Description
Latin name
Vivitrol
Release form
Powder for the preparation of a suspension for intramuscular administration of prolonged action
Packaging
1 bottle complete with solvent
Pharmacological action of
Naltrexone is an opioid antagonist with the highest affinity for opioid mu receptors. In addition to the antagonism of opioid receptors, the drug does not have or has a very insignificant degree of internal activity. The use of the drug for unknown reasons can cause narrowing of the pupil. The use of Vivitrol is not accompanied by the development of tolerance or mental and physiological dependence. In patients with physical opioid dependence, the administration of the drug causes withdrawal symptoms. Naltrexone blocks the effects of opioids, competing with opioid receptors in the brain. The neurobiological mechanisms responsible for reducing alcohol consumption observed in patients with alcohol dependence treated with naltrexone are not fully understood, but it is assumed that the mechanism of action affects the endogenous opioid system. Blockade can be overcome by increasing doses of opioids, which is manifested by symptoms such as increased histamine secretion. Vivitrol is not a remedy for aversive therapy and does not cause a disulfiram-like reaction when taking opiates or alcohol.
Indications
The drug is indicated for the treatment of alcohol dependence in patients who are able to refrain from drinking alcohol before starting treatment. Patients should not actively consume alcohol at the beginning of Vivitrol treatment. Drug treatment should be part of an appropriate alcohol dependence elimination program, including psychosocial support.
The drug is indicated for (treating and) preventing the relapse of opioid dependence after opioid detoxification. Patients should not take opioids at the beginning of treatment with the drug.
Children and elderly patients
There are no data on the safety and effectiveness of the drug in children. An insufficient number of patients over 65 years old were included in the clinical trials of Vivitrol to compare the effect of treatment in elderly patients and in younger patients.
Contraindications
Vivitrol is contraindicated in: Patients taking narcotic analgesics
Patients with ongoing physiological opioid dependence
Patients in state of acute withdrawal of opioids
B failed a provocative test with naloxone or a positive test for the presence of opioids in the urine.
Patients with hypersensitivity to the active substance of the drug, or to any of its excipients and solvent components.
Use during pregnancy and lactation
Pregnancy
The preparation is classified as Category C in terms of toxicity. The effect of Vivitrol on pregnant women has not been studied. Vivitrol should be prescribed during pregnancy only if the potential benefit of its use exceeds the potential risk to the fetus.
Lactation
Naltrexone and 6-beta naltrexol with breast milk have been isolated with oral administration of naltrexone. Due to the potential carcinogenicity and the likelihood of serious side effects in infants, a decision should be made whether to discontinue Vivitrol therapy during breastfeeding or to discontinue lactation during treatment with the drug, depending on the importance of therapy to the mother.
Powder mixed with: lactic and glycolic acid (polymer: 75:25 DL JN1). The vial contains 430 mg of naltrexone (excess 12.9%).
Solvent: sodium carmellose (sodium carboxymethyl cellulose), polysorbate 20, sodium chloride, water for injection.
Dosage and administration of
Vivitrol should be administered by qualified healthcare professionals only using the components provided in the package. Do not replace packaging components. The recommended dose of Vivitrol is 380 mg IM once every 4 weeks or once a month. The drug should be injected into the gluteal muscle, alternating buttocks. Vivitrol can not be administered intravenously! If the patient misses the introduction of the next dose, the next injection should be done as quickly as possible. Before using Vivitrol, oral administration of naltrexone is not required.
Side effects
From the gastrointestinal tract: nausea, vomiting, diarrhea, frequent bowel movements, gastrointestinal upset, loose stools, abdominal pain, stomach discomfort, dry mouth, anorexia, decreased or increased appetite, taste perversion, gastroesophageal disease, constipation, flatulence, hemorrhoids, colitis, gastrointestinal bleeding, paralytic ileus, perrectal abscess, gastroenteritis,
tooth abscess From the respiratory system: upper respiratory tract infections, laryngitis, sinusitis, pharyngitis (including streptococcal), nasopharyngitis, sore throat, dyspnea, nasal congestion, chronic obstructive pulmonary disease, flu, bronchitis, pneumonia
General disorders and reactions at the injection site: pain, soreness, tightness, swelling, itching, hemorrhage, asthenia, anxiety, lethargy, lethargy, fever, lethargy, trembling, chest pain, chest tightness, toothache, weight loss
motor body system: arthritis, joint pain, stiffness in joints, back pain, limb pain, muscle spasm, muscle twitching, stiffness in muscles
From the skin and subcutaneous tissues: rash, papular rashes, prickly sweating, sweating, including including at night, itching, cellulite, conjunctivitis
From the nervous system: headache, migraine, dizziness, fainting, drowsiness, sedative, impaired attention, migraine, decreased mental activity, cramps, ischemic stroke, cerebral artery aneurysms
Mental disorders: irritability, sleep disturbance, alcohol withdrawal syndrome , agitation, euphoria, delirium
On the part of the metabolism: heat stroke, dehydration, hypercholesterolemia
On the part of the cardiovascular system: increased blood pressure, hot flashes, thrombosis deep veins, pulmonary thrombosis, palpitations, atrial fibrillation, myocardial infarction, angina pectoris, unstable angina pectoris, congestive heart failure, coronary atherosclerosis
From the blood and lymphatic system: lymphadenopathy, including cervical adenitis, increased leukocytes in the blood
From the immune system: seasonal allergies, hypersensitivity reactions, including angioedema and urticaria
From the genitourinary system: miscarriage, decreased libido, urinary tract infections
From the hepatobiliary system: cholelithiasis, increased levels A AST, acute cholecystitis.
Drug Interaction
Not studied. Naltrexone is an antagonist of opioid-containing medicines (e.g., cough, cold, antidiarrheal drugs and opioid analgesics). Because naltrexone is not a substrate of cytochrome c enzymes, inducers or inhibitors of these enzymes are unlikely to affect the clearance of Vivitrol. Safety indicators for the use of Vivitrol with and without antidepressants are the same.
Overdose
Overdose is limited. Single doses of 784 mg were administered to 5 healthy volunteers. There were no serious side effects. In case of overdose, appropriate supportive treatment should be performed.
Storage conditions
In the refrigerator at a temperature of 2 ° C to 8 ° C. At a temperature of no higher than 25 ° C for no more than 7 days. Do not expose to temperatures above 25 ° C. Keep out of the reach of children. Do not freeze.
Expiration
2 years.
Deystvuyuschee substances
Naltrexone
dosage form
dosage form
suspension for injection
Johnson and Johnson, USA
