Although the extent of protein binding of hydrocodone in human plasma has not been definitively determined, structural similarities to related opioid analgesics suggest that hydrocodone is not extensively protein bound. CYP3A4 mediated N-demethylation to norhydrocodone is the primary metabolic pathway of hydrocodone with a lower contribution from CYP2D6 mediated O-demethylation to hydromorphone. Hydromorphone is formed from the O-demethylation of hydrocodone and may contribute to the total analgesic effect of hydrocodone.
Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs [see Drug Interactions 7. Published in vitro studies have shown that N-demethylation of hydrocodone to form norhydrocodone can be attributed to CYP3A4 while O-demethylation of hydrocodone to hydromorphone is predominantly catalyzed by CYP2D6 and to a lesser extent by an unknown low affinity CYP enzyme. Hydrocodone and its metabolites are eliminated primarily in the kidneys. The mean plasma half-life of hydrocodone is approximately 4 hours.
Carcinogenicity, mutagenicity, and fertility studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution; however, published information is available for the individual active ingredients or related active ingredients. Carcinogenicity studies were conducted with codeine, an opiate related to hydrocodone. Carcinogenicity, mutagenicity, and fertility studies with homatropine have not been conducted.
Hydrocodone bitartrate and homatropine methylbromide oral solution is a red colored, cherry flavored oral solution containing 5 mg hydrocodone bitartrate, USP and 1. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed. Inform patients that the use of hydrocodone bitartrate and homatropine methylbromide oral solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions 5.
Instruct patients not to share hydrocodone bitartrate and homatropine methylbromide oral solution with others and to take steps to protect hydrocodone bitartrate and homatropine methylbromide oral solution from theft or misuse. Instruct patients how to measure and take the correct dose of hydrocodone bitartrate and homatropine methylbromide oral solution.
Advise patients to measure hydrocodone bitartrate and homatropine methylbromide oral solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage. Advise patients to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [see Dosage and Administration 2.
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting hydrocodone bitartrate and homatropine methylbromide oral solution and that it can occur even at recommended dosages [see Warnings and Precautions 5. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions 5. Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as hydrocodone bitartrate and homatropine methylbromide oral solution may produce marked drowsiness [see Warnings and Precautions 5.
Inform patients and caregivers that potentially fatal additive effects may occur if hydrocodone bitartrate and homatropine methylbromide oral solution is used with benzodiazepines or other CNS depressants, including alcohol.
Advise patients to avoid concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution with benzodiazepines or other CNS depressants and instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter products that contain alcohol, during treatment with hydrocodone bitartrate and homatropine methylbromide oral solution [see Warnings and Precautions 5. Advise patients of the potential for severe constipation [see Warnings and Precautions 5.
Inform patients that anaphylaxis has been reported with ingredients contained in hydrocodone bitartrate and homatropine methylbromide oral solution. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications 4 , Adverse Reactions 6 ]. Inform patients not to take hydrocodone bitartrate and homatropine methylbromide oral solution while using or within 14 days of stopping any drugs that inhibit monoamine oxidase.
Patients should not start MAOIs while taking hydrocodone bitartrate and homatropine methylbromide oral solution [see Drug Interactions 7. Inform patients that hydrocodone bitartrate and homatropine methylbromide oral solution may cause orthostatic hypotension and syncope.
Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur e. Advise patients that use of hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended during pregnancy [see Use in Specific Populations 8.
Inform female patients of reproductive potential that use of hydrocodone bitartrate and homatropine methylbromide oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions 5.
Inform female patients of reproductive potential that hydrocodone bitartrate and homatropine methylbromide oral solution can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations 8.
Advise women that breastfeeding is not recommended during treatment with hydrocodone bitartrate and homatropine methylbromide oral solution [see Use in Specific Populations 8. Inform patients that chronic use of opioids, such as hydrocodone, a component of hydrocodone bitartrate and homatropine methylbromide oral solution, may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations 8.
Inform patients that hydrocodone bitartrate and homatropine methylbromide oral solution could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions 5.
Inform patients that hydrocodone bitartrate and homatropine methylbromide oral solution could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs.
Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications [see Adverse Reactions 6 , Drug Interactions 7. Advise patients to properly dispose of unused hydrocodone bitartrate and homatropine methylbromide oral solution. Advise patients to throw the drug in the household trash following these steps.
