Mislim Tablet 25 mg (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 50 mg of naltrexone hydrochloride orally once daily. Placebo-controlled studies have evaluated administration of this dose for up to 12 weeks; however, other doses or treatment durations were not evaluated in these studies. 2. Blocking the effects of exogenous opioids 1) Treatment should be initiated 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. If opioid withdrawal symptoms continue to be observed based on the test results, this medicine should not be administered. However, the naloxone challenge test may be repeated after 24 hours. 3) Treatment should be initiated cautiously, with the dose increased gradually. The initial dose is 25 mg. After observing the patient for one hour, if no withdrawal symptoms occur, the remainder of the daily dose (25 mg) may be administered, for a total daily dose of 50 mg. 4) Administration 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 other day ○ 150 mg every 3 days However, since administration of more than 50 mg at one time may increase the risk of hepatocellular injury, this regimen should be used only when the benefits of improved adherence outweigh the risk of hepatocellular toxicity. 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> The naloxone challenge test can be performed by either of two routes: 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 withdrawal symptoms or signs for approximately 30 seconds. If no withdrawal symptoms occur, inject the remaining 0.6 mg and observe the patient's condition for 20 minutes for the occurrence 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 withdrawal symptoms or signs. 3. Interpretation of results If none of the above symptoms or signs occur, initiate treatment with this medicine. If they occur, defer treatment with this medicine and repeat the naloxone challenge test after 24 hours.

This medication has the potential to cause liver damage, so it is crucial to adhere strictly to the prescribed dosage. Excessive dosage, especially, can severely impair liver function. Patients with liver disease or compromised liver function should avoid this medication or take it with caution. This medication should not be administered to patients using opioid analgesics or those dependent on opioids. Furthermore, patients experiencing acute opioid withdrawal symptoms should not use this medication. This medication is not intended for patients with certain liver diseases, kidney diseases, allergic reactions, children under 18, elderly patients, pregnant women, or nursing mothers. If symptoms of liver dysfunction (abdominal pain, jaundice, etc.) occur while taking this medication, consult a physician immediately. Patients taking this medication should not take opioids indiscriminately, as this could lead to life-threatening overdose symptoms. This medication may interact with other medications, so it is essential to inform the prescribing physician of any concurrently taken medications. Women who are pregnant or may become pregnant should not take this medication, and nursing mothers should also refrain from using it. Regular liver function tests are important to detect any liver damage while taking this medication. In cases of overdose, appropriate treatment should be sought immediately under medical supervision. It should be stored in a secure location out of reach of children, and it is advisable not to transfer it to other containers. This medication does not induce opioid dependence, but due to its opioid-blocking action, withdrawal symptoms may occur, so caution is advised.

• Increased liver enzyme levels
• severe withdrawal symptoms
• headache
• nervousness
• insomnia
• anxiety
• depression
• suicidal thoughts
• suicide attempts
• fatigue

This medication may be sensitive to light, so it should be stored in a sealed container that blocks light. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help preserve the medication’s efficacy and safety.

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle