DESCRIPTION
id: 4c4a3a6c-04dc-46f7-810f-35ccdefbfaad
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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: 4,5α- 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:
Hydrocodone bitartrate and acetaminophen tablets, USP for oral administration are available in a variety of strength as described in the following table.
In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, starch, and stearic acid.
Meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
id: 1164860f-3cba-4711-85ca-affd1a770821
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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
id: d1b2c7f4-58e0-4f13-895e-819cbc35fcb1
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
id: b85c6d56-ded3-4d76-8fe0-9dd186c4e203
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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.
ADVERSE REACTIONS
id: 948d37ee-0287-43f4-97a0-66630af8018f
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The most frequently reported adverse reactions include: 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:
Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes.
Gastrointestinal System: Prolonged administration of hydrocodone bitartrate and acetaminophen tablets may produce constipation.
Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. (see
OVERDOSAGE
).
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological: Skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potential effects of high dosage are listed in the
OVERDOSAGE
section.
OVERDOSAGE
id: 6a41f019-6ff7-4ed3-ae0c-ca7aaecbcb1e
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
DOSAGE AND ADMINISTRATION
id: 1cbc5e38-8d5f-4503-83ca-d7e4c997b784
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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.
The usual adult dosage for Hydrocodone Bitartrate and Acetaminophen Tablets USP is:
7.5 mg/500 mg – The usual dosage is one or two tablets every four to six hours as needed for pain.The total daily dosage should not exceed 6 tablets.
HOW SUPPLIED
id: 3bd81ef5-acab-4d93-a2df-034ab8e63b5f
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Hydrocodone bitartrate and acetaminophen Tablets USP are available in the following strength:
7.5 mg/500 mg: 7.5 mg hydrocodone bitartrate and 500 mg acetaminophen, capsule-shaped, white tablets bisected on one side and debossed with Watson;385 on the other side, supplied in bottles of 40.
They are supplied by Keltman Pharmaceuticals Inc. as follows:
|
NDC
|
Strength
|
Quantity/Form
|
Color
|
Source Prod. Code
|
| 68387-230-10 |
7.5 mg / 500 mg |
10 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-15 |
7.5 mg / 500 mg |
15 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-30 |
7.5 mg / 500 mg |
30 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-40 |
7.5 mg / 500 mg |
40 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-50 |
7.5 mg / 500 mg |
50 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-60 |
7.5 mg / 500 mg |
60 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-90 |
7.5 mg / 500 mg |
90 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-01 |
7.5 mg / 500 mg |
100 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-12 |
7.5 mg / 500 mg |
120 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
| 68387-230-51 |
7.5 mg / 500 mg |
150 Tablets in a Plastic Bottle |
WHITE |
00591-0385 |
Store at 20 – 25°C (68 – 77°F). (See USP for Controlled Room Temperature).
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Manufactured and Distributed By:
Watson Laboratories, Inc.
Corona, CA 92880 USA
Flowood, MS 39232
United States
This Product was Repackaged By:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 7.5 mg/500 mg
id: c5d66beb-3d46-4b8e-a46f-70d640498da0
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Hydrocodone Bitartrate and Acetaminophen Tablets, USP
7.5 mg/500 mg
Rx Only
