Journistar Extended-Release Tablet 16mg (Hydromorphone Hydrochloride)

Adult dosage

As with other opioid analgesics, adequate assessment of the patient is important to ensure safe and effective administration of this drug for pain management. The patient’s current medical condition, as well as the nature of the pain, affects dose selection. Because individual patients may respond differently to opioid medications, it is recommended that treatment be initiated at a conservative dose in all patients and that the dose be adjusted to an appropriate level based on adverse reactions and analgesic effect. This drug should be administered at the lowest effective dose for the shortest possible duration. Instruct patients to take this drug once daily at approximately the same time, swallowing the tablet whole with a glass of water without chewing, cutting, or crushing it. As with other potent opioid medications, appropriate prophylactic treatment for known adverse reactions (e.g., constipation) should be considered. This drug should not be administered more than once every 24 hours. If a patient misses a scheduled dose, they should take the next dose immediately and begin a new 24-hour dosing cycle. 1. Adult patients (18 years or older) currently receiving opioid analgesics on a regular basis It is recommended that this drug be administered once daily in the morning. For patients currently receiving opioid analgesics on a regular basis, the initial dose of this drug is based on the previous daily opioid dose, using standard equianalgesic ratios. For opioids other than morphine, first calculate the total daily dose in morphine equivalents, then use the table below to calculate the total daily dose of this drug. Conversion table: Multiplication factors for converting the daily dose of an existing opioid medication to the daily dose of this drug (daily mg of existing opioid medication x factor = daily mg of this drug) Existing opioid medication Oral existing opioid medication (factor) Parenteral existing opioid medication (factor) Morphine 0.2 0.6 Hydromorphone 1 4 Because of individual patient variability and differences between formulations, no definitive conversion ratio is satisfactory for all patients. Therefore, after starting treatment at the recommended initial dose of this drug, close patient monitoring and dose adjustment are recommended. Round down to the nearest dose that is a multiple of 8 mg of this drug, as clinically necessary. Other opioid analgesics that provide analgesia for 24 hours should be discontinued when treatment with this drug is initiated. This drug may be used with usual doses of non-opioid analgesics. 2. Supplemental analgesics In addition to once-daily treatment with this drug, supplemental analgesics in the form of immediate-release products (e.g., immediate-release hydromorphone) for control of breakthrough pain may be made available to all patients with chronic pain. Use the conversion table when converting. For an individual patient, the dose of immediate-release hydromorphone used as a supplemental analgesic should generally not exceed 10% to 25% of the 24-hour dose of this drug (see table below). Recommended initial doses of supplemental analgesics Daily dose (mg) / strength of immediate-release hydromorphone tablet (mg) 4 / - 8 / 2 16 / 2 32 / 4 64 / 8 3. Individualization of dosage and maintenance of treatment After initiating treatment with this drug, dose adjustment may be required to achieve the optimal balance between pain relief and opioid-related adverse reactions in the patient. If pain increases or analgesia is inadequate, gradual dose increases may be necessary. Increase the dose every 4 doses, and do not do so more frequently. For example, if the first dose is taken on Monday, the dose may be increased after the fourth dose on Thursday. At each dose-adjustment step, consider increasing the daily dose of this drug being taken by 25∼100 %. Once the patient is stabilized on once-daily treatment with this drug, treatment may be continued at that dose as long as adequate pain relief is maintained. The use of 24-hour opioid medications and changes in treatment should be appropriately reassessed periodically. 4. Discontinuation of treatment Abrupt discontinuation of treatment with this drug may cause withdrawal symptoms in patients who are physically dependent on opioids and receive this drug daily. In general, when opioid use must be discontinued, the dose should be tapered gradually. Serious withdrawal symptoms, uncontrolled pain, and suicide have been reported when patients physically dependent on opioids abruptly discontinue opioid analgesics. Therefore, if discontinuation of treatment with this drug is required, the patient should reduce the dose of this drug by 50 % every 2 days until reaching the lowest possible dose at which treatment can be safely discontinued. If withdrawal symptoms occur, discontinue the taper; the dose should be increased slightly until opioid withdrawal symptoms resolve. Then restart dose reduction with longer intervals between reductions of this drug, or while switching to another opioid medication at an equianalgesic dose. 5. Patients with renal impairment For patients with moderate (creatinine clearance 40~60mL/min) or severe (creatinine clearance < 30mL/min) renal impairment, use 1/4 ~ 1/2 of the usual hydromorphone hydrochloride dose (refer to Precautions for Use, section 10. Administration to Patients with Renal Impairment). For patients with severe renal impairment, further extension of the dosing interval should be considered, and patients should be monitored for opioid-related adverse reactions during maintenance treatment.

