Vivitrol instructions for use
Powder Vivitrol is a pharmacological drug group drugs for the treatment of alcohol dependence. It is used to treat physical and mental dependence caused by the abuse of alcohol and narcotic drugs of the opiate group.
Release form and composition
The drug Vivitrol is available in the form of sterile white or light yellow powder. The main active ingredient of the drug is naltrexone, which is adsorbed on a molecule of a copolymer of lactic acid and glycolic acid. The concentration of naltrexone is 380 mg in 1 vial 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 carboxymethyl cellulose).
- Sodium chloride.
- Water for injections.
The carton pack contains 1 bottle of powder, 1 ampoule with solvent and a syringe with a needle for intramuscular administration. It also contains instructions for the use of the drug.
The active ingredient of the drug Vivitrol naltrexone blocks the opiate receptors in the brain, which react to the ingestion of drugs and alcohol. Therefore, during the use of the drug, there is no feeling of euphoria and an imperative desire to take a psychoactive substance, in the case of psychological and physical dependence. Naltrexone can also cause constriction of the pupils, but the mechanism of this effect remains unknown.
Powder Vivitrol is a compound with prolonged action. After its intramuscular injection, the active substance is gradually released into the blood (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 reached within 2 hours after the intramuscular injection of the drug, a repeated peak is noted in 7-10 days. Starting from the 2nd week after the injection, the concentration of naltrexone in the blood gradually decreases. The active ingredient is partially bound to plasma proteins, is well distributed in the tissues of the body, penetrates the blood-brain barrier into the brain tissue. It can also enter the body of a developing fetus during pregnancy and into breast milk during lactation. Naltrexone metabolism occurs in various cells and tissues of the body without the participation of the P450 microsomal enzyme system. Decomposition products are eliminated from the body to a greater extent by urine. The half-life (the time during which half the dose of the drug is excreted from the body) 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 taking alcohol for several days. Vivitrol is also used for the prophylactic treatment of relapse of opiate addiction (physical and mental dependence of a person after using opiate drugs, primarily poppy derivatives). The drug is used during long-term psychosomatic rehabilitation of the patient after the main course of treatment of alcohol or opiate addiction.
The use of powder for intramuscular administration of 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 anesthetic drugs.
- Continuing the use of opiate drugs or alcohol during therapy.
- Persons who have not passed the provocative naloxone test (a positive result of such a test indicates a recent use of opiate compounds) or with the presence of residual traces of opiates in the urine in her laboratory test.
- The drug is contraindicated in patients who are in a state of abstinence to opiate drugs (abrupt cancellation of the introduction of drugs, leading to pronounced mental, somatic and functional disorders in the body).
- Various liver diseases (hepatitis, cirrhosis of the liver ), accompanied by its pronounced functional deficiency.
- Pregnancy at any time and during breastfeeding.
- Children under the age of 18 years.
Before starting the drug Vivitrol, you must make sure that there are no contraindications.
Dosing and Administration
The drug Vivitrol is a dosage form for parenteral intramuscular administration. It is inserted into the gluteus muscle only by a medical professional and using the components (solvent, syringe and needle) that make up the package. You can not enter the drug yourself, replace the components required for the introduction. Before intramuscular injection, the powder is dissolved 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 the observance of the rules of asepsis and antisepsis. When repeated administration of the buttocks alternate, it is not recommended to twice enter the drug in the same buttock. The dosage of the drug Vivitrol is 1 bottle, which is administered 1 time per month (4 weeks). The duration of the course of use of such therapy is determined by the narcologist on an individual basis. In the case of missed administration of the drug, the next dose must be entered as soon as possible.
After intramuscular injection of Vivitrol solution (after appropriate dissolution of the powder in a solvent) a number of side effects from various organs and systems can develop in the body, these include:
- Respiratory organs - laryngitis and pharyngitis (inflammation of the mucous membrane of the larynx and pharynx), flu-like condition.
- Gastrointestinal - nausea, vomiting, diarrhea, toothache, increased appetite, gastrointestinal bleeding and functional intestinal obstruction.
- Blood biochemical parameters - increased activity of liver enzymes AST and ALT, indicating damage to the hepatocytes (liver cells).
- Central nervous system - insomnia at night and daytime sleepiness, headache, periodic loss of consciousness (fainting), dizziness, decreased libido (sexual desire for the opposite sex).
- Cardiovascular system - increased systemic blood pressure (arterial hypertension), chest pain in the region of the heart, deep vein thrombosis, the appearance of hot flashes.
- Sense organs - visual impairment, in the form of fog before the eyes, conjunctivitis (inflammation of the conjunctiva of the eyes).
- Metabolism (metabolism) - increasing the level of cholesterol in the blood, dehydration (dehydration), heat stroke.
- Musculoskeletal system - pain in muscles and joints, muscle spasm, stiffness of movements in the joints.
- The urinary system - infectious and inflammatory processes in the kidneys and urinary tract.
- Allergic reactions - skin rash, itching, hives (characteristic rash and swelling of the skin, resembling a stinging nettle), angioedema Quincke (pronounced swelling of the skin and subcutaneous tissue with predominant localization in the face and genitals). In rare cases, severe systemic allergic reactions may develop 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 infiltration, its pain. In case of non-observance of the rules of asepsis and antiseptics during the administration of the drug, an infectious complication may develop in the form of an abscess (formation of a limited cavity filled with pus).
The frequency and combination of the development of negative effects after the use of the drug 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 takes a narcologist.
The course of treatment with a powder for intramuscular injection of Vivitrol is necessarily carried out taking into account a number of special instructions, which include:
- The active ingredient of the drug does not interact with other drugs, however, if they are taken together, 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 mental changes of the patient, especially the development of a depressive state.
- It is important that the injection of the drug is carried out only by a medical professional, according to the rules of asepsis and antisepsis.
- During the course of treatment with Vivitrol, it is advisable to conduct periodic laboratory monitoring of blood parameters, the functional state of the liver and kidneys.
- It is not recommended to perform work associated with the need for increased concentration of attention and speed of psychomotor reactions, since during the use of the drug, severe dizziness, visual disturbances and other side effects can occur.
In the pharmacy network, powder for intravenous administration of Vivitrol is available only by prescription. It is not recommended to use it alone or on the recommendation of a third party.
There is practically no evidence of an overdose of the drug Vivitrol. It is believed that if you exceed the recommended therapeutic dose may develop nausea, vomiting, abdominal pain. In such cases, medical monitoring of the patient’s condition is performed. If necessary, a general detoxification and symptomatic therapy. In cases of severe overdose, the administration of opiate substances that are naltrexone antagonists can be addressed.
Analogues of the drug on the active substance and therapeutic effect are naloxone and naltrexone for oral administration in the form of tablets.
Terms and conditions of storage
Shelf life of the powder for intramuscular injection 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. Temperatures up to + 25 ° C are allowed, but not longer than 7 days. Keep out of the reach of children.
The average cost of the drug Vivitrol in pharmacies in Moscow is 16275-19125 rubles.