient’s ingestion of the drug. Maintenance therapy with Naltrexone EF

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

You can use other treatment regimens:

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

This scheme is convenient for patients with a long-term opioid withdrawal 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 at a dose of 50 mg 1 time/day. The minimum course of treatment is 3 months.

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

Overdose

Currently, there are no data on the possibility of overdose of Naltrexone EF. If necessary, conduct symptomatic therapy and provide observation in a specialized hospital.

Special instructions

Naltrexone EF is intended for inpatient and outpatient treatment under the supervision of an addiction specialist. Drug treatment is recommended to be accompanied by a course of psychotherapy.

During treatment, the patient should have a Naltrexone EF appointment card with them to inform other health care providers if an emergency is needed. If it is necessary to overcome the blockade of opioid receptors (introductory 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.

Form of production

Solid gelatin capsules No. 4, white capsule body, dark green lid.

Capsule contents: white or almost white powder.

Active ingredient

Naltrexone

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults as directed by your doctor

Indications

Alcoholism, Drug Addiction