home drugs a-z list side results drug center lortab 10 (hydrocodone bitartrate and also acetaminophen tablets) medicine


What is Lortab 10 and also how is the used?Lortab 10 is a prescription medication used come treat the symptoms of middle to severe pain. Lortab 10 might be used alone or with other medications.

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Lortab 10 belongs to a course of drugs called Analgesics, Opioid Combos.

It is not well-known if Lortab 10 is safe and effective in children younger than 2 years of age.

What are the possible side impacts of Lortab 10?

Lortab 10 may reason serious side effects including:

noisy breathing,sighing,shallow breathing,nausea,upper stomach pain,tiredness,loss that appetite,dark urine,clay-colored stools,vomiting,dizziness, andworsening exhaustion or weakness

Get medical help right away, if girlfriend have any of the symptoms listed above.

The most typical side results of Lortab 10 include:

dizziness,drowsiness,feeling tired,nausea,vomiting,stomach pain,constipation, andheadache

Tell the doctor if girlfriend have any kind of side effect that bothers you or that does not go away.

These room not all the possible side effects of Lortab 10. For more information, questioning your medical professional or pharmacist.

Call your medical professional for medical advice about side effects. You may report side results to FDA at 1-800-FDA-1088.

DESCRIPTION

Hydrocodone bitartrate and also acetaminophen is offered in tablet form for dental administration.

WARNING: May it is in habit forming (see PRECAUTIONS, Information for Patients, and also DRUG ABUSE and DEPENDENCE).

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

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C18H21NO3•C4H6O6 • 2 ½ H2O M.W. 494.490

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

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C8H9NO2 M.W. 151.16

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

Hydrocodone Bitartrate........................................... 10 mgAcetaminophen.................................................... 500 mg

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


INDICATIONS

Lortab 10 (hydrocodone bitartrate and also acetaminophen tablets) /500 tablet computers (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg) are shown for the relief the moderate to moderately significant pain.

DOSAGE and ADMINISTRATION

Dosage must be changed according come severity of ache and an answer of the patient. However, it need to be retained in mental that tolerance to hydrocodone can construct with continued use and that the incidence the untoward results is sheep related.

The usual adult dosage is one tablet every 4 to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

HOW SUPPLIED

Lortab ® 10/500 tablet computers (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg) contain hydrocodone bitartrate 10 mg and acetaminophen 500 mg. Castle are offered as pink, capsule-shaped, bisected tablets, debossed "ucb" ~ above one side and "910" on the other side, in containers that 100 tablet computers NDC 50474-910-01, 500 tablets NDC 50474-910-50, and also in hospital unit-dose packages of 100 tablet computers <4 X 25> NDC 50474- 910-60.

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

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

A Schedule CIII Narcotic


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SIDE EFFECTS

The most typically reported adverse reactions are light-headedness, dizziness, sedation, nausea and also vomiting. These impacts seem come be an ext prominent in ambulatory than in non-ambulatory patients, and also some of these adverse reactions may be alleviated if the patient lies down.

Other disadvantage reactions include:

Central worried System: Drowsiness, psychological clouding, lethargy, special needs of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, atmosphere changes.

Gastrointestinal System: prolonged administration that Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets may develop constipation.

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

Respiratory Depression: hydro codon bitartrate may produce dose-related respiratory depression by acting straight on the brain stem respiratory tract centers (see OVERDOSAGE).

Special Senses: instances of hearing impairment or irreversible loss have been reported mainly in patients through chronic overdose.

Dermatological: Skin rash, pruritus.

The following adverse drug occasions may it is in borne in mind as potential effects of acetaminophen: allergy reactions, rash, thrombocytopenia, agranulocytosis.

Potential impacts of high dosage are provided in the OVERDOSAGE section.

DRUG ABUSE and DEPENDENCE

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

Abuse and Dependence: Psychic dependence, physical dependence, and also tolerance may build upon repeated management of narcotics; therefore, this product must be prescribed and administered through caution. However, psychic dependency is unlikely to build when hydro-codon bitartrate and also acetaminophen tablet computers are supplied for a quick time for the therapy of pain.

