Naltra Tablet 25 mg (Naltrexone Hydrochloride)

Adult dosage

Naltrexone hydrochloride treatment may be initiated only if the physician determines that opioids have not been used within 7 ∼ 10 days before treatment. 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) Before initiating treatment, perform 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 medication if opioid withdrawal symptoms are still observed following the test. However, the naloxone challenge test may be repeated after 24 hours. 3) Initiate treatment cautiously, gradually increasing the dose. The initial dose is 25 mg. After observing the patient for one hour, if no withdrawal symptoms occur, the remaining 25 mg of the daily dose (50 mg) may be administered. 4) Administration 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. ○ 50 mg daily on weekdays and 100 mg on Saturday ○ 100 mg every 2 days ○ 150 mg every 3 days However, administration of more than 50 mg per dose may increase the risk of hepatocellular injury; therefore, this regimen should be used only when the benefit of improved adherence outweighs 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 of two routes: intravenous or subcutaneous injection. 1. Test procedure 1) Challenge test by intravenous injection Draw 0.8 mg of naloxone into a sterile syringe. Inject 0.2 mg of naloxone and, with the needle 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 withdrawal symptoms for 20 minutes. 2) Challenge test by subcutaneous injection Inject 0.8 mg of naloxone subcutaneously and observe the patient's condition for withdrawal symptoms or signs for approximately 20 minutes. If none of the above symptoms or signs occur, initiate treatment with this medication. If they occur, delay treatment with this medication and repeat the naloxone challenge test after 24 hours.

This medication can cause damage to the liver, so the prescribed dosage must be strictly followed. Caution is needed as overdose may lead to liver function problems. Individuals with liver disease or compromised liver function must consult a doctor before using this medication. Patients currently taking opioid analgesics or with opioid dependence should not use this medication as it can trigger acute withdrawal symptoms. It is safer for pregnant or breastfeeding women, children and adolescents under 18 years of age, and the elderly not to use this medication. Since this medication blocks the action of opioids, it must be taken under the direction of a physician when used in conjunction with opioid medications, and arbitrarily taking excessive opioids is very dangerous. If abdominal pain, jaundice symptoms, or unusual reactions occur while taking this medication, consult a physician immediately. During the course of taking this medication, there may also be potential interactions with other drugs, so it is essential to inform the attending physician of all medications currently being taken. Additionally, this medication must be kept out of the reach of children and the prescribed method and dosage must be strictly adhered to.

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

This medication is sensitive to light and should be stored in a dark place, in a sealed container to prevent air exposure. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Light yellow round film-coated tablets

Package unit

30 tablets/bottle/CASE, 100 tablets/bottle/CASE