HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET USP 10MG/325MG CSII

DESCRIPTION

id: b840b217-3d6f-48d5-a16d-6904061ac5a6
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 5a  Epoxy 3 methoxy 17 methylmorphinan 6 one tartrate1 1 hydrate 2 5 It has the following structural formula Acetaminophen, 4  Hydroxyacetanilide, a slightly bitter white odorless crystalline powder is a nonopiate non salicylate analgesic and antipyretic. It has the following structural formula Hydrocodone bitartrate and acetaminophen tablets USP for oral administration are available in the following strengths 10mg 325mg  10mg Hydrocodone Bitartrate USP 325mg Acetaminophen USP Discontinued the following strengths 10mg 500mg  10mg Hydrocodone Bitartrate USP 500mg Acetaminophen USP
10mg 650mg  10mg Hydrocodone Bitartrate USP 650mg Acetaminophen USP

BOXED WARNING

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displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

HEPATOTOXICITY
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

CLINICAL PHARMACOLOGY

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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

Pharmacokinetics

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displayName: PHARMACOKINETICS SECTION
FDA Article Code: 43682-4

The behavior of the individual components is described below
Hydrocodone Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, Ndemethylation and 6-keto reduction to the corresponding 6-a- and 6-b-hydroxy-metabolites. See 
Overdosage
for toxicity information. Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information

INDICATIONS AND USAGE

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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

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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

WARNINGS

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displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well Serious skin reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity Hypersensitivity  anaphylaxis There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs include swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritis, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Tablets, USP for patients with acetaminophen allergy

PRECAUTIONS

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displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

General
Special Risk Patients: As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen tablets should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.
Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen tablets are used postoperatively and in patients with pulmonary disease

Information for Patients

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displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0

Hydrocodone, like all narcotics, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided. Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed

Laboratory Tests

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displayName: LABORATORY TESTS SECTION
FDA Article Code: 34075-2

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests

Drug Interactions

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displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7

Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone

Drug and Laboratory Test Interactions

id: 2f503f33-2c34-4a2e-8384-1398e4dfbcba
displayName: DRUG & OR LABORATORY TEST INTERACTIONS SECTION
FDA Article Code: 34074-5

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid

Carcinogenesis, Mutagenesis, Impairment of Fertility

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displayName: CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
FDA Article Code: 34083-6

No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility

Pregnancy

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displayName: PREGNANCY SECTION
FDA Article Code: 42228-7

Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Nonteratogenic Effects
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal

Labor and Delivery

id: b002df17-bde2-4462-a67f-0949e77721ef
displayName: LABOR & DELIVERY SECTION
FDA Article Code: 34079-4

As with all narcotics, administration of hydrocodone bitartrate and acetaminophen tablets to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used

Nursing Mothers

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displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2

Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

Pediatric Use

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displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0

Safety and effectiveness in pediatric patients have not been established

Geriatric Use

id: 5791cca2-146f-481e-b0ee-ad3006d500ee
displayName: GERIATRIC USE SECTION
FDA Article Code: 34082-8

Clinical studies of hydrocodone bitartrate and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The most frequently reported adverse reactions are
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

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displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

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

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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION

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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

HOW SUPPLIED

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone Bitartrate and Acetaminophen tablets, USP are available in the following strengths:
10mg 325mg 10mg of Hydrocodone Bitartrate and 325mg of Acetaminophen.White to off white, scored, oblong biconvex tablets, debossed
IP110 on obverse and bisected on the reverse
They are supplied as follows 12634-144-78 Bottle of 12
12634-144-85 Bottle of 15
12634-144-79 Bottle of 25
12634-144-91 Blister Pack UD of 1
12634-144-61 Blister Pack Card 10
12634-144-52 Blister Pack Card 12
12634-144-55 Blister Pack Card 15 10mg 500mg 10mg of Hydrocodone Bitartrate and 500mg of Acetaminophen.Capsule-shaped, blue tablets bisected on one side and debossed
with Watson540 on the other side
DISCONTINUED 12634-978-95 Bottle of 5
12634-978-00 Bottle of 10
12634-978-85 Bottle of 15
12634-978-71 Bottle of 30
12634-978-91 Blister Pack UD of 1
12634-978-55 Blister Pack Card of 15 10mg 650mg 10mg of Hydrocodone Bitartrate and 650mg of Acetaminophen. White to off white, scored, oblong, biconvex tablets, debossed
IP114 on obverse, a bisected on the reverse
DISCONTINUED 12634-256-79 Bottle of 5
12634-256-50 Bottle of 50
12634-256-91 Blister Pack UD of 1

Storage

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displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

Dispense in a tight, light-resistant container as defined in the
USP with a child-resistant closure. Store at 20 – 25°C (68 – 77°F). (See USP for Controlled Room Temperature).

PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Hydocodone Bitartrate 

And Acetaminophen 10 325mg 25 Tablets
NDC 12634-144-79 CII
COMPARE TO  NORCO Rx Only Repackaged and Distributed by

Apotheca, Inc.
Phoenix, AZ 85006 A Schedule CIII Controlled Drug Substance – DISCONTINUED 12-31-2014
NDC 12634-978-55 Card 15 Tablets

Each Tablet Contains

Hydocodone Bitartrate 10 mg
Acetaminophen 500 mg
Usual Adult Dosage

See insert for full prescribing information
One tablet every four to six hours, as needed for pain. Total daily dosage should not exceed six tablets
Repackaged and Distributed by Apotheca, Inc
Phoenix, AZ 85006 Hydrocodone Bitartrate And Acetaminophen 10 650mg 
30 Tablets CIII – DISCONTINUED 12-31-2013 NDC 12634-256-71 COMPARE TO  LORCET Rx Only