Jurnista Extended Release 4 mg (Hydromorphone Hydrochloride)

Adult dosage

Do not administer this drug more than once every 24 hours. If a patient does not take this drug 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 regular opioid analgesics It is recommended that this drug be administered once daily in the morning. In patients currently receiving regular opioid analgesics, the starting dose of this drug is based on the previous daily opioid dose, using standard equianalgesic conversion 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 drug. Conversion table: Multiplication factors for converting the daily dose of an existing opioid to the daily dose of this drug (daily mg of existing opioid x factor = daily mg of this drug) Existing opioid / Existing oral opioid (factor) / Existing parenteral opioid (factor) Morphine / 0.2 / 0.6 Hydromorphone / 1 / 4 Round down to the nearest dose that is a multiple of 8 mg of this drug, as clinically needed. 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. Rescue analgesics In addition to once-daily treatment with this drug, a rescue analgesic in an immediate-release formulation (e.g., immediate-release hydromorphone) may be made available to all patients with chronic pain to control breakthrough pain. Use the conversion table when switching. In each individual, the dose of immediate-release hydromorphone as a rescue medication should generally not exceed 10 % to 25 % of the 24-hour dose of this drug (see table below). Recommended starting dose of rescue analgesic Daily dose (mg) / Strength of immediate-release hydromorphone tablet (mg) 4 / - 8 / 2 16 / 2 32 / 4 64 / 8 3. Individualization of dose and maintenance of treatment If pain worsens or analgesia is inadequate, gradual dose increases 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 dose, on Thursday. At each dose adjustment, consider increasing the dose by 25∼100 % of the patient's current daily dose of this drug. 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. 4. Discontinuation of treatment If discontinuation of treatment with this drug is required, reduce the dose 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 opioid withdrawal symptoms resolve. Then resume dose reduction with longer intervals between dose reductions or switch to another opioid at an equianalgesic dose while reducing the dose. 5. Patients with renal impairment In 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 (see Precautions for Use, section 10, Administration to Patients with Renal Impairment). In patients with severe renal impairment, further extension of the dosing interval should be considered, and the patient should be monitored for opioid-related adverse reactions during maintenance treatment.

This medication is an opioid analgesic that acts on the central nervous system, and caution is advised when used in combination with other central nervous system depressants or alcohol as it may lead to severe respiratory depression, coma, and even death. There are patients who should not take this medication. For example, it may be dangerous for patients who have allergies to this medication or its ingredients, patients with increased intracranial pressure, severe respiratory depression, chronic lung disease, ongoing asthma attacks, acute abdominal conditions, patients taking MAO inhibitors, pregnant or potentially pregnant women, and children and adolescents under 18 years of age. Elderly patients and those with impaired kidney function, hypothyroidism, adrenal insufficiency, or those in a state of central nervous system depression should be treated with greater caution, and dosage adjustments and monitoring of their condition are necessary. This medication may depress respiration; thus, patients with respiratory diseases must be particularly careful and should immediately inform medical personnel if they experience breathing difficulties or irregular breathing during use. This medication can cause various side effects, including constipation, nausea, vomiting, drowsiness, dizziness, headache, insomnia, anxiety, depression, itching, rash, and more. Consultation with a specialist is advised if symptoms are severe. Patients should avoid driving or operating hazardous machinery while taking this medication, and adequate hydration and the use of laxatives as needed are recommended to prevent constipation. This medication should not be used during pregnancy, and breastfeeding should be stopped if nursing. Furthermore, abrupt discontinuation of this medication can lead to withdrawal symptoms, so the dosage should be gradually reduced under the guidance of a physician. This medication may interact with other opioid analgesics, benzodiazepines, alcohol, muscle relaxants, etc., increasing the risk of side effects, so it's essential to inform medical personnel of any other medications being taken. In the case of overdose, serious symptoms such as respiratory depression, reduced consciousness, and hypotension may occur, necessitating immediate emergency treatment and possibly the administration of an antidote. Finally, keep this medication out of reach of children and take precautions to prevent misuse or accidental ingestion.

Colitis, decreased appetite, insomnia, anxiety, depression, nervousness, confusional state, abnormal dreams, decreased libido, drowsiness, dizziness, headache, paresthesia, tremor, vertigo, palpitations, flushing, dyspnea, constipation, nausea, vomiting, diarrhea, thirst, abdominal pain, dyspepsia, intestinal gas retention, itching, sweating, rash, arthralgia, asthenia, edema, fever, chest discomfort, weight loss, falls, contusions, dehydration, mood changes, hallucinations, sedation, sensory decline, memory impairment, blurred vision, hypertension, exacerbation of gastroesophageal reflux, back pain, muscle cramps, limb pain, myalgia, dysuria, pain, drug withdrawal syndrome, chills, sleep disturbances, panic attacks, discomfort, paranoia, euphoria, lethargy, aggression, dysgeusia, attention deficit, stuttering, syncope, altered consciousness, balance disorders, coordination abnormalities, hyperesthesia, myotonia, movement disorders, crying, encephalopathy, psychomotor hyperactivity, cognitive impairment, seizures, oculogyric crisis, diplopia, dry eyes, miosis, tinnitus, tachycardia, ectopic beats, bradycardia, hypotension, rhinorrhea, bronchospasm, hypoxia, respiratory depression, hyperventilation, sneezing, dysphagia, blood in stool, abdominal distension, hemorrhoids, abnormal stools, bowel obstruction, diverticulosis, belching, impaired gastrointestinal motility, bowel obstruction, colonic perforation, anal fissure, bezoar, duodenitis, gastric outlet obstruction, painful bowel movements, erythema, skin burning sensation, urinary retention, polyuria, hesitancy in urination, urinary disorders, erectile dysfunction, sexual dysfunction, influenza-like symptoms, malaise, feeling of temperature change, abnormal sensation, feeling anxious, gait disorders, hangover, feeling drunk, decreased serum potassium, increased liver enzymes, increased serum amylase, decreased serum testosterone, decreased body temperature, overdose, hypersensitivity, angioedema, urticaria, sleep apnea syndrome, yawning, sneezing, tearing, sweating, nausea, mydriasis, gibberish, convulsions, trembling, pain in muscles and joints throughout the body, respiratory distress, palpitations, unconsciousness, coma, skeletal muscle relaxation, cool skin, miosis, bradycardia, hypotension, apnea, cardiovascular collapse, cardiac arrest

This medication is sensitive to light; therefore, it should be stored in a light-resistant container. Furthermore, it is important to store it in a cool place, at a temperature below 25 degrees Celsius, to maintain its effectiveness.

Appearance

Light brown, round, bilayered, convex film-coated extended release tablet

Package unit

28 tablets (7 tablets * 4 PTP) / box