Vivitrol user's manual
Vivitrol powder is a pharmacological preparation of a group of drugs for the treatment of alcohol dependence. It is used to treat physical and mental dependence caused by the abuse of alcohol and drugs of the opiate group.
Form of issue and composition
The drug Vivitrol is available in the form of a sterile powder of white or light yellow color. The main active substance of the drug is naltrexone, which is adsorbed on the copolymer molecule of lactic and glycolic acid. The concentration of naltrexone is 380 mg in 1 bottle of powder. Also in the composition of the drug is a solution for dissolving the powder before its intramuscular injection, such a solution in its composition contains auxiliary components, which include:
- Polysorbate 20.
- Carmellose sodium (sodium carboxymethylcellulose).
- Sodium chloride.
- Water for injections.
A cardboard pack contains 1 bottle of powder, 1 ampoule with a solvent and a syringe with a needle for intramuscular injection. It also contains instructions for the use of the drug.
The active substance of the drug Vivitrol naltrexone blocks opiate receptors of the brain, which react to the ingestion of drugs and alcohol. Therefore, during the use of the drug, there is no sense of euphoria and an imperative desire to take a psychoactive substance, in the presence of psychological and physical dependence. Also, naltrexone may cause pupillary narrowing, but the mechanism of this effect remains unknown.
Vivitrol powder is a compound with a prolonged action. After its intramuscular injection, the active substance is released into the blood gradually (this is possible due to the adsorption of naltrexone on copolymers of lactic and glycolic acid). The peak concentration of the active substance in the blood is achieved already in 2 hours after intramuscular injection of the drug, the repeated peak is observed after 7-10 days. Starting from the 2nd week after the administration, the concentration of naltrexone in the blood gradually decreases. The active substance partially binds to blood plasma proteins, it is well distributed in the tissues of the body, it penetrates the blood-brain barrier into the brain tissue. It can also enter the developing fetus during pregnancy and into breast milk during lactation. Naltrexone metabolism occurs in various cells and tissues of the body without the enzymatic microsomal system P450. The products of decay are excreted from the body more in the urine. Half-life (the time during which half the dose of the drug is excreted) is on average 10 days.
Indications for use
The main indication for the use of powder for intramuscular injection of Vivitrol is the treatment of alcohol dependence. Before the introduction of the drug, the patient should refrain from drinking alcohol for several days. Vivitrol is also used for the preventive treatment of the relapse of opiate dependence (physical and mental dependence of a person after using opiate narcotic drugs, primarily poppy derivatives). The drug is used during prolonged psychosomatic rehabilitation of the patient after the main course of therapy for alcohol or opiate dependence.
Contraindications for use
The use of powder for intramuscular injection Vivitrol is contraindicated in a number of pathological and physiological conditions of the body, which include:
- Individual intolerance or hypersensitivity to naltrexone or excipients of the drug.
- Patients who are prescribed a course of narcotic pain medication.
- Continued use of opiate drugs or alcohol on therapy.
- Persons who have not undergone a provocative naloxone test (a positive result of this test indicates a recent use of opiate compounds) or with the presence of residual traces of opiates in the urine during laboratory testing.
- The drug is contraindicated in patients who are in a state of abstinence to opiate narcotic substances (abrupt withdrawal of narcotic substances, resulting in severe mental, somatic and functional disorders in the body).
- Various liver diseases (hepatitis, cirrhosis of the liver ), accompanied by its pronounced functional insufficiency.
- Pregnancy at any time and period of breastfeeding.
- Children under the age of 18 years.
Before using Vivitrol, it is necessary to make sure that there are no contraindications.
Dosing and Administration
Vivitrol is a dosage form for parenteral intramuscular injection. It is injected into the gluteus muscle only by a medical worker and using components (solvent, syringe and needle) included in the package of the drug. Do not administer the drug yourself, replace the components necessary for administration. Before intramuscular injection, the powder dissolves in a special solvent, which is contained in the ampoule included in the package. The intramuscular injection itself is carried out in the outer-upper quadrant of one of the buttocks with observance of the rules of aseptic and antiseptic. With repeated administration of the buttocks alternate, it is not recommended to inject the drug twice into the same buttock. Dosage of the drug Vivitrol is 1 vial, which is administered 1 time per month (4 weeks). The duration of the course of use of such therapy is determined by the physician of the narcologist on an individual basis. In case of missed administration of the drug, the next dose should be administered as soon as possible.
