Applies to homatropine / hydrocodone: oral solution, oral syrup, oral tablet.
Warning
Oral route (Tablet; 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 syndromeAddiction, Abuse, and MisuseHydrocodone bitartrate/homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone bitartrate/homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing hydrocodone bitartrate/homatropine methylbromide, prescribe hydrocodone bitartrate/homatropine methylbromide for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate/homatropine methylbromide. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate/homatropine methylbromide or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone bitartrate/homatropine methylbromide, especially by children, can result in a fatal overdose of hydrocodone.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/homatropine methylbromide. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate/homatropine methylbromide.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone bitartrate/homatropine methylbromide with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone bitartrate/homatropine methylbromide in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of hydrocodone bitartrate/homatropine methylbromide in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone bitartrate/homatropine methylbromide. The co-ingestion of alcohol with hydrocodone bitartrate/homatropine methylbromide may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Neonatal Opioid Withdrawal SyndromeHydrocodone bitartrate/homatropine methylbromide is not recommended for use in pregnant women. Prolonged use of hydrocodone bitartrate/homatropine methylbromide during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If hydrocodone bitartrate/homatropine methylbromide 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.
Oral route (Tablet)
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.
Serious side effects
Along with its needed effects, homatropine / 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 homatropine / hydrocodone:
More common
- Lightheadedness, dizziness, or fainting
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
- Agitation
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- change in the ability to see colors, especially blue or yellow
- chills
- confusion
- constipation
- constricted, pinpoint, or small pupils (black part of the eye)
- cough
- cough producing mucus
- dark urine
- decrease in the frequency of urination
- decrease in urine volume
- diarrhea
- difficult, painful, or troubled breathing
- difficulty in passing urine (dribbling)
- difficulty swallowing
- discouragement
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- feeling sad or empty
- fever
- general feeling of tiredness or weakness
- headache
- hives, itching, skin rash
- hoarseness
- indigestion
- irregular, fast or slow, or shallow breathing
- irritability
- lack of appetite
- loss of consciousness
- loss of interest or pleasure
- lower back or side pain
- muscle aches
- nausea
- nervousness
- overactive reflexes
- pain or cramping in the stomach
- painful urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale or blue lips, fingernails, or skin
- poor coordination
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- restlessness
- seeing double
- seeing, hearing, or feeling things that are not there
- seizures
- shakiness and unsteady walk
- shivering
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- talking or acting with excitement you cannot control
- tightness in the chest
- tingling of the hands or feet
- trembling or shaking
- trouble concentrating
- trouble sleeping
- twitching
- uncontrolled movements of the face
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual weight gain or loss
- vomiting
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking homatropine / hydrocodone:
Symptoms of overdose
- Difficult or troubled breathing
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
Other side effects
Some side effects of homatropine / 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
- Dry mouth
Incidence not known
- Back pain
- decreased appetite
- difficulty in moving
- drowsiness
- false or unusual sense of well-being
- fear or nervousness
- feeling of warmth
- increased sweating
- joint pain
- mood changes
- muscle pain or stiffness
- redness of the face, neck, arms and occasionally, upper chest
- relaxed and calm
- sleepiness
- trouble getting pregnant
For Healthcare Professionals
Applies to homatropine / hydrocodone: oral syrup, oral tablet.
General
The most commonly reported adverse effects have included sedation (somnolence, mental clouding, lethargy) impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation.[Ref]
Nervous system
Serotonin syndrome has been reported with concomitant opioids and serotonergic drugs[Ref]
Frequency not reported: Coma, somnolence, facial dyskinesia, tremor, insomnia, migraine, increased intracranial pressure, seizure, dizziness, decreased mental alertness with impaired mental and/or physical abilities, serotonin syndrome, tinnitus[Ref]
Respiratory
Frequency not reported: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression including fatal respiratory depression, sinusitis, upper respiratory tract infection
Cardiovascular
Frequency not reported: Increased blood pressure, decreased blood pressure, tachycardia, chest pain, orthostatic hypotension, palpitations, syncope, prolonged QT interval, hot flush, atrial fibrillation, myocardial infarction, arrhythmias including premature ventricular contractions, flushing[Ref]
Other
Frequency not reported: Peripheral edema, death, falling injuries, accidental overdose, neonatal opioid withdrawal syndrome[Ref]
Gastrointestinal
Frequency not reported: Abdominal pain, bowel obstruction, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, dysgeusia, ischemic colitis, increase of serum amylase, dry mouth, biliary tract spasm (spasm of the sphincter of Oddi)[Ref]
Genitourinary
Frequency not reported: Ureteral spasm, spasm of vesicle sphincters, urinary retention, urinary tract infection, hypogonadism, infertility[Ref]
Hypersensitivity
Frequency not reported: Anaphylaxis
Psychiatric
Frequency not reported: Agitation, anxiety, confusion, fear, dysphoria, depression
Dermatologic
Frequency not reported: Hyperhidrosis, rash, pruritus[Ref]
Endocrine
Frequency not reported: Adrenal insufficiency, androgen deficiency
Adrenal insufficiency has been reported with opioid use, most often following greater than one month of use. Androgen deficiency has been reported with chronic opioid use.
Musculoskeletal
Frequency not reported: Arthralgia, backache, muscle spasm
Ocular
Frequency not reported: Miosis, visual disturbances
Metabolic
Frequency not reported: Decreased appetite
