Source: Marketing Authorisation Holder Revision Year: 2022
Hypersensitivity to hydromorphone or to any of the excipients listed in section 6.1.
Patients who have had surgical procedures and/or underlying disease that would result in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction.
The management of acute or post-operative pain.
Patients with severely decreased liver function.
Patients with respiratory insufficiency.
Patients with acute abdominal pain of unknown origin.
Patients with status asthmaticus.
Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see section 4.5).
Concomitant treatment with buprenorphine, nalbuphine or pentazocine (see section 4.5).
Patients in a coma state.
During labour and delivery.
Opioid analgesics, including hydromorphone, may cause severe hypotension in an individual whose ability to maintain blood pressure is compromised by a depleted blood volume or concomitant administration of medicinal products such as phenothiazines or general anaesthetics (see section 4.5).
JURNISTA should not be used in situations with risk of paralytic ileus. If during treatment, paralytic ileus is suspected, the treatment should be stopped.
In the case of planned chordotomy or other pain-relieving operations, patients should not be treated with JURNISTA within 24 hours after the operation. Thereafter, a new dose should be used in accordance with the changed need for pain relief if needed.
Respiratory depression is the most important hazard of opioid preparations but occurs most frequently in overdose situations, in the elderly, in the debilitated, and in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate doses may dangerously decrease respiration. JURNISTA, like all other opioids, should be used with extreme caution in patients having a substantially decreased respiratory reserve or pre-existing respiratory depression and in patients with chronic obstructive pulmonary disease. Severe pain antagonises the respiratory depressant effects of opioids. However, should pain suddenly subside, these effects may rapidly become manifest. Patients who are scheduled for regional anaesthetic procedures or other interruptions of pain transmission pathways should not receive JURNISTA within 24 hours of the procedure.
Concomitant use of alcohol and JURNISTA may increase the undesirable effects of JURNISTA; concomitant use should be avoided. The concomitant use of JURNISTA with CNS depressants, including benzodiazepines, alcohol and some narcotic drugs, may disproportionately increase the CNS depressant effects, such as profound sedation, respiratory depression, coma and death. If concomitant use of JURNISTA with a CNS depressant is clinically necessary, prescribe the lowest effective dosages and minimum duration for both drugs, and follow patients closely for signs of respiratory depression and sedation (see section 4.5).
The respiratory depressant effects of opioids with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury or raised intracranial pressure. Opioids produce effects which may obscure neurological signs of further ncreases in intracranial pressure in patients with head injuries. JURNISTA should only be administered under such circumstances when considered essential and then with extreme caution.
Like other opioids, hydromorphone causes a reduction in gastrointestinal motility associated with an increase in smooth muscle tone. Constipation is a frequent undesirable effect reported with the treatment with opioids. Patients should be advised on measures to prevent constipation and prophylactic laxative use should be considered. Extra caution should be used in patients with chronic constipation.
Clinical conditions or medicinal products that cause a sudden and significant shortening of gastrointestinal transit time may result in decreased hydromorphone absorption with JURNISTA and may potentially lead to withdrawal symptoms in patients with a physical dependence on opioids.
The administration of opioids may obscure the diagnosis or clinical course of acute abdominal conditions. Therefore it is important to make sure that the patient is not suffering from intestinal occlusion, especially of the ileus before initiation of treatment. Hydromorphone also can cause an increase in biliary tract pressure as a result of spasm in the sphincter of Oddi. Caution should therefore be exercised in the administration of JURNISTA to patients with inflammatory or obstructive bowel disorders, acute pancreatitis secondary to biliary tract disease and in patients about to undergo biliary surgery.
The JURNISTA tablet is non-deformable and does not appreciably change in shape in the gastrointestinal tract. There have been very rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of medicinal products in non-deformable controlledrelease formulations (see section 4.3).
Patients should be advised not to be alarmed if they notice what appears to be the JURNISTA tablet in their stools, as it is simply the non-dissolvable shell.
JURNISTA, like all opioid analgesics, should be administered with caution and in reduced dosages in patients with renal insufficiency or mild to moderate hepatic insufficiency, adrenocortical insufficiency, myxedema, hypothyroidism, prostatic hypertrophy or urethral stricture. Caution should also be exercised in the administration of JURNISTA to patients with central nervous system (CNS) depression, kyphoscoliosis, toxic psychosis, acute alcoholism, delirium tremens, or convulsive disorders.
