Vicodin ES (Hydrocodone Bitartrate and Acetaminophen): Side Effects, Uses, Dosage, Interactions, Warnings (2024)

Description for Vicodin ES

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

WARNING: May be habit-forming (see PRECAUTIONS, PATIENT INFORMATION /Caregivers, and Drug Abuse And Dependence).

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 nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP is available in the following strengths:

VICODIN® : Hydrocodone Bitartrate........................ 5 mg

WARNING:It May be habit-forming.

Acetaminophen.................................... 300 mg

VICODIN ES®: Hydrocodone Bitartrate........................ 7.5 mg

WARNING:It May be habit-forming.

Acetaminophen.................................... 300 mg

VICODIN HP®: Hydrocodone Bitartrate........................ 10 mg

WARNING:It May be habit-forming.

Acetaminophen.................................... 300 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

This product complies with USP dissolution test 2.

Uses for Vicodin ES

Hydrocodone bitartrate and acetaminophen tablets areindicated for the relief of moderate to moderately severe pain.

Dosage for Vicodin ES

Dosage should be adjusted according to the severity ofthe pain and the response of the patient. However, it should be kept in mindthat tolerance to hydrocodone can develop with continued use and that theincidence of untoward effects is dose related.

VICODIN® (Hydrocodone Bitartrate and AcetaminophenTablets, USP 5 mg/300 mg): The usual adult dosage is one or two tabletsevery four to six hours as needed for pain. The total daily dosage should notexceed 8 tablets.

VICODIN ES® (Hydrocodone Bitartrate andAcetaminophen Tablets, USP 7.5 mg/300 mg): The usual adult dosage is onetablet every four to six hours as needed for pain. The total daily dosage shouldnot exceed 6 tablets.

VICODIN HP® (Hydrocodone Bitartrate andAcetaminophen Tablets, USP 10 mg/300 mg): The usual adult dosage is onetablet every four to six hours as needed for pain. The total daily dosage shouldnot exceed 6 tablets.

HOW SUPPLIED

VICODIN®, VICODIN ES® and VICODIN HP® (HydrocodoneBitartrate and Acetaminophen) Tablets, USP are supplied as follows:

VICODIN® 5 mg/300 mg

White, capsule-shaped, bisected tablets, debossed “5”score “300”on one side and “VICODIN” on the other side in bottles of 100and 500 tablets:

Bottles of 100 - NDC 0074-3041-13
Bottles of 500 - NDC 0074-3041-53

VICODIN ES® 7.5 mg/300 mg

White, capsule-shaped, bisected tablets, debossed “7.5”score “300” on one side and “VICODIN ES” on the other side in bottles of 100and 500 tablets:

Bottles of 100 - NDC 0074-3043-13
Bottles of 500 - NDC 0074-3043-53

VICODIN HP® 10 mg/300 mg

White, capsule-shaped, bisected tablets, debossed “10”score “300” on one side and “VICODIN HP” on the other side in bottles of 100and 500 tablets:

Bottles of 100 - NDC 0074-3054-13
Bottles of 500 - NDC 0074-3054-53

Storage

Store at 20° to 25°C (68° to 77°F). [See USPControlled Room Temperature].

PHARMACIST: Dispense in a tight, light-resistantcontainer with a child-resistant closure.

A Schedule II Narcotic

Manufactured for: AbbVie Inc., North Chicago, IL 60064U.S.A. Manufactured by: Mikart, Inc., Atlanta, GA 30318, 1122F00 Revised: Aug 2014

Side Effects for Vicodin ES

The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea and vomiting. These effects seemto be more prominent in ambulatory than in nonambulatory patients, and some ofthese adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

Central Nervous System

Drowsiness, mental clouding, lethargy, impairment ofmental and physical performance, anxiety, fear, dysphoria, psychic 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 urinaryretention have been reported with opiates.

Respiratory Depression

Hydrocodone bitartrate may produce dose-related respiratorydepression by acting directly on the brain stem respiratory centers (see OVERDOSAGE).

Special Senses

Cases of hearing impairment or permanent loss have beenreported predominantly in patients with chronic overdose.

Dermatological

Skin rash, pruritus.

The following adverse drug events may be borne in mind aspotential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Potential effects of high dosage are listed in the OVERDOSAGEsection.

Drug Abuse And Dependence

Controlled Substance

Hydrocone bitartrate and acetaminophen tablets isclassified as a Schedule II controlled substance.

Abuse And Dependence

Psychic dependence, physical dependence, and tolerancemay develop upon repeated administration of narcotics; therefore, this productshould be prescribed and administered with caution. However, psychic dependenceis unlikely to develop when hydrocodone bitartrate and acetaminophen tabletsare used for a short time for the treatment of pain.

