Hydrocodone Bitartrate and Homatropine Methylbromide
Generic: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION
Basic Information
Manufacturer
KVK-Tech, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
9a737416-08e0-4df6-897e-cf9d1b5f0b01
Indications & Usage
1 INDICATIONS AND USAGE Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult 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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)] , reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
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 adult patients 18 years of age and older.
(1) Limitations of Use Not indicated for pediatric patients under 18 years of age.
(1) Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
(1, 5.1)
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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)] , reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
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 adult patients 18 years of age and older.
(1) Limitations of Use Not indicated for pediatric patients under 18 years of age.
(1) Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
(1, 5.1)
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).
Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term.
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 1-800-862-3895 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).
Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term.
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 1-800-862-3895 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.