Hydrocodone Bitartrate and Homatropine Methylbromide
Generic: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Basic Information
Manufacturer
KVK-Tech, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
26d7c90c-5e6b-4bdb-b06f-c76173a01c21
Indications & Usage
1 INDICATIONS AND USAGE Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in patients 18 years of age and older.
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.
Hydrocodone bitartrate and homatropine methylbromide is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in patients 18 years of age and older.
(1) Limitations of Use (1) Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, 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.
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.
Hydrocodone bitartrate and homatropine methylbromide is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in patients 18 years of age and older.
(1) Limitations of Use (1) Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, 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.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: 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.
Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids.
Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation.
(6) To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc.
at 1-800-862-3865 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids.
Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation.
(6) To report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc.
at 1-800-862-3865 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.