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hydrocodone/guaifenesin (Rx)Brand and Other Names:Obredon, Flowtuss

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral solution: Schedule II

  • (2.5mg/200mg)/5mL
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Cough

Indicated for symptomatic relief of cough and to loosen mucus associated with the common cold/flu

10 mL (ie, 5mg hydrocodone/400 mg guaifenesin) PO q4-6hr; not to exceed 6 doses (60 mL) in 24 hr

<18 years: Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Common

  • Central nervous system: Headache, dizziness, sedation (somnolence)
  • Gastrointestinal system: Nausea, diarrhea
  • Cardiovascular system: Decreased blood pressure
  • Vascular system: hot flush

Other

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

Contraindications

Known hypersensitivity to hydrocodone bitartrate, guaifenesin, or the inactive ingredients

Coadministration with MAOI therapy or within 14 days of stopping MAOIs

Cautions

Hydrocodone may cause dose-related respiratory depression by directly acting on brain stem respiratory center; use with caution and keep out of reach of children

The 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 ICP

Hydrocodone can produce drug dependence and has the potential for abuse

May produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks; avoid concurrent use with alcohol or other CNS depressants because of additional impairment

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

Concurrent use of anticholinergics with hydrocodone may produce paralytic ileus

Coadministration with MAOIs or tricyclic antidepressants one may increase the effect of either the antidepressant or hydrocodone (also see Contraindications)

Not be used for a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm requiring expectoration

Caution in patients with diabetes, thyroid disease, Addison disease, prostatic hypertrophy, urethral stricture, or asthma

Caution in patients with severe renal or hepatic impairment

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Pregnancy & Lactation

Pregnancy Category: C; use in mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used

Lactation: Hydrocodone is known to be distributed in human breast milk; 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: Centrally-acting opioid antitussive

Guaifenesin: Elicits expectorant action that promotes or facilitates the removal of secretions from the respiratory tract

Pharmacokinetics

Hydrocodone

  • Half-life: 5 hr
  • Peak plasma time: 1.25 hr
  • Peak plasma concentration: 12.6 ng/mL
  • AUC: 80.9 ng•hr/mL

Guaifenesin

  • Half-life: 20 minutes
  • Peak plasma time: 1.25 hr
  • Peak plasma concentration: 3.7 mcg/mL
  • AUC: 4.2 mcg•hr/mL
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Administration

Instructions

May take with or without food

Measure dose with accurate milliliter measuring device

Do not use a household teaspoon to measure the dose

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Images

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Formulary

FormularyPatient Discounts

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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