Applies to chlorpheniramine / hydrocodone: oral solution. Other dosage forms:
- oral suspension extended release
Warning
Oral route (Solution)
Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression, Accidental Ingestion, Medication Errors; Cytochrome P450 3A4 Interaction; Concomitant Use with Benzodiazepines or Other CNS Depressants; Interaction with Alcohol; Neonatal Opioid Withdrawal SyndromeHydrocodone bitartrate/chlorpheniramine maleate exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor closely for these behaviors and conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk.Accidental ingestion of hydrocodone bitartrate/chlorpheniramine maleate, especially by children, can result in a fatal overdose of hydrocodone.Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/chlorpheniramine maleate. Dosing errors can result in accidental overdose and death.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone. Avoid the use of hydrocodone bitartrate/chlorpheniramine maleate in patients taking CYP3A4 inhibitors or inducers. 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 the use of hydrocodone bitartrate/chlorpheniramine maleate in patients taking benzodiazepines, other CNS depressants, or alcohol.Instruct patients not to consume alcohol or any products containing alcohol while taking hydrocodone bitartrate/chlorpheniramine maleate because co-ingestion can result in fatal plasma hydrocodone levels.Hydrocodone bitartrate/chlorpheniramine maleate is not recommended for use in pregnant women. Prolonged use of hydrocodone bitartrate/chlorpheniramine maleate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If hydrocodone bitartrate/chlorpheniramine maleate is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Serious side effects
Along with its needed effects, chlorpheniramine / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking chlorpheniramine / hydrocodone:
Incidence not known
- Bloating
- constipation
- decrease in the frequency or amount of urination
- difficulty in passing urine (dribbling)
- spasm of the throat
- stomach cramps or pain
- tightness of the chest
- trouble breathing
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur while taking chlorpheniramine / hydrocodone:
Symptoms of overdose
- Blurred vision
- chest pain or discomfort
- cold and clammy skin
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extreme sleepiness or unusual drowsiness
- irregular, fast or slow, or shallow breathing
- no muscle tone or movement
- pale or blue lips, fingernails, or skin
- slow or irregular heartbeat
- sweating
- unusual tiredness or weakness
Other side effects
Some side effects of chlorpheniramine / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Anxiety or irritability
- dizziness
- drowsiness
- dry mouth
- headache
- irregular heartbeat
- nausea
- sleepiness or unusual drowsiness
Incidence not known
- Chills
- fast heartbeat
- fever
- flushing or redness of the skin
- hives or welts, itching skin, or rash
- stomach discomfort or upset
For Healthcare Professionals
Applies to chlorpheniramine / hydrocodone: oral capsule extended release, oral liquid, oral suspension extended release.
General
The more commonly reported adverse effects have included, sedation, somnolence, mental clouding, dizziness, nausea and vomiting.[Ref]
Respiratory
Frequency not reported: Dose-related respiratory depression including fatal respiratory depression, dryness of the pharynx, dryness of respiratory passages, laryngismus, wheezing, breathing trouble[Ref]
Nervous system
Frequency not reported: Sedation, somnolence, drowsiness, lethargy, mental and physical impairment, dizziness, headache, facial dyskinesia, feeling faint, lightheadedness, tremor[Ref]
Psychiatric
Frequency not reported: Mental clouding, confusion, anxiety, fear, dysphoria, psychic dependence, mood changes, euphoria, agitation, irritability
Gastrointestinal
Frequency not reported: Nausea, vomiting, constipation, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, loss of appetite[Ref]
Cardiovascular
Frequency not reported: Chest tightness
Dermatologic
Frequency not reported: Skin rash, pruritus, erythema, urticaria, excessive perspiration[Ref]
Genitourinary
Frequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention, dysuria, urinary frequency, urinary hesitancy[Ref]
Ocular
Frequency not reported: Blurred, double, or other visual disturbances
