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Check Drug InteractionsHydrocodone Bitartrate And Homatropine Methylbromide Prescribing Information
Addiction, Abuse, and Misuse
Hydrocodone bitartrate and homatropine methylbromide exposes patients
and other users to the risks of opioid addiction, abuse, and misuse, which can l
ead to overdose and death. Reserve hydrocodone bitartrate and 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 and homatropine
methylbromide, prescribe hydrocodone bitartrate and homatropine
methylbromide for the shortest duration that is consistent with individual
patient treatment goals, monitor all patients regularly for the development of
addition or abuse, and refill only after reevaluation of the need for continued
treatment [
see Warnings and Precautions (5.1)
].Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with
use of hydrocodone bitartrate and homatropine methylbromide. Monitor for
respiratory depression, especially during initiation of hydrocodone bitartrate
and homatropine methylbromide therapy or when used in patients at higher
risk [
see Warnings and Precautions (5.2)
].Accidental Ingestion
Accidental ingestion of even one dose of hydrocodone bitartrate and
homatropine methylbromide, especially by children, can result in a fatal
overdose of hydrocodone [
see Warnings and Precautions (5.2)
].Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering
hydrocodone bitartrate and homatropine methylbromide. Dosing errors can
result in accidental overdose and death. Always use an accurate milliliter
measuring device when measuring and administering hydrocodone bitartrate
and homatropine methylbromide [
see Dosage and Administration (2.1),
Warnings and Precautions (5.5)
].Cytochrome P450 3A4 Interaction
The concomitant use of hydrocodone bitartrate and 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 and homatropine
methylbromide in patients taking a CYP3A4 inhibitor or inducer [
see Warnings
and Precautions (5.7), Drug Interactions (7.2, 7.3)
].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 the use of hydrocodone
bitartrate and homatropine methylbromide in patients taking benzodiazepines,
other CNS depressants, or alcohol [
see Warning and Precautions (5.8), Drug
Interactions (7.5)
]Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription
or non-prescription products that contain alcohol while taking hydrocodone
bitartrate and homatropine methylbromide. The co-ingestion of alcohol
with hydrocodone bitartrate and homatropine methylbromide may result in
increased plasma levels and a potentially fatal overdose of hydrocodone [
see W
arnings and Precautions (5.8) and Drug Interactions (7.1)
].Neonatal Opioid Withdrawal Syndrome
Hydrocodone bitartrate and homatropine methylbromide is not recommended
for use in pregnant women [see Use in Specific Populations (8.1)]. Prolonged
use of hydrocodone bitartrate and 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 and 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 [
see
Warnings and Precautions (5.13)
]. Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in patients 18 years of age and older.
Important Limitations of Use
:- Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].
- Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and 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.
Tablet: Each tablet contains hydrocodone bitartrate 5 mg; and homatropine methylbromide 1.5 mg and supplied as white to off-white, round shaped biconvex tablets, debossed “K” above bisect “55” on one side and plain on the other side [
see Description (11)
].
Oral solution: Each 5 mL contains hydrocodone bitartrate 5 mg; and homatropine methylbromide 1.5 mg and available as clear red colored, cherry flavored oral solution [
see Description (11)
].Hydrocodone bitartrate and homatropine methylbromide is contraindicated for:
- All children younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)].
Hydrocodone bitartrate and homatropine methylbromide is also contraindicated in patients with:
- Significant respiratory depression [see Warnings and Precautions (5.2)].
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.4)].
- Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.9)].
- Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide [see Adverse Reactions (6)].
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, abuse, and misuse [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)]
- Life-threatening respiratory depression [see Warnings and Precautions (5.2, 5.3, 5.4, 5.8), Overdosage (10)]
- Accidental overdose and death due to medication errors [see Warnings and Precautions (5.5)]
- Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.6)]
- Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.8), Drug Interactions (7.1, 7.4)]
- Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.9)]
- Increased intracranial pressure [see Warnings and Precautions (5.10)]
- Obscured clinical course in patients with head injuries [see Warnings and Precautions (5.10)]
- Seizures [see Warnings and Precautions (5.11)]
- Severe hypotension [see Warnings and Precautions (5.12)]
- Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.13)]
- Adrenal insufficiency [see Warnings and Precautions (5.14)]
The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or homatropine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions to hydrocodone bitartrate and homatropine methylbromide include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation.
Other reactions include:
Anaphylaxis
: Anaphylaxis has been reported with hydrocodone, one of the ingredients in hydrocodone bitartrate and homatropine methylbromide.Body as a whole
: Coma, death, fatigue, falling injuries, lethargy.Cardiovascular
: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.Central Nervous System
: Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor.Dermatologic
: Flushing, hyperhidrosis, pruritus, rash.Endocrine/Metabolic
: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids.Gastrointestinal
: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi).Genitourinary
: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.Laboratory
: Increases in serum amylase.Musculoskeletal
: Arthralgia, backache, muscle spasm.Ophthalmic
: Miosis (constricted pupils), visual disturbances.Psychiatric
: Agitation, anxiety, confusion, fear, dysphoria, depression.Reproductive
: Hypogonadism, infertility.Respiratory
: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection.Other
: Drug abuse, drug dependence, opioid withdrawal syndrome.To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc. at 1-215-579-1842 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
.No specific drug interaction studies have been conducted with hydrocodone bitartrate and homatropine methylbromide.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available