Warnings and Precautions (5.9)]. ]. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [ Warnings and Precautions (5.8), 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, 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. 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 Oral Solution, 5 mg/1.5 mg per 5 mL. Rinse the measuring device with water after each use. Biochemical Data Summary. For further information, see full prescribing information for naloxone hydrochloride. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. 6-11yrs: 2.5mL every 4-6hrs as needed; max 15mL/24hrs. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in patients who are taking a CYP3A4 inhibitor or inducer. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. 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. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. see Warnings and Precautions (5.1)]. ], which can lead to overdose and death [ The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and to electrical stimulation. Abuse of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL poses a risk of overdose and death. Some of the side-effects may be rare but serious. No evidence of tumorigenicity was observed in male and female mice at codeine dietary doses up to 400 mg/kg/day (approximately equivalent to 110 times the MRHD of hydrocodone on a mg/m Monitor these patients for signs of hypotension after initiating Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. see see In animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose (MRHD) ( 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. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL also contains the following inactive ingredients: Alcohol (less than 0.1%), Caramel, NF; Cherry Flavor; D&C Red No. DOT Classification: Not a DOT controlled material (United States). Acute overdose 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, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, circulatory collapse, cardiac arrest, and death. Advise both patients and caregivers about the risks of respiratory depression and sedation if Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is used with benzodiazepines, alcohol, or other CNS depressants [, Patients must not consume alcoholic beverages, or prescription or non-prescription products containing alcohol, while on Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL therapy. Use in Specific Populations (8.1)]. Adverse Reactions (6)]. 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. How should I take Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL? Tell your healthcare provider right away if you are pregnant or think you may be pregnant. Aug 1, 2012. 7.4)]. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions. 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 Oral Solution, 5 mg/1.5 mg per 5 mL. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. ]. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in patients who are taking benzodiazepines or other CNS depressants [ Hydrocodone is a narcotic antitussive (cough suppressant). Hydrocodone Bitartrate / Homatropine Methylbromide 5 mg - 1.5 mg / 5 mL Syrup Unit Dose Cup 5 mL CII, Hydrocodone Bitartrate / Homatropine Methylbromide 5 mg - 1.5 mg Tablet Bottle 100 Tablets CII, Codeine Phosphate / Guaifenesin 10 mg - 100 mg / 5 mL Liquid Bottle 473 mL CV, Hydrocodone Bitartrate / Homatropine Methylbromide 5 mg - 1.5 mg / 5 mL Syrup Bottle 16 oz. Patients with severe hepatic impairment may have higher plasma concentrations than those with normal hepatic function [ see Children are at higher risk for respiratory depression. 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 [ 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. "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Because of the risk of respiratory depression, avoid the use of opioid antitussives, including Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients. see see see In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [ 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. see There are case reports of excessive sedation and respiratory depression in breastfed infants exposed to hydrocodone. Indications for: Hydrocodone Bitartrate/Homatropine Methylbromide Syrup Cough. If concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL with a CYP3A4 inhibitor or inducer is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal [ Store Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL at room temperature between 68F to 77F (20C to 25C). Two-year studies in F344/N rats and B6C3F1 mice were conducted to assess the carcinogenic potential of codeine. Molecular Weight: 370.28. You can help Wikipedia by expanding it. see Risks from Concomitant Us e with Benzodiazepines or Other CNS Depressants. 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 To reduce the risk of overdose and respiratory depression, ensure that the dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is communicated clearly and dispensed accurately [, 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. Labels, All Index Warnings and Precautions (5.8)]. have a blockage (obstruction) in your bowel such as a paralytic ileus. As with all narcotics, administration of hydrocodone bitartrate and homatropine methylbromide to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used. Adverse Reactions (6)]. 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. 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, 5 mg/1.5 mg per 5 mL. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. Concomitant use of opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. You can ask your pharmacist or healthcare provider for information about Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL that is written for health professionals. We recognize our responsibility and see it as an opportunity to improve lives and to make a lasting social impact. are breastfeeding. Life-threatening breathing problems (respiratory depression). Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule III narcotic. Respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [
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