Rx Product Guide

   
   
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Hydrocodone Bitartrate / Acetaminophen (HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen)
Trade Name(s):   Anexsia 5/500
  ·Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Anexsia 7.5/650
  ·Tablets 7.5 mg hydrocodone bitartrate/650 mg acetaminophen
  Anexsia 10/660
  ·Tablets 10 mg hydrocodone bitartrate/660 acetaminophen
  Ceta-Plus
  ·Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Co-Gesic
  ·Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Duocet
  ·Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Dolacet
  ·Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Duradyne DHC
  ·Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Hydrogesic
  ·Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Lorcet 10/650
  ·Tablets 10 mg hydrocodone bitartrate/650 mg acetaminophen
  Lorcet Plus
  ·Tablets 7.5 mg hydrocodone bitartrate/650 mg acetaminophen
  Lortab 5/500
  ·Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Lortab 7.5/500
  ·Tablets 7.5 mg hydrocodone bitartrate/500 mg acetaminophen
  Lortab 10/500
  ·Tablets 10 mg hydrocodone bitartrate/500 mg acetaminophen
  Margesic H
  ·Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Norco
  ·Tablets 10 mg hydrocodone bitartrate/325 mg acetaminophen
  Stagesic
  ·Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
  T-Gesic
  ·Capsules 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Vicodin
  ·Tablets 5 mg hydrocodone bitartrate/500 mg acetaminophen
  Vicodin ES
  ·Tablets 7.5 mg hydrocodone bitartrate/750 mg acetaminophen
  Vicodin HP
  ·Tablets 10 mg hydrocodone bitartrate/660 mg acetaminophen
  Zamicet
  ·Solution 10 mg hydrocodone/325 mg acetaminophen per 15 mL
  Zydone
  ·Tablets 7.5 mg hydrocodone bitartrate/400 mg acetaminophen
  ·Tablets 10 mg hydrocodone bitartrate/400 mg acetaminophen

Indicates Canadian Trade Name.


Class: Opioid analgesic combination

Action: 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: Management of mild to moderate pain.

Contraindications: Hypersensitivity to acetaminophen, hydrocodone, or similar compounds.

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.
Lab Test Interferences: 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.

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

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

miscellaneous:
Allergic reactions.
Precautions:
Monitoring: 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 impairment: Use with caution in patients with severe renal impairment.
Hepatic function impairment: 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: Signs & 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/Family Education:
  • 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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