Trade Name: Hydrocodone Bitartrate and Acetaminophen

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 10; 325 mg/1; mg/1

Storage and handling

HYDROCODONE BITARTRATE; ACETAMINOPHEN Opioid Agonist [EPC],Opioid Agonists [MoA]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • Arrayn- Hydrocodone bitartrate and acetaminophen u00a0tablets exposes patients and other users to the risks of opioid addiction, u00a0abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing hydrocodone bitartrate and acetaminophen tablets, and monitor all patients regularly for the development of these behaviors or conditions [see n n n ].n n n n- Arrayn- To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administrationu00a0n- (FDA) has required a REMS for these products [see n n n ]. Under the requirements of the REMS, drug companies with approvedu00a0n n n n- opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers areu00a0n- strongly encouraged to
  • Arrayn- Serious, life-threatening, or fatal u00a0respiratory depression may occur with use of hydrocodone bitartrate and u00a0acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [seen n n ].n n n n- u00a0n- Arrayn- Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can u00a0result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets [see n n n ].n n n n- Arrayn- Prolonged use of hydrocodone bitartrate u00a0and acetaminophen tablets during pregnancy can result in neonatal opioid u00a0withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by u00a0neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal u00a0syndrome and ensure that appropriate treatment will be available [see n n n ].n n n n- u00a0n- Arrayn- The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with all Cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used Cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentrations. Monitor patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see n n n , n n n , n n n ; n n n ].n n n n- u00a0n- Arrayn- Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see n n n ).n n n n- Arrayn- Concomitant use of opiods with benzodiazepines or other central nervous system (CNS) depressants including alcohol, may result in profound sedation, respiratory depression, coma, and death. [see n n n ,n n n ; n n n ]n n n n- u00a0n- u2022 Reserve concomitant prescribing of Hydrocodone bitartrate and acetaminophen tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.n- u00a0n- u2022 Limit dosages and durations to the minimum required.n- u2022 Follow patients for signs and symptoms of respiratory depression and sedation.
  • Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.n n n n Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5u03b1-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:u00a0n nn
  • Acetaminophen, 4u2019-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylateu00a0analgesic and antipyretic. It has the following structural formula:
  • Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table.n n n n Each hydrocodone bitartrate and acetaminophen tablet contains:n nn
  • In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.n n n n Meets USP Dissolution Test 1.n nn
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  • Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.n n n n n n n Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see n n n ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]n nn
  • Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with:n n n n n
  • u2022u00a0Significant respiratory depression [see n n n ]n nn
  • u2022u00a0Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see n n n ]n nn
  • u2022u00a0Known or suspected gastrointestinal obstruction, including paralytic ileus [see n n n ]n nn
  • u2022u00a0Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [seen n n n ]n nn
  • Addiction, u00a0Abuse, and Misuse:
  • Hydrocodone u00a0bitartrate and acetaminophen tablet contains hydrocodone and acetaminophen a u00a0Schedule CII controlled substance. As an opioid, hydrocodone bitartrate and acetaminophen tablets exposes users to the risks of addiction, abuse, and misuse [see n n n n .n nn
  • Although the risk of addiction in any individual is unknown, it can occur in patients u00a0appropriately prescribed hydrocodone bitartrate and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.
  • Assess each patientu2019s risk for opioid addiction, abuse, or misuse prior to prescribing hydrocodone u00a0bitartrate and acetaminophen tablets, and monitor all patients receiving hydrocodone u00a0bitartrate and acetaminophen tablets for the development of these behaviors or u00a0conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental u00a0illness (e.g., major depression). The potential for these risks should not, u00a0however, prevent the proper management of pain in any given patient. Patients u00a0at increased risk may be prescribed opioids such as hydrocodone bitartrate and u00a0acetaminophen tablets, but use in such patients necessitates intensive u00a0counseling about the risks andproper use of hydrocodone bitartrate and acetaminophen tablets along with intensive u00a0monitoring for signs of addiction, abuse, and misuse.
  • Opioids are u00a0sought by drug abusers and people with addiction disorders and are subject to u00a0criminal diversion. Consider these risks when prescribing or dispensing hydrocodone u00a0bitartrate and acetaminophen tablets. 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 [see n n n ;n n n ]. Contact local state professional licensing board or state controlled u00a0substances authority for information on how to prevent and detect abuse or diversion of this product.n nn
  • Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
  • Healthcare providers are strongly encouraged to do all of the following:
  • u2022u00a0Complete a n n n offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.n nn
  • u2022u00a0Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. The n n n can be obtained at this link: n n n n
  • u2022u00a0Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them.
  • u2022u00a0Consider using other tools to improve patient, household, and community safety, such as patient- prescriber agreements that reinforce patient- prescriber responsibilities.
  • To obtain further information on the opioid analgesic REMS and for a list of accredited REMSu00a0CME/CE, call 800-503-0784, or log on to n n n . The FDA Blueprint can be found at n n n .n nn
  • Arrayn- Array
  • Serious, u00a0life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive u00a0measures, and use of opioid antagonists, depending on the patientu2019s clinical u00a0status [see n n n ]. Carbon dioxide (COn n n ) retention from u00a0opioid-induced respiratory depression can exacerbate the sedating effects of opioids.n nn
  • While u00a0serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydrocodone bitartrate and acetaminophen tablets, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage u00a0increases of hydrocodone bitartrate and acetaminophen tablets.
  • To reduce the risk of respiratory depression, proper dosing and titration of hydrocodone bitartrate and acetaminophen tablets are essential [see n n n ]. Overestimating the hydrocodone bitartrate and acetaminophen tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.n nn
  • Accidental ingestion of u00a0hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone and acetaminophen.n n n n Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see n n n ].n n n n
  • Neonatal u00a0Opioid Withdrawal Syndrome
  • Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.u00a0Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see n n n ;n n n n , n n n ].u00a0n nn
  • Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
  • Concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of Hydrocodone Bitartrate and Acetaminophen Tablets and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression [see WARNINGS], particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Tablets is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in Hydrocodone Bitartrate and Acetaminophen Tablets-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. When adding CYP3A4 inhibitors or discontinuing CYP3A4 inducers in Hydrocodone Bitartrate and Acetaminophen Tablets-treated patients, follow patients at frequent intervals and consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Tablets until stable drug effects are achieved [see n n n ].n nn
  • Concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with CYP3A4 inducers or discontinuation of an 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. When using Hydrocodone Bitartrate and Acetaminophen Tablets with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, follow patients at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur [see n n n ].n nn
  • Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
  • P
  • Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see n n n ].n nn
  • If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.
  • Advise both patients and caregivers about the risks of respiratory depression and sedation when Hydrocodone Bitartrate and Acetaminophen Tablets are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see n n n ].n nn
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
  • The use of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
  • Patients with Chronic Pulmonary Disease: Hydrocodone Bitartrate and Acetaminophen Tablet-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 Acetaminophen Tablets [see WARNINGS; Life-Threatening Respiratory Depression].
  • Elderly, Cachetic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see n n n n Life-Threatening Respiratory Depression].n nn
  • Follow such patients closely, particularly when initiating and titrating Hydrocodone Bitartrate and Acetaminophen Tablets and when Hydrocodone Bitartrate and Acetaminophen Tablets is given concomitantly with other drugs that depress respiration [see n n n Life-Threatening Respiratory Depression]. Alternatively, consider the use of non-opioid analgesics in these patients.n nn
  • Adrenal Insufficiency
  • Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
  • Severe Hypotension
  • Hydrocodone Bitartrate and Acetaminophen Tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see PRECAUTIONS; Drug Interactions]. Follow these patients for signs of hypotension after initiating or titrating the dosage of Hydrocodone Bitartrate and Acetaminophen Tablets. In patients with circulatory shock Hydrocodone Bitartrate and Acetaminophen Tablets may cause vasodilatation that can further reduce cardiac output and blood pressure. Avoid the use of Hydrocodone Bitartrate and Acetaminophen Tablets with circulatory shock.
  • Hepatotoxicity
  • Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
  • The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
  • Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.
  • Serious Skin Reactions
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
  • Hypersensitivity/Anaphylaxis
  • There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Tablets for patients with acetaminophen allergy [see n n n ].n nn
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
  • In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Hydrocodone Bitartrate and Acetaminophen Tablets may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Follow such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Hydrocodone Bitartrate and Acetaminophen Tablets.
  • Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with impaired consciousness or coma.
  • Risks of Use in Patients with Gastrointestinal Conditions
  • Hydrocodone Bitartrate and Acetaminophen Tablets are contraindicated in patients with gastrointestinal obstruction, including paralytic ileus.
  • The administration of Hydrocodone Bitartrate and Acetaminophen Tablets or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
  • Hydrocodone may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
  • Increased Risk of Seizures in Patients with Seizure Disorders
  • The hydrocodone in Hydrocodone Bitartrate and Acetaminophen Tablets may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Follow patients with a history of seizure disorders for worsened seizure control during hydrocodone bitartrate and acetaminophen tablet therapy.
  • Withdrawaln- Arrayn- DOSAGE AND ADMINISTRATION, DRUG ABUSE AND DEPENDENCE
  • Additionally Avoid the use of mixed agonist/antagonist (e.g, pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Hydrocodone Bitartrate and Acetaminophen Tablets. In these patients, mixed agonist/antagonist and partial analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms.
