Using alcohol or tobacco with certain medicines may also cause interactions to occur. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:. Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming causing mental or physical dependence or cause an overdose.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions. Measure the oral liquid correctly using the marked measuring spoon, oral syringe, or medicine cup.
The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
Keep from freezing. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet.
Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www. It is very important that your doctor check your or your child's progress while you are using this medicine.
This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If your cough does not improve or if it gets worse within 5 days, call your doctor. This medicine will add to the effects of alcohol and other CNS depressants medicines that can make you drowsy or less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
Check with your doctor before taking any of these medicines while you are using this medicine. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation.
Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.
Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions 6 ].
Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
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. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions.
Homatropine methylbromide has several mild but undesirable clinical properties resulting from its antisecretory effects. These can include: dry mouth, loss of visual accommodation, photophobia, and difficulty in urination. The extent of the above actions is dictated by dose, dose escalation, therefore, results in progressively aversive symptoms in patients.
Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was Maximum serum levels were achieved at 1. Food has no significant effect on the extent of absorption of hydrocodone. 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.
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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. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
Do not start, stop, or change the dosage of any medicines without your doctor's approval. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers such as codeine, hydromorphone , alcohol, marijuana cannabis , drugs for sleep or anxiety such as alprazolam, lorazepam, zolpidem , muscle relaxants such as carisoprodol, cyclobenzaprine , or antihistamines such as cetirizine, diphenhydramine.
Check the labels on all your medicines such as allergy or cough-and-cold products because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Examples include azole antifungals such as ketoconazole , macrolide antibiotics such as erythromycin , mifepristone, HIV medications such as ritonavir , rifamycins such as rifabutin, rifampin , certain drugs used to treat seizures such as carbamazepine, phenytoin , among others.
Make sure laboratory personnel and all your doctors know you use this drug. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call Otherwise, call a poison control center right away.
US residents can call their local poison control center at Canada residents can call a provincial poison control center. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose.
Take your next dose at the regular time. Do not double the dose to catch up. Store in a tightly closed container at 77 degrees F 25 degrees C away from light and moisture. Brief storage between degrees F degrees C is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed.
Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. We are unable to switch you to this area of care.
Hydromet 5 mg View more photos. Tell your doctor if your cough does not get better in 5 days. In the US - Call your doctor for medical advice about side effects. Some products that may interact with this drug include: other anticholinergic drugs e.
Do not share this medication with others. Sharing it is against the law. Information last revised October Copyright c First Databank, Inc. Drug Encyclopedia. No volver a mostrar esto.
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