Physical dependence, the condition in which continued administration of the medicine is forced to stop the illustration of a tap the money syndrome, assumes clinically far-ranging proportions just after several weeks of ongoing narcotic use, although part mild level of physical dependency may construct after a couple of days of drug therapy. Tolerance, in i m sorry increasingly large doses are compelled in order to create the same degree of analgesia, is manifested at first by a shortened term of analgesic effect, and subsequently by to reduce in the intensity of analgesia. The price of advancement of yongin varies amongst patients.

DRUG INTERACTIONS

patient receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or various other CNS depressants (including alcohol) concomitantly through hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When an unified therapy is contemplated, the sheep of one or both agents must be reduced.

The usage of MAO inhibitors or tricyclic antidepressants through hydrocodone preparations may rise the impact of one of two people the antidepressant or hydrocodone.

Drug/Laboratory test Interactions: acetaminophen may produce false-positive test outcomes for urinary 5-hydroxyindoleacetic acid.


WARNINGS

Respiratory Depression: in ~ high sheep or in perceptible patients, hydro codon may produce dose-related respiratory depression by acting directly on the mind stem respiratory center. Hydrocodone additionally affects the facility that controls respiratory rhythm, and also may produce irregular and periodic breathing.

Head Injury and also Increased Intracranial Pressure: The respiratory tract depressant results of narcotics and also their volume to elevate cerebrospinal liquid pressure might be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting boost in intracranial pressure. Furthermore, narcotics develop adverse reactions which might obscure the clinical food of patients through head injuries.

Acute abdominal muscle Conditions: The management of narcotics might obscure the diagnosis or clinical food of patients v acute abdominal muscle conditions.


PRECAUTIONS

General: Special risk Patients: together with any type of narcotic analgesic agent, Lortab 10 (hydrocodone bitartrate and also acetaminophen tablets) /500 tablets need to be used with fist in elderly or debilitated patients, and those with severe disability of hepatic or renal function, hypothyroidism, Addison"s disease, prostatic hypertrophy or urethral stricture. The usual precautions must be observed and also the possibility of respiratory tract depression should be maintained in mind.

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

Carcinogenesis, Mutagenesis, handicap of Fertility: No enough studies have been carried out in pets to determine whether hydro-codon or acetaminophen have actually a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Teratogenic Effects: Pregnancy group C: There are no adequate and also well-controlled research studies in pregnant women. Lortab 10 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets have to be used throughout pregnancy only if the potential advantage justifies the potential danger to the fetus.

Nonteratogenic Effects: Babies born to mothers who have actually been acquisition opioids consistently prior to delivery will it is in physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, boosted respiratory rate, raised stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome go not always correlate v the duration of maternal opioid use or dose. There is no consensus on the best technique of regulating withdrawal.

Labor and Delivery: as with all narcotics, management of this product come the mother shortly before delivery may result in some level of respiratory depression in the newborn, specifically if greater doses are used.

Nursing Mothers: paracetamol is excreted in chest milk in small amounts, however the meaning of its results on nursing infants is not known. The is not well-known whether hydrocodone is excreted in human being milk. Because many drugs space excreted in human being milk and because of the potential for severe adverse reaction in nursing infants from hydrocodone and also acetaminophen, a decision must be made even if it is to discontinue parenting or to discontinue the drug, taking into account the prestige of the medicine to the mother.

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

Geriatric Use: Clinical researches of hydro codon bitartrate and also acetaminophen tablet computers did not incorporate sufficient number of topics aged 65 and also over to identify whether castle respond differently from younger subjects. Various other reported clinical experience has actually not established differences in responses in between the elderly and also younger patients. In general, dose an option for an elderly patient have to be cautious, usually beginning at the low end of the dosing range, mirroring the better frequency of diminished hepatic, renal, or cardiac function, and also of concomitant condition or various other drug therapy.

Hydrocodone and the major metabolites of acetaminophen are well-known to be considerably excreted through the kidney. Thus the risk of toxicity reactions might be better in patients v impaired renal duty due to the build-up of the parental compound and/or metabolites in the plasma. Since elderly patient are an ext likely to have lessened renal function, treatment should be taken in sheep selection, and also it might be advantageous to screen renal function.

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


OVERDOSE

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

Signs and Symptoms:

Hydrocodone: significant overdose v hydrocodone is defined by respiratory tract depression (a diminish in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis) too much somnolence proceeding to stupor or coma, skeleton muscle flaccidity, cold and also clammy skin, and also sometimes bradycardia and also hypotension. In major overdosage, apnea, circulatory collapse, cardiac arrest and also death may occur.

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

Early symptoms adhering to a perhaps hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and also laboratory proof of hepatic toxicity may not be evident until 48 come 72 hours post-ingestion.

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

Treatment: A solitary or lot of overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation through a local poison control center is recommended.

Immediate treatment consists of support of cardiorespiratory role and measures to alleviate drug absorption. Vomiting must be induced mechanically, or through syrup the ipecac, if the patience is alert (adequate pharyngeal and also laryngeal reflexes). Dental activated charcoal (1 g/kg) need to follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If recurring doses are used, the cathartic could be included with alternative doses together required. Hypotension is typically hypovolemic and should respond come fluids. Vasopressors and also other supportive measures should it is in employed as indicated. A cuffed endo-tracheal tube need to be inserted prior to gastric lavage that the unconscious patient and, when necessary, to carry out assisted respiration.

Meticulous attention have to be given to maintaining adequate pulmonary ventilation. In severe situations of intoxication, peritoneal dialysis, or best hemodialysis might be considered. If hypoprothrombinemia occurs as result of acetaminophen overdose, vitamin K should be administered intravenously.

Naloxone, a drug antagonist, can reverse respiratory tract depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is provided parenterally. Since the expression of activity of hydrocodone may exceed the of the naloxone, the patient should be preserved under constant surveillance and repeated doses of the antagonist should be administered as required to maintain adequate respiration. A narcotic antagonist have to not be administered in the absence of clinically far-reaching respiratory or cardiovascular depression.

If the sheep of paracetamol may have exceeded 140 mg/kg, acetylcysteine must be administered as early on as possible. Serum acetaminophen levels should be obtained, because levels four or an ext hours adhering to ingestion help predict acetaminophen toxicity. Execute not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be acquired initially, and repeated in ~ 24-hour intervals.

Methemoglobinemia end 30% should be treated with methylene blue by slow-moving intravenous administration.

The toxic dose for adults for paracetamol is 10 g.

CONTRAINDICATIONS

This product have to not it is in administered to patients who have previously showed hypersensitivity to hydrocodone or acetaminophen.

Patients well-known to it is in hypersensitive to various other opioids may exhibit overcome sensitivity to hydrocodone.


CLINICAL PHARMACOLOGY

Hydrocodone is a semisynthetic narcotic analgesic and antitussive through multiple action qualitatively comparable to those that codeine. Many of these involve the main nervous system and smooth muscle. The specific mechanism of activity of hydrocodone and also other opiates is no known, although it is believed to relate come the presence of opiate receptors in the central nervous system. In enhancement to analgesia, medicine may create drowsiness, transforms in mood and also mental clouding.

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

Pharmacokinetics: The habits of the individual materials is explained below.

Hydrocodone: complying with a 10 mg dental dose of hydro-codon administered to five adult male subjects, the mean peak concentration to be 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to it is in 3.8 ± 0.3 hours. Hydro-codon exhibits a complicated pattern that metabolism consisting of O- demethylation, N-demethylation and 6-keto palliation to the matching 6-α- and 6-β- hydroxymetabolites.

See OVERDOSAGE because that toxicity information.

Acetaminophen: acetaminophen is rapidly took in from the gastrointestinal tract and is distributed throughout many body tissues. The plasma half-life is 1.25 to 3 hours, but may be boosted by liver damage and following overdosage. Elimination of paracetamol is principally by liver management (conjugation) and subsequent renal excretion that metabolites. About 85% the an oral dose shows up in the urine within 24 hrs of administration, most as the glucuronide conjugate, with little amounts of other conjugates and also unchanged drug.

See OVERDOSAGE because that toxicity information.


PATIENT INFORMATION

Hydrocodone, favor all narcotics, may impair psychological and/or physical abilities compelled for the power of possibly hazardous work such together driving a vehicle or operating machinery; patients should be cautioned accordingly.

Alcohol and also other CNS depressants may produce an additive CNS depression, when taken through this mix product, and also should be avoided.

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

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Laboratory Tests: In patient with serious hepatic or renal disease, results of therapy need to be monitored through serial liver and/or renal role tests.