Lortab

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away acetaminophen and hydrocodone is against the law.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

This medicine can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and hydrocodone.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and hydrocodone.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

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.

Serious side effects have been reported with Lortab.

At high doses or in sensitive patients, hydrocodone may produce respiratory depression. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. The respiratory depressant effects of hydrocodone may be exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Hydrocodone may also produce adverse reactions that may obscure the clinical course of patients with head injuries.

Hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Hydrocodone suppresses the cough reflex; caution should be exercised when Lortab is used postoperatively and in patients with pulmonary disease.

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.

Lortab can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Lortab affects you.

Do not take Lortab if you are allergic to Lortab or to any of its ingredients or are allergic to any other opioid medication.

• Store Lortab at room temperature.
• Protect from exposure to light.
• Keep this and all medicines out of the reach of children.

Hydrocodone and acetaminophen combination is used to relieve moderate to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Hydrocodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

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

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-hydroxy-metabolites. 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.

The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System: Prolonged administration of Lortab may produce constipation.

Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center (see OVERDOSAGE).

Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Dermatological: Skin rash, pruritus.

The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. Potential effects of high dosage are listed in the OVERDOSAGE section.

Misuse, Abuse, and Diversion of Opioids

Lortab contain hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Lortab, and other opioids used in analgesia can be abused and are subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

"Drug seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Lortab, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

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

Lortab is a combination analgesic used for the short-term relief of moderate-to-moderately severe pain; however, use is limited by the dependence and addiction potential of the hydrocodone component.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose can also cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.