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 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Anexsia 7.5/650
- Tablets 7.5 mg hydrocodone bitartrate/650 mg acetaminophen
Trade Names:
Anexsia 10/660
- Tablets 10 mg hydrocodone bitartrate/660 acetaminophen
Trade Names:
Ceta-Plus
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Co-Gesic
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Duocet
- Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Dolacet
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Duradyne DHC
- Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Hydrocet
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Hydrogesic
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Hy-Phen
- Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Lorcet 10/650
- Tablets 10 mg hydrocodone bitartrate/650 mg acetaminophen
Trade Names:
Lorcet-HD
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Lorcet Plus
- Tablets 7.5 mg hydrocodone bitartrate/650 mg acetaminophen
Trade Names:
Lortab 5/500
- Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Lortab 7.5/500
- Tablets 7.5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Lortab 10/500
- Tablets 10 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Margesic H
- Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Norco
- Tablets 10 mg hydrocodone bitartrate/325 mg acetaminophen
Trade Names:
Stagesic
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
T-Gesic
- Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Vicodin
- Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
Trade Names:
Vicodin ES
- Tablets 7.5 mg hydrocodone bitartrate/750 mg acetaminophen
Trade Names:
Vicodin HP
- Tablets 10 mg hydrocodone bitartrate/660 mg acetaminophen
Trade Names:
Zamicet
- Solution 10 mg hydrocodone/325 mg acetaminophen per 15 mL
Trade Names:
Zydone
- Tablets 7.5 mg hydrocodone bitartrate/400 mg acetaminophen
- Tablets 10 mg hydrocodone bitartrate/400 mg acetaminophen
Pharmacology
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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.
AdultsPO 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/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
AnticholinergicsMay produce paralytic ileus.
Carbamazepine, hydantoins, sulfinpyrazoneMay 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.
MAOIsMay cause additive CNS toxicity; may cause decreased BP.
Tricyclic antidepressants, phenothiazinesMay 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
MonitorMonitor 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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Hydrocodone Bitartrate/Acetaminophen Side Effects