Physical dependence, the condition in which continuedadministration of the drug is required to prevent the appearance of awithdrawal syndrome, assumes clinically significant proportions only afterseveral weeks of continued narcotic use, although some mild degree of physicaldependence may develop after a few days of narcotic therapy. Tolerance, inwhich increasingly large doses are required in order to produce the same degreeof analgesia, is manifested initially by a shortened duration of analgesic effect,and subsequently by decreases in the intensity of analgesia. The rate ofdevelopment of tolerance varies among patients.

Drug Interactions for Vicodin ES

Patients receiving other narcotics, antihistamines,antipsychotics, antianxiety agents, or other CNS depressants (includingalcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets mayexhibit an additive CNS depression. When combined therapy is contemplated, thedose 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/Laboratory Test Interactions

Acetaminophen may produce false-positive test results forurinary 5-hydroxyindoleacetic acid.

Warnings for Vicodin ES

Hepatotoxicity

Acetaminophen has been associated with cases of acuteliver failure, at times resulting in liver transplant and death. Most of thecases of liver injury are associated with the use of acetaminophen at dosesthat exceed 4000 milligrams per day, and often involve more than oneacetaminophen-containing product. The excessive intake of acetaminophen may beintentional to cause self-harm or unintentional as patients attempt to obtainmore pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individualswith underlying liver disease and in individuals who ingest alcohol whiletaking acetaminophen.

Instruct patients to look for acetaminophen or APAP onpackage labels and not to use more than one product that containsacetaminophen. Instruct patients to seek medical attention immediately upon ingestionof more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactionssuch as acute generalized exanthematous pustulosis (AGEP), Stevens-JohnsonSyndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.Patients should be informed about the signs of serious skin reactions, and useof the drug should be discontinued at the first appearance of skin rash or anyother sign of hypersensitivity.

Hypersensitivity/anaphylaxis

There have been post-marketing reports ofhypersensitivity and anaphylaxis associated with use of acetaminophen. Clinicalsigns included swelling of the face, mouth and throat, respiratory distress, urticaria,rash, pruritus, and vomiting. There were infrequent reports of life-threateninganaphylaxis requiring emergency medical attention. Instruct patients todiscontinue hydrocodone bitartrate and acetaminophen tablets immediately andseek medical care if they experience these symptoms. Do not prescribehydrocodone bitartrate and acetaminophen tablets for patients withacetaminophen allergy.

Respiratory Depression

At high doses or in sensitive patients, hydrocodone mayproduce dose-related respiratory depression by acting directly on the brainstem respiratory center. Hydrocodone also affects the center that controls respiratoryrhythm, and may produce irregular and periodic breathing.

Head Injury And Increased Intracranial Pressure

The respiratory depressant effects of narcotics and theircapacity to elevate cerebrospinal fluid pressure may be markedly exaggerated inthe presence of head injury, other intracranial lesions or a preexistingincrease in intracranial pressure. Furthermore, narcotics produce adversereactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosisor clinical course of patients with acute abdominal conditions.

Precautions for Vicodin ES

General

Special Risk Patients

As with any narcotic analgesic agent, hydrocodonebitartrate and acetaminophen tablets should be used with caution in elderly or debilitatedpatients 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 respiratorydepression should be kept in mind.

Cough Reflex

Hydrocodone suppresses the cough reflex; as with allnarcotics, caution should be exercised when hydrocodone bitartrate andacetaminophen tablets are used postoperatively and in patients with pulmonarydisease.

Laboratory Tests

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

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies have been conducted in animals todetermine whether hydrocodone or acetaminophen have a potential forcarcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies inpregnant women. Hydrocodone bitartrate and acetaminophen tablets should be usedduring pregnancy only if the potential benefit justifies the potential risk tothe fetus.

Nonteratogenic Effects

Babies born to mothers who have been taking opioidsregularly prior to delivery will be physically dependent. The withdrawal signsinclude irritability and excessive crying, tremors, hyperactive reflexes,increased respiratory rate, increased stools, sneezing, yawning, vomiting, andfever. The intensity of the syndrome does not always correlate with theduration of maternal opioid use or dose. There is no consensus on the bestmethod of managing withdrawal.

Labor And Delivery

As with all narcotics, administration of this product tothe mother shortly before delivery may result in some degree of respiratorydepression in the newborn, especially if higher doses are used.

Nursing Mothers

Acetaminophen is excreted in breast milk in smallamounts, 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 drugsare excreted in human milk and because of the potential for serious adversereactions in nursing infants from hydrocodone and acetaminophen, a decisionshould be made whether to discontinue nursing or to discontinue the drug,taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have notbeen established.

