Hydrocodone Bitartrate And Acetaminophen Solution

Hydrocodone Bitartrate And Acetaminophen Solution

Hydrocodone Bitartrate And Acetaminophen Solution Recall

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Questions & Answers

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.

Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS, Pediatric Use). If use of hydrocodone bitartrate and acetaminophen oral solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring.

Head Injury and Increased Intracranial Pressure

The 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 Conditions

The 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 oral solution contains 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 oral solution 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 oral solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

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

Uses

Hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain.

History

There is currently no drug history available for this drug.

Other Information

Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration.

Warning: May be habit forming (see PRECAUTIONS, Information for Patients, and DRUG ABUSE AND DEPENDENCE).

Hydrocodone bitartrate is an opioid analgesic and antitussive which 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). It has the following structural formula:

image of Hydrocodone bitartrate chemical structure

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:

image of Acetaminophen chemical structure

Hydrocodone bitartrate and acetaminophen oral solution contains:


Per 5 mL
Per 10 mL
Per 15 mL
Hydrocodone Bitartrate
2.5 mg
5 mg
7.5 mg
Acetaminophen
167 mg
334 mg
500 mg
Alcohol
7%
7%
7%

In addition hydrocodone bitartrate and acetaminophen oral solution contains the following inactive ingredients: citric acid, glycerin, methylparaben, propylene glycol, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow No. 10 as coloring and natural and artificial flavoring.

Hydrocodone Bitartrate And Acetaminophen Solution Manufacturers


  • Physicians Total Care, Inc.
    Hydrocodone Bitartrate And Acetaminophen Solution [Physicians Total Care, Inc.]
  • Rebel Distributors Corp
    Hydrocodone Bitartrate And Acetaminophen Solution [Rebel Distributors Corp]
  • Pharmaceutical Associates, Inc.
    Hydrocodone Bitartrate And Acetaminophen Solution [Pharmaceutical Associates, Inc.]
  • Atlantic Biologicals Corps
    Hydrocodone Bitartrate And Acetaminophen Solution [Atlantic Biologicals Corps]
  • A-s Medication Solutions Llc
    Hydrocodone Bitartrate And Acetaminophen Solution [A-s Medication Solutions Llc]
  • Pharmaceutical Associates, Inc.
    Hydrocodone Bitartrate And Acetaminophen Solution [Pharmaceutical Associates, Inc.]
  • Apotheca, Inc
    Hydrocodone Bitartrate And Acetaminophen Solution [Apotheca, Inc]
  • Cardinal Health
    Hydrocodone Bitartrate And Acetaminophen Solution [Cardinal Health]
  • Aidarex Pharmaceuticals Llc
    Hydrocodone Bitartrate And Acetaminophen Solution [Aidarex Pharmaceuticals Llc]
  • Precision Dose Inc.
    Hydrocodone Bitartrate And Acetaminophen Solution [Precision Dose Inc.]
  • Lehigh Valley Technologies, Inc.
    Hydrocodone Bitartrate And Acetaminophen Solution [Lehigh Valley Technologies, Inc.]
  • Apotheca, Inc
    Hydrocodone Bitartrate And Acetaminophen Solution [Apotheca, Inc]
  • Pharmaceutical Associates, Inc.
    Hydrocodone Bitartrate And Acetaminophen Solution [Pharmaceutical Associates, Inc.]
  • A-s Medication Solutions Llc
    Hydrocodone Bitartrate And Acetaminophen Solution [A-s Medication Solutions Llc]
  • Vistapharm Inc.
    Hydrocodone Bitartrate And Acetaminophen Solution [Vistapharm Inc.]

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