Distributed by: Actavis Pharma, Inc. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution are not for children under 18 years of age. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution can cause serious side effects, including:.
Call your healthcare provider or get emergency medical help right away if anyone taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution has any of the symptoms below:. Accidental use of even 1 dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, especially by a child, is a medical emergency and can cause breathing problems respiratory depression which can lead to death. If a child accidentally takes Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, get emergency medical help right away.
Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above. Opioid withdrawal in a newborn. Use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
Tell your healthcare provider right away if you are pregnant or think you may be pregnant. Ask your healthcare provider if you have any questions about this information. Before you take Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution with certain other medicines can cause side effects or affect how well Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution or the other medicines work. Do not start or stop taking other medicines without talking to your healthcare provider.
Ask your healthcare provider if you are not sure if you take one of these medicines. Call your doctor for medical advice about side effects. Remove unused Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution from the container and mix it with an undesirable, non-toxic substance such as cat litter or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw it away in the household trash. You can also follow your state or local guidelines on how to safely throw away Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution.
General information about the safe and effective use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution for a condition for which it was not prescribed. Do not give Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution that is written for health professionals.
Active ingredients: hydrocodone bitartrate and homatropine methylbromide. This Medication Guide has been approved by the U. Food and Drug Administration. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.
Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info.
NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Approval: Hydrocodone bitartrate and homatropine methylbromide oral solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Monitor closely, especially upon initiation or when used in patients at higher risk. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients taking CYP3A4 inhibitors or inducers.
Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients taking benzodiazepines, other CNS depressants, or alcohol. Prolonged use of hydrocodone bitartrate and homatropine methylbromide oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life- threatening if not recognized and treated.
If hydrocodone bitartrate and homatropine methylbromide oral solution 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. May increase intracranial pressure and obscure the clinical course of head injuries. Avoid use in patients with circulatory shock. Discontinue if serotonin syndrome is suspected.
Monitor for reduced effect. May cause fetal harm. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and homatropine methylbromide oral solution.
Accidental Ingestion Accidental ingestion of even one dose of hydrocodone bitartrate and homatropine methylbromide oral solution, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions 5. Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate and homatropine methylbromide oral solution.
Cytochrome P 3A4 Interaction The concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution with all cytochrome P 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. 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.
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 oral solution.
Neonatal Opioid Withdrawal Syndrome Hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended for use in pregnant women [see Use in Specific Populations 8. Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for: All children younger than 6 years of age [see Warnings and Precautions 5. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions 5.
Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions 5. Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution [see Adverse Reactions 6 ]. Asthma and Other Pulmonary Disease The use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [ s ee Contraindications 4 ].
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [see Warnings and Precautions 5. Other reactions include: Anaphylaxis : Anaphylaxis has been reported with hydrocodone, one of the ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution. Dermatologic : Flushing, hyperhidrosis, pruritus, rash.
Musculoskeletal : Arthralgia, backache, muscle spasm. Ophthalmic : Miosis constricted pupils , visual disturbances. Reproductive : Hypogonadism, infertility. Other : Drug abuse, drug dependence, opioid withdrawal syndrome. Based on the animal data, advise pregnant women of the potential risk to a fetus.
Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Data Human Data Hydrocodone A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy.
Animal Data Reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide; however, studies are available with individual active ingredients or related active ingredients. H omatropine Animal studies with homatropine are not available. Hydrocodone Hydrocodone is present in breast milk.
Homatropine No information is available on the levels of homatropine in breast milk or on milk production. Clinical Considerations Infants exposed to hydrocodone bitartrate and homatropine methylbromide through breast milk should be monitored for excess sedation and respiratory depression. Risks Specific to Abuse of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution Hydrocodone bitartrate and homatropine methylbromide oral solution is for oral use only. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of hydrocodone bitartrate and homatropine methylbromide oral solution together with institution of appropriate therapy.
Hemodialysis is not routinely used to enhance the elimination of hydrocodone from the body. Homatropine Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine. Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models.
Concentration—Adverse Reaction Relationships There is a relationship between increasing hydrocodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.
Homatropine Homatropine methylbromide has several mild but undesirable clinical properties resulting from its antisecretory effects. Distribution Although the extent of protein binding of hydrocodone in human plasma has not been definitively determined, structural similarities to related opioid analgesics suggest that hydrocodone is not extensively protein bound.
