White oval tablet u03

Risk cannot be ruled out during pregnancy. What is the most important information I should know about acetaminophen and hydrocodone? Keep the white oval tablet u03 in a place where others cannot get to it. An overdose of acetaminophen can damage your liver or cause death.

Limitations of Use Because of the risks of addiction, abuse, and misuse , with opioids, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen. Each tablet contains 7. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Dispense in a tight, light-resis tan t container as defined in the USP with a child-resis tan t closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug subs tan ce.

White oval tablet u03

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. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS ]. Accidental Ingestion Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ]. Cytochrome P 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with all Cytochrome P 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used Cytochrome P 3A4 inducer may result in an increase in hydrocodone plasma concentrations. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.

Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. A Schedule C-II controlled drug substance. They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.

If you are a consumer or patient please visit this version. 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. Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following adose increase [see WARNINGS ]. Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets[see WARNINGS ]. Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized andtreated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in apregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ].

Limitations of Use Because of the risks of addiction, abuse, and misuse , with opioids, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen. Each tablet contains 7. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Dispense in a tight, light-resis tan t container as defined in the USP with a child-resis tan t closure. Keep this and all medication out of the reach of children.

White oval tablet u03

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. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS ]. Accidental Ingestion Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ].

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Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. When discontinuing Hydrocodone Bitartrate and Acetaminophen Tablets, gradually taper the dosage using a patient specific plan that considers the following: the dose of Hydrocodone Bitartrate and Acetaminophen Tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. Limit dosages and durations to the minimum required. Lactation Advise nursing mothers to monitor infants for increased sleepiness more than usual , breathing difficulties, or limpness. Because theduration of opioid reversal is expected to be less than the duration of actionof hydrocodone bitartrate and acetaminophen tablets in hydrocodone bitartrateand acetaminophen tablets, carefully monitor the patient until spontaneousrespiration is reliably re-established. Pharmacokinetics The behavior of the individual components is described below. Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in withdrawal in the neonate. Hydrocodone bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, asubstance with a high potential for abuse similar to other opioids including withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity e. Just one dose can cause death in someone using this medicine accidentally or improperly. Risks from concomitant use with Benzodiazepines or other CNS Depressants Concomitant use of opiods with benzodiazepines or other central nervous system CNS depressants including alcohol, may result in profound sedation, respiratory depression, coma, and death. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. A narcotic antagonist should not be administered in theabsence of clinically significant respiratory or cardiovascular depression.

If you are a consumer or patient please visit this version. 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 4, milligrams per day, and often involve more than one acetaminophen-containing product see WARNINGS.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Drug Label Info. Not all possible interactions are listed here. Follow patients for respiratory depression and sedation at frequent intervals. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Monitor patients closely for respiratory depression, especiallywithin the first 24 to 72 hours of initiating therapy with and following dosage increases of hydrocodone bitartrate and acetaminophen tablets. Hydrocodone Bitartrate and Acetaminophen Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Since the duration of action of hydrocodone may exceed that of theantagonist, the patient should be kept under continued surveillance, andrepeated doses of the antagonist should be administered as needed to maintainadequate respiration. The causal role of opioids inthe syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.