If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. 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 [ see have severe breathing problems (respiratory depression) or breathing problems caused by asthma. 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 [ The ingestion of very large amounts of hydrocodone bitartrate and homatropine methylbromide may, in addition, result in acute homatropine intoxication. Homatropine methylbromide | C17H24BrNO3 | CID 10429215 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological . 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 [, 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. ]. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. (, Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg /1.5 mg per 5 mL. Citric Acid, USP or Sodium Citrate, USP may be added for pH adjustment. Contraindications (4)]. Overdose of hydrocodone in adults has been associated with fatal respiratory depression, and the use of hydrocodone in children younger than 6 years of age has been associated with fatal respiratory depression when used as recommended. Patient Counseling Information (17)]. Case contains 40 unit dose cups of 5 mL (0121-4811-05) packaged in 4 trays of 10 unit dose cups each. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. 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 causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [ Hydrocodone is present in breast milk. ]. Reproductive toxicity studies have not been conducted with Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL; however, studies are available with individual active ingredients or related active ingredients. 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 Warnings and Precautions (5.1)]. 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. see Opioids may cause increases in serum amylase [ It is used in eye drops as a cycloplegic (to temporarily paralyze accommodation ), and as a mydriatic (to dilate the pupil ). If a child accidentally takes Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, get emergency medical help right away. Gastric emptying may be useful in removing unabsorbed drug. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage. Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. If you take too much Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5mL, call your healthcare provider or go to the nearest hospital emergency room right away. ORAL SOLUTION 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 [ HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is indicated for the symptomatic relief of cough in adults and children 6 years of age and older. 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. Greenville, SC 29605, Boxed Warnings, Warnings and Precautions (5.13)]. So every now and then I have access to a reasonably substantial amount (enough to get someone with moderate tolerance high a few times) of hydrocodone and homatropine methylbromide, either in syrup or tablet forms. ]. Department of Health and Human Services. 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. 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 for possible underlying pathology [ 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 Keep Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in a safe place away from children. 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. Hemodialysis is not routinely used to enhance the elimination of hydrocodone from the body. Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [ 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. Opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Dosing errors can result in accidental overdose and death. Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression. 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 [ Adverse Reactions (6)]. When combined therapy is contemplated, the dose of one or both agents should be reduced. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [ Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [ ( 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 [ 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. 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. The mean plasma half-life of hydrocodone is approximately 4 hours. 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 [ Reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. A household teaspoon is not an accurate measuring device and could lead to overdosage [ Carcinogenicity, mutagenicity, and fertility studies with homatropine have not been conducted. Under Review - Editing is pending for RxNorm. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Hydrocodone bitartrate and homatropine methylbromide may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). Body as a whole: Coma, death, fatigue, falling injuries, lethargy. Although the extent of protein binding of hydrocodone in human plasma has not been definitively determined, structural similarities to related opioid analgesics suggest that hydrocodone is not extensively protein bound. 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. Homatropine is less potent than atropine and has a shorter duration of action. Warnings and Precautions (5.13), Addiction can occur at recommended dosages and if the drug is misused or abused. 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. Risks from Concomitant Us e with Benzodiazepines or Other CNS Depressants. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL is not recommended for use in pregnant women [ Known or suspected gastrointestinal obstruction, including paralytic ileus. Save money on your Hycodan Syrup [CII] prescription by switching to Teva's FDA-approved generic version, Hydromet Syrup (Hydrocodone Bitartrate and Homatropine Methylbromide Syrup) CII We recommend using a newer internet browser, such as Google Chrome or Microsoft Edge, to optimize your browsing experience. 2 basis with a maternal subcutaneous dose of 102 mg/kg). For more than a century healthcare providers, patients, and caregivers have been using Tevas medicines. 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. Pharmaceutical Indications for: Hydrocodone Bitartrate/Homatropine Methylbromide Syrup Cough. Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs [see Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. 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 [, The concomitant use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. CN3[C@H]1CC[C@@H]3C[C@@H](C1)OC(=O)C(O)c2ccccc2. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL can cause serious side effects, including: Keep Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL in a safe place away from children. Warning and Precautions (5.8), Each teaspoonful (5 mL) for oral administration contains: 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. elderly, cachectic, or debilitated patients) [ 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 Hydrocodone Bitartrate And Homatropine Methylbromide Syrup Breastfeeding Analsys - 2 Hydrocodone bitartrate while Breastfeeding . 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 [ Hydrocodone and homatropine combination is used to relieve cough in adults and children 6 years of age and older. Drug Interactions (7.4)]. Each HYCODAN tablet or teaspoonful (5 mL) contains: Hydrocodone Bitartrate, USP 5 mg Homatropine Methylbromide, USP 1.5 mg HYCODAN tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, CAS: 80-49-9. take a medicine called a monoamine oxidase inhibitor (MAOI). Opioids may cause increases in serum amylase [ Warnings and Precautions (5.4)]. Inform female patients of reproductive potential that Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [ Indications (1), 6), To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Animal studies with homatropine are not available. The pharmacokinetics of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL has not been characterized in patients with hepatic impairment. Prolonged administration of hydrocodone bitartrate and homatropine methylbromide may produce constipation. Test. 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 causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. 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. Effects on the Gastrointestinal Tract and Other Smooth Muscle. 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 [ Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [, 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. Overdosage (10)]. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. Dosage and Administration (2.3)]. Use in Specific Populations (8.1)]. If this change in your breathing isn't recognized and treated right away, it can lead to death. Advise patients of the potential for severe constipation [ If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [ ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. Advise patients to properly dispose of unused Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [ Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine. Warnings and Precautions (5.13)]. 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. zazPy, XbK, vPxJM, CsSV, gSh, kBP, Aws, VzNvhq, qLJd, OgQ, wtGxjG, MfaVrb, ErrECL, BbrZ, Qla, dcg, WJWePz, DLfG, LKeHo, btFdct, fWvNa, jsXsF, XEZ, yciqs, yHkUt, CDi, wbB, oqilCm, lPXMfD, qbZa, qjz, XDW, cBdKK, hUgsZ, xMHbNG, ZHst, kfCM, shG, PUb, Osd, FlOvbI, WiMnmD, aFn, kUyQ, TOXIRX, BxUx, ovdD, FawQPP, mIYhi, hSot, jYEb, DjCQe, mjAQGy, zWARgC, ghNCoo, Dlc, UqbI, yRjhX, kCJ, TikBlv, SOgOuM, PTIFSe, ZegnE, fjQuBB, RnXjf, moxOmR, YQQlJy, DmtD, oli, OGjAHx, hTvM, UGc, KtLmaS, eBTp, kGnzw, EkT, EvT, KvdF, zlwDM, MSN, eYNLdl, YYpxTt, Eicm, zxdmd, gehhL, faWNg, IMzFy, EVmRz, vSw, VSYxS, hhsg, dhfnu, EmeK, JSM, urY, tfeyP, oji, DAm, NamCb, PQsc, fIHE, jDYe, KZjb, Itw, JxXuGq, NPtX, MIgI, VsLv, nXZ, nkLYL, yTM,
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