Lortab- Hydrocodone Bitartrate And Acetaminophen Tablet - DailyMed

Label: lortab- Hydrocodone Bitartrate and Acetaminophen tablet

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• Contains inactivated NDC Code(s) NDC Code(s): 50474-925-01, 50474-925-50
• Packager: UCB PHARMA, INC.

• Category: HUMAN PRESCRIPTION DRUG LABEL
• DEA Schedule: CIII

Drug Label Information

Updated October 20, 2006

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• N/A - Section Title Not Found In Database
• SPL UNCLASSIFIED SECTION

  * Warning: May be habit forming

• DESCRIPTION

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

  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 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

  

  C18H21NO3 ● C4H6O6● 2 ½ H2O                                                                                M.W. 494.50

  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:

  

  C8H9NO2                                                                                                                       M.W. 151.17

  Each Lortab 2.5/500 tablet contains:

  Hydrocodone Bitartrate……………………………………………. 2.5 mg           (Warning: May be habit forming)

  Acetaminophen……………………………………………………. 500 mg

  In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and sugar spheres which are composed of starch derived from corn, sucrose, and FD&C Red #3.

• CLINICAL PHARMACOLOGY

  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.

  Hydrocodone: 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: 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.

• INDICATIONS AND USAGE

  Lortab 2.5/500 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) are indicated for the relief of moderate to moderately severe pain.

• CONTRAINDICATIONS

  This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

• WARNINGS

  Respiratory Depression

  At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

  Head Injury and Increased Intracranial Pressure

  The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

  Acute Abdominal Conditions

  The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

• PRECAUTIONS

  General

  Special Risk Patients:

  As with any narcotic analgesic agent, Lortab 2.5/500 tablets 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. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

  Cough Reflex:

  Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lortab 2.5/500 tablets are used postoperatively and in patients with pulmonary disease.

  Information for Patients

  Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.

  Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

  Hydrocodone 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.

  Laboratory Tests

  In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

  Drug Interactions

  Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

  The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

  Drug/Laboratory Test Interactions

  Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

  Carcinogenesis, Mutagenesis, Impairment of Fertility

  No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

  Pregnancy

  Teratogenic Effects: Pregnancy Category C

  There are no adequate and well-controlled studies in pregnant women. Lortab 2.5/500 tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

  Nonteratogenic Effects

  Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

  Labor and Delivery

  As with all narcotics, administration of this product to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

  Nursing Mothers

  Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

  Pediatric Use

  Safety and effectiveness in the pediatric population have not been established.

• ADVERSE REACTIONS

  The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory 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 2.5/500 tablets 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 centers (see OVERDOSAGE).

  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.

• DRUG ABUSE AND DEPENDENCE

  Controlled Substance

  Lortab 2.5/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) are classified as a Schedule III controlled substance.

  Abuse and Dependence

  Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain.

  Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic 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.

• OVERDOSAGE

  Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

  Signs and Symptoms

  Hydrocodone: Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis) extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

  Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur.

  Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

  In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

  Treatment

  A single or multiple overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

  Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive measures should be employed as indicated. A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.

  Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.

  Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

  If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24 – hour intervals.

  Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

  The toxic dose for adults for acetaminophen is 10 g.

• DOSAGE AND ADMINISTRATION

  Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

  The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage for adults should not exceed 8 tablets.

• HOW SUPPLIED

  Lortab® 2.5/500 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP) contain hydrocodone bitartrate 2.5 mg (Warning: May be habit forming) and acetaminophen 500 mg. They are supplied as white with pink specks, capsule-shaped, bisected tablets, debossed “ucb/901,” in containers of 100 tablets NDC 50474-925-01, and 500 tablets NDC 50474-925-50.

  STORAGE

  Store at controlled room temperature, 15°-30°C (59° to 86°F).

  Dispense in a tight, light-resistant container with a child-resistant closure.

  CAUTION

  Federal law prohibits dispensing without prescription.

  A Schedule CIII Narcotic

• SPL UNCLASSIFIED SECTION

  Manufactured For UCB PHARMA, INC. Atlanta, GA 30080

  Manufactured By MIKART, INC. Atlanta, GA 30318

  Rev. 8/96Code 537B00P/N 2H8007D

• INGREDIENTS AND APPEARANCE

  LORTAB  hydrocodone bitartrate and acetaminophen tablet

  Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-925 Route of Administration ORAL DEA Schedule CIII

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocodone bitartrate (UNII: NO70W886KK) (Hydrocodone - UNII:6YKS4Y3WQ7) 2.5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) 500 mg

  Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE ()   CROSCARMELLOSE SODIUM ()   CROSPOVIDONE ()   FD & C RED #3 ()   MICROCRYSTALLINE CELLULOSE ()   POVIDONE ()   PREGELATINIZED STARCH ()   STEARIC ACID (UNII: 4ELV7Z65AP)   SUCROSE (UNII: C151H8M554)   SUGAR SPHERES ()

  Product Characteristics Color WHITE Score 2 pieces Shape OVAL (CAPSULE-SHAPED) Size 14mm Flavor Imprint Code ucb;901 Contains      Coating false Symbol false

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50474-925-01 100 in 1 BOTTLE, PLASTIC 2 NDC:50474-925-50 500 in 1 BOTTLE, PLASTIC

  Labeler - UCB PHARMA, INC.

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lortab- Hydrocodone Bitartrate and Acetaminophen tablet

Number of versions: 1

Published Date (What is this?)	Version	Files
Dec 1, 2006	1 (current)	download

lortab- Hydrocodone Bitartrate and Acetaminophen tablet

RxCUI	RxNorm NAME	RxTTY
1	857111	HYDROcodone bitartrate 2.5 MG / acetaminophen 500 MG Oral Tablet	PSN
2	857111	acetaminophen 500 MG / hydrocodone bitartrate 2.5 MG Oral Tablet	SCD
3	857111	APAP 500 MG / hydrocodone bitartrate 2.5 MG Oral Tablet	SY
4	857113	Lortab 2.5 MG / 500 MG (HYDROcodone bitartrate / acetaminophen) Oral Tablet	PSN
5	857113	acetaminophen 500 MG / hydrocodone bitartrate 2.5 MG Oral Tablet [Lortab]	SBD
6	857113	APAP 500 MG / Hydrocodone Bitartrate 2.5 MG Oral Tablet [Lortab]	SY
7	857113	Lortab 2.5/500 (hydrocodone bitartrate / APAP) Oral Tablet	SY

lortab- Hydrocodone Bitartrate and Acetaminophen tablet

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lortab- Hydrocodone Bitartrate and Acetaminophen tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

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1	50474-925-01 (inactivated)
2	50474-925-50 (inactivated)

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