HYCOFENIX® (hydrocodone bitartrate, pseudoephedrine hydrochloride, and guaifenesin) oral solution, CII is a combination of hydrocodone, an opioid antitussive, pseudoephedrine, a nasal decongestant, and guaifenesin, an expectorant indicated for the symptomatic relief of cough, nasal congestion, and to loosen mucus associated with the common cold.
Important Limitations of Use: Not indicated for pediatric patients under 18 years of age.
Important Safety Information
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
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.
See full prescribing information for complete boxed warning.
HYCOFENIX is contraindicated in patients:
- With a known hypersensitivity to hydrocodone bitartrate, pseudoephedrine hydrochloride, guaifenesin, or any of the inactive ingredients of HYCOFENIX.
- Receiving a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI.
- With narrow angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease.
WARNINGS AND PRECAUTIONS:
- Risks from Concomitant Use with Benzodiazepines or other CNS Depressants: Concomitant use with benzodiazepines or other CNS drugs, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking these medications. Concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. It is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol. Advise patients and caregivers about these risks.
- Respiratory Depression: Dose-related respiratory depression can occur, so use with caution. Hydrocodone overdose in adults and use in children under 6 has been associated with fatal respiratory depression. Respiratory depression can be antagonized by naloxone hydrochloride and supportive measures.
- Drug Dependence: HYCOFENIX is a Schedule II controlled substance and has the potential for being abused. Drug dependence (psychic dependence, physical dependence, and tolerance) may develop upon repeated administration. Prescribe opioids with caution.
- Head Injury and Increased Intracranial Pressure: 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 pre-existing increase in intracranial pressure. Opioids may obscure the clinical course of patients with head injuries. Avoid HYCOFENIX use in these patients.
- Activities Requiring Mental Alertness: Hydrocodone can produce marked drowsiness and impair driving or operating machinery. Advise patients not to engage in hazardous activities requiring alertness or coordination.
- Acute Abdominal Conditions: Use HYCOFENIX with caution in patients with acute abdominal conditions as it may obscure the diagnosis or clinical course.
- Co-administration with Anticholinergics: The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Use with caution.
- Co-administration with Monoamine Oxidase Inhibitors (MAOIs) or Tricyclic Antidepressants: HYCOFENIX should not be used in patients receiving MAOIs or within 14 days of stopping such therapy. Co-administration of MAOIs or tricyclic antidepressants and hydrocodone may cause additive CNS effects. An increase in blood pressure or hypertensive crisis can occur.
- Cardiovascular and Central Nervous System Effects: HYCOFENIX contains pseudoephedrine hydrochloride which can produce cardiovascular and central nervous system effects such as insomnia, dizziness, weakness, tremor, and arrhythmias. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. HYCOFENIX should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or coronary artery disease.
- Persistent Cough: HYCOFENIX should not be used in patients with persistent or chronic cough (e.g., due to smoking, asthma, chronic bronchitis, emphysema), or where cough is accompanied by excessive phlegm.
- Dosing: Patients should use an accurate milliliter dosing device to avoid overdose.
- Coexisting Conditions: HYCOFENIX should be used with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy, urethral stricture, or asthma.
- Renal Impairment: Use with caution in patients with severe renal impairment.
- Hepatic Impairment: Use with caution in patients with severe hepatic impairment.
ADVERSE REACTIONS: The most common adverse reactions in patients taking a single dose of HYCOFENIX in the clinical trial setting include: headache, dizziness, sedation (somnolence), nausea, diarrhea, decreased blood pressure, hot flush.
- No specific drug interactions have been studied.
- Avoid use of HYCOFENIX with benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol), as concomitant use may cause an additive CNS depressant effect.
- Do not use HYCOFENIX with MAOIs or tricyclic antidepressants as concomitant use may increase the effects of either drug.
- Hydrocodone should be administered cautiously to persons receiving anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects.
PREGNANCY: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal data, HYCOFENIX may cause fetal harm. Babies born to mothers who have been taking opioids regularly will be physically dependent. Withdrawal symptoms include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. Intensity of the syndrome does not always correlate with dose or duration of maternal opioid use.
LABOR AND DELIVERY: As with all opioids, administration of HYCOFENIX to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
NURSING MOTHERS: Hydrocodone and pseudoephedrine are known to be excreted into breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue HYCOFENIX, taking into account the importance of the drug to the mother.
PEDIATRIC USE: The safety and effectiveness of HYCOFENIX in pediatric patients under 18 years of age has not been established. The use of hydrocodone in children less than 6 years of age is associated with fatal respiratory depression.
GERIATRIC USE: Clinical studies with HYCOFENIX have not been conducted in geriatric populations. Dose selection for an elderly patient should be made with caution, starting at the low end of the dosing range, reflecting the greater frequency of concomitant disease or other drug therapy.
Please see additional Important Safety Information, including Drug Interactions and boxed warning, in full Prescribing Information.