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HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP
CIII
| 5 mg/325 mg | 5 mg/500 mg | |||
| 7.5 mg/325 mg | 7.5 mg/500 mg | 7.5 mg/650 mg | 7.5 mg/750 mg | |
| 10 mg/325 mg | 10 mg/500 mg | 10 mg/650 mg | 10 mg/660 mg | 10 mg/750 mg |
Rx only
DESCRIPTION
Hydrocodone Bitartrate and Acetaminophen Tablets are 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: 4,5α-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:
Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains:
| Tablet | Hydrocodone Bitartrate USP | Acetaminophen USP |
| 5 mg/325 mg | 5 mg | 325 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: crospovidone NF, magnesium stearate NF, microcrystalline cellulose NF, povidone USP, pregelatinized starch NF, silicon dioxide NF, and stearic acid NF.
The 10 mg/650 mg tablet also contains FD & C Blue No. 1 Aluminum Lake 12%.
Meets USP Dissolution Test 1.
CLINICAL PHARMACOLOGY
Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.
The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.
Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
WARNINGS
PRECAUTIONS
General
Pregnancy
ADVERSE REACTIONS
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Signs and Symptoms
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the 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.
The usual adult dosage for Hydrocodone Bitartrate and Acetaminophen Tablets USP is:
|
Product Strength |
Usual Adult Dosage as needed for pain |
The total 24-hour dosage should not exceed |
|---|---|---|
| 5 mg/325 mg | One to two tablets every four to six hours | 12 tablets |
| 5 mg/500 mg | One to two tablets every four to six hours | 8 tablets |
| 7.5 mg/325 mg | One tablet every four to six hours | 8 tablets |
| 7.5 mg/500 mg | One tablet every four to six hours | 6 tablets |
| 7.5 mg/650 mg | One tablet every four to six hours | 6 tablets |
| 7.5 mg/750 mg | One tablet every four to six hours | 5 tablets |
| 10 mg/325 mg | One tablet every four to six hours | 6 tablets |
| 10 mg/500 mg | One tablet every four to six hours | 6 tablets |
| 10 mg/650 mg | One tablet every four to six hours | 6 tablets |
| 10 mg/660 mg | One tablet every four to six hours | 6 tablets |
| 10 mg/750 mg | One tablet every four to six hours | 5 tablets |
HOW SUPPLIED
Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows:
| Strength | How Supplied | Each tablet contains: | Description of tablet | |
|---|---|---|---|---|
| Hydrocodone Bitartrate | Acetaminophen | |||
| 5 mg/325 mg | Bottles of 100 ……… NDC No. 0406-0365-01 Unit Dose (10x10) … NDC No. 0406-0365-62 |
5 mg | 325 mg | It is available as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. |
| 5 mg/500 mg | Bottles of 100 ….……NDC No. 0406-0357-01 Bottles of 500 …….…NDC No. 0406-0357-05 Unit Dose (10x10) .….NDC No. 0406-0357-62 |
5 mg | 500 mg | It is available as a capsule-shaped white tablet debossed with M357 on one side and bisected on the other side. |
| 7.5 mg/325 mg | Bottles of 100 …….…NDC No. 0406-0366-01 Unit Dose (10x10) ….NDC No. 0406-0366-62 |
7.5 mg | 325 mg | It is available as an unscored oval-shaped white tablet debossed with M366 on one side. |
| 7.5 mg/500 mg | Bottles of 100 …….…NDC No. 0406-0358-01 Bottles of 500 …….…NDC No. 0406-0358-05 Unit Dose (10x10) …..NDC No. 0406-0358-62 |
7.5 mg | 500 mg | It is available as a capsule-shaped white tablet debossed with M358 on one side and bisected on the other side. |
| 7.5 mg/650 mg | Bottles of 100 ……… NDC No. 0406-0359-01 Bottles of 500 ……… NDC No. 0406-0359-05 |
7.5 mg | 650 mg | It is available as a capsule-shaped white tablet debossed with M359 on one side and bisected on the other side. |
| 7.5 mg/750 mg | Bottles of 100 ……… NDC No. 0406-0360-01 Bottles of 500 ……… NDC No. 0406-0360-05 |
7.5 mg | 750 mg | It is available as a capsule-shaped white tablet debossed with M360 on one side and bisected on the other side. |
| 10 mg/325 mg | Bottles of 100 …….… NDC No. 0406-0367-01 Bottles of 500 ….…… NDC No. 0406-0367-05 Unit Dose (10x10) ….. NDC No. 0406-0367-62 |
10 mg | 325 mg | It is available as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. |
| 10 mg/500 mg | Bottles of 100 …….… NDC No. 0406-0363-01 Bottles of 500 ……… NDC No. 0406-0363-05 Unit Dose (10x10) …. NDC No. 0406-0363-62 |
10 mg | 500 mg | It is available as a capsule-shaped white tablet debossed with M363 on one side and bisected on the other side. |
| 10 mg/650 mg | Bottles of 100 ……..…NDC No. 0406-0361-01 Bottles of 500 …….… NDC No. 0406-0361-05 Unit Dose (10x10). ….NDC No. 0406-0361-62 |
10 mg | 650 mg | It is available as a capsule-shaped blue tablet debossed with M361 on one side and bisected on the other side. |
| 10 mg/660 mg | Bottles of 100 ………. NDC No. 0406-0362-01 |
10 mg | 660 mg | It is available as a capsule-shaped white tablet debossed with M362 on one side and bisected on the other side. |
| 10 mg/750 mg | Bottles of 100 ………. NDC No. 0406-0364-01 |
10 mg | 750 mg | It is available as a capsule-shaped white tablet debossed with M364 on one side and bisected on the other side. |
Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure.