Hydromorphone

Registered South African indications:

• Pain  

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Hepatic impairment
• Respiratory depression 
• Coma 
• Acute abdomen 
• Paralytic ileus 
• Coadministration of monoamine oxidase inhibitors (or within 2 weeks of discontinuation of their use)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Elderly 
• Porphyria
• Debilitated patients
• Addiction history 
• Impaired pulmonary function 
• Head injury 
• Raised intracranial pressure 
• Convulsive disorders 
• Alcoholism 
• Toxic psychosis
• Delirium tremens
• Pancreatitis
• Hypothyroidism
• Hypotension 
• Hypovolaemia
• Adrenocortical insufficiency
• Prostatic hypertrophy
• Shock
• Post abdominal surgery 
• Chronic constipation  
• May impair ability to drive and operate machinery 

Forms avail. in SA and covered in this monograph: ER tab 

Chronic intractable pain (Opioid naive patients)

• Oral (ER tab): 4-8mg, dly; Titrate by 4-8mg at intervals of 2 days; Max initial dose: 8mg/24hrs

Chronic intractable pain (Opioid-tolerant patients)

• Oral (ER tab): Starting dose based on current opioid intake, using standard equianalgesic ratio (*see additional prescribing points for conversion table)

Dosing may be dependent on concomitant or previous use of other opioids or analgesics 

Consider equianalgaesic ratios/conversion guidelines when initiating therapy with a new agent 

Do not cut/crush/chew tablet

Not established for use in children below 18 years  

Pregnancy 

• Caution
• There are no well-controlled studies of hydromorphone in pregnant women
• Hydromorphone should not be used in pregnancy unless clearly necessary
• Hydromorphone is not recommended 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

Breastfeeding 

• Caution; not recommended
• Hydromorphone is excreted into breast milk in low amounts. Hydromorphone should not be used during breastfeeding
• Infants of breastfeeding women using opioids for postpartum pain or treatment of chronic maternal pain should be monitored for adverse events including drowsiness, sedation, limpness or feeding difficulties

Renal Impairment 

• Caution; dose adjustment recommended

Hepatic Impairment 

• Mild (Child-Pugh Class A): No dose adjustment recommended. Closely monitor liver function (LFT). Consider alternative analgesic for chronic pain management
• Moderate (Child-Pugh Class B): Start with an initial dose of 4mg/24 hrs dose. Reduce the daily recommended dose by 50%. Limit maximum daily intake to a maximum of 16mg/24 hrs in divided doses. If changes in ALT observed, discontinue
• Severe (Child-Pugh Class C): Contraindicated

Elderly 

• Caution; no dose adjustment recommended 
  Initiate at a low dose and titrate slowly to appropriate analgesic effects

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Confusional state
• Anxiety
• Insomnia
• Agitation
• Euphoric mood
• Hallucinations
• Depression
• Nightmares
• Drug dependence
• Dysphoria
• Dizziness
• Somnolence
• Headache
• Tremor
• Myoclonus
• Paraesthesia
• Sedation
• Lethargy
• Convulsions
• Dyskinesia
• Asthenia
• Hyperalgesia

Cardiovascular disorders

• Tachycardia
• Hypotension
• Flushing

Respiratory Disorders

• Dyspnoea
• Respiratory depression

Gastrointestinal Disorders

• Constipation
• Nausea and vomiting
• Dry mouth
• Abdominal pain
• Diarrhoea
• Dysgeusia
• Paralytic ileus

Hepatobiliary Disorders

•  Increased hepatic enzymes

Genitourinary Disorders 

• Urinary retention
• Erectile dysfunction

Endocrine and Metabolic Disorders

• Decreased appetite

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Hyperhidrosis
• Rash
• Urticaria

Immune and Lymphatic System Disorders

• Hypersensitivity reactions 
• Anaphylactic reactions

Sensory Disorders

• Visual impairment
• Miosis

Others

• Drug withdrawal syndrome

• Central nervous system depressants
• Monoamine oxidase inhibitors
• Alcohol
• Morphine agonist/ antagonists
• Muscle relaxants

None routine. Specific cases may require

• Respiratory depression
• Renal function
• Liver function

Conversion Table

Multiplication factors for converting the daily dose of prior opioids to the daily dose of hydromorphone ER 

Dosage (mg/day) prior opioid x factor = mg/day hydromorphone ER:

Dosages should be rounded down to the closest dose of hydromorphone available in 4mg increments.

Therapy discontinuation

Decrease the previous daily dose by 50% for 2 days, then decrease daily dose by 25% every 2 days

Similar in action to Morphine. Agonist of mu receptors.

Tablet XR 4mg

• Jurnista (Janssen) originator

Tablet XR 8mg

• Jurnista (Janssen) originator

Tablet XR 16mg

• Jurnista (Janssen) originator