Journistar Sustained Release 32 mg (Hydromorphone Hydrochloride)

Adult dosage

As with other opioid analgesics, adequate assessment of the patient is important to ensure safe and effective administration of this medication for the treatment of pain. The patient's current medical condition, as well as the nature of the pain, affects dose selection. Because individual responses to opioid medications vary, it is recommended that all patients begin treatment with a conservative dose and that the dose be adjusted to an appropriate level based on adverse reactions and analgesic effect. The lowest effective dose should be administered for the shortest possible duration. Instruct patients to take this medication 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 medication must not be administered more than once every 24 hours. If a patient misses a dose at the scheduled time, they should take the next dose immediately and begin a new 24-hour dosing cycle. 1. Adult patients (18 years and older) currently receiving opioid analgesics on a regular basis It is recommended that this medication be administered once daily in the morning. For patients currently receiving opioid analgesics on a regular basis, the starting dose of this medication is based on the previous daily dose of the opioid medication, using standard equianalgesic ratios. For opioids other than morphine, first calculate the total daily dose converted to morphine, then use the table below to calculate the total daily dose of this medication. Conversion table: Multiplication factors for converting the daily dose of the previous opioid medication to the daily dose of this medication (daily mg of previous opioid medication x factor = daily mg of this medication) Previous opioid medication Previous oral opioid medication (factor) Morphine 0.2 Hydromorphone 1 Previous parenteral opioid medication (factor) Morphine 0.6 Hydromorphone 4 Because of individual patient variability and differences between formulations, there is no definitive conversion ratio that is satisfactory for all patients. Therefore, after starting treatment at the recommended starting dose of this medication, close patient monitoring and dose adjustment are recommended. As clinically necessary, round the dose down to the nearest multiple of 8 mg of this medication. All other opioid analgesics with effects lasting 24 hours should be discontinued when treatment with this medication is initiated. This medication may be used with usual doses of non-opioid analgesics. 2. Supplemental analgesics In addition to once-daily treatment with this medication, supplemental analgesics in an immediate-release formulation for controlling breakthrough pain (e.g., immediate-release hydromorphone) may be made available to all patients with chronic pain. For conversion, the conversion table should be used. For an individual patient, the dose of immediate-release hydromorphone used as a supplement should generally not exceed 10 % to 25 % of the 24-hour dose of this medication (see table below). Recommended starting 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 initiation of this medication, dose adjustment may be necessary to achieve an optimal balance between pain relief and opioid-related adverse reactions in the patient. If pain increases or analgesia is inadequate, a gradual increase in dose may be necessary. Increase the dose every 4 administrations and do not do so more frequently. For example, if the first dose is administered on Monday, the dose may be increased after the fourth administration, on Thursday. At each dose-adjustment step, consider increasing the dose by 25∼100 % of the current daily dose of this medication. Once the patient is stabilized on once-daily treatment with this medication, treatment may continue at that dose as long as pain relief is adequately 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 medication in patients who are physically dependent on opioids and receive this medication daily may cause withdrawal symptoms. In general, when opioid use must be discontinued, the dose should be reduced gradually. Serious withdrawal symptoms, uncontrolled pain, and suicide have been reported when patients with physical opioid dependence abruptly discontinue opioid analgesics. Therefore, if discontinuation of treatment with this medication is required, the patient should reduce the dose of this medication by 50 % every 2 days until the lowest possible dose at which treatment can be safely discontinued is reached. If withdrawal symptoms occur, stop the dose reduction and slightly increase the dose until the opioid withdrawal symptoms resolve. Then, either extend the intervals between dose reductions of this medication or resume dose reduction while switching to another opioid medication at an equianalgesic dose. 5. Patients with renal impairment For patients with moderate (creatinine clearance 40~60mL/min) and severe (creatinine clearance < 30mL/min) renal impairment, use 1/4 ~ 1/2 of the usual hydromorphone hydrochloride dose (see Precautions for Use, section 10. Administration to Patients with Renal Impairment). For patients with severe renal impairment, extending the dosing interval further should also be considered, and patients should be monitored for opioid-related adverse reactions during maintenance treatment.

