Hydrocodone Bitartrate and Acetaminophen 325 mg/1
Hydrocodone Bitartrate and Acetaminophen · TABLET · ST. MARY'S MEDICAL PARK PHARMACY
Hydrocodone bitartrate and acetaminophen is a prescription pain reliever that combines an opioid with a common over-the-counter pain reliever to treat moderate pain. This tablet is taken by mouth and should be used exactly as prescribed by your doctor, as hydrocodone is a controlled substance with risks of dependence and side effects.
Key Facts
- Brand Name
- Hydrocodone Bitartrate and Acetaminophen
- Generic Name
- Hydrocodone Bitartrate and Acetaminophen
- NDC Code (Product)
60760-873- Manufacturer
- ST. MARY'S MEDICAL PARK PHARMACY
- Strength
- 325 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA202214
- Marketing Start
- 10/06/2014
Recall History
Watson Laboratories Inc
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Ascent Pharmaceuticals, Inc.
Product Mix-up
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
VistaPharm, Inc.
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Ascent Pharmaceuticals, Inc.
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Mallinckrodt Inc.
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Watson Laboratories Inc
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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, 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 or opioid combination products): 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
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 indi…
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 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 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 acetami…
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 ]
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 from 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 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 effec…
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of hydrocodone bitartrate 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 r…
Frequently Asked Questions
What is Hydrocodone Bitartrate and Acetaminophen used for?
Hydrocodone bitartrate and acetaminophen is a prescription pain reliever that combines an opioid with a common over-the-counter pain reliever to treat moderate pain. This tablet is taken by mouth and should be used exactly as prescribed by your doctor, as hydrocodone is a controlled substance with risks of dependence and side effects.
Is Hydrocodone Bitartrate and Acetaminophen a controlled substance?
Yes, Hydrocodone Bitartrate and Acetaminophen is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Hydrocodone Bitartrate and Acetaminophen?
The generic name for Hydrocodone Bitartrate and Acetaminophen is Hydrocodone Bitartrate and Acetaminophen. There are 1 other brand versions of Hydrocodone Bitartrate and Acetaminophen.
What is the NDC code for Hydrocodone Bitartrate and Acetaminophen 325 mg/1?
The NDC (National Drug Code) for Hydrocodone Bitartrate and Acetaminophen 325 mg/1 is 60760-873, listed by ST. MARY'S MEDICAL PARK PHARMACY.
Other Hydrocodone Bitartrate and Acetaminophen Dosages
- Hydrocodone Bitartrate and Acetaminophen300 mg/172162-1289
- Hydrocodone Bitartrate and Acetaminophen325 mg/172162-1991
- Hydrocodone Bitartrate and Acetaminophen325 mg/176420-215
- Hydrocodone Bitartrate and Acetaminophen325 mg/176420-875
- Hydrocodone Bitartrate and Acetaminophen300 mg/113107-211
- Hydrocodone Bitartrate and Acetaminophen300 mg/113107-212
- Hydrocodone Bitartrate and Acetaminophen300 mg/113107-213
- Hydrocodone Bitartrate and Acetaminophen325 mg/131722-996
- Hydrocodone Bitartrate and Acetaminophen217 mg/10mL0121-1544
- Hydrocodone Bitartrate and Acetaminophen325 mg/142858-201
Other Hydrocodone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)