Lorcet

Lorcet is part of the drug class:

• Anilides

Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

Acetaminophen and hydrocodone is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.

Since acetaminophen and hydrocodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how acetaminophen and hydrocodone 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.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and hydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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 Lorcet. 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.

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral syrup, oral tablet

Along with its needed effects, acetaminophen / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / hydrocodone:

• Dizziness
• lightheadedness

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blood in vomit
• bluish lips or skin
• chills
• choking
• cough or hoarseness
• dark urine
• decrease in the frequency of urination
• decrease in urine volume
• difficult or troubled breathing
• difficulty in passing urine (dribbling)
• difficulty with breathing
• difficulty with swallowing
• fast heartbeat
• fever
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• headache
• irregular, fast or slow, or shallow breathing
• light-colored stools
• loss of appetite
• lower back or side pain
• nausea or vomiting
• nosebleeds
• not breathing
• painful or difficult urination
• pale or blue lips, fingernails, or skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe or continuing stomach pain
• skin rash, hives, or itching
• sore throat
• sore tongue
• sores, ulcers, or white spots on the lips or in the mouth
• tightness in the chest
• unable to speak
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / hydrocodone:

• Bloody or cloudy urine
• change in consciousness
• chest pain or discomfort
• cold and clammy skin
• decreased awareness or responsiveness
• extreme drowsiness
• general feeling of discomfort or illness
• increased sweating
• irregular heartbeat
• lightheadedness, dizziness, or fainting
• loss of consciousness
• no blood pressure or pulse
• no muscle tone or movement
• not breathing
• severe sleepiness
• slow or irregular heartbeat
• stopping of heart
• sudden decrease in the amount of urine
• unconsciousness
• unpleasant breath odor

Some side effects of acetaminophen / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Drowsiness
• relaxed and calm
• sleepiness

• Belching
• changes in mood
• difficulty having a bowel movement (stool)
• fear or nervousness
• feeling of indigestion
• hearing loss
• impaired hearing
• pain in the chest below the breastbone
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral tablet

General

The adverse effects of hydrocodone are generally similar to the adverse effects observed with other narcotic analgesics. Acetaminophen is generally well-tolerated when administered in therapeutic doses.[Ref]

Nervous system

One study has suggested that the respiratory depression caused by hydrocodone may be of benefit in the treatment of dyspnea related to chronic obstructive pulmonary disease and restrictive lung disease. However, the potential for the precipitation of respiratory insufficiency makes such use of hydrocodone hazardous and such use should be undertaken, if at all, only with extreme caution.[Ref]

Nervous system side effects of hydrocodone include mental depression, dizziness, lightheadedness, respiratory depression (which is sometimes fatal), stupor, delirium, somnolence, agitation, and dysphoria.[Ref]

Other

Other side effects have included withdrawal symptoms, after either abrupt cessation or fast tapering of narcotic analgesics. Such symptoms may include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.[Ref]

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

The adverse effects of hydrocodone may be more likely and more severe in patients with liver disease.[Ref]

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis have been reported in alcoholic patients. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.[Ref]

Gastrointestinal

Gastrointestinal side effects with the use of acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely.

Gastrointestinal side effect including nausea, vomiting, constipation, and dry mouth are relatively common effects of narcotic analgesics.[Ref]

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Genitourinary

Genitourinary side effects including ureteral spasm, spasm of vesicle sphincters, and urinary retention have been reported.[Ref]

Dermatologic

Dermatologic side effects including narcotic-induced rashes have been reported. General erythematous skin rashes associated with acetaminophen have been reported, but are rare. A rare case of bullous erythema associated with acetaminophen has been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

Renal

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases.

The adverse effects of hydrocodone may be more likely and more severe in patients with renal insufficiency.[Ref]

Renal side effects of acetaminophen are rare and include acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, from chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Hypersensitivity

Hypersensitivity side effects to acetaminophen have been reported rarely.[Ref]

Respiratory

Respiratory side effects have included a case of eosinophilic pneumonia which has been associated with acetaminophen.[Ref]

Metabolic

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

Some side effects of Lorcet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.