HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, CII, 7.5 mg/325 mg, Rx only

/HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, CII, 7.5 mg/325 mg, Rx only
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, CII, 7.5 mg/325 mg, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP, CII, 7.5 mg/325 mg, Rx only

ID:

b197c754-5b28-4429-8407-0f9d3534c676

Code:

34391-3

DESCRIPTION


id: 3a25ba96-5943-42a0-b67c-9705d98dafa5
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
 7.5 mg/325 mg  7.5 mg  325 mg
 10 mg/325 mg  10 mg  325 mg
In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. Meets USP Dissolution Test 1.

CLINICAL PHARMACOLOGY


id: 52a720c0-5f90-494f-9f83-918350dcc646
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: e6ea36da-3789-446e-82d6-536fe24fc959
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: c6948758-9039-4fc5-aa81-96f1d6f5fefe
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: 753e5353-51fb-4c81-a16e-938cd1131ce4
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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


id: 4727faf9-c050-462c-8447-23b710d46001
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

Misuse, Abuse, and Diversion of Opioids – Hydrocodone bitartrate and acetaminophen tablets contains hydrocodone, an opioid agonist, and is a Schedule II 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.

DRUG ABUSE AND DEPENDENCE


id: 441387e3-8f52-4ca5-8bf1-dc956c611188
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

Misuse, Abuse, and Diversion of Opioids – Hydrocodone bitartrate and acetaminophen tablets contains hydrocodone, an opioid agonist, and is a Schedule II 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


id: 0c443a0c-4d9c-4c5c-842a-a54295d038cd
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION


id: e781dda5-4b5d-43a2-b00a-1d943f9aab02
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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
7.5 mg/325 mg One tablet every four to six hours   8 tablets
 10 mg/325 mg One tablet every four to six hours   6 tablets

HOW SUPPLIED


id: 40e3de79-effd-4fde-a949-21da163ac584
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows:

Strength How Supplied Each tablet contains: Description of tablet
Hydrocodone Bitartrate Acetaminophen
7.5 mg/325 mg Bottle of 6: NDC 63629-5436-1
Bottle of 15: NDC 63629-5436-2
Bottle of 20: NDC 63629-5436-3
Bottle of 28: NDC 63629-5436-4
Bottle of 30: NDC 63629-5436-5
Bottle of 40: NDC 63629-5436-6
Bottle of 56: NDC 63629-5436-7
Bottle of 60: NDC 63629-5436-8
Bottle of 90: NDC 63629-5436-9
Bottle of 120: NDC 63629-5436-0
7.5 mg 325 mg It is available as an unscored oval-shaped white tablet debossed with M365 on one side.
Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure.