Hydrocodone Bitartrate and Acetaminophen 7.5 mg; 325 mg Tablet, 10-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2311 | $2.31 / 10 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 42806-0112-01 | Epic | 100 tablets | $0.127 | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 7.5 mg/1; 325 mg 00406-0124-01 | SpecGx | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 10702-0190-01 | KVK-Tech, | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 13107-0020-01 | Aurolife | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 27808-0036-01 | Cranbury | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 31722-0942-01 | Camber | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 42858-0202-01 | Rhodes | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 50268-0400-15 | AvPAK | 50 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 60687-0407-01 | American | 100 tablets | $0.138 | AA | Availability likely | — |
| hydrocodone bitartrate and acetaminophen 7.5 mg/1; 325 mg 64380-0441-01 | Strides | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 64850-0632-01 | Elite | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 70010-0673-01 | Granules | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71930-0020-12 | Eywa | 100 tablets | $0.138 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 43386-0357-01 | Lupin | 100 tablets | $0.139 | — | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 00245-0411-01 | Upsher-Smith | 100 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 325 mg/1; 7.5 mg 60429-0591-01 | Golden | 100 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 60760-0692-30 | ST. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 63187-0658-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 63629-1940-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 63629-2295-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 63629-2296-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 63629-2297-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 63629-2469-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 65162-0115-03 | Amneal | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 68071-2494-02 | NuCare | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 68071-2645-03 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-0108-00 | Bryant | 8 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-1419-00 | Bryant | 8 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-1557-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-1970-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-2104-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mgthis 71335-2112-03 | Bryant | 10 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-2115-00 | Bryant | 8 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-2238-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-9736-00 | Bryant | 8 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 71335-9737-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 72162-1280-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 72162-1342-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 72162-1990-05 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 325 mg/1; 7.5 mg 72189-0191-30 | DirectRx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone APAP 7.5 mg/1; 325 mg 72189-0352-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone/Apap 7.5 mg/1; 325 mg 72189-0406-90 | Direct_Rx | 90 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 72865-0111-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 72865-0203-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 76420-0257-30 | Asclemed | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 76420-0876-00 | Asclemed | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 7.5 mg/1; 325 mg 87063-0050-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-2112-01 | 21 TABLET in 1 BOTTLE (71335-2112-1) | 2022-06-20 | Active |
| 71335-2112-02 | 36 TABLET in 1 BOTTLE (71335-2112-2) | 2022-06-20 | Active |
| 71335-2112-03 You're viewing this | 10 TABLET in 1 BOTTLE (71335-2112-3) | 2022-06-20 | Active |
You're viewing the smallest of 3 pack sizes for this product.
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 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 Addiction, Abuse, and Misuse: RISK EVALUATION AND MITIGATION STRATEGY (REMS) 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 patient’s risk prior to prescribing hydrocodone bitartrate and acetaminophen tablets, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS]. 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 WARNINGS]. 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 complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, e m phasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety. Life-Threatening Respiratory Depression 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 WARNINGS]. Accidental Ingestion Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen tablets [see WARNINGS]. Neonatal Opioid Withdrawal Syndrome 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 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 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 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]. 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, respi…
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets, USP are 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 [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets, USP 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
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. 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 WARNINGS ]. 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 WARNINGS ].
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/Caregivers ]. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing regulations (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
Consider prescribing naloxone, based on the patient's risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see WARNINGS, Addiction, Abuse, and Misuse, Life-Threatening Respiratory Depression, Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants ]. Consider prescribing naloxone when the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose .
Initial Dosage Initiating Treatment with Hydrocodone Bitartrate and Acetaminophen Tablets 2.5 mg/325 mg The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets. 5 mg/325 mg The usual adult dosage is one or two tablets every four to six hours as needed for pain.
The total daily dosage should not exceed 8 tablets. 7.5 mg/325 mg, 10 mg/325 mg The usual adult dosage is one tablet every four to six hours as needed for pain. 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. 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 WARNINGS ]. Frequent communication is imp…
⛔ Contraindications ▾
CONTRAINDICATIONS Hydrocodone bitartrate and acetaminophen tablets are 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 tablets expose 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 patient’s 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 monitor all patients receiving hydrocodone bitartrate and acetaminophen tablets for the development of these behaviors and 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 intensive monitoring 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 by drug abusers and people with addiction disorders and are subject to criminal diversion. 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 the proper disposal of unused drug [see PRECAUTIONS; Information for Patients ].
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. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to do all of the following: Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed.
The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG . Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them. Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient- prescriber responsibilities.
To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 800-503-0784, or log on to www.opioidanalgesicrems.com . The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint . Life-Threatening Respiratory Depression Serious, li…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 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 [see CLINICAL PHARMACOLOGY ].
🆘 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, 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 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 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 a 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. Chronic use of opioids 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 potent agonist opioids. The minimum effective analgesic concentration of hydrocodone for any individual patient may incr…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as 7.5 mg/325 mg containing 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white/white capsule shaped tablet debossed ‘T 258’ on one side and plain on other side with bisect line. NDC 71335-2112-1: 21 Tablets in a BOTTLE NDC 71335-2112-2: 36 Tablets in a BOTTLE NDC 71335-2112-3: 10 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.
Burbank, CA 91504
📋 Description ▾
DESCRIPTION Hydrocodone bitartrate and acetaminophen, USP 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 contains: Strength Hydrocodone Bitartrate Acetaminophen 2.5 mg/325 mg 2.5 mg 325 mg 5 mg/325 mg 5 mg 325 mg 7.5 mg/325 mg 7.5 mg 325 mg 10 mg/325 mg 10 mg 325 mg In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide, crospovidone, pregelatinized starch, povidone, FD&C Yellow No 6 (for strength 5 mg/325 mg), D&C Yellow No 10 (for strength 10 mg/325 mg) and stearic acid.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP complies to USP Dissolution Test 1.
💬 Medication Guide ▾
MEDICATION GUIDE Hydrocodone Bitartrate (hye" droe koe' done bye tar’ trate) and Acetaminophen (a seet"a min' oh fen) Tablets USP, CII Hydrocodone Bitartrate and Acetaminophen Tablets are: 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: Get emergency help or call 911 right away if you take too much Hydrocodone Bitartrate and Acetaminophen Tablets (overdose) . When you first start taking Hydrocodone Bitartrate and Acetaminophen Tablets, 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 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 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 Bitartrate and Acetaminophen Tablets Before taking Hydrocodone Bitartrate and Acetaminophen Tablets, tell your healthcare provider if you have a history of: head injury, seizures liver, kidney, thyroid problems problems urinating pancreas or gallbladder problems abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of Hydrocodone Bitartrate and Acetaminophen Tablets 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 passes into breast milk and may harm your baby. 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 with certain other medicines can cause serious side effects that could lead to death. When taking Hydrocodone Bitartrate and Acetaminophen Tablets: Do not change your dose. Take Hydrocodone Bitartrate and Acetaminophen Tablets exactly as prescribed by your healthcare provider.
Use the lowest dose possible for the shortest time needed. Take your prescribed dose every four to six hours as needed for pain. Do not take more than your prescribed dose.
If you miss a dose, take your next dose at your usual time. Call your healthcare provider if the dose you are taking does not control your pain. If you have been taking Hydrocodone Bitartrate and Acetaminophen Tablets regularly, do not stop taking Hydrocodone Bitartrate and Acetaminophen Tablets without talking to your healthcare provider.
Dispose of expired, unwanted, or unused Hydrocodone Bitartrate and Acetamino…