Geriatric Use

Clinical studies of hydrocodone bitartrate andacetaminophen tablets did not include sufficient numbers of subjects aged 65and over to determine whether they respond differently from younger subjects. Otherreported clinical experience has not identified differences in responsesbetween the elderly and younger patients. In general, dose selection for anelderly patient should be cautious, usually starting at the low end of thedosing range, reflecting the greater frequency of decreased hepatic, renal, orcardiac function, and of concomitant disease or other drug therapy.

Hydrocodone and the major metabolites of acetaminophenare known to be substantially excreted by the kidney. Thus the risk of toxicreactions may be greater in patients with impaired renal function due to accumulationof the parent compound and/or metabolites in the plasma. Because elderlypatients are more likely to have decreased renal function, care should be takenin dose selection, and it may be useful to monitor renal function.

Hydrocodone may cause confusion and over-sedation in theelderly; elderly patients generally should be started on low doses ofhydrocodone bitartrate and acetaminophen tablets and observed closely.

Overdose Information for Vicodin ES

Following an acute overdosage, toxicity may result fromhydrocodone or acetaminophen.

Signs And Symptoms

Hydrocodone

Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Acetaminophen

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise.Clinical and laboratory evidence of hepatic toxicity may not be apparent until48 to 72 hours post-ingestion.

Treatment

A single or multiple drug overdose with hydrocodone andacetaminophen is a potentially lethal polydrug overdose, and consultation witha regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratoryfunction and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and othersupportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

For hydrocodone overdose, primary attention should begiven to the reestablishment of adequate respiratory exchange through provisionof a patent airway and the institution of assisted or controlled ventilation.The narcotic antagonist naloxone hydrochloride is a specific antidote againstrespiratory depression which may result from overdosage or unusual sensitivityto narcotics, including hydrocodone. Since the duration of action ofhydrocodone may exceed that of the antagonist, the patient should be kept undercontinued surveillance, and repeated doses of the antagonist should be administeredas needed to maintain adequate respiration. A narcotic antagonist should not beadministered in the absence of clinically significant respiratory or cardiovascular depression.

Gastric decontamination with activated charcoal should beadministered just prior to N-acetylcysteine (NAC) to decrease systemicabsorption if acetaminophen ingestion is known or suspected to have occurredwithin a few hours of presentation. Serum acetaminophen levels should beobtained immediately if the patient presents 4 hours or more after ingestion toassess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4hours post-ingestion may be misleading. To obtain the best possible outcome,NAC should be administered as soon as possible where impending or evolvingliver injury is suspected. Intravenous NAC may be administered whencirc*mstances preclude oral administration.

Vigorous supportive therapy is required in severeintoxication. Procedures to limit the continuing absorption of the drug must bereadily performed since the hepatic injury is dose dependent and occurs earlyin the course of intoxication.

Contraindications for Vicodin ES

This product should not be administered to patients whohave previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids mayexhibit cross sensitivity to hydrocodone.

Clinical Pharmacology for Vicodin ES

Hydrocodone is a semisynthetic narcotic analgesic andantitussive with multiple actions qualitatively similar to those of codeine. Mostof these involve the central nervous system and smooth muscle. The precisemechanism of action of hydrocodone and other opiates is not known, although itis believed to relate to the existence of opiate receptors in the centralnervous system. In addition to analgesia, narcotics may produce drowsiness,changes in mood and mental clouding.

The analgesic action of acetaminophen involves peripheralinfluences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminopheninhibits prostaglandin synthetase. Therapeutic doses of acetaminophen havenegligible effects on the cardiovascular or respiratory systems; however, toxicdoses may cause circulatory failure and rapid, shallow breathing.

Pharmaco*kinetics

The behavior of the individual components is describedbelow.

Hydrocodone

Following a 10 mg oral dose of hydrocodone administeredto 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 wasdetermined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction tothe corresponding 6-α- and 6-β- hydroxy- metabolites. See OVERDOSAGEfor toxicity information.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. Theplasma half-life is 1.25 to 3 hours, but may be increased by liver damage and followingoverdosage. 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 asthe glucuronide conjugate, with small amounts of other conjugates and unchangeddrug. See OVERDOSAGE for toxicity information.

Patient Information for Vicodin ES

Information For Patients /Caregivers

• Do not take hydrocodone bitartrate and acetaminophen tablets if you are allergic to any of its ingredients.
• If you develop signs of allergy such as a rash or difficulty breathing stop taking hydrocodone bitartrate and acetaminophen tablets and contact your healthcare provider immediately.
• Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

Hydrocodone, like all narcotics, may impair the mentaland/or physical abilities required for the performance of potentially hazardoustasks such as driving a car or operating machinery; patients should becautioned accordingly.

Alcohol and other CNS depressants may produce an additiveCNS depression, when taken with this combination product, and should beavoided.

Hydrocodone may be habit forming. Patients should takethe drug only for as long as it is prescribed, in the amounts prescribed, andno more frequently than prescribed.