Dosing & Uses
Dosage Forms & Strengths
oral solution: Schedule II
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
Frequency Not Defined
- Central nervous system: Headache, dizziness, sedation (somnolence)
- Gastrointestinal system: Nausea, diarrhea
- Cardiovascular system: Decreased blood pressure
- Vascular system: hot flush
- Respiratory depression
- Drug dependence
- Increased intracranial pressure
- Decreased mental alertness with impaired mental and/or physical abilities
- Paralytic ileus
Known hypersensitivity to hydrocodone bitartrate, guaifenesin, or the inactive ingredients
Coadministration with MAOI therapy or within 14 days of stopping MAOIs
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
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
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: Centrally-acting opioid antitussive
Guaifenesin: Elicits expectorant action that promotes or facilitates the removal of secretions from the respiratory tract
- Half-life: 5 hr
- Peak plasma time: 1.25 hr
- Peak plasma concentration: 12.6 ng/mL
- AUC: 80.9 ng•hr/mL
- Half-life: 20 minutes
- Peak plasma time: 1.25 hr
- Peak plasma concentration: 3.7 mcg/mL
- AUC: 4.2 mcg•hr/mL
May take with or without food
Measure dose with accurate milliliter measuring device
Do not use a household teaspoon to measure the dose
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.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.