hydrocodone/pseudoephedrine (Rx)

Frequency Not Defined

Hydrocodone

• Bradycardia, anticholinergic effects (dry mouth, palpitation, tachycardia)
• Angina, arrhythmias, cardiac arrest, myocardial infarction, QT-interval prolongation, pectoris, syncope, severe cardiac ST segment elevation, ventricular tachycardia
• Agitation, coma, dizziness, mental clouding/depression, dysphoria, euphoria, faintness, restlessness, nervousness, weakness, sedation, seizures, visual disturbances
• Flushing, sweating, pruritus, urticaria, warmness of the face/neck/upper thorax
• Constipation, nausea, vomiting
• Urinary retention, oliguria
• Respiratory/circulatory depression, respiratory arrest, shock, cardiac arrest

Pseudoephedrine

• CNS (tremor, restlessness, etc)
• Insomnia
• Nausea
• Vomiting

Contraindications

Hydrocodone

• Absolute: acute abdominal condition, diarrhea associated with toxins, paralytic ileus, pseudomembranous colitis, respiratory depression
• Relative: asthma (acute), cardiac arrhythmia, cardiac disease, congestive heart failure, coronary artery DX, bladder outlet obstruction, GI tract obstruction, glaucoma (open & closed), hemorrhage, hiatal hernia, inflammatory bowel disease, intestinal atony, mitral valve stenosis, myasthenia gravis, obstructive uropathy, prostatic hypertrophy, reflux esophagitis, respiratory impairment, tachycardia, ulcerative colitis, urinary retention

Pseudoephedrine

• Hypsesensitivity
• Severe HTN, severe CAD
• Nonselective MAO inhibitors: risk of hypertensive reaction
• Newborns, preemies

Cautions

Hydrocodone

• Concomitant use of opioids with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol
• Concomitant use of opioid analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone
• May cause CNS depression, which may impair physical and mental abilities; use caution when performing tasks that require mental alertness
• Use caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists including codeine, hydromorphone, morphine, oxymorphone, oxycodone, and levorphanol
• May cause dose-related respiratory depression (risk increased in children, elderly, patients with pulmonary disease, and when used postoperatively
• Patients with genetic variations of CYP2D6, including poor metabolizers or extensive metabolizers, may have decreased or increased hydromorphone formation
• Identify underlying cause of cough before prescribing for cough
• Use caution in autonomic neuropathy, brain damage in children, cardiac arrhythmias, chronic lung disease, Down Syndrome, drug abuse/dependence, emotional liability, gallbladder disease, head injury, hepatic impairment, hypertension, hyperthyroidism, increased intracranial pressure, renal impairment, seizures with epilepsy, spastic paralysis in children, toxemia of pregnancy, urethral stricture, urinary tract surgery, xerostomia
• Use caution in patients with ischemic heart disease (contraindicated in severe disease), acute abdominal conditions (may obscure diagnosis or clinical course), diabetes mellitus increased intraocular pressure, prostatic hyperplasia and/or GU obstruction, pulmonary disease, adrenal insufficiency, including Addison’s disease, and debilitated patients (greater potential for respiratory depression and therapeutic dosages)

Pseudophedrine

• Mild-mod HTN, cardiac disease, hyperthyroidism, hyperglycemia, BPH, DM, glaucoma
• Many combo formulations are switching to phenylephrine due to restrictions arising from easy conversion to methamphetamine (The Combat Methamphetamine Epidemic Act of 2005 bans OTC sales of cold medicines that contain ingredients commonly used to make methamphetamine such as pseudoephedrine)
• Lactation

Pregnancy category: C

Lactation: enters breast milk; contraindicated

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Hydrocodone: Antitussive; narcotic agonist analgesic

Pseudoephedrine: Decongestant; alpha adrenergic agonist

Hydrocodone

Half-life: 3.3-4.4 hr

Duration: 4-8 hr

Peak PlasmaTime: 1.3 hr

Metabolism: liver (O-demethylation, N-demethylation, 6-keto reduction); hepatic P450 enzyme CYP2D6

Excretion: urine (mainly)

Pseudoephedrine

Half-Life: 3 hr (children); 9-16 hr (adults)

Onset: 30 min (decongestant)

Duration: 3-8 hr

Peak PlasmaTime: 1.97 hr

Concentration: 422 ng/mL

Metabolism: liver, by N-demethylation

Metabolites: Inactive

Clearance: 7.3-7.6 mL/min/kg

Excretion: Urine (43-96%)