Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. The co-ingestion of alcohol with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may result in increased plasma levels and a potentially fatal overdose of hydrocodone [, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not recommended for use in pregnant women [, 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. ]. Not indicated for pediatric patients under 18 years of age [, Contraindicated in pediatric patients less than 6 years of age [, Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [, All children younger than 6 years of age [, Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [, Known or suspected gastrointestinal obstruction, including paralytic ileus [, Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL [, Life-threatening respiratory depression [, 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 Oral Solution, 5 mg/1.5 mg per 5 mL is a prescription medicine used in adults to treat a cough. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [ Warnings and Precautions (5.2)]. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not for children under 18 years of age. Important Dosing and Administration Instructions. ], in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (e.g. Use in Specific Populations (8.1)]. Homatropine methylbromide | C17H24BrNO3 - PubChem ]. If Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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 [ Based on the animal data, advise pregnant women of the potential risk to a fetus. Warnings and Precautions (5.2)]. Contraindications (4)]. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Find patient medical information for Homatropine Methylbromide on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The most common side effects of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL include: These are not all the possible side effects of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5mL. Homatropine Methylbromide, USP 1.5 mg. Hydrocodone Bitartrate and Homatropine Methylbromide Syrup also contains: Caramel color, cherry flavor, citric acid, FD&C Red #40, methylparaben, propylparaben, purified water, sorbitol solution and sucrose syrup. Clinical Pharmacology (12.2)]. Avoid driving a car or operating machinery during treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Advise the patient to read the FDA-approved patient labeling (Medication Guide). DOT Classification: Not a DOT controlled material (United States). The hydrocodone component is a 4,5- epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (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) and may be represented by the following structural formula: Homatropine methylbromide is 8- Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenylacetyl) oxy]-8,8-dimethyl-,bromide, endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29). 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. Clinical Considerations]. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [ Hydromorphone is formed from the O-demethylation of hydrocodone and may contribute to the total analgesic effect of hydrocodone. When a patient who has been taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL regularly and may be physically dependent no longer requires therapy with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. see 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, 5 mg/1.5 mg per 5 mL may produce marked drowsiness [ If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals. To reduce the risk of respiratory depression, proper dosing of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is essential [ 1), Important Limitations of Use ( see There are case reports of excessive sedation and respiratory depression in breastfed infants exposed to hydrocodone. 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. 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. Metilbromuro de homatropina | C17H24BrNO3 - PubChem One-half (1/2) teaspoonful (2.5 mL) of the syrup every 4 to 6 hours as needed; do not exceed three (3) teaspoonfuls in 24 hours. The patient using hydrocodone bitartrate and homatropine methylbromide should be cautioned accordingly. If Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Drug Interactions (7.1, Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure. Contraindications (4)]. Greenville, SC 29605 Take Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL exactly as your healthcare provider tells you to take it. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is achieved [ Search Results For : " ABST88.COM 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) ( Drug Interactions (7.9)]. Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Call your doctor for medical advice about side effects. Warnings and Precautions (5.7)]. FDA Safety Recalls, have had a brain tumor or other brain problems, have constipation or other bowel problems, have glaucoma (increased pressure in eyes), have problems with your urinary tract or difficulty urinating, are pregnant or plan to become pregnant. Warnings and Precautions (5.2)]. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating and/or orthostatic hypotension. Hydrocodone can produce miosis, euphoria, physical and physiological dependence. You may report side effects to FDA at 1-800-FDA-1088. Hydrocodone bitartrate and homatropine methylbromide syrup is a Schedule III narcotic. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ Do not freeze the preparations if this requirement is not explicitly stated in the instructions. To reduce the risk of respiratory depression, proper dosing of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is essential [, Children are particularly sensitive to the respiratory depressant effects of hydrocodone [, Use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in children also exposes them to the risks of addiction, abuse, and misuse [ (, 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. Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. The opioid in this combination acts directly on the brain to suppress the cough reflex. ]. Prolonged administration of hydrocodone bitartrate and homatropine methylbromide may produce constipation. see 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. Inform patients that Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may cause orthostatic hypotension and syncope. Avoid starting Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL if you stopped taking an MAOI in the last 14 days. see HOMATROPINE METHYLBROMIDE see take pain medicines such as opioids (narcotics). After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [ Use in Specific Populations (8.3)]. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. Do not take Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL if you: Ask your healthcare provider if you have any questions about this information. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is for oral use only. 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? Because of the risk of life-threatening respiratory depression and death, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is contraindicated in children less than 6 years of age [ Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not recommended for use in pregnant women, including during or immediately prior to labor. (, Instruct patients not to consume alcohol or any products containing alcohol while taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg /1.5 mg per 5 mL because co-ingestion can result in fatal plasma hydrocodone levels. Pregnancy Category C: Animal reproduction studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide. Do not use Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL for a condition for which it was not prescribed. The concurrent use of anticholinergics with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may produce paralytic ileus [, The hydrocodone in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may cause spasm of the sphincter of Oddi, resulting in an increase in biliary tract pressure. see Adults 18 years of age and older: 5 mL of the oral solution every 4 to 6 hours as needed; not to exceed 30 mL in 24 hours. Rebel Distributors Corp. Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [, Do not abruptly discontinue Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in a physically-dependent patient [ Boxed WARNINGS ( These highlights do not include all the information needed to use Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution safely and effectively. Homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup uses DESCRIPTION This product contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. CII, Consumers: Please visit SimplyMedical.com, Hydrocodone Bitartrate / Homatropine Methylbromide, McKesson Acceptable Dating: we will ship >= 90 days. If this change in your breathing isn't recognized and treated right away, it can lead to death. Specs. Studies of hydrocodone bitartrate and homatropine methylbromide in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in patients 18 years of age and older. The concurrent use of anticholinergics with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL may produce paralytic ileus [ see 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. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. antitussive. What are the ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL? ]. Drug Interactions (7.1), Overdosage (10)]. 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 See full prescribing information for Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution. MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Hydrocodone bitartrate and homatropine methylbromide should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addisons disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma. (, Serious, life-threatening, or fatal respiratory depression may occur. 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. (, Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors, Seizures in patients with seizure disorders. Tell your healthcare provider if you take any of these medicines.
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