Excretion Hydrocodone and its metabolites are eliminated primarily in the kidneys. Hydrocodone Carcinogenicity studies were conducted with codeine, an opiate related to hydrocodone. Mutagenicity studies with hydrocodone have not been conducted. Fertility studies with hydrocodone have not been conducted. Homatropine Carcinogenicity, mutagenicity, and fertility studies with homatropine have not been conducted.
Dispense in a tight, light-resistant container as defined in the USP. Oral prescription where permitted by State Law. Addiction, Abuse, and Misuse Inform patients that the use of hydrocodone bitartrate and homatropine methylbromide oral solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions 5. Important Dosing and Administration Instructions Instruct patients how to measure and take the correct dose of hydrocodone bitartrate and homatropine methylbromide oral solution.
Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting hydrocodone bitartrate and homatropine methylbromide oral solution and that it can occur even at recommended dosages [see Warnings and Precautions 5.
Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions 5. Activities Requiring Mental Alertness Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as hydrocodone bitartrate and homatropine methylbromide oral solution may produce marked drowsiness [see Warnings and Precautions 5.
Interactions with Benzodiazepines and Other Central Nervous System Depressants, Including Alcohol Inform patients and caregivers that potentially fatal additive effects may occur if hydrocodone bitartrate and homatropine methylbromide oral solution is used with benzodiazepines or other CNS depressants, including alcohol.
Constipation Advise patients of the potential for severe constipation [see Warnings and Precautions 5. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in hydrocodone bitartrate and homatropine methylbromide oral solution.
MAOI Interaction Inform patients not to take hydrocodone bitartrate and homatropine methylbromide oral solution while using or within 14 days of stopping any drugs that inhibit monoamine oxidase. Hypotension Inform patients that hydrocodone bitartrate and homatropine methylbromide oral solution may cause orthostatic hypotension and syncope. Pregnancy Advise patients that use of hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended during pregnancy [see Use in Specific Populations 8.
Neonatal Opioid Withdrawal Syndrome Inform female patients of reproductive potential that use of hydrocodone bitartrate and homatropine methylbromide oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions 5. Embryo-Fetal Toxicity Inform female patients of reproductive potential that hydrocodone bitartrate and homatropine methylbromide oral solution can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations 8.
Lactation Advise women that breastfeeding is not recommended during treatment with hydrocodone bitartrate and homatropine methylbromide oral solution [see Use in Specific Populations 8. Infertility Inform patients that chronic use of opioids, such as hydrocodone, a component of hydrocodone bitartrate and homatropine methylbromide oral solution, may cause reduced fertility.
Adrenal Insufficiency Inform patients that hydrocodone bitartrate and homatropine methylbromide oral solution could cause adrenal insufficiency, a potentially life-threatening condition. Serotonin Syndrome Inform patients that hydrocodone bitartrate and homatropine methylbromide oral solution could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs.
Disposal of Unused Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution Advise patients to properly dispose of unused hydrocodone bitartrate and homatropine methylbromide oral solution. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution can cause serious side effects, including: Addiction, abuse and misuse. Taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death.
This can happen even if you take Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems. Life-threatening breathing problems respiratory depression. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution can cause breathing problems respiratory depression that can happen at any time during treatment and can lead to death.
Your risk of breathing problems is greatest when you first start taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly, or have certain other health problems. Children are at higher risk for respiratory depression.
Jump to content. Keep the medication in a place where others cannot get to it. Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. Homatropine and hydrocodone is a combination medicine used to treat runny or stuffy nose, sneezing, cough, and sinus congestion caused by allergies or the common cold.
You should not use this medicine if you are allergic to homatropine or hydrocodone, or if you have:. Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. If you use hydrocodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born.
Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant. Do not breast-feed. Hydrocodone can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Cold or cough medicine is only for short-term use until your symptoms clear up.
Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medicine in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device not a kitchen spoon. Rinse after each use. Call your doctor if your symptoms do not improve after 5 days, or if you have a fever, rash, or headaches. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days.
Do not keep leftover medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Read and carefully follow the instructions provided with this medicine about how to safely dispose of any unused portion. Since this medicine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time. Seek emergency medical attention or call the Poison Help line at You may opt-out of e-mail communications at any time by clicking on the Unsubscribe link in the e-mail.
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