Dosing & Uses
Dosage Forms & Strengths
oral solution: Schedule II
Indicated for relief of cough and nasal congestion associated with common cold or allergies in adults
5 mL PO q4-6hr PRN; not to exceed 4 doses (20 mL) in 24 hr
Renal & Hepatic Impairment
Severe renal or hepatic Impairment: Use with caution
Safety and efficacy not established
Caution advised because of greater potential for renal or hepatic impairment
Consider decreasing dose and/or frequency
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
Hydrocodone, an opioid, may result in respiratory depression, drug dependence, increased ICP, decreased mental alertness, or paralytic ileus
Pseudoephedrine, a sympathomimetic, may result in CNS effects (eg, insomnia, dizziness, weakness, tremor, convulsions or cardiovascular effects (eg, arrhythmias, increased blood pressure)
Chlorpheniramine, an antihistamine, may result in decreased mental alertness or anticholinergic effects (urinary retention, ileus)
Common adverse effects include sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, or sleeplessness; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, restlessness, insomnia, irritability, and tremor
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
Coadministration with MAOIs or within 14 ays of discontinuing MAOIs; may increase risk of hypertensive crisis
Narrow angle glaucoma
Severe hypertension or severe coronary artery disease
May cause dose-related respiratory depression; use with caution
Hydrocodone can cause drug dependence; prescribe with caution that is appropriate to the use of other opioids
Avoid use in patients with head injury or elevated ICP; opioids decrease respiratory depression and may increase ICP
May cause drowsiness; avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery
Elicits CNS depressant effects; avoid concurrent use of alcohol or other central nervous system depressants
Use with caution with acute abdominal conditions; opioids may obscure diagnosis and anticholinergics may increase risk of paralytic ileus
Coexisting conditions: Use with caution with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy or urethral stricture, or asthma
Use with TCAs may increase effects of hydrocodone or TCAs
Pseudoephedrine component may increase risk for hypertension
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone; because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Hydrocodone, chlorpheniramine, and pseudoephedrine are distributed in breast milk; caution advised, chlorpheniramine may suppress lactation is used prior to nursing
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: Antitussive; narcotic agonist analgesic
Chlorpheniramine: Antihistamine; histamine H1-receptor antagonist; also elicits anticholinergic effects
Pseudoephedrine: Decongestant; alpha adrenergic agonist
Peak Plasma Time
- Hydrocodone: 1.4 hr
- Chlorpheniramine: 2-3 hr
- Pseudoephedrine: 1.97 hr
Peak Plasma Concentration
- Hydrocodone: 10.6 ng/mL
- Chlorpheniramine: 7.2 ng/mL
- Pseudoephedrine: 212 ng/mL
- Chlorpheniramine: 4-7 L/kg (children); 6-12 L/kg (adults)
- Pseudoephedrine: 2.5 L/kg (children); 2.64-3.51 L/kg
Hydrocodone: Metabolized to hydromorphone via CYP2D6
Chlorpheniramine: GI mucosa, liver
Pseudoephedrine: Liver, by N-demethylation
- Hydrocodone: Urine (26%)
- Chlorpheniramine: Urine
- Pseudoephedrine: Urine (43-96%)
- Hydrocodone: 3.3-4.4 hr
- Chlorpheniramine: 10-13 hr (children); 14-24 hr (adults)
- Pseudoephedrine: 3 hr (children); 9-16 hr (adults)
Hydrocodone is metabolized to hydromorphone via CYP2D6; CYP2D6 poor metabolizers may not achieve adequate analgesia
Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion
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.