Norco

Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.

The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Pharmacokinetics

The behavior of the individual components is described below.

Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β- hydroxymetabolites. See OVERDOSAGE for toxicity information.

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information.

• Actavis Pharma, Inc.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Norco falls into category C. There are no well-controlled studies that have been done in pregnant women. Norco should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

In the U.S.

• Anexsia
• Ceta Plus
• Co-Gesic
• Dolorex Forte
• Hycet
• Lorcet
• Lortab
• Maxidone
• Norco
• Stagesic
• Vicodin HP
• Zydone

Available Dosage Forms:

• Tablet
• Solution
• Syrup
• Elixir
• Capsule
• Liquid

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Hydrocodone

This section provides information on the proper use of a number of products that contain hydrocodone and acetaminophen. It may not be specific to Norco. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

This medicine should come with a Medication Guide and patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For moderate to moderately severe pain:
  • For oral dosage form (capsules):
    • Adults—1 or 2 capsules every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 capsules per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (elixir):
    • Adults and children 14 years of age and older and weighing 46 kg and more—11.25 milliliters (mL) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL per day.
    • Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL per day.
    • Children 7 to 9 years of age and weighing 23 to 31 kg—5.6 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL per day.
    • Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL per day.
    • Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL per day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (7.5 milligrams [mg] per 325 mg per 15 mL solution):
    • Adults and children 14 years of age and older and weighing 46 kg and more—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
    • Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
    • Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
    • Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day.
    • Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (10 milligrams [mg] per 325 mg per 15 mL solution):
    • Adults—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
    • Children 14 years of age and older and weighing 46 kg and more—11.25 mL (2 and 1/4 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL (13 and 1/2 teaspoonfuls) per day.
    • Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
    • Children 7 to 9 years of age and weighing 23 to 31 kg—5.6 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL (6 and 1/2 teaspoonfuls) per day.
    • Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
    • Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL (1/2 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL (3 and 1/4 teaspoonfuls) per day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (5 milligrams [mg] per 325 mg tablets):
    • Adults—
      • Lortab®: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 12 tablets per day.
      • Norco®: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 tablets per day.
      • Generic: Dose depends on the strength of the tablet and must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (7.5 mg per 325 mg tablets):
    • Adults—
      • Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day.
      • Generic: Dose depends on the strength of the tablet and must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (10 mg per 325 mg tablets):
    • Adults—
      • Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 6 tablets per day.
      • Generic: Dose depends on the strength of the tablet and must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Flush any unused Norco® tablets down the toilet.

• If you have an allergy to hydrocodone, acetaminophen, or any other part of Norco.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.

This is not a list of all drugs or health problems that interact with Norco.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Feeling very sleepy.
• Trouble breathing, slow breathing, or shallow breathing.
• Feeling confused.
• Trouble walking.
• Very hard stools (constipation).
• Very bad belly pain.
• Feeling very tired or weak.
• Not able to pass urine or change in how much urine is passed.
• Hearing loss.
• Change in hearing.
• Chest pain or pressure or a fast heartbeat.
• Fever or chills.
• Sore throat.
• Mood changes.
• Very bad headache.
• Trouble passing urine.
• Any unexplained bruising or bleeding.
• Change in eyesight.
• Seizures.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Upset stomach or throwing up.
• Feeling tired or weak.
• Headache.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Norco® is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Norco® for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

• have not been tolerated, or are not expected to be tolerated
  
• have not provided adequate analgesia, or are not expected to provide adequate analgesia

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Norco will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.