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Lortab 10 (Hydrocodone Bitartrate and Acetaminophen Tablets


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5.22.2017 | Ryan Carroll
Lortab
Lortab 10 (Hydrocodone Bitartrate and Acetaminophen Tablets

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

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Other adverse reactions include:

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

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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.

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

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

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Most of these involve the central nervous system and smooth muscle. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. 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. Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine.

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.

Controlled Substance : Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg) are classified as a Schedule III controlled substance.

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See OVERDOSAGE for toxicity information.

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Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. 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.

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Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

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.

10 mg Acetaminophen. Hydrocodone Bitartrate. 500 mg.

The toxic dose for adults for acetaminophen is 10 g.

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

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The most frequently reported adverse reactions are light-headedness, 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.

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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. 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.

General : Special Risk Patients : As with any narcotic analgesic agent, Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /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.

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Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg) are indicated for the relief of moderate to moderay severe pain.

Dermatological : Skin rash, pruritus.

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

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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.

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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.

Cough Reflex : Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets are used postoperatively and in patients with pulmonary disease.

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

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

Call your doctor at once if you have any of these serious side effects:

LORTAB 10/500 (hydrocodone bitartrate and acetaminophen) Tablets, USP 10 mg/500 mg.

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

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

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.

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. Dosage should be adjusted according to severity of pain and response of the patient.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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.

Drug Interaction Tool Check Potential Drug Interactions.

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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. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. 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.

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

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

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

Manufactured by: Mallinckrodt Inc.Hobart, New York 13788. FDA rev date: 8/3/2000. Rev. Smyrna, GA 30080. Manufactured for: UCB Pharma, Inc. 03/2004.

Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.

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.

Gastrointestinal System : Prolonged administration of Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets may produce constipation.

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

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). A cuffed endo-tracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration. Vasopressors and other supportive measures should be employed as indicated. 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.

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

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

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.

Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma.

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

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

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

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

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Lortab 10/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg) contain hydrocodone bitartrate 10 mg and acetaminophen 500 mg. They are supplied as pink, capsule-shaped, bisected tablets, debossed "ucb" on one side and "910" on the other side, in containers of 100 tablets NDC, 500 tablets NDC, and in hospital unit-dose packages of 100 tablets NDC 50474- 910-60.

Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed. Hydrocodone may be habit-forming.

A Schedule CIII Narcotic.

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Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone.

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Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Geriatric Use : Clinical studies of hydrocodone bitartrate and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Drug/Laboratory Test Interactions : Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

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

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 : 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. 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.

The total daily dosage should not exceed 6 tablets. The usual adult dosage is one tablet every four to six hours as needed for pain.

Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. 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.

Visit the FDA MedWatch website or call 1-800-FDA-1088. You are encouraged to report negative side effects of prescription drugs to the FDA.

Pharmacokinetics : The behavior of the individual components is described below.

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

Potential effects of high dosage are listed in the OVERDOSAGE section.

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

See OVERDOSAGE for toxicity information.

RxList does not provide medical advice, diagnosis or treatment. 2017 by RxList Inc. See additional information.

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However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain. 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.

STORAGE : Store at 20 to 25°C (68 to 77°F).

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The following adverse drug events may be borne in mind as potential effects of acetaminophen : allergic reactions, rash, thrombocytopenia, agranulocytosis.

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Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. 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. Approximay 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.

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

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