This medication acts on the central nervous system, so taking it with alcohol or other central nervous system depressants greatly increases the risk of severe drowsiness or respiratory suppression. Therefore, when used with other sedatives or benzodiazepines, it should only be taken at minimal doses and for a short time under a doctor's instructions and careful monitoring for symptoms of respiratory distress or excessive drowsiness. This medication should never be administered to patients with certain conditions, such as those with increased intracranial pressure, severe respiratory distress, acute abdominal disease, severe liver dysfunction, pregnant women, or children and adolescents under 18. Additionally, special care should be taken when administering to the elderly, patients with reduced kidney function, those with hypothyroidism or adrenal insufficiency, and those with a history of seizures or alcohol dependence. Common side effects of this medication may include constipation, nausea, vomiting, drowsiness, dizziness, headache, sensory disturbances, tremors, lightheadedness, palpitations, flushing, shortness of breath, constipation, nausea, vomiting, diarrhea, dry mouth, abdominal pain, indigestion, intestinal gas, itching, sweating, rash, joint pain, weakness, swelling, fever, chest discomfort, weight loss, falls, bruises, dehydration, mood changes, and hallucinations. During treatment, patients should avoid driving or operating dangerous machinery, and it is advisable to maintain adequate hydration and use laxatives as needed to prevent constipation. Pregnant or nursing women should not use this medication, and breastfeeding should be discontinued if it is used. In case of overdose, severe respiratory depression and altered consciousness may occur, and immediate emergency treatment should be sought, including the possible administration of an antidote. This medication should be stored in a safe place out of reach of children and managed carefully to prevent misuse or accidental ingestion.

Enteritis, decreased appetite, insomnia, anxiety, depression, irritability, delusional state, abnormal dreams, decreased libido, drowsiness, dizziness, headache, sensory disturbances, tremors, vertigo, palpitation, flushing, dyspnea, constipation, nausea, vomiting, diarrhea, thirst, abdominal pain, dyspepsia, stomach gas retention, itching, excessive sweating, rash, joint pain, weakness, edema, fever, chest discomfort, weight loss, falls, bruising, dehydration, mood changes, hallucinations, sedation, sensory impairment, memory disturbances, blurred vision, hypertension, exacerbation of gastroesophageal reflux, back pain, muscle cramps, limb pain, myalgia, dysuria, pain, drug withdrawal syndrome, chills, sleep disorders, panic attacks, malaise, paranoia, euphoria, lethargy, aggression, taste disturbances, concentration difficulties, stuttering, syncope, altered consciousness, balance disorders, coordination abnormalities, hypersensitivity, myotonic dystrophy, movement disorders, crying, encephalopathy, psychomotor hyperactivity, cognitive impairment, seizures, paradoxical reactions, diplopia, dry eyes, miosis, tinnitus, tachycardia, extrasystoles, bradycardia, hypotension, runny nose, bronchial spasms, hypoxia, respiratory depression, hyperventilation, sneezing, dysphagia, blood in stool, abdominal distension, hemorrhoids, abnormal stools, bowel obstruction, diverticula, belching, gastrointestinal motility dysfunction, colonic perforation, anal fissure, bezoar, duodenitis, gastric reflux disorder, painful bowel movements, erythema, skin burning, urinary retention, polyuria, urinary hesitancy, urinary disorders, erectile dysfunction, sexual dysfunction, influenza-like symptoms, malaise, sensation of temperature change, abnormal feelings, anxiety, gait disturbance, hangover, feeling drunk, decreased blood potassium, increased liver enzymes, increased blood amylase, decreased blood testosterone, decreased body temperature, overdose, hypersensitivity reactions, angioedema, urticaria, sleep apnea syndrome, yawning, sneezing, tearing, sweating, nausea, pupil dilation, nonsensical speech, convulsions, tremors, pain in muscles and joints throughout the body, shortness of breath, palpitations, slow breathing, irregular breathing, apnea, coma, stupor, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, weakness, edema, cold, fever, malaise, chest discomfort, gait difficulty, influenza-like syndrome, pain, weight loss

This medication is sensitive to light; it should be kept in a container that does not let light in. Additionally, to maintain its effectiveness, it is important to store it at a cool temperature below 25 degrees Celsius.

Appearance

White, round, biconvex sustained-release tablet

Package unit

28 tablets (7 tablets * 4 PTP) / box