NDC 100 TABLETS Lortab 10/325.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 mg/325 mg CII.
Meets USP Dissolution Test 2.
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.
As with all narcotics, administration of Lortab to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
Pregnancy Category C Risk cannot be ruled out.
The usual adult dosage for Hydrocodone Bitartrate and Acetaminophen, USP is:
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. Antipyretic activity is mediated through hypothalamic heat regulating centers. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
LB8354 Rev 01 09/2014 ucb.
Each Lortab for oral administration are available in the following strengths:
NDC 100 TABLETS Lortab 7.5/325.
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.
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MULTIPLE STRENGTHS: DO NOT DISPENSE UNLESS STRENGTH IS STATED. Each tablet contains:.
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. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. See OVERDOSAGE for toxicity information.
Each Lortab contains 7.5 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 036.
Hydrocodone, like all narcotics, may impair the 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.
The behavior of the individual components is described below.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 mg/325 mg CII.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It has the following structural formula:. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5).
Available for Android and iOS devices. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
"Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. 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). "Drug seeking" behavior is very common in addicts and drug abusers.
Hydrocodone Bitartrate 5 mg Acetaminophen 325 mg Rx only ucb.
Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect.
Each Lortab contains 10 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 037.
Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common. 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.
Lortab (hydrocodone bitartrate and acetaminophen tablets) are indicated for the relief of moderate to moderay severe pain.
Smyrna, Georgia 30080. Manufactured for: UCB, Inc.
NDC 100 TABLETS Lortab 5/325.
Each tablet contains:. MULTIPLE STRENGTHS: DO NOT DISPENSE UNLESS STRENGTH IS STATED.
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.
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. There is no consensus on the best method of managing withdrawal. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.
Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lortab are used postoperatively and in patients with pulmonary disease.
Gastrointestinal System: Prolonged administration of Lortab may produce constipation.
No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.
In addition each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
Lortab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Clinical studies of Lortab (hydrocodone bitartrate 5 mg and acetaminophen 500 mg) 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.
NDC Bottles of 100 NDC Bottles of 500.
Lortab contain hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
When combined therapy is contemplated, the dose of one or both agents should be reduced. Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Lortab may exhibit an additive CNS depression.
They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 035. Each Lortab contains 5 mg of hydrocodone bitartrate and 325 mg of acetaminophen.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
CSA Schedule 2 High potential for abuse.
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. Most of these involve the central nervous system and smooth muscle. Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.
Safety and effectiveness in the pediatric patients have not been established.
Generic Name: hydrocodone bitartrate and acetaminophen Dosage Form: tablet Rx Only.
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The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
= 151.16. C 8 H 9 NO 2 M.W.
Serum acetaminophen levels should be obtained immediay if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. Intravenous NAC may be administered when circumstances preclude oral administration. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.
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. 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. 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. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. The rate of development of tolerance varies among patients.
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.
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.
Other adverse reactions include:
Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Availability Rx Prescription only.
Dispense in a tight, light-resistant container with a child-resistant closure.
A Schedule CS-II controlled drug substance.
provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Data sources include Micromedex (updated June 2nd, 2017), Cerner Multum (updated June 5th, 2017), Wolters Kluwer (updated June 6th, 2017) and others. To view content sources and attributions, please refer to our editorial policy. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.
Lortab is supplied in tablet form for oral administration.
Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.
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.
NDC Bottles of 100 NDC Bottles of 500.
Lortab can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Lortab in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE ).
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 mg/325 mg CII.
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.
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.
Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852.
MULTIPLE STRENGTHS: DO NOT DISPENSE UNLESS STRENGTH IS STATED. Each tablet contains:.
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Dermatological: Skin rash, pruritus.
The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. As with any narcotic analgesic agent, 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.
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.
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
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. 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. See OVERDOSAGE for toxicity information.
Hydrocodone Bitartrate 10 mg Acetaminophen 325 mg Rx only.
NDC Bottles of 100 NDC Bottles of 500.
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
(13). Other brands: Norco, Vicodin, Hycet, Vicodin ES, More.
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.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Hydrocodone Bitartrate 7.5 mg Acetaminophen 325 mg Rx only ucb.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediay upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center (see OVERDOSAGE ).
= 494.49. C 18 H 21 NO 3 ∙C ∙2 ½H 2 O M.W.
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:.
Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. Do not prescribe Lortab for patients with acetaminophen allergy. Instruct patients to discontinue Lortab immediay and seek medical care if they experience these symptoms. There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention.
Approval History Calendar Drug history at FDA.
Pain tramadol, acetaminophen, Tylenol, naproxen, oxycodone, aspirin, ibuprofen, amitriptyline, More.
In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. 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.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Lortab tablets should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.
Back Pain tramadol, Cymbalta, naproxen, aspirin, ibuprofen, duloxetine, diclofenac, Norco, More.
For hydrocodone overdose, primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.Lortab