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|Hydrocodone Bitartrate/Acetaminophen Hydrocodone Bitartrate/Chlorpheniramine Maleate

Hydrocodone Bitartrate/Acetaminophen

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:
Bancap-HC
- Capsules 5 mg hydrocodone bitartrate/500 mg 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:
Panacet 5/500
- Tablets 5 mg hydrocodone bitartrate/500 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:
Zydone
- Tablets 7.5 mg hydrocodone bitartrate/400 mg acetaminophen
- Tablets 10 mg hydrocodone bitartrate/400 mg acetaminophen

Mechanism of Action

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.

PO 1 to 2 tablets or capsules (hydrocodone 2.5 to 10 mg; acetaminophen 500 to 1000 mg) q 4 to 6 hr or 5 to 10 mL (elixir, 15 mL) q 4 to 6 hr prn.

PO 10 to 15 mg acetaminophen/kg/dose q 4 hr to max 2.6 g/24 hr.

Storage/Stability

Store at room temperature and protect from light.

Drug Interactions

May produce paralytic ileus.

May result in increased risk of hepatotoxicity from acetaminophen.

May cause CNS toxicity.

May cause additive CNS toxicity; may cause decreased BP.

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 hr because of narcotic-induced increase in biliary tract pressure.

Adverse Reactions

Cardiovascular

Hypotension; bradycardia.

CNS

Lightheadedness; dizziness; sedation; drowsiness; weakness; anxiety; fear; fatigue; dysphoria; psychological dependence; confusion.

GI

Nausea; vomiting; constipation.

Genitourinary

Decreased urination; urethral spasm.

Respiratory

Dyspnea; respiratory depression; irregular breathing.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and effectiveness in children have not been established.

Hepatic Function

Chronic alcoholics should limit acetaminophen intake to less than 2 g/day.

Special Risk Patients

Closely monitor elderly, debilitated patients, and those with conditions accompanied by hypoxia or hypercapnia to avoid decrease in pulmonary ventilation. Also use caution in patients 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.

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, somnolence, skeletal muscle flaccidity, bradycardia, hypotension, apnea, cardiac arrest.

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.