The following is a brief summary only. Before prescribing, consult complete prescribing information in product labeling or PDR. LORI 7.5/SO0 ,C 7.5 mg hydmcodone bitartrate [Warning: May be habit forming) and 500 mg acetaminaphen INDICATIONS: For the relief of moderate to moderately severe pain, CONTRAINDICATIONS: Hypersensitivity to acetaminophen or hydrocodone, WARNINGS: Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-relatad respiratory depression by acting directly on the brain stem respiratory center. Hydrocbdone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate ceraprospinal 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. Acute Abdominal Conditions:
The administration of narcotics may obsure the diagnosis or clinical course of patients with acute abdominal conditions, PRECAUTIONS: Special Risk Patients: AS with any narcotic analgesic agent, Lortab 7.5/50g tablets should be used with caution in eldedy 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. Information for Patients: Lortab 7,5/500 tablets, 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. Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Lortab 7.5/500 tablets are used postoperatively and in patients with pulmonary disease. Drug Interactions: Patients receiving other narcotic analgesics, antipsychctics, antianxiefy agents, or other CNS depressants (including alcohol) concomitantly with Lortab 7.5/590 tablets may exhibit an additive CNS depression. When combined therapy is col'aemplated, the dose of one or both agents should be reduced, The use of MAO inhibitors or tricylic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. The conourrent use of anticholinergics with hydrocodone may produce paralytic ileus. Use in Pregnancy: Teratogenic Effects: Pregnancy Category C. Hydrocodone has been shown 1o be terafogenic in hamsters when given in doses 700 times the human dose. There are no adequate and wellcontrolled studies in pregnant women. Lortab 7,5/50O tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic ~Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be 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 apioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1 mg/kg q6h, and paregoric 2 to 4 dreps/kg d4h, have beee used to treat withdrawal symptoms in infants, The duration of therapy is 4 to 28 days, w~th the dosage decreased as tolerated, Labor and Delivery: As with atl narcotics, administration of Lortab 7,5/500 tablets 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: it is not known whether this drug is excreted in human milk. Secause many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Lertab 7,5/500 tabJets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug te the mother, Pediatric Use: Safety and effectiveness in children have not been established. ADVERSE REACTIONS: The most frequentty observed adverse reactions include lightheededness, dizziness, sedation, nausea and vomiting. These effects seem 1o be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated ff the patient lies down. Other adverse reactions include: Central Nervous System: Drowsiness, mental clouding, lethargy, fmpairment of mental and physical performance, anxiety, fear, dyspheda, psychic dependence, mood changes. Gastrointestinal System: The antiemetic phenothiazines are useful in suppressing the nausea and vomiting which may occur (see above); however, some phenothiazine derivatives seem to be antianalgesic and to increase the amount of narcotic required to produce pain relief, while other phenothiazines reduce the amount of narcotic required to produce a given level of analgesia. Prolonged administration of Lbdab 7.5/500 tablets may produce constipation. Genitourinary System: Uretaral spasm, spasm of vesical sphincters and urinary retention have been reported. Respiratory Depression: Hydrocodone bitartrafe may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydroeodone also affects the center that contro}s respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. Apply other supportive measures when indicated. Drug Abuse and Dependence: Lortab 7.5/500 tablets are subject to the Federal Controlled Substance Act [Schedule III]. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, Lortab 7.5/500 tablets should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when Lortab 7.5/500 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 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 larger doses are required in order to produce the same degree of analgesia, is manifested initially by shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate.of development of tolerance varies among patients. DOSAGE AND ADMINISTRATION: 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. The usual adult dosage is one taplet every four to six hours as needed for pain. The total 24-hour dose should not exceed 6 tablets. Caution: Federal law prohibits dispensing without prescription.
Rev. 8/92
References: 1, Beaver WT, Aspidn and acetaminophen as constituents of analgesic combinations.