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Questions & Answers
Side Effects & Adverse Reactions
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 ZOLVITTM 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.
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.
The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
ZOLVITTM 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.
ZOLVITTM can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ZOLVITTM in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
ZOLVITTM is indicated for the relief of moderate to moderately severe pain.
There is currently no drug history available for this drug.
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 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). It has the following structural formula:
C18H21NO3 · C4H606 · 2 1/2 H2O M.W. 494.490
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:
C8H9NO2 M.W. 151.16
ZOLVITTM (hydrocodone bitartrate and acetaminophen oral solution) contains:
|Per 5 mL||Per 15 mL|
|Hydrocodone Bitartrate .........||3.33 mg||10 mg|
|Acetaminophen .....................||100 mg||300 mg|
|Alcohol ..................................||7 %||7%|
In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.