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If you are a consumer or patient please visit this version. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets.

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Lortab 7. These are not all the possible side effects of Lortab 7. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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. 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. Hydrocodone Bitartrate Meets USP dissolution test 1. Dosage should be adjusted according to severity of pain and 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.

Side effects

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. They are supplied as white with green specks, capsule-shaped, bisected tablets, debossed "ucb" on one side and "" on the other side, in containers of tablets NDCand tablets NDC Smyrna, GA Manufactured by: Mikart, Inc.

Atlanta, GA uo2 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. Central Nervous System : Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxietyfear, dysphoriapsychic dependence, mood changes. Gastrointestinal System : Prolonged administration of Lortab 7.

Genitourinary System : Ureteral spasmspasm of white sphincters and urinary retention have been reported with opiates. Special Senses : Cases of pill impairment or permanent loss have been reported predominantly in patients with chronic overdose. Dermatological : Skin rashpruritus. The following adverse drug events may be borne in mind as potential effects of acetaminophen : allergic reactions, rash, thrombocytopenia, agranulocytosis. Controlled Substance : Lortab 7.

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 ificant 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 uo2 doses are required in order to produce the same degree of analgesiais 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.

Patients pill narcotics, antihistaminesantipsychotics, 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.

Acetaminophen and hydrocodone

Respiratory Depression : At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem white center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic pill. 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 uo2 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. 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 7.

Carcinogenesis, MutagenesisImpairment 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.

Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Nonteratogenic Effects : Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal s include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawningvomiting 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 ificance 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 the importance of the drug to the mother. Pediatric Use : Safety and effectiveness in the pediatric population have not been established. Geriatric Use: Clinical studies of hydrocodone bitartrate and acetaminophen tablets did not include sufficient s of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. Hydrocodone and the major metabolites of acetaminophen are uo2 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. 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 white closely. Following an pill overdosage, toxicity may result from hydrocodone or acetaminophen. In severe overdosage, apneacirculatory 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.

Warning: addiction, abuse, and misuse: risk evaluation and mitigation strategy (rems); life-threatening respiratory depression; accidental ingestion; neonatal opioid; withdrawal syndrome; cytochrome p 3a4 interaction; hepatotoxicity and risks from concomitant use with benzodiazepines or other cns depressants

Early symptoms following a potentially hepatotoxic overdose may include: nauseavomiting, diaphoresis and pill malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults, white 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 uo2 of ipecacif the patient is alert adequate pharyngeal and laryngeal reflexes. 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 dialysisor preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously. Naloxonea narcotic antagonistcan reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0. 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 ificant respiratory or cardiovascular depression. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity.

Do not await acetaminophen assay before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at hour intervals. This product should not be administered to patients who have ly exhibited hypersensitivity to hydrocodone or acetaminophen.

Pill imprint u02

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