Hydrocodone/apap
Generic Name: hydrocodone/apap
Brand Names:
Hydrocodone/apap
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).
Overview
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).
Uses
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 w...
Dosage
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.
Side Effects
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.
Warnings
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 and conditions [see 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. 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...
Storage
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, USP securely and dispose of properly [see PRECAUTIONS/Information for Patients].
Frequently Asked Questions
What is Hydrocodone/apap used for?▼
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 w...
What are the side effects of Hydrocodone/apap?▼
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.
What are the important warnings for Hydrocodone/apap?▼
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 and conditions [see 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. 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...
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This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.