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Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen)

Trade Name : Hydrocodone Bitartrate and Acetaminophen

Par Pharmaceutical, Inc.

TABLET

Strength 5325 mg/1mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen) which is also known as Hydrocodone Bitartrate and Acetaminophen and Manufactured by Par Pharmaceutical, Inc.. It is available in strength of 5; 325 mg/1; mg/1 per ml. Read more

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.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BOXED WARNING
  • WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
  • Arrayn- Hydrocodone Bitartrate and Acetaminophen Tablets expose patients and other users to the risks of opioid addiction, abuse, 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 and conditions [see ]
  • Arrayn- 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 REMS for these products [see ]. 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
  • Arrayn- Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Tablets. Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Acetaminophen Tablets or following a dose increase [see ].
  • Arrayn- Accidental ingestion of Hydrocodone Bitartrate and Acetaminophen Tablets, especially by children, can result in a fatal overdose of Hydrocodone Bitartrate and Acetaminophen Tablets [see ].
  • Arrayn- Prolonged use of Hydrocodone Bitartrate and Acetaminophen Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required 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 [see ].
  • 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 , , ].
  • 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 , ].
  • Arrayn- 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 [see , ]
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP is supplied in tablet form for oral administration.
  • 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:
  • CHNO u2022 CHO u2022 2u00bd HOM.W. 494.49
  • Acetaminophen, 4u00b4-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
  • CHNOn M.W. 151.16
  • Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains:Hydrocodone Bitartrate u2026..... 5 mgAcetaminophen ................. 325 mg
  • Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains:Hydrocodone Bitartrate ......... 7.5 mgAcetaminophen ..................... 325 mg
  • Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains:Hydrocodone Bitartrate .......... 10 mgAcetaminophen ..................... 325 mg
  • In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
  • Meets USP Dissolution Test 1.
  • No data
  • 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.
  • Limitations of Usen- Array
  • Hydrocodone Bitartrate and Acetaminophen Tablets are contraindicated in patients with:
  • No data
  • No data
  • The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen 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.
  • The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea and vomiting.
  • Other adverse reactions include:
  • Central Nervous System
  • Gastrointestinal System
  • Genitourinary System
  • Special Senses
  • Dermatological
  • Hematological
  • No data
  • Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
  • Clinical Presentation
  • Acetaminophen
  • 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 of Overdose
  • Hydrocodone
  • 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 in hydrocodone bitartrate and acetaminophen tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. 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 initiated with care and by titration with smaller than usual doses of the antagonist.
  • Acetaminophen
  • 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 Dosage and Administration Instructions
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see ].
  • 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 ].
  • Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly [see ].
  • Initial Dosage
  • Initiating Treatment with Hydrocodone Bitartrate and Acetaminophen Tablets
  • 5 mg/325 mg:
  • 7.5 mg/325 mg:
  • 10 mg/325 mg:
  • Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Tablets
  • Conversion from Hydrocodone Bitartrate and Acetaminophen Tablets to Extended-Release Hydrocodone
  • Titration and Maintenance of Therapy
  • Individually titrate hydrocodone bitartrate and acetaminophen tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving hydrocodone bitartrate and acetaminophen tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
  • 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 .
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg n- WARNING: May be habit-forming
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg n- WARNING: May be habit-forming
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg n- WARNING: May be habit-forming
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F). [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container with a child-resistant closure.
  • Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly [see ].
  • Distributed by: Par PharmaceuticalChestnut Ridge, NY 10977
  • Rev. 08/2019
  • HYDROCODONE BITARTRATE n- AND ACETAMNOPHEN n- TABLETS CII
  • Hydrocodone Bitartrate and Acetaminophen Tablets are:
  • Important information about Hydrocodone Bitartrate and Acetaminophen Tablets:
  • Do not take Hydrocodone Bitartrate and Acetaminophen Tablets if you have:
  • Before taking Hydrocodone Bitartrate and Acetaminophen Tablets, tell your healthcare provider if you have a history of:
  • Tell your healthcare provider if you are:
  • When taking Hydrocodone Bitartrate and Acetaminophen Tablets:
  • While taking Hydrocodone Bitartrate and Acetaminophen Tablets DO NOT:
  • The possible side effects of Hydrocodone Bitartrate and Acetaminophen Tablets:
  • Get emergency 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 report side effects to FDA at 1-800-FDA-1088. n
  • Distributed by:n Chestnut Ridge, NY 10977
  • 1-800-828-9393
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Rev. 04/2019n
  • Principle Display Panel - 5mg
  • Principle Display Panel - 7.5mg
  • Principle Display Panel - 10mg

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