Lortab 10

DRUG DESCRIPTION

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

WARNING: May be habit forming (see PRECAUTIONS, Information for Patients, and DRUG ABUSE AND DEPENDENCE).

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5?- epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Hydrocodone bitartrate structural formula illustration

C18H21NO3C4H6O6 2 ? H2O M.W. 494.490

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Acetaminophen structural formula illustration

C8H9NO2 M.W. 151.16

Each Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablet contains:

Hydrocodone Bitartrate........................................... 10 mg
Acetaminophen.................................................... 500 mg

In addition, each tablet contains the following inactive ingredients: D&C Red No. 27 Aluminum Lake, D&C Red No. 30 Aluminum Lake, colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, starch (corn), and stearic acid. Meets USP dissolution test 1.

What are the precautions when taking hydrocodone bitartrate and acetaminophen tablets (Lortab 10)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., morphine, codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), severe diarrhea (e.g., pseudomembranous colitis, infectious diarrhea due to toxins).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure),...

Read All Potential Precautions of Lortab 10


Lortab 10 Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, flushing, vision changes, or mental/mood changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular breathing, slow/irregular heartbeat, change in the amount of urine.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: impairment or loss of hearing (especially with high doses for long periods).

If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., morphine, codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), severe diarrhea (e.g., pseudomembranous colitis, infectious diarrhea due to toxins).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure), abdominal/stomach problems (e.g., gallbladder disease), lung disease (e.g., asthma, chronic obstructive pulmonary disease), seizure disorders, serious head injury or brain disease, spinal problems (kyphoscoliosis), low thyroid disease (hypothyroidism), adrenal gland problems (Addison's disease), psychiatric problems (toxic psychosis).

This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of side effects of this drug.

This product contains acetaminophen which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially the possible decreased breathing and drowsiness effects.

This medication should be used only when clearly needed during pregnancy. It is not recommended for use for long periods or in high doses near the expected delivery date because of the potential for harm to an unborn baby. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this drug may pass into breast milk. Due to the potential risk to the infant, consult your doctor before breast-feeding.



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