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

Description for Vicodin HP

Hydrocodone bitartrate and acetaminophen 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 VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tablet contains:

Hydrocodone Bitartrate 10 mg
Acetaminophen 660 mg

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

Meets USP Dissolution Test 2.

Uses for Vicodin HP

VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tablets are indicated for the relief of moderateto moderately severe pain.

Dosage for Vicodin HP

Dosage should be adjusted according to severity of pain andthe response of the patient. However, it should be kept in mind that toleranceto hydrocodone can develop with continued use and that the incidence ofuntoward effects is dose related.

The usual adult dosage is one tablet every four to six hoursas needed for pain. The total daily dosage should not exceed 6 tablets.

HOW SUPPLIED

VICODIN HP® (hydrocodone bitrate and acetaminophen tablets) (hydrocodone bitartrate and acetaminophen, 10mg/660 mg) is supplied as a white, oval-shaped, tablet bisected on one side anddebossed with “VICODIN HP (hydrocodone bitrate and acetaminophen tablets) ” on the other side.

Bottles of 100-NDC #0074-2274-14
Bottles of 500-NDC #0074-2274-54

Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Revised March, 2007. Abbott Laboratories, North Chicago, IL 60064, USA

Side Effects for Vicodin HP

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 of mentaland physical performance, anxiety, fear, dysphoria, psychic dependence, moodchanges.

Gastrointestinal System

Prolonged administration of VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tablets may produce constipation.

Genitourinary System

Ureteral spasm, spasm of vesical sphincters and urinary retention 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 OVERDOSAGE section.

Drug Abuse And Dependence

Misuse, Abuse, and Diversion of Opioids

VICODIN HP (hydrocodone bitrate and acetaminophen tablets) contains hydrocodone, an opioid agonist, and is aSchedule III controlled substance. VICODIN HP (hydrocodone bitrate and acetaminophen tablets) , and other opioids, used inanalgesia can be abused and are subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, withgenetic, psychosocial, and environmental factors influencing its developmentand manifestations. It is characterized by behaviors that include one or moreof the following: impaired control over drug use, compulsive use, continued usedespite harm, and craving. Drug addiction is a treatable disease utilizing amultidisciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drugabusers. Drug-seeking tactics include emergency calls or visits near the end ofoffice hours, refusal to undergo appropriate examination, testing or referral,repeated “loss” of prescriptions, tampering with prescriptions and reluctanceto provide prior medical records or contact information for other treating physician(s).“Doctor shopping” to obtain additional prescriptions is common among drugabusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physicaldependence and tolerance. Physical dependence usually assumes clinicallysignificant dimensions only after several weeks of continued opioid use,although a mild degree of physical dependence may develop after a few days ofopioid therapy. Tolerance, in which increasingly large doses are required inorder to produce the same degree of analgesia, is manifested initially by ashortened duration of analgesic effect, and subsequently by decreases in theintensity of analgesia. The rate of development of tolerance varies amongpatients. Physicians should be aware that abuse of opioids can occur in theabsence of true addiction and is characterized by misuse for non-medical purposes,often in combination with other psychoactive substances. VICODIN HP (hydrocodone bitrate and acetaminophen tablets) , like otheropioids, may be diverted for non-medical use. Record-keeping of prescribinginformation, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribingpractices, periodic re-evaluation of therapy, and proper dispensing and storageare appropriate measures that help to limit abuse of opioid drugs.

Drug Interactions for Vicodin HP

Patients receiving narcotics, antihistamines,antipsychotics, antianxiety agents, or other CNS depressants (includingalcohol) concomitantly with VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tablets may exhibit an additive CNSdepression. When combined therapy is contemplated, the dose of one or bothagents should be reduced.

The use of MAO inhibitors or tricyclic antidepressants withhydrocodone 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 HP

Respiratory Depression

At high doses or in sensitive patients, hydrocodone mayproduce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controlsrespiratory rhythm, 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 headinjuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis orclinical course of patients with acute abdominal conditions.

Misuse, Abuse, and Diversion of Opioids

VICODIN HP (hydrocodone bitrate and acetaminophen tablets) contains hydrocodone, an opioid agonist, and is aSchedule III controlled substance. Opioid agonists have the potential for beingabused and are sought by abusers and people with addiction disorders, and aresubject to diversion.