Elderly patients are more prone to CNS adverse reactions (confusion) and gastrointestinal disturbances, and physiological reduction of renal function. Therefore, extra caution should be shown, and the initial dose should be reduced. Concomitant use of other medicinal products, especially tricyclic antidepressants, increases the risk of confusion and constipation. Diseases of the prostate gland and the urinary tract are often seen in the elderly. This contributes to the increased risk of urinary retention. The above considerations should stress the importance of caution rather than imply a restriction of the use of opioids in the elderly.
Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
In general, opioids should not be abruptly discontinued (see section 4.2).
JURNISTA should be used with caution in patients with alcoholism and other drug dependencies due to the increased frequency of opioid tolerance and psychological dependence observed in these patient populations. With abuse by parenteral routes, the tablet excipients may cause lethal complications.
With the continued use of opioids, including JURNISTA, the development of tolerance and physical dependence may be expected.
The deliberate abuse of JURNISTA may occur, as happens with other opioids, and is characterized by changes in behaviour, which are not seen in patients whose pain is treated appropriately with JURNISTA. The development of psychological dependence or an addictive effect is believed to occur only in individuals who may be predisposed in some way and is not a normal or expected response to the appropriate administration of opioids for pain management. However, even if a patient has misused opioids in the past, hydromorphone or other opioids could still be indicated in the treatment of severe pain in the patient. A requirement for an increase dose may be due to the underlying pathology and should be re-evaluated. In most cases the request reflects a real need for pain relief and should not be mistaken for inappropriate use of the medicinal product.
Even if the dose is high, an increase in dose does not reflect a development of tolerance.
Use of hydromorphone in connection with sport will imply disqualification. Hydromorphone may lead to a positive result during anti-doping checks.
Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
MAOIs may cause CNS excitation or depression, hypotension or hypertension if co-administered with opioids. JURNISTA is contraindicated for patients taking MAOIs (section 4.3).
The concomitant use of hydromorphone with morphine agonists/antagonists (buprenorphine, nalbuphine, pentazocine) could lead to a reduction of the analgesic effect by competitive blocking of receptors, thus leading to risk of withdrawal symptoms, therefore this combination is contraindicated (section 4.3).
Alcohol may enhance the pharmacodynamic effects of JURNISTA; concomitant use should be avoided. The concomitant use of JURNISTA with CNS depressants such as benzodiazepines and other hypnotics/sedatives, general anaesthetics, antipsychotics, and alcohol and some narcotic drugs may disproportionately increase the CNS depressant effects and respiratory depression. Additionally, hypotension and profound sedation, coma or death may occur. When this combination is indicated, the dose of one or both agents should be reduced.
JURNISTA like other opioids may enhance the neuromuscular blocking action of muscle relaxants and cause an increased degree of respiratory depression.
No clinical data on exposed pregnancies are available. While animal studies (see section 5.3) have revealed no teratogenic effects, reproductive toxicity has been observed. Hydromorphone has been shown to cross the placental barrier in experimental animals. The potential risk for humans from use of opiates during pregnancy is unknown.
JURNISTA should not be used during pregnancy and labour due to impaired uterine contractility and the risk of neonatal respiratory depression. Prolonged use of hydromorphone during pregnancy can result in neonatal withdrawal syndrome.
Low concentrations of hydromorphone and other opioid analgesics have been detected in human milk in clinical studies. Preclinical studies have shown that hydromorphone can be detected in milk of lactating rats. JURNISTA should not be used during breastfeeding.
The effect of hydromorphone on human fertility has not been evaluated.
JURNISTA can have a major influence on the ability to drive and use machines. This is particularly likely at the start of therapy, following an increase in dose or change of preparation.
In clinical trials with JURNISTA (n=2340), the most frequently reported adverse reactions were constipation (32%), nausea (29%), and vomiting (14%). They can usually be managed by dose reduction, laxatives (see sections 4.2 and 4.4) or antiemetics, as appropriate. Somnolence, dizziness, headache and asthenia were reported in between 11% and 16% of patients.
