A severe and sometimes deadly problem called. Reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. Hydrocodone is a semisynthetic, moderately potent, orally available opioid that, in combination with acetaminophen, is widely used for treatment of acute or chronic pain, and in combination with antihistamines or anticholinergics used to treat cough. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=6df41ed2-4ad2-4500-950e-459e0e76d9c5, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Hydrocodone for dogs, explained by a veterinarian - Betterpet Brand name: Tussigon . This includes your doctors, nurses, pharmacists, and dentists. Patients should not start MAOIs while taking hydrocodone bitartrate and homatropine methylbromide [see Drug Interactions (7.6)]. Avoid the use of hydrocodone bitartrate and homatropine methylbromide in patients taking benzodiazepines, other CNS depressants, or 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. 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. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). Hydrocodone - LiverTox - NCBI Bookshelf If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals. No specific drug interaction studies have been conducted with hydrocodone bitartrate and homatropine methylbromide. What Are Warnings and Precautions for Hydrocodone-Homatropine? The ingestion of very large amounts of hydrocodone bitartrate and homatropine methylbromide tablets may, in addition, result in acute homatropine intoxication. Hydrocodone Precautions Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). What else should I know about hydrocodone homatropine? Avoid the use of hydrocodone bitartrate and homatropine methylbromide in patients taking benzodiazepines, other CNS depressants, or alcohol [see Warnings and Precautions (5.8), Drug Interactions (7.5)]. NDC 10702-055-01 Hydrocodone Bitartrate And Homatropine Methylbromide Zutripro (hydrocodone bitartrate, pseudoephedrine, chlorpheniramine) TussiCaps (hydrocodone polistirex, chlorphineramine polistirex) 180 capsules/tablets per 90 days Tussigon tablets (hydrocodone bitartrate, homatropine) Tuxarin ER tablets (codeine, chlorpheniramine) Drug with approved MFE only Quantity FlowTuss 64 ounces (1920 mL) per 90 days Avoid driving a car or operating machinery during treatment with hydrocodone bitartrate and homatropine methylbromide. PDF HYCODAN - hydrocodone bitartrate and homatropine methylbromide tablet Hydrocodone bitartrate and homatropine methylbromide tablets should be given to a pregnant woman only if clearly needed. Mutagenicity studies with hydrocodone have not been conducted. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed. Do not take with alcohol or products that have alcohol. IEHP Search Results Search for "abst88.com168 Hydrocodone. Citations, PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 66336-0871-XX, Report Adverse Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. #1. Abuse of hydrocodone bitartrate and homatropine methylbromide poses a risk of overdose and death. You should not do both. Hydrocodone bitartrate and homatropine methylbromide tablets, USP are available as white to off-white, round shaped biconvex tablets, debossed "K" above bisect "55" on one side and plain on the other side and is available in: Bottles of 30 NDC 10702-055-03. Using this medicine (hydrocodone and homatropine tablets) for a long time during pregnancy may lead to withdrawal in the newborn baby. Life-threatening breathing problems (respiratory depression). Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone bitartrate and homatropine methylbromide tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Hydrocodone causes miosis, even in total darkness. Hydrocodone medication guide - VetDepot The maximum dose is 30 mg/9 mg (6 tablets) Field Value. . every 4 to 6 hours not to exceed 3 tablets (15 mg/4.5 mg), Hydrocodone, like other opioids, stimulates Aug 1, 2012. Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is provided. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7.4)]. If a child accidentally takes hydrocodone bitartrate and homatropine methylbromide, get emergency medical help right away. Homatropine; Hydrocodone oral syrup | Cleveland Clinic Inform patients that hydrocodone bitartrate and homatropine methylbromide could cause adrenal insufficiency, a potentially life-threatening condition. The active ingredient in Hydrocodone-Homatropine, hydrocodone, is an opioid that reduces coughing. Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate and homatropine methylbromide. Important Dosing and Administration Instructions. HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE tablet, ADVERSE REACTIONS Respiratory Depression, Carcinogenesis, Mutagenesis, Impairment of Fertility, hydrocodone bitartrate and homatropine methylbromide tablet, All Drug Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. is this? 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 (see Data). Hydrocodone-Homatropine has moderate interactions with at least 222 other drugs. Be careful going up and down Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes. Signs of an allergic reaction, like rash; Taking an opioid drug like this medicine (hydrocodone and homatropine tablets) may lead to a rare but very bad adrenal gland problem. Methylbromide Opioid analgesics and antitussives, including hydrocodone, one of the active ingredients in hydrocodone bitartrate and homatropine methylbromide, should not be used in patients with acute febrile illness associated with productive cough or in patients with chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. No evidence of tumorigenicity was observed in male and female rats at codeine dietary doses up to 70 and 80 mg/kg/day (approximately equivalent to 40 and 45 times the MRHD of hydrocodone on a mg/m2 basis, respectively). Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, hydrocodone bitartrate and homatropine methylbromide should be prescribed and administered for the shortest duration that is consistent with individual patient treatment goals and patients should be reevaluated prior to refills [see Dosage and Administration (2.3), Warnings and Precautions (5.1)]. 6-11yrs: tab every 4-6hrs as needed; max 3 tabs/24hrs. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.14)]. Do not store in a bathroom. If you are a consumer or patient please visit Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: The dosage of hydrocodone bitartrate and homatropine methylbromide should not be increased if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Dosage and Administration (2.3)]. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opiod drugs. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. If you have any questions about this medicine (hydrocodone and homatropine tablets), please talk with the doctor, pharmacist, or other health care provider. This medicine has an opioid drug in it. Your Discount Pricing for HYDROCODONE-HOMATROPINE MBR. . The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Elderly, Cachectic, or Debilitated Patients. Always use an accurate milliliter measuring device when administering hydrocodone bitartrate and homatropine methylbromide oral solution to ensure that the dose is measured and administered accurately. Do not change your dose without talking to your health care provider. Find patient medical information for hydrocodone-homatropine oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. . Hydrocodone can depress breathing, For further information, see full prescribing information for naloxone hydrochloride. 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. PDF ANTITUSSIVE HYCODAN TABLETS AND ORAL SOLUTION CII Rx - Food and Drug The risk is increased with concurrent use of hydrocodone bitartrate and homatropine methylbromide with alcohol and other central nervous system depressants [see Warnings and Precautions (5.8), Drug Interactions (7.1, 7.4)]. Before you take hydrocodone bitartrate and homatropine methylbromide, 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. SAGE provides emergency care in each of our hospitals, every day including holidays. and should be used with caution in elderly, debilitated patients and in patients 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. Inform patients that anaphylaxis has been reported with ingredients contained in hydrocodone bitartrate and homatropine methylbromide. Respiratory depression is the chief risk for elderly patients treated with opioids, including hydrocodone bitartrate and homatropine methylbromide. Hydrocodone - Wikipedia This product contains 2 medications, hydrocodone and homatropine. Tell all of your health care providers that you take this medicine (hydrocodone and homatropine tablets). Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). It's also available in 10 mg extended-release or combination form with drugs like homatropine or acetaminophen, though acetaminophen has been shown to cause anemia in dogs. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and homatropine methylbromide. Hydrocodone-Homatropine is a cough prescription cough-suppressant that comes in both syrup and tablet form. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic and antitussive products carries the risk of addiction even under appropriate medical use. Prices start at $14.41. You may report side effects or health problems toFDAat 1-800-FDA-1088. Hydrocodone homatropine should be stored at room temperature, 47. (Hydrocodone Bitartrate and Homatropine Methylbromide) TABLETS AND ORAL SOLUTION . Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. It may harm them. alprazolam, diazepam, and lorazepam. Homatropine blocks the action of acetylcholine, a chemical (neurotransmitter) Combining alcohol and other sedatives with hydrocodone can The most common side effects of hydrocodone are: Hydrocodone can impair thinking and the physical abilities Children are at higher risk for respiratory depression. The most common side effects include sedation and constipation. See "What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide?". Do not share your drugs with others and do not take anyone else's drugs. Hydrocodone exhibits a complex pattern of metabolism, including N-demethylation, O-demethylation, and 6keto reduction to the corresponding 6--and 6--hydroxy metabolites. Tablets, "Dispense the accompanying Medication Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Consider these risks when prescribing or dispensing hydrocodone bitartrate and homatropine methylbromide. deliberate overdoses of hydrocodone. The product's dosage form is tablet and is administered via oral form. 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. PDF 5.70 Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. Hydrocodone and Homatropine Tablets - Drugs.com Instruct patients how to measure and take the correct dose of hydrocodone bitartrate and homatropine methylbromide. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of hydrocodone bitartrate and homatropine methylbromide tablets and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs . Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression. Mental and physical Children Dosage: <6yrs: not recommended. Pediatric patients are particularly sensitive to the respiratory depressant effects of hydrocodone, Use of hydrocodone bitartrate and homatropine methylbromide in pediatric patients also exposes them to the risks of addiction, abuse, and misuse, The use of hydrocodone bitartrate and homatropine methylbromide in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)]. Check with your take pain medicines such as opioids (narcotics). The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. Manufactured by: Genus Lifesciences Inc., Allentown, PA 18102. If this medicine (hydrocodone and homatropine tablets) is taken by Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Hydrocodone | VCA Animal Hospital It is not known whether these effects on fertility are reversible [see Adverse Reactions (6), Clinical Pharmacology (12.2)]. 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. The concomitant use of hydrocodone bitartrate and homatropine methylbromide and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [see Warnings and Precautions (5.7)]. If you have been taking this medicine (hydrocodone and homatropine tablets) on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Log . The dose for adults and children older than 12 years is one tablet (5 mg/1.5 mg) orally every 4 to 6 hours. 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 addiction or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1)]. Administration. Hydrocodone bitartrate (brand names: Tussigon, Hycodan, Vicodin, Norco, Lortabs) is an opiate agonist utilized to deal with pain and cough in dogs. Overdosage of homatropine can cause mydriasis and cycloplegia (fixed and dilated pupils), dry mouth and eyes, decreased sweating, hyperthermia, flushing, headache, visual blurring, gastrointestinal symptoms, constipation, urinary retention, tachycardia and palpitations, anxiety, restlessness, agitation, hallucinations, convulsions, cardiac arrhythmias and coma. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression. Bottles of 90 NDC 10702-055-09. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. 2) Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking or breaking out of a garbage bag, or to dispose of in accordance with local state guidelines and/or regulations. Use with caution in debilitated or geriatric pets, pets with a head injury, or pets that have thyroid, heart, lung . It is not known whether this drug is excreted in human milk. Homatropine methylbromide has several mild but undesirable clinical properties resulting from its antisecretory effects. Human: Oral tablets: Hydrocodone 5 mg and Homatropine 1.5 mg; Oral syrup: Hydrocodone 5 mg/5 mL (1 mg/mL) with Homatropine 1.5 mg/5 mL (0.3 mg/mL). General information about the safe and effective use of hydrocodone bitartrate and homatropine methylbromide. Classes - pdr.net Avoid the use of hydrocodone bitartrate and homatropine methylbromide if you: What are the possible side effects of hydrocodone bitartrate and homatropine methylbromide? CII. This copyrighted material has been downloaded from a licensed data provider. HYCODAN contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting opioid antitussive. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. [See USP Controlled Room Temperature.]. Cold and Flu: Finding Relief for Your Cough. Opioids may cause increases in serum amylase, Accidental overdose and death due to medication errors, Decreased mental alertness with impaired mental and/or physical abilities, Interactions with benzodiazepines and other CNS depressants, Paralytic ileus, gastrointestinal adverse reactions, Obscured clinical course in patients with head injuries, certain medicines to treat a fungal infection, certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C. Hydrocodone bitartrate and homatropine methylbromide is a prescription medicine used in adults 18 years of age and older to treat a cough. Information last revised May 2022. Log in for pricing and availability. How should I dispose of hydrocodone bitartrate and homatropine methylbromide? Methylbromide A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. Based on the animal data, advise pregnant women of the potential risk to a fetus. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Keep hydrocodone bitartrate and homatropine methylbromide in a safe place away from children. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. & Articles, All a second compound added to most hydrocodone products. However, many people have no side effects or only have minor side effects. One (1) tablet every 4 to 6 hours as needed; do not exceed six (6) tablets in 24 hours. 24/7 Emergency Services. 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. Rinse the measuring device with water after each use. The published literature suggests that homatropine may decrease milk production based on its anticholinergic effects (see Clinical Considerations). Doctors Lechlade - info.bt.com The standard dose of hydrocodone used to suppress coughing in dogs is .22 mg/kg every 6-12 hours. any drug without checking with your doctor. mg/1.5 mg) orally every 4 to 6 hours. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use; presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible; if adrenal insufficiencies once diagnosed, treat with, The Wean patient off the opioid to allow adrenal function to recover and continue, Other opioids may be tried as some cases reported the use of a different opioid without recurrence of adrenal insufficiency; the information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency, Medication contains hydrocodone, a Schedule II controlled substance; as an opioid, medication exposes users to risks of addiction, abuse, and misuse, Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed with the medication; addiction can occur at recommended dosages and if the drug is misused or abused, Risks are increased in patients with a personal or family history of, Consider risks when prescribing or dispensing medication; strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on proper disposal of unused drug, Contact the local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product, Serious, life-threatening, or fatal respiratory depression is reported with the use of opioids, including hydrocodone, one of the active ingredients in the drug combination; hydrocodone produces dose-related respiratory depression by directly acting on the. You must check If you have questions, talk with your doctor. Because opioid agonists may increase biliary tract pressure, with resultant increase in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after administration of a dose of hydrocodone bitartrate and homatropine methylbromide. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Copy the URL below and paste it into your RSS Reader application. Call your doctor if you have a lowered interest in sex, fertility combinations may lead to confusion, high blood pressure, tremor, hyperactivity, Carcinogenicity studies were conducted with codeine, an opiate related to hydrocodone. The concomitant use of anticholinergic drugs with hydrocodone bitartrate and homatropine methylbromide may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus [see Warnings and Precautions (5.9)]. Dosing errors can lead to accidental overdose and death. 5mg/1.5mg hydrocodone / homatropine (30 tablets) edit. Monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression. These can include: dry mouth, loss of visual accommodation, photophobia, and difficulty in urination. Classes - physician.pdr.net 5mg/1.5mg . Do not take hydrocodone bitartrate and homatropine methylbromide if you: Ask your healthcare provider if you have any questions about this information. You could have more side effects. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of opioids; therefore, hydrocodone bitartrate and homatropine methylbromide tablets should be prescribed and administered with caution. The maximum dose is 30 mg/9 mg (6 tablets) in 24 hours. Oral prescription where permitted by state law. PDF Hydrocodone with Homatropine - MSPCA-Angell
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