HYDROCODONE BITARTRATE AND ACETAMINOPHEN, 5/500mg TABLETS USP, CIII

/HYDROCODONE BITARTRATE AND ACETAMINOPHEN, 5/500mg TABLETS USP, CIII
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, 5/500mg TABLETS USP, CIII2018-09-06T09:12:40+00:00

Prescription Drug Name:

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, 5/500mg TABLETS USP, CIII

ID:

084efc66-f1e9-4000-8694-e251b41b5991

Code:

34391-3

DESCRIPTION


id: 75892f85-8af4-4ec7-92e8-09576371a36c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. The 10 mg/650 mg tablet also contains FD & C Blue No. 1 Aluminum Lake 12%. Meets USP Dissolution Test 1.

CLINICAL PHARMACOLOGY


id: 880fc7df-7d34-4341-a6fd-9fc1b7c6cd7f
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: 002b2b38-1e9c-4649-859a-7201b6f614e7
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: 898e3d3f-dba4-4dd3-827c-82ac79bd046d
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: 627cce39-67d3-41e6-bec3-d1e77f59f623
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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:

OVERDOSAGE


id: 14e4913b-ec41-4e14-9f9e-7df5ae16754d
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

DOSAGE AND ADMINISTRATION


id: 20588cb7-f8ed-4cea-96d1-47a1536c39ae
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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


id: 44c3d3e9-4801-4e52-b259-6934670db5d1
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg are supplied as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M357 on one side and bisected on the other side. The tablets are supplied in: Boxes of 10×10 UD 100 NDC 63739-455-10
Boxes of 25×30 UD 750 NDC 63739-455-01
Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/325 mg are supplied as an unscored oval-shaped white tablet debossed with M366 on one side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M358 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/650 mg are supplied as a capsule-shaped white tablet debossed with M359 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/750 mg are supplied as a capsule-shaped white tablet debossed with M360 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/325 mg are supplied as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M363 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/650 mg are supplied as a capsule-shaped blue tablet debossed with M361 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/660 mg are supplied as a capsule-shaped white tablet debossed with M362 on one side and bisected on the other side. Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/750 mg are supplied 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.

REPRESENTATIVE PACKAGING


id: c2d23501-88b3-43e6-a5cd-e65ee6622a00
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 63739-455-10 Hydrocodone Bitartrate 5 mg
and Acetaminophen 500 mg
Tablets, USP CIII
UD 100 Tablets (10×10) Rx Only EACH TABLET CONTAINS:
Hydrocodone Bitartrate USP …………………….. 5 mg
Acetaminophen USP ……………………………..500 mg
USUAL DOSAGE: See package insert for complete dosage recommendations. DISPENSE in a tight, light-resistant container (as defined in USP). STORE at 20°-25°C (68°-77°F).
[see USP Controlled Room Temperature].
Protect from light.
Mfg. By: Mallinckrodt Inc., Hazelwood, MO 63042 USA