Hwanin Naltrexone Tablet 25 mg (Naltrexone Hydrochloride)

Adult dosage

Treatment with naltrexone hydrochloride may be initiated only if the physician determines that the patient has not used opioids within 7 ∼ 10 days before treatment. If opioid dependence is suspected, a naloxone challenge test should be performed. 1. Treatment of alcohol dependence Adults: Administer 50 mg of naltrexone hydrochloride orally once daily. Placebo-controlled studies have evaluated administration of this dose for up to 12 weeks; other doses or treatment durations were not evaluated in these studies. 2. Blocking the effects of exogenous opioids 1) Treatment should be started only after a urine test confirms that the patient has not used opioids for at least 7 ∼ 10 days before treatment. 2) If opioid dependence is suspected, perform the following naloxone challenge test. Do not administer this drug if opioid withdrawal symptoms continue to be observed during the test. However, the naloxone challenge test may be repeated after 24 hours. 3) Initiate treatment cautiously, increasing the dose gradually. The initial dose is 25 mg. After observing the patient for one hour, if no withdrawal symptoms occur, the remaining 25 mg of the daily dose (50 mg) may be administered. 4) A dose of 50 mg once daily can adequately block the effects of intravenously administered narcotics (this dose blocks the effects of 25 mg of intravenously administered heroin). To improve patient adherence to medication, the dosing schedule may be adjusted as follows: ○ 50 mg daily on weekdays and 100 mg on Saturday ○ 100 mg every 2 days ○ 150 mg every 3 days However, doses exceeding 50 mg at a time may increase the risk of liver cell injury, so this regimen should be used only when the benefit of improved medication adherence outweighs the risk of hepatotoxicity. In addition, administration of more than 150 mg at one time is not recommended because it may increase the likelihood of adverse reactions. <Naloxone challenge test> Do not perform the test in patients showing signs or symptoms of opioid withdrawal or in patients whose urine test detects opioids. The naloxone challenge test may be performed by either the intravenous or subcutaneous route. 1. Test procedure 1) Intravenous challenge test Draw 0.8 mg of naloxone into a sterile syringe. Inject 0.2 mg of naloxone and observe the patient for signs or symptoms of withdrawal for approximately 30 seconds, with the needle remaining in the patient’s vein. If no withdrawal symptoms occur, inject the remaining 0.6 mg and observe the patient for withdrawal symptoms for 20 minutes. 2) Subcutaneous challenge test Inject 0.8 mg of naloxone subcutaneously and observe the patient for signs or symptoms of withdrawal for approximately 20 minutes. 2. Monitor the patient’s vital signs and withdrawal symptoms during the observation period and under the specified conditions. 3. Interpretation of results If none of the above symptoms or signs occur, initiate treatment with this drug. If they occur, delay treatment with this drug and repeat the naloxone challenge test after 24 hours.

This medication may cause liver damage, so it should not be taken in doses exceeding the recommended amount. If the patient has poor liver function or shows signs of hepatitis, use should be discontinued immediately and a doctor should be consulted. It is very dangerous to take large amounts of opioid drugs indiscriminately while on this medication, as it may lead to serious side effects or life-threatening situations. Patients using opioid analgesics or those with opioid dependence, as well as those with acute withdrawal symptoms, should not take this medication. Furthermore, it should be avoided by patients with severe liver dysfunction, renal impairment, certain genetic disorders, pregnant or nursing women, children under 18 years old, and the elderly. Patients with active hepatic disease or known allergies to specific pigments included in this medication should use it with caution. Various side effects such as headache, insomnia, anxiety, nausea, dizziness may occur during use, and if these symptoms persist, medical advice should be sought. This medication should be taken strictly according to a physician's prescription and instructions, with caution regarding possible interactions when taken with other medications. Pregnant or nursing women should not take this medication, and use should be avoided by children and the elderly. In case of overdose, appropriate treatment should be carried out under professional medical supervision. This medication should be kept out of reach of children and should not be transferred to another container. If symptoms of liver damage such as abdominal pain, jaundice of the eyes, or changes in urine color occur, use should be stopped immediately and the patient should consult a doctor.

• Hepatocyte damage
• increased liver enzymes
• severe withdrawal symptoms
• headache
• irritability
• insomnia
• anxiety
• depression
• suicidal thoughts
• suicide attempts

This medication is photosensitive and should be stored in light-blocking containers. Additionally, it is important to maintain the effectiveness of the medication by storing it at room temperature, specifically between 1 degree and 30 degrees Celsius.

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle