Dosage and Administration (2.1)]. 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. 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. see Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule III narcotic. . Homatropine Methylbromide, USP . see We recommend using a newer internet browser, such as Google Chrome or Microsoft Edge, to optimize your browsing experience. 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. It is on the World Health Organization's List of Essential Medicines.[1]. Hydrocodone and homatropine combination is used to relieve cough in adults and children 6 years of age and older. Respiratory depression is the chief risk for elderly patients treated with opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Infants exposed to Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL through breast milk should be monitored for excess sedation and respiratory depression. Advise women that breastfeeding is not recommended during treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL [ Homatropine is used to treat duodenal or stomach ulcers or intestine problems. Instruct patients to take steps to store Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL securely and to properly dispose of unused Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in accordance with the local state guidelines and/or regulations. Advise patients not to increase the dose or dosing frequency of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL because serious adverse events such as respiratory depression may occur with overdosage [, Prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL for the shortest duration that is consistent with individual patient treatment goals [, Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [ Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries. Set id: 95828fad-323e-4510-acbf-6d354b25b887, hydrocodone bitartrate and homatropine methylbromide syrup. Hydrocodone, one of the active ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The published literature suggests that homatropine may decrease milk production based on its anticholinergic effects ( ]. Warnings and Precautions (5.1)]. How should I dispose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL? ]. Discontinue Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL if serotonin syndrome is suspected. Inform female patients of reproductive potential that use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [ Indications (1), as between 15mg and 40mg. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of hydrocodone in pediatric patients, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not indicated for use in patients younger than 18 years of age [ Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, prescribe Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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. Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Reserve Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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. Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 5.2 ng/mL. Ophthalmic: Miosis (constricted pupils), visual disturbances. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [ Homatropine belongs to a class of drugs known as anticholinergics. ]. Clinical Trials, 8600 Rockville Pike, Bethesda, MD, 20894 USA. If you are a consumer or patient please visit Talk to your healthcare provider if this is a concern for you. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of hydrocodone in pediatric patients, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not indicated for use in patients younger than 18 years of age [ see Warnings and Precautions (5.2)]. Policies. Homatropine (Equipin, Isopto Homatropine) is an anticholinergic medication that is an antagonist at muscarinic acetylcholine receptors and thus the parasympathetic nervous system. . Monitor patients closely, especially within the first 24-72 hours of initiating therapy or when used in patients at higher risk. Warnings and Precautions (5.4)]. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, hydrocodone bitartrate and homatropine methylbromide should be prescribed and administered with caution. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Fertility studies with hydrocodone have not been conducted. elderly, cachectic, or debilitated patients) [ decrease in mental and physical performance. see You can also follow your state or local guidelines on how to safely throw away Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. InChI=1S/C16H21NO3/c1-17-12-7-8-13(17)10-14(9-12)20-16(19)15(18)11-5-3-2-4-6-11/h2-6,12-15,18H,7-10H2,1H3/t12-,13+,14+,15? Administer Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL by the oral route only. Tell your healthcare provider if your cough does not get better within 5 days of treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in patients with circulatory shock.In patients with circulatory shock, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may cause vasodilation that can further reduce cardiac output and blood pressure. ]. Risks from Concomitant Us e with Benzodiazepines or Other CNS Depressants. It occurs as a white crystal or fine white crystalline powder. Methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. ]. Uses of Homatropine: It is used to treat eye swelling. Remove unused Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5mL 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. It is not known if these fertility problems will be reversible, even after you stop taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. are breastfeeding. Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not recommended for use in pregnant women. 7.4)]. Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. Patients with renal impairment may have higher plasma concentrations than those with normal function [ Drug Interactions (7.1), Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg /1.5 mg per 5 mL exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. see Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression. Taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL with certain other medicines can cause side effects or affect how well Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL or the other medicines work. Warnings and Precautions (5.4)]. If this change in your breathing isn't recognized and treated right away, it can lead to death. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. Advise patients to always use an accurate milliliter measuring device when measuring and administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL oral solution. Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above. ]. Drug Interactions (7.4)]. Patients should not start MAOIs while taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL [ 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 Oral Solution, 5 mg/1.5 mg per 5 mL. I drank 60ml, 18mg of homatropine and was fine. It is a peripherally acting anticholinergic medication that inhibits muscarinic acetylcholine receptors and thus the parasympathetic nervous system. National Institutes of Health. Each spoonful (5 mL) of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration. What is the most important information I should know about Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL? Always use an accurate milliliter measuring device when administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL oral solution to ensure that the dose is measured and administered accurately. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Monitor patients with a history of seizure disorders for worsened seizure control during Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL therapy. CII, Package Not Child-Resistant see Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Warnings and Precautions (5.1)]. The dosage of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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 [, Elderly, Cachectic, or Debilitated Patients, Dosing errors can result in accidental overdose and death. Adverse Reactions (6), 2 retention can further increase intracranial pressure. Addiction can occur at recommended dosages and if the drug is misused or abused. Homatropine has broad, nonspecific anticholinergic / antimuscarinic activity that similar to, although less potent than, atropine. Hydrocodone bitartrate and homatropine methylbromide syrup should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide. Based on the animal data, advise pregnant women of the potential risk to a fetus. Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL therapy or when used in patients at higher risk [, Accidental ingestion of even one dos e of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, especially by children, can result in a fatal overdose of hydrocodone [, Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. 6-11yrs: 2.5mL every 4-6hrs as needed; max 15mL/24hrs. are pregnant. It should not be used for persistent coughs from smoking or long-term breathing problems (e.g., asthma, emphysema), or for coughs with a lot of mucus or fluids (productive coughs), unless directed by your doctor. see No information is available on the levels of homatropine in breast milk or on milk production. It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. 33; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF and Sorbitol Solution, USP. Drug Interactions (7.5)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate calibrated measuring device and can provide instructions for measuring the correct dose. Overdose and death due to medicine dosing errors. The hydrocodone in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may result in constipation or obstructive bowel disease, especially in patients with underlying intestinal motility disorders. In embryofetal development studies with pregnant rabbits and mice dosed throughout the period of organogenesis, codeine produced no adverse developmental effects at doses approximately 30 and 160 times, respectively, the MRHD of hydrocodone (on a mg/m Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers. No information is available on the effects of hydrocodone on milk production. 5.8)]. Reproductive: Hypogonadism, infertility. Hydrocodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. In an embryofetal development study in pregnant hamsters dosed on gestation day 8 during the period of organogenesis, hydrocodone induced cranioschisis, a malformation, at approximately 45 times the MRHD (on a mg/m Opioids may cause increases in serum amylase [, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Accidental ingestion of even one dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, especially by children, can result in respiratory depression and death. see Clinical Pharmacology (12.2)]. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of hydrocodone in pediatric patients, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not indicated for use in patients younger than 18 years of age [ For you peptic ulcer s ) NEW whether this drug is misused or abused is unknown receptors thus Measuring device and such use could lead to overdosage and serious adverse [ Suggests that Homatropine may decrease milk production potential for severe constipation [ see Warnings Precautions Be offset by an increased degree of respiratory depression opioids ( narcotics.. Who should not be administered to five adult male subjects, the mean peak concentration was 23.6 5.2.! 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