Hydrocodone Acetaminophen
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS
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 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.
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
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
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
| Strength |
Hydrocodone Bitartrate |
Acetaminophen |
| 2.5 mg/500 mg |
2.5 mg |
500 mg |
| 5 mg / 500 mg |
5 mg |
500 mg |
| 7.5 mg / 325 mg |
7.5 mg |
325 mg |
| 7.5 mg / 500 mg |
7.5 mg |
500 mg |
| 7.5 mg / 650 mg |
7.5 mg |
650 mg |
| 7.5 mg / 750 mg |
7.5 mg |
750 mg |
| 10 mg / 325 mg |
10 mg |
325 mg |
| 10 mg / 500 mg | 10 mg |
500 mg |
| 10 mg / 650 mg | 10 mg |
650 mg |
| 10 mg / 660 mg | 10 mg |
660 mg |
| 10 mg / 750 mg |
10 mg |
750 mg |
In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate,microcrystalline cellulose, povidone, starch, and stearic acid; except the 7.5mg/325mg, 10 mg/325 mg and 10 mg/500 mg tablets do not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD and C Yellow # 6 Aluminum Lake; the 7.5 mg/650 mg tablets include FD and C Red #40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D and C Yellow # 10 Aluminum Lake; the 10 mg/500 mg tablets include FD and C Blue #2 Aluminum Lake; and the 10 mg/650mg tablets include FD and C Blue #1 Aluminum Lake and D and C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.
Sources
Hydrocodone Acetaminophen Manufacturers
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Redpharm Drug Inc.
![Hydrocodone Acetaminophen (Hydrocodone, Acetaminophen) Tablet [Redpharm Drug Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hydrocodone Acetaminophen | Redpharm Drug Inc.
DOSAGE AND ADMINISTRATION
2.5 mg/500 mg
Dosage should be adjusted according to the severity of the 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/500 mg
The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.
7.5 mg/325 mg
7.5 mg/500 mg
7.5 mg/650 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
10 mg/325 mg
10 mg/500 mg
10 mg/650 mg
10 mg/660 mg
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets.
10 mg/750 mg
The usual adult dosage is one table every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets.
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