Hydrocodone Bitartrate With Acetaminophen Recall

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Questions & Answers

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Side Effects & Adverse Reactions

Respiratory Depression:

At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial PressureThe respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. Acute Abdominal ConditionsThe administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Misuse, Abuse, and Diversion of Opioids

Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

Hydrocodone bitartrate and acetaminophen tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

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History

There is currently no drug history available for this drug.

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Other Information

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.
 
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5a- 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:

Hydrocodone bitartrate and acetaminophen tablets, USP for oral administration are available in the following strengths

• 5mg/325mg 5mg Hydrocodone Bitartrate USP 325mg Acetaminophen USP
  

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch,
stearic acid and sugar spheres which are composed of starch derived from corn, sucrose, and FD and C Yellow #6. Meets USP Dissolution Test 1..

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