Irexon Tablets 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 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) 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. Do not administer this drug if opioid withdrawal symptoms are still observed on 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 occur, 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 narcotics (this dose blocks the effects of 25 mg of intravenously administered heroin). To improve patient adherence, the dosing schedule may be adjusted as follows. ○ 50 mg daily on weekdays, 100 mg on Saturday ○ 100 mg every other day ○ 150 mg every 3 days However, doses exceeding 50 mg at one time may increase the risk of hepatocellular injury. Such dosing should be used only when the benefit of improved medication 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> 1. Test procedure 1) Challenge test by intravenous injection Draw 0.8 mg of naloxone into a sterile syringe. Inject 0.2 mg 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 occur, inject the remaining 0.6 mg and observe the patient's condition for 20 minutes for the onset of withdrawal symptoms. 2) Challenge test by subcutaneous injection Inject 0.8 mg of naloxone subcutaneously and observe the patient's condition for approximately 20 minutes for signs or symptoms of withdrawal. 3. Interpretation of results If none of the above symptoms or signs occur, initiate treatment with this drug. If they occur, defer treatment with this drug and repeat the naloxone challenge test after 24 hours.

This medication can cause hepatocellular damage in the case of overdose, so the recommended dosage must be strictly adhered to. Patients with compromised liver function should not use this medication, and if symptoms of hepatitis appear, immediate medical attention should be sought. Patients currently receiving opioid analgesics or those with opioid dependence should not be administered this medication, nor should it be given to patients experiencing acute withdrawal symptoms. Patients with known hypersensitivity to this medication, severely impaired renal and hepatic function, children and adolescents under 18 years of age, elderly patients, and pregnant or breastfeeding women should not take this medication. Patients with certain genetic metabolic abnormalities such as lactose intolerance should also avoid this medication. Patients with active liver disease or allergies to excipients in this medication should use it cautiously. This medication blocks opioid receptors, so stopping opioid medications suddenly or taking them in large quantities can be very dangerous and life-threatening. During treatment with this medication, mental changes, depression, insomnia, headaches, indigestion, and other side effects may occur, so if any unusual symptoms arise, consult a physician. If opioid analgesics are needed, appropriate doses and types should be selected considering the effects of this medication, and instructions from the attending physician should be strictly followed during treatment. Regular liver function tests should be conducted to monitor for liver damage, and if symptoms of abdominal pain, jaundice (yellowing of the skin or eyes) appear, medication should be immediately discontinued and a physician should be notified. This medication may have interactions with other drugs, so if other medications are being taken, it is essential to inform a physician or pharmacist. This medication should be stored out of the reach of children, and transferring it to another container should be avoided.

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

This medication should be stored in a tightly sealed container that blocks light, and it is best kept at room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's effectiveness safely.

Appearance

Pale yellow, rectangular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle