Hydrocodone Bitartrate and Acetaminophen 10 mg; 325 mg Tablet, 100-count — NDC 60687-418-01 (Billing 60687-0418-01)
This is a package of 100 tablets of Hydrocodone Bitartrate and Acetaminophen 10 mg; 325 mg Tablet from American Health Packaging, marketed since Apr 2019 and currently FDA-listed; retail pharmacies pay about $0.1523 per tablet (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 030623
- GCN: 70330
- GPI-14 (Medi-Span): 65991702100305
- HICL (First Databank): 001730
- AHFS class code: 28:08.08.00
- RxCUI (RxNorm): 856999
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.152 | $15.23 / 100 tablet |
| Medicaid paysCMS SDUD · 12 mo | $8.06 | $806.24 / 100 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.2311 | $23.11 / 100 tablet |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60687-0418-01 You're viewing this Main listing | 100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK | 2019-04-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 42806-0113-01 | Epic | 100 tablets | $0.135 | AA | FDA listed | save 12% |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 00406-0125-01 | SpecGx | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 10702-0191-01 | KVK-Tech, | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 13107-0021-01 | Aurolife | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 27808-0037-01 | Cranbury | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 31722-0997-01 | Camber | 100 tablets | $0.152 | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 42858-0203-01 | Rhodes | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 50268-0402-15 | AvPAK | 50 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 53746-0110-01 | Amneal | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mgthis 60687-0418-01 | American | 100 tablets | $0.152 | AA | Availability likely | — |
| hydrocodone bitartrate and acetaminophen 10 mg/1; 325 mg 64380-0442-01 | Strides | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 64850-0633-01 | Elite | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71930-0021-12 | Eywa | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 43386-0358-01 | Lupin | 100 tablets | $0.153 | — | Availability likely | +1% |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 00245-0412-01 | Upsher-Smith | 100 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 55700-0991-30 | Quality | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 60429-0592-01 | Golden | 100 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 60760-0871-30 | ST. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 60760-0872-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63187-0120-20 | Proficient | 20 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63187-0778-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 63304-0497-01 | Sun | 100 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-1938-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2298-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2299-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2300-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2470-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2471-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-8886-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 66267-0319-30 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 68071-4941-06 | NuCare | 6 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 70010-0674-01 | Granules | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71205-0660-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1271-00 | Bryant | 120 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1339-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1418-00 | Bryant | 120 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1444-01 | Bryant | 21 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2105-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2118-00 | Bryant | 120 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2740-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-9602-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-9735-00 | Bryant | 120 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-1281-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-1991-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-2271-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 325 mg/1; 10 mg 72189-0348-30 | DirectRx | 30 tablets | — | AA | FDA listed | — |
| Norco 10 mg/1; 325 mg 72189-0399-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone/APAP 10 mg/1; 325 mg 72189-0650-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72865-0112-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72865-0204-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 76420-0215-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 76420-0877-00 | Asclemed | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 82804-0003-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 87063-0051-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDRCODONE BITARTRATE AND ACETAMINOPHEN TABLETS. Addiction, Abuse, and Misuse Because the use of Hydrocodone Bitartrate and Acetaminophen Tablets 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 risk prior to prescribing and reassess all patients regularly for the development of these behaviors or conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Tablets especially during initiation or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of Hydrocodone Bitartrate and Acetaminophen Tablets are essential [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of Hydrocodone Bitartrate and Acetaminophen Tablets especially by children, can result in a fatal overdose of Hydrocodone [see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants 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.
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 [see WARNINGS , PRECAUTIONS; DRUG INTERACTIONS ]. Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS ].
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in Hydrocodone Bitartrate and Acetaminophen Tablets 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 Bitartrate and Acetaminophen Tablets 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 CLINICAL PHARMACOLOGY , WARNINGS , PRECAUTIONS; Drug Interactions ]. 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. [see WARNINGS , OVERDOSAGE ].
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablet 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, which can occur at any dosage or duration [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone Bitartrate and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Hydrocodone Bitartrate and Acetaminophen Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Hydrocodone Bitartrate and Acetaminophen Tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors.
Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see WARNINGS ]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydrocodone Bitartrate and Acetaminophen Tablets. Consider this risk when selecting an initial dose and when making dose adjustments [see WARNINGS ].
Initial Dosage Use of Hydrocodone Bitartrate and Acetaminophen Tablets as the First Opioid Analgesic 5 mg/325 mg Initiate treatment with Hydrocodone Bitartrate and Acetaminophen Tablets in a dosing range of 1 to 2 tablets every 4 to 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets. The total daily dosage should not exceed 8 tablets.
7.5mg/325 mg 10 mg/325 mg Initiate treatment with Hydrocodone Bitartrate and Acetaminophen Tablets with 1 tablet every 4 to 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets. The total daily dosage should not exceed 6 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 patient’s 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. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with Hydrocodone Bitartrate and Acetaminophen Tablets [see WARNINGS, Life-Threatening Respiratory Depression ; PRECAUTIONS, Information for Patients and/or Caregivers ].
Inform… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Hydrocodone Bitartrate and Acetaminophen Tablet is contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see WARNINGS , ADVERSE REACTIONS ]
⚠️ Warnings ▾
WARNINGS Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a Schedule II controlled substance. As an opioid, Hydrocodone Bitartrate and Acetaminophen Tablet exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Acetaminophen Tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Hydrocodone Bitartrate and Acetaminophen Tablets and reassess all patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).
The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Hydrocodone Bitartrate and Acetaminophen Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Hydrocodone Bitartrate and Acetaminophen Tablets along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS, Life-Threatening Respiratory Depression ; Dosage and Administration , Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose ].
Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Acetaminophen Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug.
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Life-Threatening Respiratory Depression Serious, life-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 measures, and use of opioid antagonists, depending on the patient’s clinical status [see OVERDOSAGE ]. Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, 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.
To reduce the risk of respiratory depression, proper dosing and titration of Hydrocodone Bitartrate and Acetaminophen Tablets is essential [see DOSAGE AND ADMINISTRATION ]. Overestimating the Hydrocodone Bitartrate and Acetaminophen Tablets dosage when converting patients from another opioid product can result in a fatal overdose. Accidental ingestion of even one dose of Hydrocodone Bitartrate and Acetaminophen Tablets, especially by children, can result in respiratory depression and death due to an overdose of Hydrocodone Bitartrate and Acetaminophen Tablets.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see PRECAUTIONS, Information for Patients and/or Caregivers ]. Opioids can cause sleep-related breathing disorders including cen… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of Hydrocodone Bitartrate and Acetaminophen Tablet. 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 light-headedness, dizziness, sedation, nausea and vomiting.
Other adverse reactions include: Central Nervous System – Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes. Gastrointestinal System – Constipation. Genitourinary System – Ureteral spasm, spasm of vesical sphincters, and urinary retention.
Special Senses – Cases of Hearing impairment or permanent loss have been reported predominately in patients with chronic overdose. Dermatological – Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions Hematological – Thrombocytopenia, agranulocytosis. Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets. Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids for an extended period of time [see CLINICAL PHARMACOLOGY ].
Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see WARNINGS ]. Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
🔄 Drug Interactions ▾
Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of the Hydrocodone Bitartrate and Acetaminophen Tablets, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Tablets is achieved [see WARNINGS ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentration will decrease [see CLINICAL PHARMACOLOGY ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Tablets. If concomitant use is necessary, consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Tablets until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation.
If a CYP3A4 inhibitor is discontinued, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved. Evaluate for signs or symptoms of opioid withdrawal. Inducers of CYP3A4 The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of Hydrocodone Bitartrate and Acetaminophen Tablets [see CLINICAL PHARMACOLOGY ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Tablets [see WARNINGS ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentration will increase [see CLINICAL PHARMACOLOGY ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved. Evaluate the patient for signs and symptoms of opioid withdrawal.
If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Tablets dosage reduction and follow for signs of respiratory depression. Benzodiazepines and Other CNS Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, such as benzodiazepines and other sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction, educate them on the signs and symptoms of respiratory depression (including sedation).
If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS ]. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e.… [Excerpted — this section continues on DailyMed.]
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects There are no adequate and well-controlled studies in pregnant women. Hydrocodone Bitartrate and Acetaminophen Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity, abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS ].
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of Hydrocodone Bitartrate and Acetaminophen Tablets in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to Hydrocodone Bitartrate and Acetaminophen Tablets. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Titrate the dosage of Hydrocodone Bitartrate and Acetaminophen Tablets slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see WARNINGS ]. Hydrocodone and acetaminophen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.
Hepatic Impairment Patients with hepatic impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with hepatic impairment and regularly evaluate for adverse events such as respiratory depression and sedation. Renal Impairment Patients with renal impairment may have higher plasma hydrocodone concentrations than those with normal function.
Use a low initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with renal impairment and regularly evaluate for adverse events such as respiratory depression and sedation.
🆘 Overdosage ▾
OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Clinical Presentation Acute overdosage 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, hypoglycemia, 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. 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 of Overdose Hydrocodone In case of overdose, priorities are the re-establishment 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. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to Opioid overdose, administer an opioid antagonist.
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 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.
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 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Pharmacodynamics Effects on the Central Nervous System The principal therapeutic action of hydrocodone is analgesia. Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers.
The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Hydrocodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings).
Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.
Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see ADVERSE REACTIONS ].
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Use of opioids for an extended period of time may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the 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 [see ADVERSE REACTIONS ].
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration–Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with agonist opioids. The minimum effective analgesic concentration of hydrocodone for any individual pa… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
Mechanism of Action Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as: Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5/325 Peach colored capsule shaped tablets, one side scored and other side debossed with “WES 301”. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in: Unit dose packages of 100 (10x10) NDC 60687-396-01 Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5/325 White colored capsule shaped tablets, one side scored and other side debossed with “WES 302”.
Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in: Unit dose packages of 100 (10 x 10) NDC 60687-407-01. Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10/325 Blue colored capsule shaped tablets, one side scored and other side debossed with “WES 303”.
Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in: Unit dose packages of 100 (10 x 10) NDC 60687-418-01. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Store Hydrocodone Bitartrate and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. DEA Order Form Required.
📋 Description ▾
DESCRIPTION Hydrocodone Bitartrate and Acetaminophen is available in tablet 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 4,5α-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: Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg contains: Hydrocodone Bitartrate………………………..5 mg Acetaminophen………………………..…….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate………………………..7.5 mg Acetaminophen……………………………….325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg contains: Hydrocodone Bitartrate………………………..10 mg Acetaminophen……………………………….325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, FD&C yellow#6 aluminum lake (5 mg/325 mg only), and FD&C blue#1 aluminum lake (10 mg/325 mg only).
Meets USP Dissolution Test 2. Hydrocodone Structural Formula Acetaminophen Structural Formula
💬 Information for Patients ▾
Information for Patients/Caregivers Advise the patient to read the FDA-approved patient labeling (Medication Guide) . Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Hydrocodone Bitartrate and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving hydrocodone bitartrate and acetaminophen tablets unsecured can pose a deadly risk to others in the home. [see WARNINGS , DRUG ABUSE AND DEPENDENCE ] Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly.
Expired, unwanted, or unused Hydrocodone Bitartrate and Acetaminophen Tablets should be disposed of by flushing the unused medication down the toilet if a drug take -back option is not readily available. Inform patients that they can visit www.fda.gov/drugsdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines. Addiction, Abuse, and Misuse Inform patients that the use of Hydrocodone Bitartrate and Acetaminophen Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ].
Instruct patients not to share Hydrocodone Bitartrate and Acetaminophen Tablets with others and to take steps to protect Hydrocodone Bitartrate and Acetaminophen Tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Acetaminophen Tablets or when the dosage is increased, and that it can occur even at recommended dosages. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see WARNINGS, Life Threatening Respiratory Depression ].
Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ]. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Acetaminophen Tablets is used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS and PRECAUTIONS; Drug Interactions ].
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with Hydrocodone Bitartrate and Acetaminophen Tablets. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) [see WARNINGS, Life-Threatening Respiratory Depression ; DOSAGE AND ADMINISTRATION ].
Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered [see OVERDOSAGE ]. If naloxone is prescribed, also advise patients and caregivers: How to treat with naloxone in the event of an opioid overdose To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency To read the Patient Information (or other educational material) that will come with their naloxone.
Emphasiz… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
Medication Guide 8439601/1124 Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Acetaminophen (a seet” a min’ oh fen) Tablets, USP CII Hydrocodone Bitartrate and Acetaminophen Tablet, USP is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. An opioid pain medicine that can put you at risk for overdose and death.
Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about Hydrocodone Bitartrate and Acetaminophen Tablets, USP: Get emergency help or call 911 right away if you take too much Hydrocodone Bitartrate and Acetaminophen Tablets, USP (overdose). When you first start taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. Taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your Hydrocodone Bitartrate and Acetaminophen Tablets.
They could die from taking it. Selling or giving away Hydrocodone Bitartrate and Acetaminophen Tablets is against the law. Store Hydrocodone Bitartrate and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take Hydrocodone Bitartrate and Acetaminophen Tablets, USP if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines. known hypersensitivity to hydrocodone or acetaminophen, or any ingredient in hydrocodone and acetaminophen tablets. Before taking Hydrocodone Bitartrate and Acetaminophen Tablets USP, tell your healthcare provider if you have a history of: head injury, seizures problems urinating abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems. liver, kidney, thyroid problems pancreas or gallbladder problems Tell your healthcare provider if you are: Noticing your pain getting worse.
If your pain gets worse after you take Hydrocodone Bitartrate and Acetaminophen Tablets, do not take more of Hydrocodone Bitartrate and Acetaminophen Tablets, without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Hydrocodone Bitartrate and Acetaminophen Tablets. Are pregnant or planning to become pregnant .
Use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breastfeeding . Hydrocodone Bitartrate and Acetaminophen Tablets, USP pass into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness.
Seek immediate medical care if you notice these signs. living in a household where there are small children or someone who has abused street or prescription drugs. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP with certain other medicines can cause serious side effects that could lead to death. When taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP: Do not change your dose.
Take Hydro… [Excerpted — this section continues on DailyMed.]
⚠️ Precautions ▾
PRECAUTIONS Risks of Driving and Operating Machinery Hydrocodone Bitartrate and Acetaminophen Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Hydrocodone Bitartrate and Acetaminophen Tablets and know how they will react to the medication [see PRECAUTIONS; Information for Patients/Caregivers ]. Information for Patients/Caregivers Advise the patient to read the FDA-approved patient labeling (Medication Guide) .
Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Hydrocodone Bitartrate and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving hydrocodone bitartrate and acetaminophen tablets unsecured can pose a deadly risk to others in the home. [see WARNINGS , DRUG ABUSE AND DEPENDENCE ] Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly.
Expired, unwanted, or unused Hydrocodone Bitartrate and Acetaminophen Tablets should be disposed of by flushing the unused medication down the toilet if a drug take -back option is not readily available. Inform patients that they can visit www.fda.gov/drugsdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines. Addiction, Abuse, and Misuse Inform patients that the use of Hydrocodone Bitartrate and Acetaminophen Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ].
Instruct patients not to share Hydrocodone Bitartrate and Acetaminophen Tablets with others and to take steps to protect Hydrocodone Bitartrate and Acetaminophen Tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Acetaminophen Tablets or when the dosage is increased, and that it can occur even at recommended dosages. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see WARNINGS, Life Threatening Respiratory Depression ].
Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ]. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Acetaminophen Tablets is used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS and PRECAUTIONS; Drug Interactions ].
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with Hydrocodone Bitartrate and Acetaminophen Tablets. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) [see WARNINGS, Life-Threatening Respiratory Depression ; DOSAGE AND ADMINISTRATION ].
Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emer… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Hydrocodone is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Hydrocodone Bitartrate and Acetaminophen Tablets and any potential adverse effects on the breastfed infant from Hydrocodone Bitartrate and Acetaminophen Tablets or from the underlying maternal condition. Infants exposed to Hydrocodone Bitartrate and Acetaminophen Tablets through breast milk should be monitored for excess sedation and respiratory depression.
Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.
🧬 Pharmacokinetics ▾
Pharmacokinetics The behavior of the individual components is described below. Hydrocodone Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours.
Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α-and 6-β-hydroxymetabolites. See OVERDOSAGE for toxicity information. CYP3A4 mediated N-demethylation to norhydrocodone is the primary metabolic pathway of hydrocodone with a lower contribution from CYP2D6 mediated O-demethylation to hydromorphone.
Hydromorphone is formed from the O-demethylation of hydrocodone and may contribute to the total analgesic effect of hydrocodone. Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs [see PRECAUTIONS; Drug Interactions ]. N-demethylation of hydrocodone to form norhydrocodone via CYP3A4 while O-demethylation of hydrocodone to hydromorphone is predominantly catalyzed by CYP2D6 and to a lesser extent by an unknown low affinity CYP enzyme.
Hydrocodone and its metabolites are eliminated primarily in the kidneys. Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. A small fraction (10-25%) of acetaminophen is bound to plasma proteins.
The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: conjugation with glucuronide; conjugation with sulfate; and oxidation via the cytochrome, P450-dependent, mixed-function oxidase enzyme pathway to form a reactive intermediate metabolite, which conjugates with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates.
The principal cytochrome P450 isoenzyme involved appears to be CYP2E1, with CYP1A2 and CYP3A4 as additional pathways. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information.
🧬 Pharmacodynamics ▾
Pharmacodynamics Effects on the Central Nervous System The principal therapeutic action of hydrocodone is analgesia. Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.
Hydrocodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.
Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased.
Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope.
Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see ADVERSE REACTIONS ]. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon.
Use of opioids for an extended period of time may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the 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 [see ADVERSE REACTIONS ].
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration–Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with agonist opioids. The minimum effective analgesic concentration of hydrocodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance [see DOSAGE AND ADMINISTRATION ]. Concentration–Adverse Reaction Relationships There is a relationship between increasing hydrocodone plasma concentration and increasing frequency of dose- related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.
In opioid- tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see DOSAGE AND ADMINISTRATION ].
🔒 Drug Abuse and Dependence ▾
DRUG ABUSE AND DEPENDENCE Controlled Substance Hydrocodone Bitartrate and Acetaminophen Tablet contains hydrocodone, a Schedule II controlled substance. Abuse Hydrocodone Bitartrate and Acetaminophen Tablet contains hydrocodone, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings]. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed.
Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of Hydrocodone Bitartrate and Acetaminophen Tablets increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death.
The risk is increased with concurrent abuse of Hydrocodone Bitartrate and Acetaminophen Tablets with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction.
All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of Hydrocodone Bitartrate and Acetaminophen Tablets abuse include those with a history of prolonged use of any opioid including products containing Hydrocodone those with a history of drug or alcohol abuse, or those who use Hydrocodone Bitartrate and Acetaminophen Tablets in combination with other abused drugs. “Drug-seeking” behavior is very common in persons with substance use disorders.
Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Hydrocodone Bitartrate and Acetaminophen Tablets like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Risks Specific to Abuse of Hydrocodone Bitartrate and Acetaminophen Tablets Abuse of Hydrocodone Bitartrate and Acetaminophen Tablet poses a risk of overdose and death. The risk is increased with concurrent use of Hydrocodone Bitartrate and Acetaminophen Tablets with alcohol and/or other CNS depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to p… [Excerpted — this section continues on DailyMed.]
🔒 Controlled Substance ▾
Controlled Substance Hydrocodone Bitartrate and Acetaminophen Tablet contains hydrocodone, a Schedule II controlled substance.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies to evaluate the carcinogenic potential of the combination of Hydrocodone Bitartrate and Acetaminophen Tablets have not been conducted. Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice were fed a diet containing acetaminophen up to 6000 ppm.
Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0.8 times the maximum human daily dose (MHDD) of 4 grams/day, based on a body surface area comparison. In contrast, there was no evidence of carcinogenic activity in male rats that received up to 0.7 times or mice at up to 1.2-1.4 times the MHDD, based on a body surface area comparison. Mutagenesis In the published literature, acetaminophen has been reported to be clastogenic when administered at 1500 mg/kg/day to the rat model (3.6-times the MHDD, based on a body surface area comparison).
In contrast, no clastogenicity was noted at a dose of 750 mg/kg/day (1.8-times the MHDD, based on a body surface area comparison), suggesting a threshold effect. Impairment of Fertility In studies conducted by the National Toxicology Program, fertility assessments with acetaminophen have been completed in Swiss CD-1 mice via a continuous breeding study. There were no effects on fertility parameters in mice consuming up to 1.7 times the MHDD of acetaminophen, based on a body surface area comparison.
Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1.78 times the MHDD (based on a body surface comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing. Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1.2 times the MHDD and greater (based on a body surface comparison) result in decreased testicular weights, reduced spermatogenesis, reduced fertility, and reduced implantation sites in females given the same doses.
These effects appear to increase with the duration of treatment. The clinical significance of these findings is not known. Infertility Use of opioid for an extended period of time may cause reduced fertility in females and males of reproductive potential.
It is not known whether these effects on fertility are reversible [see ADVERSE REACTIONS ].
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel – Carton – 5 mg/325 mg – 100 UD NDC 60687- 396 -01 Hydrocodone Bitartrate and Acetaminophen CII Tablets, USP 5 mg/325 mg 100 Tablets (10 x 10) Rx Only PHARMACIST: Dispense with Medication Guide to each patient. Each Tablet Contains: Hydrocodone bitartrate, USP...............................................5 mg Acetaminophen, USP........................................................325 mg Usual Adult Dosage: One or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.
See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. DEA Order Form Required FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from NDC # 71930-019, Eywa Pharma Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 739601 0439601/1124 5 mg 325mg Hydrocodone APAP Tablets Carton.jpg
Package/Label Display Panel – Blister – 5 mg/325 mg Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/325 mg CII 5 mg 325mg Hydrocodone APAP Tablet Blister.jpg
Package/Label Display Panel – Carton – 7.5 mg/325 mg NDC 60687- 407 -01 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII 7.5 mg/325 mg 100 Tablets (10 x 10) Rx Only PHARMACIST: Dispense with the accompanying Medication Guide to each patient. Each Tablet Contains: Hydrocodone bitartrate, USP......................................7.5 mg Acetaminophen, USP..................................................325 mg Usual Adult Dosage: One tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. DEA Order Form Required FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from NDC # 71930-020, Eywa Pharma Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 740701 0440701/0924 7.5 mg 325mg Hydrocodone APAP Tablets Carton.jpg
Package/Label Display Panel – Blister – 7.5 mg/325 mg Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/325 mg CII 7.5 mg 325mg Hydrocodone APAP Tablet Blister.jpg
Package/Label Display Panel – Carton – 10 mg/325 mg NDC 60687- 418 -01 Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII 10 mg/325 mg 100 Tablets (10 x 10) Rx Only PHARMACIST: Dispense with Medication Guide to each patient. Each Tablet Contains: Hydrocodone bitartrate, USP.......................................10 mg Acetaminophen, USP..................................................325 mg Usual Adult Dosage: One tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. DEA Order Form Required FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from NDC # 71930-021, Eywa Pharma Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 741801 0439601/1124 10 mg 325mg Hydrocodone APAP Tablets Carton.jpg
Package/Label Display Panel – Blister – 10 mg/325 mg Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/325 mg CII 10 mg 325mg Hydrocodone APAP Tablet Blister.jpg