hydromorphone and antispasmodics

N02AG04

Forms & Strengths

Fixed-dose combination products containing hydromorphone hydrochloride and various antispasmodic agents (e.g., belladonna alkaloids, hyoscyamine, or dicyclomine)
Oral tablets
Suppositories

Adult Dosing

Individualized titration based on severity of pain and antispasmodic requirement
Typically 1 tablet or suppository orally or rectally every 4 to 6 hours as needed for severe pain accompanied by smooth muscle spasm
Maximum daily dose limited by both the opioid component (risk of respiratory depression) and the antispasmodic component (anticholinergic toxicity)

Pediatric Dosing

Not recommended for pediatric use due to risks of potent opioid toxicity and severe anticholinergic adverse effects
Safety and efficacy in pediatric patients have not been established

Indications

Management of moderate to severe pain associated with painful visceral smooth muscle spasms where combination therapy is deemed appropriate

Mechanism of Action

Hydromorphone is a semi-synthetic mu-opioid receptor agonist that alters perception of and response to pain through central nervous system pathways
Antispasmodic agents exert direct relaxant effects on smooth muscle and/or anticholinergic (antimuscarinic) blockade to relieve gastrointestinal, biliary, or genitourinary spasms

Contraindications

Hypersensitivity to hydromorphone, belladonna alkaloids, or any component of the formulation
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or absence of resuscitative equipment
Known or suspected paralytic ileus or gastrointestinal obstruction
Narrow-angle glaucoma
Severe hepatic impairment
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days

Adverse Reactions

Respiratory depression
Central nervous system depression (sedation, dizziness, somnolence, confusion)
Anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, tachycardia, diminished sweating)
Nausea, vomiting, and abdominal distension
Orthostatic hypotension
Physical dependence, tolerance, and withdrawal syndrome with prolonged use

Drug Interactions

Central nervous system depressants (alcohol, benzodiazepines, other opioids, sedatives, hypnotics): profound sedation, respiratory depression, coma, and death
Anticholinergic drugs (antihistamines, tricyclic antidepressants, antipsychotics): additive anticholinergic toxicity resulting in severe constipation, paralytic ileus, or heat stroke
Mixed agonist-antagonist or partial agonist opioid analgesics (buprenorphine, pentazocine): may precipitate withdrawal or reduce analgesic efficacy
CYP3A4 inhibitors and inducers: potential alteration of hydromorphone metabolism

Curated Content: Needs Vetting Before Put to Clinical Use