Respiratory depression was reported in approximately 0.1% of patients.
The table below shows the adverse reactions observed during clinical trials and postmarketing experience with JURNISTA.
| System Organ Class | Adverse Reaction | ||||
|---|---|---|---|---|---|
| Frequency | |||||
| Very Common (1/10) | Common (1/100 to <1/10) | Uncommon (1/1000 to <1/100) | Rare ( 1/10,000 to <1/1000) | Very Rare (<1/10,000) | |
| Infections and infestations | Gastroenteritis | Diverticulitis | |||
| Immune system disorders | Hypersensitivity | ||||
| Endocrine disorders | Hypogonadism | ||||
| Metabolism and nutrition disorders | Dehydration, Decreased appetite | Fluid retention, Increased appetite | Hyperuricaemia | ||
| Psychiatric disorders | Hallucination, Confusional state, Depression, Anxiety, Mood altered, Nervousness, Restlessness, Insomnia, Abnormal dreams | Panic attack, Paranoia, Listless, Dysphoria, Euphoric mood, Libido decreased, Sleep disorder | Aggression | ||
| Nervous system disorders | Somnolence, Dizziness, Headache | Sedation, Memory impairment, Tremor, Paraesthesia, Hypoaesthesia | Encephalopath,y Depressed level of consciousness, Syncope, Balance disorder, Disturbance in attention, Dyskinesia, Dysarthria, Hyperaesthesia, Coordination abnormal, Myoclonus, Crying, Dysgeusia | Convulsion, Psychomotor hyperactivity, Cognitive disorder, Hyperreflexia | |
| Eye disorders | Vision blurred | Diplopia, Dry eye | Miosis | ||
| Ear and labyrinth disorders | Vertigo | Tinnitus | |||
| Cardiac disorders | Tachycardia, Extrasystoles, Palpitations | Bradycardia | |||
| Vascular disorders | Hypertension, Flushing | Hypotension | |||
| Respiratory, thoracic and mediastinal disorders | Dyspnoea | Respiratory depression, Respiratory distress, Bronchospasm, Hypoxia, Rhinorrhoea | Hyperventilation, Sneezing | ||
| Gastrointestinal disorders | Constipation, Nausea, Vomiting | Diarrhoea, Abdominal pain, Dyspepsia, Oesophageal reflux aggravated, Dry mouth | Diverticulum, Intestinal obstruction, Gastrointestinal motility disorder, Abdominal distension, Dysphagia, Haemorrhoids, Haematochezia, Abnormal faeces, Flatulence, Eructation | Large intestine perforation, Ileus, Anal fissure, Impaired gastric emptying, Duodenitis, Painful defaecation, Bezoar | |
| Skin and subcutaneous tissue disorders | Hyperhidrosis, Pruritus, Rash | Angioedema, Urticaria, Erythema | Skin burning sensation | ||
| Musculoskeletal and connective tissue disorders | Arthralgia, Myalgia, Back pain, Pain in extremity, Muscle spasms | ||||
| Renal and urinary disorders | Dysuria | Urinary retention, Urinary hesitation, Pollakiuria, Micturition disorder | |||
| Reproductive system and breast disorders | Erectile dysfunction, Sexual dysfunction | ||||
| General disorders and administration site conditions | Asthenia | Drug withdrawal syndrome, Oedema, Pyrexia, Chills, Chest discomfort, Pain | Influenza-like illness, Gait disturbance, Feeling jittery, Feeling abnormal, Malaise, Feeling of body temperature change | Feeling drunk ,Hangover | |
| Investigations | Weight decreased | Blood potassium decreased, Hepatic enzyme increased | Blood amylase increased, Body temperature decreased, Blood testosterone decreased | ||
| Injury, poisoning and procedural complications | Fall, Contusion | Overdose | |||
The following additional adverse reactions have been reported with other hydromorphone hydrochloride formulations: dependence, drug tolerance and biliary colic. The following terms of unknown frequencies have been reported in the literature: respiratory failure, delirium and amenorrhoea.
Respiratory depression may be more likely in certain subgroups of patients (see section 4.4).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Not applicable.
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