Hydrocodone Bitartrate / Acetaminophen

Pronunciation: (HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen)
Class: Opioid analgesic combination

Trade Names

Anexsia 5/500
- Tablets hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Anexsia 7.5/650
- Tablets hydrocodone bitartrate 7.5 mg/acetaminophen 650 mg

Anexsia 10/660
- Tablets hydrocodone bitartrate 10 mg/acetaminophen 660

Co-Gesic
- Capsules hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Duocet
- Tablets hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Dolacet
- Capsules hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Duradyne DHC
- Tablets hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Hydrogesic
- Capsules hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Lorcet 10/650
- Tablets hydrocodone bitartrate 10 mg/acetaminophen 650 mg

Lorcet Plus
- Tablets hydrocodone bitartrate 7.5 mg/acetaminophen 650 mg

Lortab 5/500
- Tablets hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Lortab 7.5/500
- Tablets hydrocodone bitartrate 7.5 mg/acetaminophen 500 mg

Lortab 10/500
- Tablets hydrocodone bitartrate 10 mg/acetaminophen 500 mg

Margesic H
- Tablets hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Norco
- Tablets hydrocodone bitartrate 10 mg/acetaminophen 325 mg

Stagesic
- Capsules hydrocodone bitartrate 5 mg/acetaminophen 500 mg

T-Gesic
- Capsules hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Vicodin
- Tablets hydrocodone bitartrate 5 mg/acetaminophen 500 mg

Vicodin ES
- Tablets hydrocodone bitartrate 7.5 mg/acetaminophen 750 mg

Vicodin HP
- Tablets hydrocodone bitartrate 10 mg/acetaminophen 660 mg

Zamicet
- Solution hydrocodone 10 mg/acetaminophen 325 mg per 15 mL

Zydone
- Tablets hydrocodone bitartrate 7.5 mg/acetaminophen 400 mg
- Tablets hydrocodone bitartrate 10 mg/acetaminophen 400 mg

Pharmacology

Inhibits synthesis of prostaglandins and binds to opiate receptors in CNS and peripherally blocks pain impulse generation; produces antipyresis by direct action on hypothalamic heat-regulating center; causes cough suppression by direct central action in medulla; may produce generalized CNS depression.

Indications and Usage

Management of mild to moderate pain.

Contraindications

Hypersensitivity to acetaminophen, hydrocodone, or similar compounds.

Dosage and Administration

Varies according to product and strength.

Adults

PO 1 to 2 tablets or capsules (hydrocodone 2.5 to 10 mg; acetaminophen 500 to 1,000 mg) every 4 to 6 h or 5 to 10 mL (elixir, solution 15 mL) every 4 to 6 h as needed. Max, 6 doses/day ( Zamicet )

Children (younger than 12 yr of age)

PO 10 to 15 mg acetaminophen/kg/dose every 4 h to max 2.6 g per 24 h.

Children (2 to 13 years of age and at least 12 kg)

Zamicet 0.2 mL/kg. Max, 6 doses/day.

General Advice

• Use calibrated measuring device to measure liquid doseforms.

Storage/Stability

Store at room temperature and protect from light.

Drug Interactions

Anticholinergics

May produce paralytic ileus.

Carbamazepine, hydantoins, sulfinpyrazone

May result in increased risk of hepatotoxicity from acetaminophen.

CNS depressants (eg, barbiturates, ethyl alcohol, other narcotics)

May cause CNS toxicity. Avoid concurrent use with alcohol.

MAOIs

May cause additive CNS toxicity; may cause decreased BP.

Tricyclic antidepressants, phenothiazines

May cause additive CNS toxicity.

Laboratory Test Interactions

With Chemstrip bG , Dextrostix , and Visidex II home blood glucose systems, may cause false decrease in mean glucose values. May give false-positive urinary 5-hydroxyindoleacetic acid test. Amylase or lipase may be increased for 24 h because of narcotic-induced increase in biliary tract pressure.

Adverse Reactions

Cardiovascular

Hypotension; bradycardia; circulatory collapse.

CNS

Lightheadedness; dizziness; sedation; drowsiness; weakness; anxiety; fear; fatigue; dysphoria; psychological dependence; confusion; euphoria; malaise; lethargy; mental clouding; mood changes; somnolence progressing to stupor or coma.

Dermatologic

Cold and clammy skin; diaphoresis; pruritus; rash.

GI

Nausea; vomiting; constipation; abdominal pain; gastric distress; heartburn; hepatitis; occult blood loss; peptic ulcer.

Genitourinary

Decreased urination; urethral spasm; renal toxicity; spasm of vesical sphincters.

Respiratory

Dyspnea; respiratory depression; irregular breathing; acute airway obstruction.

Miscellaneous

Allergic reactions.

Precautions

Monitor Monitor liver and/or renal function tests in patients with severe hepatic or renal disease. Closely monitor elderly, debilitated patients, and those with conditions accompanied by hypoxia or hypercapnia to avoid decrease in pulmonary ventilation.

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and effectiveness in children have not been established. Safety and effectiveness in children younger than 2 years of age have not been established ( Zamicet ).

Elderly

Use with caution.

Renal Function

Use with caution in patients with severe renal impairment.

Hepatic Function

Use with caution in patients with severe hepatic impairment. Chronic alcoholics should limit acetaminophen intake to less than 2 g/day.

Special Risk Patients

Use caution in patients with head injury, other intracranial lesions or a preexisting increase in intracranial pressure, with acute abdominal conditions, hypothyroidism, Addison disease, prostatic hypertrophy, or urethral stricture, or patients who are debilitated or sensitive to CNS depressants. Because of cough suppressant effects, exercise caution when using postoperatively or in patients with pulmonary disease.

Sulfite Sensitivity

Use caution in sulfite-sensitive individuals; some commercial preparations contain sodium bisulfite.

Respiratory depression

May occur.

Overdosage

Symptoms

Blood dyscrasias, respiratory depression, and hepatic necrosis (all may occur up to several days after overdose); renal tubular necrosis, hypoglycemic coma, nausea, vomiting, diaphoresis, malaise, skeletal muscle flaccidity, bradycardia, hypotension, apnea, cardiac arrest, hearing impairment or permanent hearing loss, loss of consciousness, pinpoint pupils, convulsions, cold/clammy skin, circulatory collapse, somnolence progressing to stupor or coma.

Patient Information

• Instruct patient to take before pain becomes severe.
• Advise patient to take with food or milk.
• When medication is being used for acute pain, advise patient of possible addiction and explain that drug should be used for short term only.
• Advise patient to change position slowly and to use caution when ambulating and performing other activities requiring mental alertness such as driving or operating machinery.
• Instruct patient to eat high-fiber diet, maintain adequate fluid intake, and use stool softener or bulk laxative to prevent constipation.
• Advise patient to avoid alcohol and any other drug that causes drowsiness such as sleeping aids and antihistamines.
• Instruct patient to discontinue drug and notify health care provider if blurred vision, rash, or yellowing of skin occurs.
• If lightheadedness, dizziness, drowsiness, nausea, or vomiting occur, advise patient to lie down until symptoms subside and to notify health care provider if symptoms persist.

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