  • When discontinuing Hydrocodone Bitartrate and Acetaminophen Tablets, gradually taper the dosage [see DOSAGE AND ADMINISTRATION]. Do not abruptly discontinue Hydrocodone Bitartrate and Acetaminophen Tablets [see n n n ] in patients who have been using Hydrocodone Bitartrate and Acetaminophen Tablets around the clock for more than 5 days.n nn
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  • The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and Tablets. Because these reactions are 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.n n n The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.n n n n n n Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.u00a0n n n n n n u00a0constipation.n n n n n n n Ureteral spasm, spasm of vesical sphincters and urinary retention.u00a0u00a0n n n n n n Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.u00a0n n n n n n n Skin rash, pruritus,u00a0Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactionsHematological - Thrombocytopenia, agranulocytosis.n n n Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.n n n u2022u00a0n n n : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.n n n u2022u00a0n n n : Anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets.n n n u2022u00a0n n n : Cases of androgen deficiency have occurred with chronic use of opioids [see n n n ].n nn
  • Controlled u00a0Substancen- Abusen- Arrayn- Risks u00a0Specific to Abuse of Hydrocodone Bitartrate and Acetaminophen Tablets
  • Arrayn- Array
  • Dependencen- DOSAGE AND ADMINISTRATION, WARNINGSn- Array
  • Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.n n n n n n
  • Acute overdose with hydrocodone bitartrate and acetaminophen tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.n n n n Acetaminophenu00a0n nn
  • Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur.
  • Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
  • Treatment u00a0of Overdosen- Hydrocodonen- u00a0
  • In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
  • The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to hydrocodone bitartrate and acetaminophen tablets overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydrocodone bitartrate and acetaminophen tablets overdose.
  • Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone bitartrate and acetaminophen tablets in hydrocodone bitartrate and acetaminophen tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
  • In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.n n n n
  • Acetaminophenu00a0
  • Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
  • Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
  • Important u00a0Dosage and Administration Instructionsn- Arrayn- Arrayn- Array
  • Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see n n n ]. n nn
  • Follow patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly [see n n n ].n nn
  • Initial Dosage
  • Initiating Treatment with Hydrocodone Bitartrate and Acetaminophen Tablets
  • Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Tablets
  • There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Hydrocodone Bitartrate and Acetaminophen Tablets. It is safer to underestimate a patientu2019s 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage than to overestimate the 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage and manage an adverse reaction due to overdose.
  • Conversion from Hydrocodone Bitartrate and Acetaminophen Tablets to Extended-Release Hydrocodone
  • The relative bioavailability of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Tablets compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression.
  • Arrayn- Array
  • If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the hydrocodone bitartrate and acetaminophen tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
  • Safe Reduction or Discontinuation of Hydrocodone Bitartrate and Acetaminophen Tablets
  • Do not abruptly discontinue hydrocodone bitartrate and acetaminophen tablets in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
  • When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking hydrocodone bitartrate and acetaminophen tablets, there are a variety of factors that should be considered, including the dose of hydrocodone bitartrate and acetaminophen tablets the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.
  • There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on hydrocodone bitartrate and acetaminophen tablets who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.
  • It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. 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. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
  • When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see n n n ].n nn
  • Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg
  • NDC 66267-319-30 BOTTLES OF 30n n n n n n n Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] n n nStore Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see n ].n n nDispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep this and all medication out of the reach of children.n n n n nA Schedule C-II controlled drug substance.n n n n n n n n n n n nDistributed by:n n n n n n279 Princeton-Hightstown Roadn n nEast Windsor, NJ 08520n n n n nRevised: 04/2019n
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
  • HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fenn n n n
  • Hydrocodone Bitartrate and Acetaminophen Tablets aren- :
  • Important u00a0information aboutu00a0n- Hydrocodone Bitartrate and Acetaminophen Tabletsn- :
  • Do not takeu00a0n- Hydrocodone Bitartrate and Acetaminophen Tabletsn- u00a0if you have:
  • Before u00a0taking Hydrocodone Bitartrate and Acetaminophen Tablets, tell your healthcare provider if you have a history of:
  • Tell your u00a0healthcare provider if you are:
  • When takingu00a0n- Hydrocodone Bitartrate and Acetaminophen Tabletsn- :
  • While u00a0taking Hydrocodone Bitartrate and Acetaminophen Tablets DO NOT:
  • The u00a0possible side effects of hydrocodone Bitartrate and Acetaminophen Tablets:
  • Get u00a0emergency medical help if you have:
  • These are not all the possible side effects of hydrocodone bitartrate and acetaminophen tablets. Call your doctor for medical advice about side effects. You may also request medical information or to report suspected adverse reactions, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088.n n n n
  • What are the ingredients in Hydrocodone Bitartrate and Acetaminophen Tablets?
  • Active Ingredients: n- Array
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration. n n n n Dispense with Medication Guide available atn n n n n
  • Distributed by:n n n n n 279 Princeton-Hightstown Roadn n n East Windsor, NJ 08520n n n n Revised: 04/2019u00a0u00a0n nn
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Hydrocodone Bitartrate and Acetaminophen (Hydrocodone Bitartrate and Acetaminophen) which is also known as Hydrocodone Bitartrate and Acetaminophen and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 10; 325 mg/1; mg/1.

Hydrocodone Bitartrate and Acetaminophen (Hydrocodone Bitartrate and Acetaminophen) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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