Dosing and uses of Rezira (hydrocodone/pseudoephedrine)
Adult dosage forms and strengths
hydrocodone/pseudoephedrine
oral liquid: Schedule II
- (5mg/60mg)/5mL
Cough/Cold/Allergies
5 mL q4-6hr prn; not to exceed 4 doses (20 mL) in 24 hr
Pediatric dosage forms and strengths
Safety and efficacy not established
Rezira (hydrocodone/pseudoephedrine) adverse (side) effects
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
Warnings
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
- 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
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 and 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.
Pharmacology of Rezira (hydrocodone/pseudoephedrine)
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%)