VICODIN HP (hydrocodone bitrate and acetaminophen tablets) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing VICODIN HP in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see Drug Abuse And Dependence).

Precautions for Vicodin HP

General

Special Risk Patients

As with any narcotic analgesic agent, VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tabletsshould be used with caution in elderly or debilitated patients, and those withsevere impairment of hepatic or renal function, hypothyroidism, Addison'sdisease, prostatic hypertrophy or urethral stricture. The usual precautionsshould be observed and the possibility of respiratory depression should be keptin mind.

Cough Reflex

Hydrocodone suppresses the cough reflex; as with allnarcotics, caution should be exercised when VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tablets are usedpostoperatively and in patients with pulmonary disease.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of 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 andwell-controlled studies in pregnant women. VICODIN HP (hydrocodone bitrate and acetaminophen tablets) 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, and fever. 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 VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tabletsto the 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 small amounts,but the significance of its effects on nursing infants is not known. It is notknown whether hydrocodone is excreted in human milk. Because many drugs areexcreted 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 the pediatric population havenot been established.

Geriatric Use

Clinical studies of VICODIN HP® (hydrocodone bitrate and acetaminophen tablets) (hydrocodone bitartrate andacetaminophen 10 mg/660 mg) did not include sufficient numbers of subjects aged65 and over to determine whether they respond differently from younger subjects.Other reported 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, or cardiac function, and of concomitant disease or other drug therapy.

Hydrocodone and the major metabolites of acetaminophen areknown to be substantially excreted by the kidney. Thus the risk of toxicreactions may be greater in patients with impaired renal function due toaccumulation of the parent compound and/or metabolites in the plasma. Becauseelderly patients are more likely to have decreased renal function, care shouldbe taken in 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 HP

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 stuporor 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, potentiallyfatal hepatic necrosis is the most serious adverse effect. Renal tubularnecrosis, hypoglycemic coma, and thrombocytopenia may also occur.

Early symptoms following a potentially hepatotoxic overdosemay include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72hours post-ingestion.

In adults, hepatic toxicity has rarely been reported withacute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Treatment

A single or multiple 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. Vomiting should be inducedmechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) shouldfollow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included withalternate doses as required. Hypotension is usually hypovolemic and shouldrespond to fluids. Vasopressors and other supportive measures should beemployed as indicated. A cuffed endo-tracheal tube should be inserted beforegastric lavage of the unconscious patient and, when necessary, to provideassisted respiration.

Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, orpreferably hemodialysis may be considered. If hypoprothrombinemia occurs due toacetaminophen overdose, vitamin K should be administered intravenously.

Naloxone, an opioid antagonist, can reverse respiratorydepression and coma associated with opioid overdose. Naloxone hydrochloride 0.4mg to 2 mg is given parenterally. Since the duration of action of hydrocodonemay exceed that of the naloxone, the patient should be kept under continuoussurveillance and repeated doses of the antagonist should be administered asneeded to maintain adequate respiration. An opioid antagonist should not beadministered in the absence of clinically significant respiratory or cardiovascular depression.

If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophenlevels should be obtained, since levels four or more hours following ingestionhelp predict acetaminophen toxicity. Do not await acetaminophen assay resultsbefore initiating treatment. Hepatic enzymes should be obtained initially, and repeatedat 24-hour intervals.

Methemoglobinemia over 30% should be treated with methyleneblue by slow intravenous administration.

The toxic dose for adults for acetaminophen is 10 g.

Contraindications for Vicodin HP

This product should not be administered to patients who havepreviously exhibited hypersensitivity to hydrocodone or acetaminophen.

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

Clinical Pharmacology for Vicodin HP

Hydrocodone is a semisynthetic narcotic analgesic andantitussive with multiple actions qualitatively similar to those of codeine.Most of 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 central nervoussystem. In addition to analgesia, narcotics may produce drowsiness, changes inmood 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 ofacetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses 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 administered tofive adult male subjects, the mean peak concentration was 23.6 ± 5.2ng/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. The plasma half-life is1.25 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 oraldose appears in the urine within 24 hours of administration, most as theglucuronide conjugate, with small amounts of other conjugates and unchangeddrug. See OVERDOSAGE for toxicity information.

Patient Information for Vicodin HP

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 take thedrug only for as long as it is prescribed, in the amounts prescribed, and nomore frequently than prescribed.