After intramuscular injection of a solution of Vivitrol (after appropriate dissolution of the powder in the solvent), the body may develop a number of side effects from various organs and systems, including:
- Respiratory organs - laryngitis and pharyngitis (inflammation of the mucous larynx and pharynx), influenza-like condition.
- Gastrointestinal tract - nausea, vomiting, diarrhea, development of toothache, increased appetite, gastrointestinal bleeding and functional intestinal obstruction.
- Biochemical blood indices are an increase in the activity of liver enzymes AST and ALT, indicating damage to hepatocytes (liver cells).
- Central nervous system - sleeplessness at night and drowsiness during the day, headache, periodic loss of consciousness (fainting), dizziness, decreased libido (sexual attraction to the opposite sex).
- Cardiovascular system - increase in the level of systemic arterial pressure (arterial hypertension), chest pain in the heart, deep vein thrombosis, the appearance of tides.
- Organs of the senses - a violation of vision, in the form of the appearance of fog in front of the eyes, conjunctivitis (inflammation of the conjunctiva of the eyes).
- Metabolism (metabolism) - increased blood cholesterol levels, dehydration (dehydration), heat stroke.
- Musculoskeletal system - pain in the muscles and joints, muscle spasm, stiffness of movements in the joints.
- Genitourinary system - infectious and inflammatory processes in the kidneys and urinary tract.
- Allergic reactions - skin rash, itching, urticaria (characteristic rash and swelling of the skin resembling a nettle burn), angioedema of Quincke (pronounced swelling of the skin and subcutaneous tissue with predominant localization in the face and genital organs) is possible. In rare cases, there may be a development of severe systemic allergic reaction in the form of anaphylactic shock (progressive reduction in systemic arterial pressure and multiple organ failure).
- Local reactions of muscles and tissues in the area of drug administration - the development of the infiltrate, its soreness. In case of non-compliance with the rules of asepsis and antiseptics during the introduction of the drug, it is possible to develop an infectious complication in the form of an abscess (the formation of a restricted cavity filled with pus).
The frequency and combination of development of negative effects after application of the preparation are significantly different. There are also differences in the development of side effects during the treatment of alcohol and opiate addiction. With the development of negative reactions, the decision to cancel Vivitrol is taken by a doctor, a narcologist.
The course of treatment with the powder for intramuscular administration of Vivitrol is necessarily carried out taking into account a number of special instructions, which include:
- The active substance of the drug does not interact with other drugs, however, in the case of their joint administration, it is necessary to observe.
- There are cases of attempted suicide (suicide) during the use of the drug, so it is important to pay attention to the patient's mental changes, especially to the development of a depressed state.
- It is important that the injection is given only by a medical professional, according to the rules of aseptic and antiseptic.
- During the course of treatment with the drug Vivitrol it is desirable to conduct periodic laboratory monitoring of blood parameters, functional state of the liver and kidneys.
- It is not recommended to perform work related to the need for increased concentration of attention and speed of psychomotor reactions, as during the use of the drug there may be severe dizziness, visual impairment and other side effects.
In the pharmacy network, the powder for intravenous administration of Vivitrol is dispensed only by prescription. It is not recommended to use it independently or on the recommendation of third parties.
There is practically no evidence of an overdose of Vivitrol. It is believed that if the recommended therapeutic dose is exceeded, nausea, vomiting, and abdominal pain may develop. In such cases, medical monitoring of the patient's condition is carried out. If necessary, general detoxification and symptomatic therapy is carried out. With a severe overdose, the question of administering opiate substances, which are a naltrexone antagonist, can be addressed.
The analogues of the drug for the active substance and the therapeutic effect are Naloxone and Naltrexone for oral administration in the form of tablets.
Terms and conditions of storage
The shelf life of the powder for intramuscular injection of Vivitrol is 3 years from the date of its manufacture. The preparation should be stored in a dark, dry place at an air temperature of +2 to + 8 ° C. Temperature exposure is allowed up to + 25 ° C, but not longer than 7 days. Keep away from children.
The average cost of the drug Vivitrol in pharmacies in Moscow is - 16275-19125 rubles.