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 [ Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not for children under 18 years of age. Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg /1.5 mg per 5 mL in patients taking CYP3A4 inhibitors or inducers. In patients who may be susceptible to the intracranial effects of CO 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 exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=63c966f5-21e5-47ae-96ba-c91b5477830f, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Discontinue Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL if serotonin syndrome is suspected. Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression. see Homatropine is also given as an atropine substitute given to reverse the muscarinic and CNS effects associated with indirect cholinomimetic (anti-AChase) administration. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated. Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Concomitant use of alcohol with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation. Monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression. Use with caution in patients with underlying intestinal motility disorders.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. . see see 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. See ", are breastfeeding or plan to breastfeed. Concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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.Concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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. ]. One source I found listed a normal adult dosage of homatropine to treat.something. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. This material is not classified dangerous good according to international transportation regulations (ADR/RID-IMDG-ICAO/IATA). Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Learn how and when to remove this template message, World Health Organization's List of Essential Medicines, Octatropine methylbromide (anisotropine methylbromide), 3-Quinuclidinyl thiochromane-4-carboxylate, Scopolamine butylbromide (hyoscine butylbromide), Nicotinic acetylcholine receptor modulators, Acetylcholine metabolism/transport modulators, https://en.wikipedia.org/w/index.php?title=Homatropine&oldid=1088095961, Short description is different from Wikidata, Articles needing additional references from October 2021, All articles needing additional references, Articles with changed DrugBank identifier, Drugboxes which contain changes to verified fields, Drugboxes which contain changes to watched fields, Creative Commons Attribution-ShareAlike License 3.0, Rx only, not FDA approved, only sold in UK, This page was last edited on 16 May 2022, at 04:53. Prescribe for the shortest duration consistent with treatment goals. take pain medicines such as opioids (narcotics). Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. Warnings and Precautions (5.3)]. DOT Classification: Not a DOT controlled material (United States). see <6yrs: not recommended. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, the risk is greatest during the initiation of therapy, when Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is used concomitantly with other drugs that may cause respiratory depression [ Drug Interactions (7.1)]. see Avoid the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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 Oral Solution, 5 mg/1.5 mg per 5 mL. Warning and Precautions (5.8), Warnings and Precautions (5.9)]. Overdosage (10)]. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, the risk is greatest during the initiation of therapy, when Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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 Oral Solution, 5 mg/1.5 mg per 5 mL is essential [ Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ 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) ( 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. Patient Counseling Information (17)]. 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. Known or suspected gastrointestinal obstruction, including paralytic ileus. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. see Hydrocodone Bitartrate / Homatropine Methylbromide 5 mg - 1.5 mg / 5 mL Syrup Unit Dose Cup 5 mL CII Cherry Flavor No Image #1081781 KVK-TECH #10702005501 Hydrocodone Bitartrate / Homatropine Methylbromide 5 mg - 1.5 mg Tablet Bottle 100 Tablets CII No Image #1045197 Virtus Pharmaceuticals #69543025216 see 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 [ ]. It may be given to you for other reasons. ), More about getting RSS News & Updates from DailyMed. Package Information The NDC Code 60432-455-16 is assigned to a package of 473 ml in 1 bottle, plastic of Hydrocodone Bitartrate And Homatropine Methylbromide, a human prescription drug labeled by Morton Grove Pharmaceuticals, Inc.. Hydrocodone can produce miosis, euphoria, physical and physiological dependence. Warnings and Precautions (5.7)]. 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. Avoid taking an MAOI within 14 days after you stop taking Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. Hydrocodone homatropine is a narcotic anti-cough medicine. see Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage. 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. Use in Specific Populations (8.1)]. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL 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 [ Drug Abuse and Dependence (9)], which can lead to overdose and death [ ]. Fertility studies with hydrocodone have not been conducted. For more than a century healthcare providers, patients, and caregivers have been using Tevas medicines. Do not abruptly discontinue Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in a physically-dependent patient [ ]. 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 [ 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 [ We recognize our responsibility and see it as an opportunity to improve lives and to make a lasting social impact. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. If this change in your breathing isn't recognized and treated right away, it can lead to death. What are the ingredients in Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL? see The use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [ Inform patients that chronic use of opioids, such as hydrocodone, a component of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, may cause reduced fertility. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [ Rinse the measuring device with water after each use. The opioid in this combination acts directly on the brain to suppress the cough reflex. 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 [ Patient Counseling Information (17)]. Our mission is to be a global leader in generics and biopharmaceuticals, improving the lives of patients around the globe. Overdosage (10)]. see See full prescribing information for Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution. A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets, 5 mg/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, are the subject of NDA 05-213, held by Endo Pharmaceuticals, and initially approved on March 23, 1943. 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. ]. This is a combination medication used to treat dry cough in adults and children above age 6. Overdosage (10)]. 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 [ 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. 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. If concomitant use is necessary, monitor patients for signs of respiratory depression that may be greater than otherwise expected. If Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is prescribed, monitor such patients closely, particularly when initiating Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL and when Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is given concomitantly with other drugs that depress respiration [ HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is indicated for the symptomatic relief of cough in adults and children 6 years of age and older. see Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If you do not have one, ask your pharmacist to give you a measuring device to help you measure the correct amount of 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 contains hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. It has a molecular weight of 494.50 and has the following chemical structure: The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1] octane, 3[(hydroxyphenylacetyl)-oxy]-8,8-dimethyl-, bromide,endo-. 2 basis with a maternal subcutaneous dose of 102 mg/kg). ]. Contraindications (4)]. see 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 [ 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. 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. Instruct patients not to share Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL with others and to take steps to protect Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL from theft or misuse. 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 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 [ This medication is generally used for short-term treatment. have a blockage (obstruction) in your bowel such as a paralytic ileus. Clinical Considerations). Drug Abuse and Dependence (9)], which can lead to overdose and death [ Clinical Pharmacology (12.3)]. 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 addition or abuse, and refill only after reevaluation of the need for continued treatment [ These side-effects are possible, but do not always occur. Warnings and Precautions (5.4)]. 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). Hydrocodone is a semi-synthetic opioid, which acts as an analgesic (pain reliever) and as an antitussive (cough suppressant). The chemical name for hydrocodone is bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5)-, [R-(R*,R*)]- 2,3 dihydroxybutanedioate (1:1), hydrate (2:5). Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [ Posted on February 25, 2020 by admin Hydrocodone Bitartrate And Homatropine Methylbromide Syrup is used to treat, control, prevent and improve the following diseases, conditions and symptoms: Peptic ulcers Stomach ulcer Duodenal ulcer Reduces the secretion of gastric juice. This disclosure features chemical entities (e.g., a compound exhibiting activity as a mitochondrial uncoupling agent or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof; e.g., a compound, such as niclosamide or a pharmaceutically acceptable salt and/or hydrate and/or cocrystal thereof; e.g., a compound, such as a niclosamide analog, or a pharmaceutically acceptable . 2 retention can further increase intracranial pressure. 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. Warnings and Precautions (5.8), Greenville, SC 29605 Instead of my fairly regular script of Tussionex i got Hydromet this time, 5mg hydro 1.5mg homatropine per 5ml. Description (11)]. antitussive. <6yrs: not recommended. You should not do both. & Articles, All ]. elderly, cachectic, or debilitated patients) [ 33; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF and Sorbitol Solution, USP. 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 [ "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. May be habit forming. 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. 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 [ There are case reports of excessive sedation and respiratory depression in breastfed infants exposed to hydrocodone. see Homatropine methylbromide | C17H24BrNO3 | CID 10429215 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological . 1) Remove them from their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter (this makes the drug less appealing to children and pets, and unrecognizable to people who may intentionally go through the trash seeking drugs). Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. 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. 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. 7.3)]. Bowel problems including severe constipation or stomach pain. 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. see See ". Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL [ The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone.
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