FDA

Hydrocodone Bitartrate and Acetaminophen

Approved 11 Apr 2012OralTablet

The FDA lists this product in 60 strengths and forms.

Indications

Hydrocodone bitartrate and acetaminophentablets are indicated for the management of relief of moderate to moderatelysevere pain, pain severe enough to require an opioid analgesic and for whichalternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, andmisuse, with opioids, even at recommended doses [see WARNINGS ], reserve hydrocodonebitartrate and acetaminophen tablets for use in patients for whom alternativetreatment 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

Contraindications

Hydrocodonebitartrate 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]
Hypersensitivity to hydrocodone or acetaminophen
Hypersensitive to other opioids which may exhibit cross-sensitivity to hydrocodone

Warnings and precautions

Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablet contains hydrocodone and acetaminophen a Schedule CII controlled substance. As an opioid, hydrocodone bitartrate andacetaminophen tablets exposes users to the risks of addiction, abuse, andmisuse [see DRUG ABUSE AND DEPENDENCE ]. Although therisk 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 orabused.

Assess eachpatient’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 or conditions. Risks are increased in patients with a personal or family historyof substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).

Indications

Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Contraindications

Hydrocodonebitartrate 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]
Hypersensitivity to hydrocodone or acetaminophen
Hypersensitive to other opioids which may exhibit cross-sensitivity to hydrocodone

Warnings and precautions

Interactions

Drug Interactions Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantlywith hydrocodone bitartrate and acetaminophen tablets may exhibit an additiveCNS depression. When combined therapy is contemplated, the dose of one or bothagents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Hydrocodone bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, asubstance with a high potential for abuse similar to other opioids including withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixedagonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), orpartial agonists (buprenorphine). Physical dependence may not occur to aclinically significant degree until after several days to weeks of continuedopioid usage.

Hydrocodone bitartrate and acetaminophen tablets can be abusedand is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. Benzodiazepines and other Central Nervous System (CNS) Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants such as alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increases the risk of 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. Follow patients closely for signs of respiratory depression and sedation [see WARNINGS ]. Serotonergic Drugs The concomitantuse of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin andnorepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs),triptans, 5-HT 3 receptor antagonists, drugs that effect theserotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), andmonoamine oxidase (MAO) inhibitors (those intended to treat psychiatricdisorders and also others, such as linezolid and intravenous methylene blue),has resulted in serotonin syndrome [see PRECAUTIONS ; Information for Patients/Caregivers].

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue hydrocodone bitartrateand acetaminophen tablets if serotonin syndrome is suspected.

Hydrocodone Bitartrate and Acetaminophen

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Hydrocodone Bitartrate and Acetaminophen

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Interactions

Pregnancy and breastfeeding

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance