FDA Label for Hydrocodone Bitartrate And Acetaminophen
View Indications, Usage & Precautions
Hydrocodone Bitartrate And Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Medsource Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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, 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
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.
Adverse Reactions
The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Drug Abuse And Dependence
Misuse, Abuse, and Diversion of Opioids – Hydrocodone bitartrate and acetaminophen tablets contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids used in analgesia can be abused and are subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.
“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Hydrocodone bitartrate and acetaminophen tablets, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Overdosage
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Dosage And Administration
Dosage should be adjusted according to the severity of the pain and the 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 0406-0365-01 Bottles of 500 ……… NDC 0406-0365-05 Unit Dose (10 x 10) … NDC 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 90 ….……NDC 0406-0357-09 Bottles of 100 ….……NDC 0406-0357-01 Bottles of 500 …….…NDC 0406-0357-05 Unit Dose (10 x 10) .….NDC 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 0406-0366-01 Bottles of 500 …….…NDC 0406-0366-05 Unit Dose (10 x 10) ….NDC 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 0406-0358-01 Bottles of 500 …….…NDC 0406-0358-05 Unit Dose (10 x 10) …..NDC 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 0406-0359-01 Bottles of 500 ……… NDC 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 90 ….……NDC 0406-0360-09 Bottles of 100 ……… NDC 0406-0360-01 Bottles of 500 ……… NDC 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 0406-0367-01 Bottles of 500 ….…… NDC 0406-0367-05 Unit Dose (10 x 10) ….. NDC 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 0406-0363-01 Bottles of 500 ……… NDC 0406-0363-05 Unit Dose (10 x 10) …. NDC 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 0406-0361-01 Bottles of 500 …….… NDC 0406-0361-05 Unit Dose (10 x 10). ….NDC 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 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 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.
Package Label - Principal Display Panel - 5 Mg/500 Mg Bottle
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