Naltrexone Tablets (Naltrexone Hydrochloride)

Adult dosage

Naltrexone hydrochloride treatment 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, perform a naloxone challenge test. 1. Treatment of alcohol dependence Adults: Administer naltrexone hydrochloride 50 mg orally once daily. Placebo-controlled studies have evaluated administration of this dose for up to 12 weeks, but other doses or treatment durations were not evaluated in these studies. 2. Blockade of the effects of exogenous opioids 1) Start treatment only 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 on 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 appear, the remaining portion of the daily dose (25 mg) may be administered, for a total of 50 mg. 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). The dosing schedule may be adjusted as follows to improve patient adherence to medication: ○ 50 mg daily on weekdays, 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 regimens should be used only when the benefit of improved medication adherence outweighs the risk of hepatotoxicity. In addition, a single dose exceeding 150 mg is not recommended because it may increase the likelihood of adverse reactions. <Naloxone challenge test> Do not perform in patients with signs or symptoms of opioid withdrawal or in patients whose urine test detects opioids. The naloxone challenge test may be performed by either intravenous or subcutaneous injection. 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 about 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 about 20 minutes for signs or symptoms of withdrawal. 2. Monitor the patient's vital signs and withdrawal symptoms during the observation period. It is also important to ask the patient carefully about symptoms. Signs and symptoms of withdrawal include, but are not limited to, the following: 1) Signs of withdrawal: nasal congestion, runny nose, lacrimation, yawning, sweating, tremor, vomiting, piloerection 2) Symptoms of withdrawal: feeling changes in body temperature, joint, bone, or muscle pain, abdominal cramps, chills (a sensation as if insects are crawling on the skin), etc. 3. Interpretation of results If none of the above symptoms or signs are present, initiate treatment with this medicine. If any are present, defer treatment with this medicine and repeat the naloxone challenge test after 24 hours.

This medication may cause liver damage; therefore, do not exceed the recommended dosage. In cases of overdose, liver function may deteriorate, and patients at risk of liver damage should discontinue use according to their doctor's instructions. This medication can be dangerous when used with opioid analgesics; therefore, patients taking opioids or those with opioid dependence should not take this medication. Sudden high doses of opioids can lead to life-threatening severe side effects, so caution is required. It is not safe for patients with poor liver or kidney function, pregnant women, children under the age of 18, or the elderly to use this medication. Regular liver function tests should be conducted while on this medication, and if symptoms such as abdominal pain or yellowing of the skin or eyes occur, consult a doctor immediately. There may be interactions when taken with other medications, so it is essential to inform your physician or pharmacist about current medications. In cases where opioid analgesics are needed, the effects of this medication may increase the need for larger amounts, and side effects such as respiratory depression may worsen. While taking this medication, avoid alcohol or other substance abuse, and if symptoms of suicidal impulses or depression arise, seek professional help immediately. Store out of reach of children, and take exactly as directed by your physician.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is best to store it at room temperature between 1°C and 30°C. Proper storage will maintain the drug's efficacy and safety.

Appearance

This medication is a light yellow, rectangular film-coated tablet.

Package unit

30 tablets/bottle, 100 tablets/bottle