LORTAB (Hydrocodone Bitartrate and Acetaminophen Tablets, Elixir)

For healthcare professionals

LORTAB^® 5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg CIII
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LORTAB^® 10 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg CIII
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LORTAB^® 7.5 mg/500 mg
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg CIII
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LORTAB^® Elixir
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/500 mg per 15 mL
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INDICATION
LORTAB^® (hydrocodone bitartrate and acetaminophen tablets) 5/500-mg, 7.5/500-mg, and 10/500-mg tablets and elixir are indicated for the relief of moderate to moderately severe pain.

LORTAB^® tablets and elixir are contraindicated in patients with known hypersensitivity to hydrocodone or acetaminophen. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.

IMPORTANT SAFETY INFORMATION

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Patients should be cautioned that LORTAB^® may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, not to take LORTAB^® with alcohol and other CNS depressants as it may produce an additive CNS depression, and that LORTAB^® may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. The health care professional should consider the potential for misuse, abuse and diversion before prescribing or dispensing LORTAB^®.
LORTAB^® tablets and elixir are contraindicated in patients with known hypersensitivity to hydrocodone or acetaminophen. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. Do not prescribe LORTAB^® for patients with acetaminophen allergy.

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LORTAB^® may produce dose-related respiratory depression, or may produce irregular and periodic breathing. These effects and narcotics capacity to elevate cerebrospinal fluid pressure may be exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure.
Narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions and may also obscure the clinical course of patients with head injuries.
LORTAB^® should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture.
Caution should be exercised when LORTAB^® is used postoperatively and in patients with pulmonary disease since hydrocodone suppresses the cough reflex.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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About LORTAB^® | Prescribing Information • LORTAB^® 5 mg/500 mg • LORTAB^® 7.5 mg/500 mg • LORTAB^® 10 mg/500 mg • LORTAB^® Elixir

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LORTAB^® is a registered trademark of the UCB Group of Companies.