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Hydrocodone Bitartrate And Acetaminophen (Hydrocodone Bitartrate And Acetaminophen)

Trade Name : Hydrocodone Bitartrate and Acetaminophen

Pharmaceutical Associates, Inc.

SOLUTION

Strength 7.5325 mg/15mLmg/15mL

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

Delivery Process

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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 Pharmaceutical Associates, Inc.. It is available in strength of 7.5; 325 mg/15mL; mg/15mL 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

Packaging and Delivery

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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.

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About GNH

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.

Read more
  • No data
  • I07720919
  • Revised: September 2019
  • WARNING: RISK OF MEDICATION ERRORS; 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- Risk of Medication Errors
  • Ensure accuracy when prescribing, dispensing, and administering n- Hydrocodone Bitartraten- and n- Acetaminophen Oral Solution.n- u00a0Dosing errors due to confusion between mg and mL, and othern- Hydrocodone Bitartrate and Acetaminophen Oral Solutionsn- of different concentrations can result in accidental overdose and death [see n- Arrayn- ].
  • Arrayn- Addiction, Abuse, and Misuse
  • Hydrocodone n- Bitartraten- and n- Acetaminophen Oral Solutionn- exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's riskn- prior to prescribing n- Hydrocodone Bitartraten- and n- Acetaminophen Oral Solutionn- , and monitor all patients regularly for the development of these behaviors n- andn- conditions [see n- Arrayn- ].
  • Arrayn- 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 REMS for these products [see n n n n n n ]. 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 n n n n n n
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of n- Hydrocodone Bitartraten- and n- Acetaminophen Oral Solution. u00a0Follow patientsn- for n- signs of n- respiratory depression, especially duringn- initiation of Hydrocodone Bitartrate and Acetaminophen Oral Solution or following a dose increase [see n- Arrayn- ].
  • Arrayn- Accidental Ingestion
  • Accidental ingestion of n- Hydrocodone Bitartraten- and n- Acetaminophen Oral Solutionn- , especially by children, can result in a fatal overdose of n- Hydrocodone Bitartraten- and n- Acetaminophen Oral Solutionn- [see n- Arrayn- ].
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of n- Hydrocodone Bitartraten- and n- Acetaminophen Oral Solutionn- 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. u00a0If 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 n- Arrayn- ].
  • Arrayn- Cytochrome P450 3A4 Interaction
  • The concomitant use of n- Hydrocodone Bitartraten- and n- Acetaminophen Oral Solutionn- with all n- Cytochromen- P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression. u00a0In addition, discontinuation of a concomitantly used n- Cytochromen- P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. u00a0n- Follown- patients receiving n- Hydrocodone Bitartrate and Acetaminophen Oral Solutionn- and any n- Cytochrome P450 3A4n- inhibitor or inducer n- for signs and symptoms of respiratory depression and sedation n- [see n- Arrayn- Arrayn- Arrayn- ].
  • Arrayn- Hepatotoxicity
  • Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. n- 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 n- see n- Arrayn- ].
  • Arrayn- Arrayn- Array
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coman- ,n- and death [see n- Arrayn- ].
  • Hydrocodone bitartrate and acetaminophen is available in liquid form for oral administration.
  • Hydrocodone bitartrate is an opioid analgesic 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:
  • Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
  • Hydrocodone Bitartrate and Acetaminophen Oral Solution contains:
  • In addition, the liquid contains the following inactive ingredients: edetate disodium, glycerin, methylparaben, propylene glycol, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow No. 10 as coloring and natural and artificial flavoring.
  • No data
  • Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
  • Limitations of Use
  • Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [seeu00a0n n n n n n n n n ], reserve Hydrocodone Bitartrate and Acetaminophen Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):n nn n nn n nn
  • Hydrocodone Bitartrate and Acetaminophen Oral Solution is contraindicated in patients with:
  • u2022 Significant respiratory depression [see n n n n ]n n n n n nu2022 Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see n n n n n nu2022 Known or suspected gastrointestinal obstruction, including paralytic ileus [see n n n n n n nu2022 Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see n n n n ]n n nn
  • No data
  • No data
  • The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and oral solution. u00a0Because 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 light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include:
  • Cardio-Renal:
  • Central Nervous System/Psychiatric:
  • Endocrine:
  • Gastrointestinal System:
  • Genitourinary System:
  • Hematologic:
  • Hypersensitivity:
  • Musculoskeletal:
  • Respiratory Depression: n- Array
  • Special Senses:
  • Skin:
  • To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210.
  • Array
  • No data
  • Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
  • Clinical Presentation
  • Acute overdosage with Hydrocodone Bitartrate and Acetaminophen Oral Solution 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.
  • Acetaminophen
  • Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. u00a0Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. u00a0Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. u00a0Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
  • Treatment of Overdose
  • Hydrocodone
  • In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. u00a0Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. u00a0Cardiac 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. u00a0For clinically significant respiratory or circulatory depression secondary to Hydrocodone Bitartrate and Acetaminophen Oral Solution overdose, administer an opioid antagonist. u00a0Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to Hydrocodone Bitartrate and Acetaminophen Oral Solution overdose.
  • Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in Hydrocodone Bitartrate and Acetaminophen Oral Solution carefully monitor the patient until spontaneous respiration is reliably reestablished. u00a0If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.
  • In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. u00a0The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. u00a0If 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
  • Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease absorption if acetaminophen is known or suspected to have occurred within a few hours of presentation. u00a0Serum 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 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. u00a0Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs in the course of intoxication.
  • No data
  • Hydrocodone Bitartrate and Acetaminophen Oral Solution is a yellow-colored, fruit flavored liquid containing 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol.u00a0
  • It is supplied in the following oral dosage forms:
  • NDC 0121-0772-04:u00a0 4 fl oz (118 mL) bottle
  • NDC 0121-0772-16: u00a016 fl oz (473 mL) bottle
  • NDC 0121-4772-05: u00a0 5 mL unit dose cup
  • NDC 0121-4772-40:u00a0 Case contains 40 unit dose cups of 5 mL (0121-4772-05) packaged in4 trays of 10 unit dose cups each.
  • NDC 0121-1544-10:u00a0 10mL unit dose cup
  • NDC 0121-1544-40:u00a0 Case contains 40 unit dose cups of 10 mL (0121-1544-10) packaged in 4 trays of 10 unit dose cups each.
  • NDC 0121-2316-15: u00a015mL unit dose cup
  • NDC 0121-2316-40: u00a0Case contains 40 unit dose cups of 15 mL (0121-2316-15) packaged in 4 trays of 10 unit dose cups each.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].u00a0Dispense in a tight, light-resistant container with a child-resistant closure.
  • Store Hydrocodone Bitartrate and Acetaminophen Oral Solution securely and dispose of properly [see n n n ].n nn
  • MANUFACTURED BY
  • Pharmaceutical Associates, Inc.
  • Greenville, SC 29605
  • www.paipharma.comu00a0
  • R09/19
  • Hydrocodone Bitartrate (hye-droe-koe-done bye-tar-trate) and Acetaminophen (a-seet-a-min-oh-fen) Oral Solution CII
  • Hydrocodone Bitartrate and Acetaminophen Oral Solution is:
  • Important information about Hydrocodone Bitartrate and Acetaminophen Oral Solution:
  • Do not take n- Hydrocodone Bitartrate and Acetaminophen Oral Solution if you have:
  • Before taking Hydrocodone Bitartrate and Acetaminophen Oral Solution, tell your healthcare provider if you have a history of:
  • Tell your healthcare provider if you are:
  • When taking Hydrocodone Bitartrate and Acetaminophen Oral Solution:
  • While taking Hydrocodone Bitartrate and Acetaminophen Oral Solutionn- DO NOT:
  • The possible side effects of Hydrocodone Bitartrate and Acetaminophen Oral Solution:
  • Get emergency medical help if you have:
  • These are not all the possible side effects of Hydrocodone Bitartrate and Acetaminophen Oral Solution.u00a0 Call your doctor for medical advice about side effects. u00a0You may report side effects to FDA at 1-800-FDA-1088. n n n n n n n
  • Manufactured and Distributed By:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Issued 04/2019
  • No data
  • NDC 0121-0772-16
  • Hydrocodone Bitartrate andn n n n n n n n n Acetaminophen Oral Solutionn n n n n n n n n CIIn n n n n n n n n
  • 7.5 mg/325 mg per 15 mL
  • Rx ONLY
  • 16 fl oz (473 mL)
  • Arrayn- Pharmaceuticaln n n n n n n n n Associates, Inc.n n n n n n n n n n- Array
  • NDC 0121-0772-04
  • Hydrocodone Bitartrate andn n n n n n n n n Acetaminophen Oral Solutionn n n n n n n n n CIIn n n n n n n n n
  • 7.5 mg/325 mg per 15 mL
  • Rx ONLY
  • 4 fl oz (118 mL)
  • Arrayn- Pharmaceuticaln n n n n n n n n Associates, Inc.n n n n n n n n n n- Array
  • Delivers n n n n n n n n n n NDC 0121-2316-15n nn n nn n nn
  • HYDROCODONE BITARTRATEn- and ACETAMINOPHEN ORAL SOLUTION
  • CII
  • 7.5 mg/325 mg per 15 mL
  • Alcohol 6.7%
  • FOR INSTITUTIONAL USE ONLY
  • Usual Dosage: See Package Insert forn n n n n n n n n Complete Dosage Recommendations.n n n n n n n n n n n PHARMACEUTICAL ASSOCIATES, INC.n n n n n n n n n GREENVILLE, SC 29605n nn n nn n nn
  • A47721502
  • Delivers n n n n n n n n n n NDC 0121-1544-10n nn n nn n nn
  • HYDROCODONE BITARTRATEn- and ACETAMINOPHEN ORAL SOLUTION
  • CII
  • 5 mg/217 mg per 10 mL
  • Alcohol 6.7%
  • FOR INSTITUTIONAL USE ONLY
  • Usual Dosage: See Package Insert forn n n n n n n n n Complete Dosage Recommendations.n n n n n n n n n n n PHARMACEUTICAL ASSOCIATES, INC.n n n n n n n n n GREENVILLE, SC 29605n nn n nn n nn
  • A47721003
  • Delivers n n n n n n n n n n NDC 0121-4772-05n nn n nn n nn
  • HYDROCODONE BITARTRATE CIIn- and ACETAMINOPHEN ORAL SOLUTION
  • CII
  • 2.5 mg/108 mg per 5 mL
  • Alcohol 6.7%
  • FOR INSTITUTIONAL USE ONLY
  • Usual Dosage: See Package Insert forn n n n n n n n n Complete Dosage Recommendations.n n n n n n n n n n n PHARMACEUTICAL ASSOCIATES, INC.n n n n n n n n n GREENVILLE, SC 29605n nn n nn n nn
  • A47720501

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