Traxone Tablets 25 mg (Naltrexone Hydrochloride)

Adult dosage

Naltrexone hydrochloride may be initiated only when 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, but other doses or treatment durations were not evaluated in these studies. 2. Blocking the effects of exogenous opioids 1) Begin treatment only after urine testing 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 persist during the test, this drug should not be administered. 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. Observe the patient for 1 hour; if no withdrawal symptoms occur, the remainder of the daily dose (25 mg) may be administered. 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). To improve medication adherence, 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, because administration of more than 50 mg at one time may increase the risk of hepatocellular injury, this schedule should be used only when the benefits of improved medication adherence outweigh the risk of hepatotoxicity. Administration of more than 150 mg at one time is also not recommended because it may increase the likelihood of adverse reactions. <Naloxone challenge test> 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 and, with the needle remaining 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 for withdrawal symptoms for 20 minutes. 2) Subcutaneous challenge test Administer 0.8 mg of naloxone subcutaneously and observe the patient for withdrawal symptoms or signs for approximately 20 minutes. If none of the above symptoms or signs occur, initiate treatment with this drug. If they do occur, delay treatment with this drug and repeat the naloxone challenge test after 24 hours.

This medication can cause liver damage; therefore, it is essential to adhere to the prescribed dosage. If overdose occurs, there is a risk of toxicity to liver cells, so caution is required. It is advisable not to use this drug in patients with poor liver function or symptoms of hepatitis. In patients taking opioid medications or those who are opioid-dependent, this drug is contraindicated as it may precipitate acute withdrawal symptoms. Because this drug acts as an opioid receptor blocker, dosage adjustments and careful monitoring are necessary if opioid analgesia is required. Attempts by patients to increase opioid intake in order to counteract the effects of this medication are highly dangerous and can be life-threatening. This drug should not be administered to pregnant or potentially pregnant women, nursing mothers, children under 18 years of age, and the elderly. This drug contains lactose and should not be used in patients with lactose intolerance or related genetic disorders. Liver function tests should be conducted regularly during treatment to monitor for liver toxicity. Consult with a physician or pharmacist when using this drug in conjunction with other medications as interactions may occur. While taking this medication, sudden withdrawal symptoms or adverse reactions may arise; patients should immediately report any symptoms to healthcare providers. Furthermore, patients should inform all healthcare providers that they are taking this medication to ensure appropriate management in emergency situations. This drug must be taken strictly according to a physician's prescription and instructions, and patients should not change the dosage or discontinue use on their own. Store this medication in a safe place out of reach of children and avoid transferring it to other containers.

• Elevated liver enzymes
• severe withdrawal symptoms
• headache
• nervousness
• insomnia
• anxiety
• depression
• suicidal thoughts
• suicide attempts
• fatigue

This medication is sensitive to light; therefore, it should be stored in a container that protects it from light. Additionally, it should be kept in a tightly sealed container that allows for minimal airflow and stored at room temperature between 1 and 30 degrees Celsius.

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle