Zydone
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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.
The respiratory depressant effects of opioids 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, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.
The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
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
ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is indicated for the relief of moderate to moderately severe pain.
History
There is currently no drug history available for this drug.
Other Information
ZYDONE (hydrocodone bitartrate and acetaminophen tablets), for oral administration, contain hydrocodone bitartrate and acetaminophen in the following strengths:
| Hydrocodone Bitartrate, USP | 5 mg |
| Acetaminophen, USP | 400 mg |
| Hydrocodone Bitartrate, USP | 7.5 mg |
| Acetaminophen, USP | 400 mg |
| Hydrocodone Bitartrate, USP | 10 mg |
| Acetaminophen, USP | 400 mg |
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. The 5 mg/400 mg strength contains FD&C Yellow No. 10; 7.5 mg/400 mg contains FD&C Blue No. 2; and 10 mg/400 mg contains FD&C Red No. 40.
ZYDONE Tablets meet USP Dissolution Test 1.
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:
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:
Sources
Zydone Manufacturers
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Stat Rx Usa Llc
![Zydone (Hydrocodone Bitartrate And Acetaminophen) Tablet [Stat Rx Usa Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zydone | Stat Rx Usa Llc
Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
5 mg/400 mg: The usual adult dose is one or two tablets every four to six hours as needed for pain.
The total daily dosage should not exceed eight tablets.
7.5 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed six tablets.
10 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed six tablets.
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