Narex Tablets (Naltrexone Hydrochloride)

Adult dosage

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 naltrexone hydrochloride 50 mg orally once daily. Placebo-controlled studies have evaluated 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) Initiate treatment after performing a urine test to confirm 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 medicine if opioid withdrawal symptoms continue to be observed after the test. However, the naloxone challenge test may be repeated after 24 hours. 3) Initiate treatment cautiously and increase the dose gradually. The initial dose is 25 mg. After observing the patient for one hour, if no withdrawal symptoms appear, the remainder of the daily dose (25 mg) may be administered to make a total of 50 mg. 4) A dose of 50 mg once daily can adequately block the effects of intravenously administered opioids (this dose blocks the effects of 25 mg of intravenously administered heroin). The dosing schedule may be adjusted as follows to improve patient adherence to medication: ○ 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 one time may increase the risk of hepatocellular injury; such doses should be used only when the benefit of improved adherence outweighs the risk of hepatotoxicity. In addition, doses exceeding 150 mg at one time are not recommended because they 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, with the needle still in the patient's vein, observe for signs or symptoms of withdrawal for approximately 30 seconds. If no withdrawal symptoms appear, inject the remaining 0.6 mg and observe the patient's condition for 20 minutes for the appearance of withdrawal symptoms. 2) Subcutaneous challenge test Inject 0.8 mg of naloxone subcutaneously and observe the patient's condition for approximately 20 minutes for signs or symptoms of withdrawal.

This medication can cause liver damage, so it should not be taken in excess of the prescribed dosage. Care must be taken as hepatotoxicity may occur in case of overdose. Patients currently on opioid analgesics or those with opioid dependence should not use this medication, as it may cause acute withdrawal symptoms. Patients with severely impaired liver or kidney function, pregnant or breastfeeding women, children and adolescents under 18 years of age, and the elderly should not use this medication. Patients with allergic reactions to this medication or genetic issues such as lactose intolerance should also avoid it. Patients with active liver disease or allergy to any of the components of this medication should use it cautiously. It is important to have regular liver function tests during the use of this medication to detect liver damage early. Trying to counteract the effects of this medication by taking excessive opioid drugs is very dangerous and may be life-threatening. Consult a physician when using this medication in conjunction with other drugs due to possible interactions. If severe abdominal pain, jaundice, or changes in urine color occur during treatment, consult a physician immediately. This medication must be taken according to the prescribed dosage and regimen, and it should not be discontinued or increased arbitrarily. Store it out of reach of children and do not transfer to another container.

• Liver cell damage
• elevated liver enzymes
• headache
• irritability
• insomnia
• anxiety
• depression
• suicidal thoughts
• suicide attempts
• fatigue

This medication should be stored in a tightly closed container that protects it from light and at a temperature between 1°C and 30°C. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance

Light yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle