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Lorcet (Hydrocodone Bitartrate and Acetaminophen Tablet) Side


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12.21.2017 | Jennifer Bargeman
Lorcet
Lorcet (Hydrocodone Bitartrate and Acetaminophen Tablet) Side

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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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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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Lorcet 10/650 should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

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

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

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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.

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

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

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

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Vasopressors and other supportive measures should be employed as indicated. Hypotension is usually hypovolemic and should respond to fluids. The first dose should be accompanied by an appropriate cathartic. 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. If repeated doses are used, the cathartic might be included with alternate doses as required. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.

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. Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine.

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.

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A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. 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. Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose.

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Lorcet 10/650 is indicated for the relief of moderate to moderay severe pain.

Lorcet 10/650 tablets contain hydrocodone, an opioid agonist, and are a Schedule III controlled substance. Lorcet 10/650, and other opioids used in analgesia can be abused and are subject to criminal diversion.

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.

Dermatological: Skin rash, pruritus.

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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. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

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

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.

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

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.

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

Each Lorcet 10/650 tablet for oral administration contains: Hydrocodone Bitartrate...............................10 mg.

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

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

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

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 the severity of the pain and the response of the patient.

“Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. “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).

Lorcet 10/650, Hydrocodone Bitartrate and Acetaminophen Tablets, each tablet of which contains hydrocodone bitartrate 10 mg (WARNING:May be habit-forming) and acetaminophen 650 mg, are light-blue, capsule-shaped, scored tablets, debossed “UAD” on one side and “63 50” on the other side, and are supplied in containers of 100 tablets, NDC and in containers of 500 tablets, NDC.

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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.

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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.

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

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

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. The most frequently reported adverse reactions include lightheadedness, dizziness, sedation, nausea and vomiting.

As with any narcotic analgesic agent, Lorcet 10/650 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.

Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Lorcet 10/650 may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

LORCET (hydrocodone bitartrate and acetaminophen) Tablets.

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

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

As with all narcotics, administration of Lorcet 10/650 to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

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

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This should be considered when prescribing or dispensing Lorcet 10/650 in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see Drug Abuse And dependence ). Lorcet 10/650 tablets contain hydrocodone, an opioid agonist, and are a Schedule III controlled substance. Lorcet 10/650 can be abused in a manner similar to other opioid agonists, legal or illicit. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

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

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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-a and 6-b-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.

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

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

See OVERDOSAGE for toxicity information.

The behavior of the individual components is described below.

Manufactured for: UAD Laboratories, Division of, Forest Pharmaceuticals, Inc., St. 01/08. Rev. Manufactured by: Mikart, Inc., Atlanta, GA 30318. Louis, MO 63045.

Prolonged administration of Lorcet 10/650 may produce constipation.

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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.

Hepatic enzymes should be obtained initially, and repeated at 24- hour intervals. Do not await acetaminophen assay results before initiating treatment. If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. The toxic dose for adults for acetaminophen is 10 g. Methemoglobinemia over 30% should be treated with methylene blue by slow, intravenous administration. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity.

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

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Store at 20° to 25°C (68° to 77°F).

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.

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This product complies with Dissolution Test 1.

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Safety and effectiveness in pediatric patients have not been established.

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.

Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. 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. It is not known whether hydrocodone is excreted in human milk.

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

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See OVERDOSAGE for toxicity information.

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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.

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Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lorcet 10/650 is used postoperatively and in patients with pulmonary disease.

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In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and FD&C Blue #1 Lake.

Other adverse reactions include:

Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. The rate of development of tolerance varies among patients. 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. Abuse and addiction are separate and distinct from physical dependence and tolerance. 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. Lorcet 10/650, like other opioids, may be diverted for non-medical use.

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Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Lorcet 10/650 and observed closely.

WARNING: May be habit-forming. Acetaminophen.650 mg.

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

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

Lorcet 10/650 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.

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. 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.

Other reported clinical experience has not identifed differences in responses between the elderly and younger patients. 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.

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