hydrocodone/pseudoephedrine/guaifenesin (Rx)

Brand and Other Names:Hycofenix
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

hydrocodone/pseudoephedrine/gauifenesin

oral solution: Schedule III

  • (2.5mg/30mg/200mg)/5mL
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Cough with Congestion

Temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions when these conditions are complicated by tenacious mucus or mucus plugs and congestion

10 mL PO q4-6hr; not to exceed 4 doses (40 mL) per 24 hr

<18 years: Safety and efficacy not established

Use of hydrocodone in children aged <6 years is associated with fatal respiratory depression

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Adverse Effects

Frequency Not Defined

Hydrocodone

  • Respiratory depression
  • Drug dependence
  • Increased intracranial pressure
  • Decreased mental alertness with impaired mental and/or physical abilities
  • Paralytic ileus

Pseudoephedrine

  • CNS effects (eg, insomnia, dizziness, weakness, tremor, or convulsions)
  • Cardiovascular system effects (eg, arrhythmias, or increased blood pressure), cardiovascular collapse with accompanying hypotension
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Warnings

Contraindications

Documented hypersensitivity

Patients receiving MAOI therapy or within 14 days of stopping such therapy

Narrow angle glaucoma

Urinary retention

Severe hypertension

Severe coronary artery disease

Cautions

Hydrocodone produces dose-related respiratory depression by directly acting on brain stem respiratory centers

Hydrocodone can produce drug dependence and tolerance may develop upon repeated administration; prescribe with same degree of caution as use of other opioid drugs

Respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure

Hydrocodone may produce marked drowsiness and impair mental and physical abilities required for hazardous activities (eg, driving); concurrent use with alcohol or other CNS depressants should be avoided

Caution in patients with acute abdominal conditions; hydrocodone may obscure the diagnosis or clinical course of acute abdominal illness

Concurrent use of anticholinergics with hydrocodone may cause paralytic ileus

Use of MAOIs or TCAs with hydrocodone may increase the effect of either the antidepressant or hydrocodone; do not use with MAOIs or within 14 days of stopping an MAOI

Pseudoephedrine can produce cardiovascular and CNS effects in some patients (eg, insomnia, dizziness, weakness, tremor, or arrhythmias); CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension has also been reported

Do not for persistent or chronic cough (eg, associated with smoking, asthma, chronic bronchitis, or emphysema), or where cough is accompanied by excessive phlegm

Measure dose with accurate milliliter measuring device to avoid overdose

Caution with diabetes, thyroid disease, Addison disease, prostatic hypertrophy, urethral stricture, and asthma

Caution with severe renal or hepatic impairment

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Pregnancy & Lactation

Pregnancy

Pregnancy category: C

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent; the withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever; the intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose

As with all opioids, administration to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used

Lactation

Caution; hydrocodone and pseudoephedrine are known to be excreted in human milk; no studies have been performed to determine if guaifenesin is excreted into breastmilk

The potential for serious adverse reactions in nursing infants from hydrocodone exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

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.

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Pharmacology

Mechanism of Action

Hydrocodone: Antitussive; narcotic agonist analgesic

Pseudoephedrine: Decongestant; alpha adrenergic agonist

Guaifenesin: Reduces viscosity of secretions by increasing amount of respiratory tract fluid

Pharmacokinetics

Hydrocodone

  • Half-life: 3.3-4.4 hr
  • Duration: 4-8 hr
  • Peak plasma time: 1.3 hr
  • Concentration: 23.6 ng/mL
  • 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 plasma time: 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%)

Guaifenesin

  • Half-Life: 1 hr
  • Onset: 30 min
  • Duration: 4-6 hr
  • Metabolism: liver
  • Metabolite: b-(2-methoxyphenoxy) lactic acid
  • Excretion: Urine
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Administration

Instructions

Measure dose with accurate milliliter measuring device to prevent overdose (ie, household teaspoon is not an accurate measuring device)

Administer with food if GI upset occurs

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Images

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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.

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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.
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