coma, and death. It is added in low doses to discourage Two-year studies in F344/N rats and B6C3F1 mice were conducted to assess the carcinogenic potential of codeine. However, one fixed-dose trial failed to demonstrate a greater benefit of the 20 mg dose over the 10 mg dose. Genus Lifesciences Inc. Management of respiratory depression includes discontinuation of hydrocodone bitartrate and homatropine methylbromide, close observation, supportive measures, and use of opioid antagonists (e.g., naloxone), depending on the patient's clinical status, While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydrocodone bitartrate and homatropine methylbromide, the risk is greatest during the initiation of therapy, when hydrocodone bitartrate and homatropine methylbromide is used concomitantly with other drugs that may cause respiratory depression, To reduce the risk of respiratory depression, proper dosing of hydrocodone bitartrate and homatropine methylbromide is essential. Other: Drug abuse, drug dependence, opioid withdrawal syndrome. . You may report side effects or health problems toFDAat 1-800-FDA-1088. The use of hydrocodone in children younger than 6 years has led to deadly breathing problems. What should I avoid while taking hydrocodone bitartrate and homatropine methylbromide? Hydrocodone is a powerful opiate, so it can cause some animal patients to experience certain side-effects after the drug has been administered. Physostigmine may be used parenterally for the treatment of the signs and symptoms of homatropine toxicity. Inform patients not to take hydrocodone bitartrate and homatropine methylbromide while using or within 14 days of stopping any drugs that inhibit monoamine oxidase. is this? PubMed, The patient using hydrocodone bitartrate and homatropine methylbromide tablets should be cautioned accordingly. Hydrocodone-Homatropine may be used alone or with other medications. Do not flush down a toilet or pour down a drain unless you are told to do so. If you have questions about side effects, call your doctor. Hydrocodone-Homatropine has minor interactions with the following drugs: Hypersensitivity to hydrocodone, homatropine, or any inactive primary, See What Are Side Effects Associated with Using Hydrocodone-Homatropine?, The hydrocodone in the medication may increase the frequency of seizures in patients with, Therapy may cause severe hypotension including, Monitor these patients for signs of hypotension after initiating therapy; in patients with, This medication is not recommended for use in pregnant women; prolonged use during pregnancy can result in withdrawal in the, Observe newborns for signs of neonatal opioid withdrawal syndrome and manage; accordingly, advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Central Nervous System: Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor. 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. Hydrocodone and Homatropine Tablets - Clinical Pharmacology Mechanism of Action. Oral Solution. If you have questions, talk with your doctor. Get Label RSS Feed, The clinical significance of these findings is unknown. Using this medicine (hydrocodone and homatropine tablets) for a long time during pregnancy may lead to withdrawal in the newborn baby. July 1985. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. If you are 65 or older, use this medicine (hydrocodone and homatropine tablets) with care. Elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see Warnings and Precautions (5.4)]. 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 The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. This syrup has a cherry flavor and is made by various manufacturers, including Endo Pharmaceuticals and Morton Grove Pharmaceuticals. are pregnant. (1:1) hydrate (2:5), a fine white crystal or crystalline powder which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50) an may be represented by the following structural formula: Homatropine methylbromide is 8- Azoniabicyclo[3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy]-. In addition, abuse of opioids can occur in the absence of true addiction. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. ", "What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide", "Who should not take hydrocodone bitartrate and homatropine methylbromide? The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. Hydrocodone bitartrate and homatropine methylbromide tablets may produce doserelated respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). If you have any questions about this medicine (hydrocodone and homatropine tablets), please talk with the doctor, pharmacist, or other health care provider. The instructions on bottle say 1 teaspoon every 4 hours for cough. It is not known whether this drug is excreted in human milk. Avoid the use of hydrocodone bitartrate and homatropine methylbromide in patients who are taking a CYP3A4 inhibitor or inducer. Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above. Cough. Avoid driving and doing other tasks or actions that call for alertness while you take this medicine (hydrocodone and homatropine tablets). 8, 8-dimethyl-, bromide, endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29). in 24 hours. 1.5 mg Tablet Bottle 100 Tablets CII HYDROCODONE+HOMATROPINE, TAB 5-1.5MG (100/BT) CII D/S. Use with caution in patients with underlying intestinal motility disorders. The co-ingestion of alcohol with hydrocodone bitartrate and homatropine methylbromide may result in increased plasma levels and a potentially fatal overdose of hydrocodone, Hydrocodone bitartrate and homatropine methylbromide is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus, The concurrent use of anticholinergics with hydrocodone bitartrate and homatropine methylbromide may produce paralytic ileus. Compare . Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. It is used primarily as a cough suppressant (antitussive) in dogs, working on receptors within the brain. Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Each Hydrocodone Bitartrate and Homatropine Methylbromide Tablet contains: Hydrocodone Bitartrate and Homatropine Methylbromide Tablets also contain: anhydrous lactose, dicalcium phosphate anhydrous, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate. Anybody have any. When combined therapy is contemplated, the dose of one or both agents should be reduced. The maximum dose is 30 mg/9 mg (6 tablets) in 24 hours. View Labeling Archives, Your Discount Pricing for HYDROCODONE-HOMATROPINE MBR. Avoid the use of hydrocodone bitartrate and homatropine methylbromide in patients who are taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days. "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Do not breast-feed while you take this medicine (hydrocodone and homatropine tablets). (HIGH-droe-KOE-dohn by-TAR-trate and hoe-MAT-troe-peen METH-ill-BROE-mide) Opioid drugs can put you at risk for addiction, abuse, and misuse. Hydrocodone bitartrate (brand names: Tussigon, Hycodan, Vicodin, Norco, Lortabs) is an opiate agonist utilized to deal with pain and cough in dogs. Patients with severe hepatic impairment may have higher plasma concentrations than those with normal hepatic function [see Clinical Pharmacology (12.3)]. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. The drug is commonly prescribed as extended-release tablets to help with chronic severe pain from conditions like fibromyalgia. Package insert / prescribing information Throw away unused or expired drugs. 10702-055-01. DESCRIPTION . Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Avoid the use of hydrocodone bitartrate and homatropine methylbromide in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Events, (What Which drugs or supplements interact with hydrocodone homatropine? 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. Inform patients that the use of hydrocodone bitartrate and homatropine methylbromide, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. If you take too much hydrocodone bitartrate and homatropine methylbromide, call your healthcare provider or go to the nearest hospital emergency room right away. We comply with the HONcode standard for trustworthy health information. a second compound added to most hydrocodone products. Give primary attention to the reestablishment of adequate respiratory exchange through provision of a patent and protected airway and the institution of assisted or controlled ventilation. Advise patients to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [see Dosage and Administration (2.1), Warnings and Precautions (5.5)]. Methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. #1. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide tablets in pediatric patients under six have not been established. Hydrocodone homatropine should be stored at room temperature, ml of syrup. Avoid the use of hydrocodone bitartrate and homatropine methylbromide while taking a CYP3A4 or CYP2D6 inhibitor. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Last updated on Aug 1, 2022. Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension. It has a molecular weight of 494.50 and has the following chemical structure: C18H21NO3 C4H6O6 2H2O MW 494.490. Monitor patients for signs of urinary retention or reduced gastric motility when hydrocodone bitartrate and homatropine methylbromide is used concomitantly with anticholinergic drugs. Advise patients not to increase dose or dosing frequency; serious adverse events such as respiratory depression may occur with overdosage; the dosage should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying . This medicine is not for use in children younger than 18 years of age. Homatropine blocks the action of acetylcholine, a chemical (neurotransmitter) No information is available on the effects of hydrocodone on milk production. Taking hydrocodone bitartrate and homatropine methylbromide with certain other medicines can cause side effects or affect how well hydrocodone bitartrate and homatropine methylbromide or the other medicines work. Warnings and Precautions (5.13), Use in Specific Populations (8.1)]. The use of hydrocodone bitartrate and homatropine methylbromide tablets in children less than 6 years of age has been associated with cases of fatal respiratory depression (see ADVERSE REACTIONS Respiratory Depression). Hydrocodone Precautions Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of hydrocodone bitartrate and homatropine methylbromide together with institution of appropriate therapy. 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. Do not take 2 doses at the same time or extra doses. Aug 1, 2012. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage. combinations may lead to confusion, high blood pressure, tremor, hyperactivity, Do not change your dose without talking to your health care provider. Tell all of your health care providers that you take this medicine (hydrocodone and homatropine tablets). Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug, Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including hydrocodone, one of the active ingredients in hydrocodone bitartrate and homatropine methylbromide. [See USP Controlled Room Temperature.] Interactions with Benzodiazepines and Other Central Nervous System Depressants, Including Alcohol. Bottles of 90 NDC 10702-055-09. What Other Drugs Interact with Hydrocodone-Homatropine? Concomitant use of hydrocodone bitartrate and homatropine methylbromide with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease hydrocodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to hydrocodone.
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