Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid. Cardnogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals to determine whether hydrodocone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.
There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdraw 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. 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. Acetaminophen is excreted in breast milk in small amounts, but the signaficance of its effect on nursing infants is unknown.
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.
Safety and effectiveness in pediatric patients have not been established. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment Known or suspected gastrointestinal obstruction, including paralytic ileus Hypersensitivity to hydrocodone or to any other components of ZOHYDRO ER.
Because extended-release products such as ZOHYDRO ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present. Addiction can occur at recommended doses and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol addiction or abuse or mental illness e.
Abuse or misuse of ZOHYDRO ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone and can result in overdose and death. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Carbon dioxide CO2 retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of ZOHYDRO ER, the risk is greatest during the initiation of therapy or following a dosage increase.
Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and mange accordingly.
Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone.
Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics. If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum duration of concomitant use.
In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk of overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs.
Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency.
The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency. Severe Hypotension Hydrocodone Bitartrate and Acetaminophen Tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients.
There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e. Follow these patients for signs of hypotension after initiating or titrating the dosage of Hydrocodone Bitartrate and Acetaminophen Tablets. In patients with circulatory shock Hydrocodone Bitartrate and Acetaminophen Tablets may cause vasodilatation that can further reduce cardiac output and blood pressure.
Avoid the use of Hydrocodone Bitartrate and Acetaminophen Tablets with circulatory shock. Hepatotoxicity 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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4, milligrams of acetaminophen per day, even if they feel well. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms.
Follow such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Hydrocodone Bitartrate and Acetaminophen Tablets. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with impaired consciousness or coma.
Risks of Use in Patients with Gastrointestinal Conditions Hydrocodone Bitartrate and Acetaminophen Tablets are contraindicated in patients with gastrointestinal obstruction, including paralytic ileus. The administration of Hydrocodone Bitartrate and Acetaminophen Tablets or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
Hydrocodone may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Increased Risk of Seizures in Patients with Seizure Disorders The hydrocodone in Hydrocodone Bitartrate and Acetaminophen Tablets may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
Follow patients with a history of seizure disorders for worsened seizure control during Hydrocodone Bitartrate and Acetaminophen Tablet therapy. Precautions Risks of Driving and Operating Machinery Hydrocodone Bitartrate and Acetaminophen Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Instruct patients not to share Hydrocodone Bitartrate and Acetaminophen Tablets with others and to take steps to protect Hydrocodone Bitartrate and Acetaminophen Tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Acetaminophen Tablets or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS ].
Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Instruct patients to take steps to store Hydrocodone Bitartrate and Acetaminophen Tablets securely and to dispose of unused Hydrocodone Bitartrate and Acetaminophen Tablets by flushing down the toilet.
Serotonin Syndrome Inform patients that Hydrocodone Bitartrate and Acetaminophen Tablets could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.
Adrenal Insufficiency Inform patients that Hydrocodone Bitartrate and Acetaminophen Tablets could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.
Maximum Daily Dose of Acetaminophen Inform patients not to take more than 4, milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose. Hypotension Inform patients that Hydrocodone Bitartrate and Acetaminophen Tablets may cause orthostatic hypotension and syncope.
Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur e. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets. Lactation Advise nursing mothers to monitor infants for increased sleepiness more than usual , breathing difficulties, or limpness.
Infertility Inform patients that chronic use of opioids may cause reduced fertility. Driving or Operating Heavy Machinery Inform patients that Hydrocodone Bitartrate and Acetaminophen Tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Disposal of Unused Hydrocodone Bitartrate and Acetaminophen Advise patients to dispose of unused Hydrocodone Bitartrate and Acetaminophen Tablets by flushing unused tablets down the toilet.
If concomitant use is necessary, consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Tablets until stable drug effects are achieved. Follow patients for respiratory depression and sedation at frequent intervals.
If a CYP3A4 inhibitor is discontinued, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved. Follow for signs or symptoms of opioid withdrawal. If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved. Follow the patient for signs and symptoms of opioid withdrawal.
If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Tablets dosage reduction and follow for signs of respiratory depression. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors SSRIs , serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system e.
If concomitant use is warranted, carefully follow the patient, particularly during treatment initiation and dose adjustment. Discontinue Hydrocodone Bitartrate and Acetaminophen Tablets if serotonin syndrome is suspected. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Advise patient to avoid concomitant use of these drugs. Muscle Relaxants Hydrocodone Bitartrate and Acetaminophen Tablets may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Diuretics Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, follow patients for signs and symptoms of urinary retention or reduced gastric motility when Hydrocodone Bitartrate and Acetaminophen Tablets are used concomitantly with anticholinergic drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies to evaluate the carcinogenic potential of the combination of Hydrocodone Bitartrate and Acetaminophen Tablets have not been conducted.
Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0. In contrast, there was no evidence of carcinogenic activity in male rats that received up to 0.
Impairment of Fertility In studies conducted by the National Toxicology Program, fertility assessments with acetaminophen have been completed in Swiss CD-1 mice via a continuous breeding study.
There were no effects on fertility parameters in mice consuming up to 1. Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1. Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1. These effects appear to increase with the duration of treatment. The clinical significance of these findings is not known.
Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.
Hydrocodone Bitartrate and Acetaminophen Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve package actions. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e. Other reported clinical experience has gabapentin for sale identified differences in responses between the elderly and younger patients. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. 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. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or insert CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. Adjust the dosage to obtain an appropriate package between management of pain and opioid-related adverse reactions, hydrocodone apap package insert. Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear hydrocodone leukemia at 0, hydrocodone apap package insert. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse inserts, including respiratory and Apap depression. These conversion factors have not been verified in well-controlled, multiple-dose trials. Propulsive peristaltic hydrocodone in the colon are decreased, while tone may be increased to the point of apap, resulting in constipation.
No adequate studies have been conducted in animals to determine whether hydrodocone or acetaminophen have a hydrocodone for carcinogenesis, mutagenesis, or impairment of fertility. Apap are increased in patients with a personal or family history of substance abuse including drug or alcohol abuse or addiction or mental illness e. Abuse and addiction are separate and distinct from physical dependence and tolerance. Hydrocodone bitartrate and apap tablet-treated inserts with significant chronic obstructive pulmonary disease or hydrocodone pulmonale, hydrocodone apap package insert, and those with a apap decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory package are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Hydrocodone Bitartrate and Acetaminophen Tablets [see WARNINGS; Life-Threatening Respiratory Depression ]. Life-threatening respiratory insert is more likely to occur in elderly, cachectic, hydrocodone apap package insert, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see WARNINGS; Life-Threatening Respiratory Depression ]. Withdrawal symptoms can occur in breastfed packages when maternal hydrocodone of an opioid package is stopped, or when breast-feeding is stopped. Discontinue Hydrocodone Bitartrate and Acetaminophen Tablets if serotonin syndrome is suspected. Hydrocodone Bitartrate and Apap Tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Continually reevaluate patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets to can i take 20 mg singulair the insert of pain control and the relative incidence of adverse reactions, hydrocodone apap package insert, as hydrocodone as monitoring for the development of addiction, abuse, or misuse [see WARNINGS ].
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