Adult: Initial dosages are individualised based on severity of pain, prior analgesic use and risk factors for addiction, abuse, or misuse. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Opioid-naive or opioid non-tolerant patients: As hydrocodone bitartrate extended-release cap: Usual initial dose: 10 mg bid (every 12 hours). Dose can be adjusted in increments of 10 mg bid every 3-7 days. Max: 80 mg daily (only for patients with established opioid tolerance). As hydrocodone bitartrate extended-release tab: 20 mg once daily (every 24 hours). Dose may be adjusted in increments of 10-20 mg every 3-5 days. Max: 80 mg daily (only for patients with established opioid tolerance). Opioid-resistant patients: Initial daily dose is based on the daily opioid requirement; for conversion, initial daily dose should be based on the guide that 10 mg of hydrocodone is equivalent to approx 15 mg of oral morphine. Refer to individual product for detailed guidelines. Elderly: Initiate at the lower end of dosing range, with careful titration.
As extended-release cap: Initiate at a low dose. As extended-release tab: Moderate to severe and ESRD: Reduce initial dose by 50%, with careful titration.
Severe: As extended-release cap: Initiate at 10 mg 12 hourly, with careful titration. As extended-release tab: Reduce initial dose by 50%, with careful titration.
Significant respiratory depression, acute or severe bronchial asthma (in unmonitored setting), known or suspected gastrointestinal obstruction (e.g. paralytic ileus). Children <18 years.
Patient with heart failure, electrolyte abnormalities, bradyarrhythmias, hypovolaemia, CV disease (e.g. MI), impaired consciousness or coma, delirium tremens, thyroid dysfunction, adrenocortical insufficiency (e.g. Addison's disease), prostatic hypertrophy, urethral stricture, head injury, intracranial lesions, increased intracranial pressure, history of seizure disorder, mental health conditions (e.g. anxiety), toxic psychosis, acute abdominal conditions, biliary tract dysfunction, acute pancreatitis, morbid obesity, COPD or cor pulmonale, risk factors for sleep-disordered breathing. Avoid abrupt withdrawal. Moderate to severe renal or severe hepatic impairment. Pregnancy (prolonged use may result in neonatal opioid withdrawal syndrome) and lactation.
Significant: QT prolongation, constipation, severe hypotension (including orthostatic hypotension, syncope), sedation. Cardiac disorders: Hypertension. Gastrointestinal disorders: Nausea, vomiting, dyspepsia, gastroenteritis, upper abdominal pain, diarrhoea, abdominal pain, decreased appetite, xerostomia, abdominal distress, GERD. General disorders and administration site conditions: Fever, fatigue. Investigations: Increased gamma-glutamyl transferase, increased cholesterol. Metabolism and nutrition disorders: Dehydration, hypokalaemia, increased appetite Musculoskeletal and connective tissue disorders: Back pain, muscle spasm, tremor, arthralgia, bone fracture, injury to the joint, joint sprain, limb pain, musculoskeletal pain, myalgia, neck pain, osteoarthritis, chills. Nervous system disorders: Dizziness, headache, chills, migraine, paresthesia. Psychiatric disorders: Euphoria, dysphoria, anxiety, insomnia, depression. Renal and urinary disorders: UTI. Respiratory, thoracic and mediastinal disorders: Bronchitis, nasal congestion, nasopharyngitis, oropharyngeal pain, sinusitis, upper respiratory tract infection, cough, dyspnoea. Skin and subcutaneous tissue disorders: Rash, pruritus, hyperhidrosis, night sweats. Vascular disorders: Hot flush. Potentially Fatal: Respiratory depression.
PO: C (Prolonged use may cause neonatal opioid withdrawal syndrome.)
Patient Counseling Information
This drug may impair mental and physical abilities, if affected, do not drive or operate machinery.
Monitor pain relief, respiratory and mental status, BP; signs of misuse, abuse, and addiction; signs or symptoms of hypogonadism or hypoadrenalism.
Symptoms: Respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils; pulmonary oedema, bradycardia, hypotension, or complete airway obstruction may occur. Management: Re-establish patient airway with controlled ventilation. Employ supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary oedema. Cardiac arrest or arrhythmias will require advanced life support techniques. May administer naloxone HCl or nalmefene as antidote to respiratory depression.
Concurrent use with anticholinergic agents may increase risk of urinary retention which may lead to paralytic ileus. Strong laxatives (e.g. lactulose) may decrease absorption and plasma concentration of hydrocodone. Decreased efficacy with CYP3A4 inducers. Risk of serotonin syndrome with serotonergic drugs (e.g. TCAs, SSRIs, MAOIs). Reduced analgesic effect with mixed agonist/antagonist (e.g. nalbuphine) or partial agonist (e.g. buprenorphine) analgesics, may precipitate withdrawal symptoms. May enhance the neuromuscular blocking effect of skeletal muscle relaxants. May reduce the efficacy of diuretics.
Potentially Fatal: Additive pharmacologic effect with benzodiazepines or other CNS depressants, which may result to respiratory depression, profound sedation, or coma. Concomitant use with CYP3A4 inhibitors may lead to fatal overdose.
Ethanol increases plasma levels of hydrocodone which may result to fatal overdose.
Description: Hydrocodone is a phenanthrene derivative opiate agonist that binds to opioid receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain. Pharmacokinetics: Absorption: Time to peak plasma concentration: 5 hours (extended-release cap); 6-30 hours (extended-release tab). Distribution: Crosses the placenta and enters breast milk. Volume of distribution: Approx 1,300-1,400 L. Plasma protein binding: 36%. Metabolism: Undergoes hepatic metabolism via O-demethylation by CYP2D6 isoenzyme to hydromorphone (active metabolite) and N-demethylation by CYP3A4 isoenzyme to norhydrocodone (major metabolite). Excretion: Via urine (26%, with approx 12% as unchanged drug, 5% as norhydrocodone, 4% as conjugated hydrocodone, 3% as 6-hydrocodol, and 0.21% as conjugated 6-hydromorphol). Elimination half-life: Approx. 7-9 hours (extended-release).
R05DA03 - hydrocodone ; Belongs to the class of opium alkaloids and derivatives. Used as cough suppressant.
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