Hydrocodone bitartrate and acetaminophen

Hydrocodone bitartrate and acetaminophen
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.

Dosage

• 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.

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydrocodone bitartrate and acetaminophen tablet in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydrocodone bitartrate and acetaminophen tablet in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Hydrocodone bitartrate and acetaminophen FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydrocodone bitartrate and acetaminophen tablet in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydrocodone bitartrate and acetaminophen tablet in pediatric patients.

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

Warnings

• Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

• Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

• Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Adverse Reactions

Clinical Trials Experience

• 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:

• • Central Nervous System:

Drowsiness, mental clouding, lethargy, impairment of mental 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 urinary retention have been reported with opiates.

• • Respiratory Depression

Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center .

• • Special Senses

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

• • Dermatological

Skin rash, pruritus.

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

Postmarketing Experience

There is limited information regarding Hydrocodone bitartrate and acetaminophen Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Hydrocodone bitartrate and acetaminophen Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Hydrocodone bitartrate and acetaminophen in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydrocodone bitartrate and acetaminophen in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hydrocodone bitartrate and acetaminophen during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen in geriatric settings.

Gender

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hydrocodone bitartrate and acetaminophen in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hydrocodone bitartrate and acetaminophen in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Hydrocodone bitartrate and acetaminophen Administration in the drug label.

Monitoring

There is limited information regarding Hydrocodone bitartrate and acetaminophen Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Hydrocodone bitartrate and acetaminophen and IV administrations.

Overdosage

=Following an acute overdosage, toxicity may result from hydrocodone 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 thrombocytopenia 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 until 48 to 72 hours post-ingestion.

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

Treatment

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

• Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.

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

• Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered 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 acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.

• Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

• The toxic dose for adults for acetaminophen is 10 g

Pharmacology

There is limited information regarding Hydrocodone bitartrate and acetaminophen Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Hydrocodone bitartrate and acetaminophen Mechanism of Action in the drug label.

Structure

There is limited information regarding Hydrocodone bitartrate and acetaminophen Structure in the drug label.

Pharmacodynamics

There is limited information regarding Hydrocodone bitartrate and acetaminophen Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Hydrocodone bitartrate and acetaminophen Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Hydrocodone bitartrate and acetaminophen Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Hydrocodone bitartrate and acetaminophen Clinical Studies in the drug label.

How Supplied

There is limited information regarding Hydrocodone bitartrate and acetaminophen How Supplied in the drug label.

Storage

There is limited information regarding Hydrocodone bitartrate and acetaminophen Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Hydrocodone bitartrate and acetaminophen Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Hydrocodone bitartrate and acetaminophen tablet interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

HYDROCODONE ACETAMINOPHEN

Look-Alike Drug Names

There is limited information regarding Hydrocodone bitartrate and acetaminophen Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.