In some cases, the patient reported that the prescriber abruptly discontinued the benzodiazepine rather than prescribing a taper to mitigate withdrawal symptoms. An important limitation in the assessment of these cases was the difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.
Download form or call to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to FDA What is FDA doing? What are benzodiazepines and how can they help me?
What should health care professionals do? What should patients, parents, and caregivers do? What did FDA find? What is my risk? How do I report side effects from a benzodiazepine? How can I get new safety information on medicines I'm prescribing or taking? List of Benzodiazepines. Facts about Benzodiazepines. They are also used as premedication before some medical procedures see List of Benzodiazepines.
Most benzodiazepines are recommended for use for weeks or months. However, the dose, frequency, and duration of treatment vary depending on the patient, the medicine being prescribed, and the medical condition it is being used to treat. Benzodiazepines work by binding to GABA receptors in the brain to slow brain activity, causing drowsy or calming effects.
Common side effects of benzodiazepines include drowsiness, dizziness, weakness, and slowed breathing. Benzodiazepines are commonly prescribed medicines. Additional Information for Patients. FDA is requiring the Boxed Warning be updated for all benzodiazepine medicines to include warnings about the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.
Do not drink alcohol with benzodiazepines. Alcohol can increase the risk of serious and life-threatening side effects. Always inform all your health care professionals about all the medicines you are taking, including prescription and OTC medicines and other substances. It is helpful to keep a list of all your current medicines in your wallet or another location where it is easily retrieved.
You can fill out and print a copy of My Medicine Record. Take benzodiazepines and all medicines exactly as your health care professional prescribes. Seek medical attention immediately by going to an emergency room or calling if you experience serious side effects and have symptoms like trouble breathing. Most benzodiazepines are recommended for use for periods of weeks or months.
However, the dose, frequency, formulation, and duration of treatment vary depending on the patient, the medical condition treated, and the medicine prescribed. Patients who have been taking a benzodiazepine for weeks or months should not suddenly stop taking your benzodiazepine without first discussing a plan for gradually getting off the medicine with your health care professional.
Stopping benzodiazepines abruptly or reducing the dosage too quickly can result in serious withdrawal reactions, including seizures, which can be life-threatening. Even when the benzodiazepine dosage is decreased gradually, you may experience withdrawal symptoms, such as abnormal involuntary movements, anxiety, blurred vision, memory problems, irritability, insomnia, muscle pain and stiffness, panic attacks, and tremors. Contact your health care professional if you experience more severe withdrawal symptoms, such as: Catatonia unable to speak, rigid body, repetitive and meaningless movements Seizures Delirium tremens shaking, shivering, irregular heartrate, sweating Depression Hallucinations seeing or hearing things that others do not see or hear Thoughts about killing yourself or someone else Mania euphoria, delusions, overactivity Psychosis false beliefs Treatments other than benzodiazepine medicines may be useful to manage some conditions, such as insomnia, stress and anxiety.
Misuse occurs when the medication is not taken as prescribed to manage a medical condition for example, taking more than the recommended dose or taking medicine prescribed for someone else. Dependence may also lead some individuals to continue using the medicine to avoid symptoms of withdrawal.
It is important to lock up benzodiazepines and dispose of them properly to keep them from being taken accidentally by children or falling into the wrong hands. Read the patient Medication Guide every time you receive a prescription for a benzodiazepine because there may be new or important additional information about your medicine.
The Medication Guide explains the important things you need to know about the medicine, including the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine. Additional Information for Health Care Professionals. Standardized screening tools are available. Particular caution should be taken when prescribing benzodiazepines with opioids and other medicines that depress the CNS, which has resulted in serious side effects, including severe respiratory depression and death.
Advise patients to seek immediate medical attention if they experience symptoms such as trouble breathing. Careful medication management by health care professionals can reduce the increased risk of serious side effectsTake precautions when benzodiazepines are used in combination with opioid addiction medications. Warn patients and caregivers about the risks of abuse, misuse, addiction, dependence, and withdrawal with benzodiazepines and the associated signs and symptoms.
Also alert them of the serious risks of taking benzodiazepines with alcohol or other substances, including opioids. Anxiety disorders are a serious condition. If you and your doctor decide that XANAX is right for you, the tools and information below can help you take an active role in managing your anxiety disorder. Eligibility required. Terms and conditions apply. By providing your phone number and selecting "Text," you consent to receive autodialed marketing and other texts from Viatris and its service providers regarding your XANAX Savings.
You understand that providing this consent is not required or a condition of purchasing any products and services. You will receive a text asking you to confirm your receipt. Message and data rates may apply. Privacy Policy at: www. Terms at: www. For help, text HELP to To opt out, text STOP to a confirmation text will be sent. For questions contact XANAX is a benzodiazepine medicine.
Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants including street drugs can cause severe drowsiness, breathing problems respiratory depression , coma, and death. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to XANAX during pregnancy [see Use in Specific Populations 8. This product's labeling may have been updated. For the most recent prescribing information, please visit www.
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Approval: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation. Before prescribing XANAX and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.
Dosage may be increased, at intervals of every 3 to 4 days, to a maximum recommended daily dose of 4 mg, given in divided doses. Use the lowest possible effective dose and frequently assess the need for continued treatment. Panic Disorder : Recommended starting oral dosage is 0.
The dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day. Some patients may require an even slower dosage reduction.
Prescribe the least number of tablets feasible to avoid intentional overdosage. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions 5.
The use of benzodiazepines, including XANAX, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing XANAX and throughout treatment, assess each patient's risk for abuse, misuse, and addiction [see Warnings and Precautions 5. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of XANAX after continued use may precipitate acute withdrawal reactions, which can be life-threatening.
XANAX tablets are available as: 0. XANAX is contraindicated in patients: with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions 6. Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [see Drug Abuse and Dependence 9. Interdose Symptoms Early morning anxiety and emergence of anxiety symptoms between doses of XANAX have been reported in patients with panic disorder taking prescribed maintenance doses.
The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions 5.
The data in the two tables below are estimates of adverse reaction incidence among adult patients who participated in: 4-week placebo-controlled clinical studies with XANAX dosages up to 4 mg per day for the acute treatment of generalized anxiety disorder Table 1 Short-term up to 10 weeks placebo-controlled clinical studies with XANAX dosages up to 10 mg per day for panic disorder, with or without agoraphobia Table 2.
Nervous system disorders Insomnia Endocrine disorders: Hyperprolactinemia General disorders and administration site conditions: Edema peripheral Hepatobiliary disorders: Hepatitis, hepatic failure Investigations: Liver enzyme elevations Psychiatric disorders: Hypomania, mania Reproductive system and breast disorders: Gynecomastia, galactorrhea Skin and subcutaneous tissue disorders: Photosensitivity reaction, angioedema, Stevens-Johnson syndrome.
Table 4: Clinically Significant Drug Interactions with XANAX Opioids Clinical implication The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
Benzodiazepines interact at gamma-aminobutyric acid GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Prevention or management Limit dosage and duration of concomitant use of XANAX and opioids, and monitor patients closely for respiratory depression and sedation [see Warnings and Precautions 5. Examples Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorpenol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol.
Examples Psychotropic medications, anticonvulsants, antihistaminics, ethanol, and other drugs which themselves produce CNS depression. Examples Carbamazepine, phenytoin Ritonavir Clinical implication Interactions involving ritonavir and alprazolam are complex and time dependent. Short term administration of ritonavir increased alprazolam exposure due to CYP3A4 inhibition. Alprazolam exposure was not meaningfully affected in the presence of ritonavir.
No dosage adjustment of XANAX is necessary in patients receiving ritonavir for more than 10 to14 days [see Dosage and Administration 2. Prevention or management In patients on digoxin therapy, measure serum digoxin concentrations before initiating XANAX. Continue monitoring digoxin serum concentration and toxicity frequently. Reduce the digoxin dose if necessary. Risk Summary Neonates born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and neonatal withdrawal [see Warnings and Precautions 5.
Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions e.
Protracted Withdrawal Syndrome Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms e. The structural formula is: Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.
Absorption Following oral administration, peak plasma concentration of alprazolam C max occurs in 1 to 2 hours post dose.
Excretion Alprazolam and its metabolites are excreted primarily in the urine. In Vitro Studies Data from in vitro studies of alprazolam suggest a possible drug interaction of alprazolam with paroxetine. Risks from Concomitant Use with Opioids Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when XANAX is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider.
Abuse, Misuse, and Addiction Inform patients that the use of XANAX, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications e. Withdrawal Reactions Inform patients that the continued use of XANAX may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of XANAX may precipitate acute withdrawal reactions, which can be life-threatening.
Patients with Depression Advise patients, their families, and caregivers to look for signs of suicidality or worsening depression, and to inform the patient's healthcare provider immediately [see Warnings and Precautions 5.
Concomitant Medications Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see Drug Interactions 7 ]. Pregnancy Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Food and Drug Administration. XANAX is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system CNS depressants including street drugs can cause severe drowsiness, breathing problems respiratory depression , coma and death.
Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops which may lead to the heart stopping excessive sleepiness sedation Do not drive or operate heavy machinery until you know how taking XANAX with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including XANAX, which can lead to overdose and serious side effects including coma and death.
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including XANAX. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
Physical dependence and withdrawal reactions. XANAX can cause physical dependence and withdrawal reactions. Stopping XANAX suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions.
Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. Some people who suddenly stop benzodiazepines, have symptoms that can last for several weeks to more than 12 months , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. XANAX is a prescription medicine used: to treat anxiety disorders for the short-term relief of the symptoms of anxiety to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment agoraphobia XANAX is a federal controlled substance C-IV because it contains alprazolam that can be abused or lead to dependence.
Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. It is not known if XANAX is safe and effective when used to treat anxiety disorder for longer than 4 months.
It is not known if XANAX is safe and effective when used to treat panic disorder for longer than 10 weeks. XANAX may harm your unborn baby.
XANAX passes into your breast milk and may harm your baby. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start or stop other medicines without talking to your healthcare provider. If you take too much XANAX, call your healthcare provider or go to the nearest hospital emergency room right away. XANAX may cause an increase in activity and talking hypomania and mania in people who have depression.
XANAX can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XANAX affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking XANAX without first talking to your healthcare provider.
When taken with alcohol or drugs that cause sleepiness or dizziness, XANAX may make your sleepiness or dizziness much worse. The most common side effects of XANAX include: problems with coordination hypotension trouble saying words clearly dysarthria changes in sex drive libido These are not all the possible side effects of XANAX.
Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
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