hydrocodone/pseudoephedrine (Rx)

Brand and Other Names:Rezira
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & 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

Safety and efficacy not established

Next:

Adverse 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
Previous
Next:

Warnings

Black Box Warnings

Concomitant use of opioids with benzodiazepines or other central nervous system (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

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
Previous
Next:

Pregnancy & 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.

Previous
Next:

Pharmacology

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%)

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.