Hydrocodone/APAP 325 mg/1
Hydrocodone/APAP · TABLET · Direct_Rx
Hydrocodone/acetaminophen is a prescription pain reliever tablet that combines an opioid medication with acetaminophen to treat moderate pain. It is taken by mouth and should be used exactly as prescribed by your doctor.
Key Facts
- Brand Name
- Hydrocodone/APAP
- Generic Name
- Hydrocodone/APAP
- NDC Code (Product)
72189-407- Manufacturer
- Direct_Rx
- Strength
- 325 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA040409
- Marketing Start
- 12/28/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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 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 & 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 opiods and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Because the risk of overdose increases as opiod doses increase, reserve titration to higher doses of Hydrocodone Bitartrate and Acetaminophen Tablets for patients in who, lower doses are insufficiently effective and in who, the expected benefits of using a higher dose opiod 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 patie…
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 Table…
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]
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 concomi…
Frequently Asked Questions
What is Hydrocodone/APAP used for?
Hydrocodone/acetaminophen is a prescription pain reliever tablet that combines an opioid medication with acetaminophen to treat moderate pain. It is taken by mouth and should be used exactly as prescribed by your doctor.
Is Hydrocodone/APAP a controlled substance?
Yes, Hydrocodone/APAP is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Hydrocodone/APAP?
The generic name for Hydrocodone/APAP is Hydrocodone/APAP. There are 2 other brand versions of Hydrocodone/APAP.
What is the NDC code for Hydrocodone/APAP 325 mg/1?
The NDC (National Drug Code) for Hydrocodone/APAP 325 mg/1 is 72189-407, listed by Direct_Rx.