This medication is an opioid analgesic that acts on the central nervous system. Caution is required when taken with other central nervous system depressants or alcohol, as it may cause severe respiratory depression or decreased consciousness. It should not be used in patients with allergic reactions to this medication or with elevated intracranial pressure, severe dyspnea, asthma attacks, acute abdominal conditions, or other specific diseases. Elderly patients or those with poor kidney or liver function, hypothyroidism, or adrenal insufficiency should be particularly cautious when using this medication, and symptoms should be closely monitored. Various side effects such as drowsiness, dizziness, constipation, nausea, vomiting, skin rashes, and dyspnea may occur. If abnormal symptoms arise, consult medical staff immediately. This medication is not suitable for acute pain management and should be avoided before and after surgery or specific procedures. Care should be taken when driving or operating hazardous machinery, and these activities should be avoided during treatment. To prevent constipation, adequate hydration and the use of laxatives are recommended. The appearance of medication shells in stool may occur, but this only indicates that the medication has not fully dissolved. Due to the risk of drug dependence, do not suddenly decrease or discontinue the dose, and consult medical staff if withdrawal symptoms appear. This medication is not indicated for use in pregnant women or women who may become pregnant, or in children and adolescents under 18 years of age. During breastfeeding, the medication may be transmitted in breast milk, so breastfeeding should be discontinued. Patients with impaired kidney function should have their doses adjusted. In case of overdose, serious symptoms such as respiratory depression and decreased consciousness may occur, requiring immediate emergency care. This medication should be stored in a safe place out of the reach of children to prevent misuse and accidental ingestion.

Gastroenteritis, decreased appetite, insomnia, anxiety, depression, irritability, delirium, abnormal dreams, decreased libido, drowsiness, dizziness, headache, paresthesia, tremor, vertigo, palpitations, flushing, difficulty breathing, constipation, nausea, vomiting, diarrhea, thirst, abdominal pain, dyspepsia, intestinal gas retention, pruritus, hyperhidrosis, rash, arthralgia, weakness, edema, fever, chest discomfort, weight loss, falls, contusions, dehydration, mood changes, hallucinations, sedation, sensory impairment, memory disturbances, blurred vision, hypertension, worsening of gastroesophageal reflux, back pain, muscle cramps, limb pain, myalgia, dysuria, pain, drug withdrawal syndrome, chills, sleep disorders, panic attacks, discomfort, paranoia, intoxication, lethargy, aggression, taste disturbances, concentration difficulties, stuttering, syncope, altered consciousness, balance disorders, coordination disorders, sensory hyperesthesia, tonic-clonic muscle cramps, motor disturbances, crying, encephalopathy, psychomotor hyperactivity, cognitive impairment, seizures, visual disturbances, diplopia, dry eye, miosis, tinnitus, tachycardia, extrasystole, bradycardia, hypotension, rhinorrhea, bronchospasm, hypoxia, respiratory depression, hyperventilation, sneezing, dysphagia, hematochezia, abdominal distention, hemorrhoids, abnormal stools, bowel obstruction, diverticulum, belching, gastrointestinal motility disorders, bowel obstruction, colonic perforation, anal fissure, bezoars, duodenitis, gastric dumping syndrome, pain on defecation, erythema, burning sensation of the skin, urinary retention, frequency of urination, hesitancy in urination, urinary disorders, erectile dysfunction, sexual dysfunction, influenza-like symptoms, malaise, feeling of temperature changes, abnormal sensations, feeling anxious, gait disturbances, hangover, feeling drunk, decreased potassium in the blood, increased liver enzymes, increased serum amylase, decreased serum testosterone, decreased body temperature, overdose, hypersensitivity reactions, angioedema, urticaria, sleep apnea syndrome, yawning, sneezing, tearing, sweating, nausea, mydriasis, gibberish, convulsions, tremors, pain in muscles and joints throughout the body, breathlessness, palpitations, drug dependence, substance abuse, respiratory depression, coma, stupor, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, apnea, circulatory collapse, cardiac arrest, death, biliary colic, gallstone pain, eczema, urticaria, facial erythema, muscle spasms, swelling in joint areas, urgency, difficulty urinating, color change in urine, increased frequency of urination, abnormal urine odor, impotence, chills, chest discomfort, gait difficulties, influenza-like syndrome, amenorrhea

This medication is sensitive to light and should be stored in a dark container that prevents light from entering. Additionally, it is important to store it at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

Yellow, round, bilaterally convex extended-release tablet

Package unit

28 tablets (7 tablets * 4 PTP) / box