Xanax

Xanax is an FDA-registered drug product whose active ingredient is ALPRAZOLAM. It is labelled by PHARMACIA & UPJOHN COMPANY LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0009-0029, application NDA018276, label effective 20230118. It is one of 34 FDA drug label records sharing the active ingredient ALPRAZOLAM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ALPRAZOLAM are most often described in connection with: acute treatment, generalized anxiety, panic disorder, without agoraphobia, usage xanax, gad adults, benzodiazepine indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE XANAX is indicated for the: • acute treatment of generalized anxiety disorder (GAD) in adults. • treatment of panic disorder (PD), with or without agoraphobia in adults. XANAX is a benzodiazepine indicated for the: • Acute treatment of generalized anxiety disorder in adults. ( 1 ) • Treatment of panic disorder with or without agoraphobia in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION • Generalized Anxiety Disorder : ( 2.1 ) o Recommended starting oral dosage is 0.25 mg to 0.5 mg three times daily. o 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. o Use the lowest possible effective dose and frequently assess the need for continued treatment. • Panic Disorder : Recommended starting oral dosage is 0.5 mg three times daily. The dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day. ( 2.2 ) • When tapering, decrease dosage by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. ( 2.3 , 5.2 ) • See the Full Prescribing Information for the recommended dosage in geriatric patients, patients with hepatic impairment, and with use with ritonavir. ( 2.4 , 2.5 , 2.6 ) 2.1 Dosage in Generalized Anxiety Disorder The recommended starting oral dosage of XANAX for the acute treatment of patients with GAD is 0.25 mg to 0.5 mg administered three times daily. Depending upon the response, the dosage may be adjusted at intervals of every 3 to 4 days. The maximum recommended dosage is 4 mg daily (in divided doses). Use the lowest possible effective dose and frequently assess the need for continued treatment [see Warnings and Precautions (5.2) ] . 2.2 Dosage in Panic Disorder The recommended starting oral dosage of XANAX for the treatment of PD is 0.5 mg three times daily. Depending on the response, the dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day. Controlled trials of XANAX in the treatment of panic disorder included dosages in the range of 1 mg to 10 mg daily. The mean dosage was approximately 5 mg to 6 mg daily. Occasional patients required as much as 10 mg per day. For patients receiving doses greater than 4 mg per day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg per day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. The necessary duration of treatment for PD in patients responding to XANAX is unknown. After a period of extended freedom from panic attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena [see Dosage and Administration (2.3) ] . 2.3 Discontinuation or Dosage Reduction of XANAX To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions (5.3) , Drug Abuse and Dependence (9.3) ] . Reduced the dosage by no more than 0.5 mg every 3 days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens. In a controlled postmarketing discontinuation study of panic disorder patients which compared the recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. 2.4 Dosage Recommendations in Geriatric Patients In geriatric patients, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. Geriatric patients may be especially sensitive to the effects of benzodiazepines. If adverse reactions occur at the recommended starting dosage, the dosage may be reduced [see Use in Specific Populations (8.5) , Clinical Pharmacology (12.3) ] . 2.5 Dosage Recommendations in Patients with Hepatic Impairment In patients with hepatic impairment, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. If adverse reactions occur at the recommended starting dose, the dosage may be reduced [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] . 2.6 Dosage Modifications for Drug Interactions XANAX should be reduced to half of the recommended dosage when a patient is started on ritonavir and XANAX together, or when ritonavir administered to a patient treated with XANAX. Increase the XANAX dosage to the target dose after 10 to 14 days of dosing ritonavir and XANAX together. It is not necessary to reduce XANAX dose in patients who have been taking ritonavir for more than 10 to 14 days. XANAX is contraindicated with concomitant use of all strong CYP3A inhibitors, except ritonavir [see Contraindications (4) , Warnings and Precautions (5.5) ] .

4 CONTRAINDICATIONS XANAX is contraindicated in patients: • with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions (6.2) ] . • taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.6) , Warnings and Precautions (5.5) , Drug Interactions (7.1) ] • Known hypersensitivity to alprazolam or other benzodiazepines. ( 4 ) • Concomitant use with strong cytochrome P450 3A (CYP3A) inhibitors, except ritonavir. ( 4 , 5.5 , 7.1 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] • Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2) ] • Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3) ] • Effects on Driving and Operating Machinery [see Warnings and Precautions (5.4) ] • Patients with Depression [see Warnings and Precautions (5.6) ] • Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.8) ] • Risks in Patients with Impaired Respiratory Function [see Warnings and Precautions (5.9) ] The most common adverse reactions reported in clinical trials for generalized anxiety disorder and panic disorder (incidence >5% and at least twice that of placebo) include: impaired coordination, hypotension, dysarthria, and increased libido. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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). Table 1: Adverse Reactions Occurring in ≥1% in XANAX-treated Patients and Greater than Placebo-treated Patients in Placebo-Controlled Trials for Generalized Anxiety XANAX n=565 Placebo n=505 Nervous system disorders Drowsiness 41% 22% Light-headedness 21% 19% Dizziness 2% 1% Akathisia 2% 1% Gastrointestinal disorders Dry mouth 15% 13% Increased salivation 4% 2% Cardiovascular disorders Hypotension 5% 2% Skin and subcutaneous tissue disorders Dermatitis/allergy 4% 3% In addition to the adverse reactions (i.e., greater than 1%) enumerated in the table above for patients with generalized anxiety disorder, the following adverse reactions have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention. Table 2: Adverse Reactions Occurring in ≥1% in XANAX-treated Patients and Greater than Placebo-treated Patients in Placebo-Controlled Trials (Up to 10 Weeks) for Panic Disorder XANAX n=1388 Placebo n=1231 Drowsiness Fatigue and Tiredness Impaired Coordination Irritability Memory Impairment Cognitive Disorder Decreased Libido Dysarthria Confusional state 77% 49% 40% 33% 33% 29% 14% 23% 10% 43% 42% 18% 30% 22% 21% 8% 6% 8% Increased libido 8% 4% Change in libido (not specified) 7% 6% Disinhibition 3% 2% Talkativeness 2% 1% Derealization 2% 1% Gastrointestinal disorders Constipation 26% 15% Increased salivation 6% 4% Skin and subcutaneous tissue disorders Rash 11% 8% Other Increased appetite 33% 23% Decreased appetite 28% 24% Weight gain 27% 18% Weight loss 23% 17% Micturition difficulties 12% 9% Menstrual disorders 11% 9% Sexual dysfunction 7% 4% Incontinence 2% 1% In addition to the reactions (i.e., greater than 1%) enumerated in the table above for patients with panic disorder, the following adverse reactions have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice. Adverse Reactions Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo-treated group are shown in Table 3. Table 3: Discontinuation-Emergent Symptom Incidence Reported in ≥5% of XANAX-treated Patients and > Placebo-treated Patients n=number of patients. XANAX-treated Patients n=641 Nervous system disorders Insomnia 29.5% Light-headedness 19.3% Abnormal involuntary movement 17.3% Headache 17.0% Muscular twitching 6.9% Impaired coordination 6.6% Muscle tone disorders 5.9% Weakness 5.8% Psychiatric disorders Anxiety 19.2% Fatigue and Tiredness 18.4% Irritability 10.5% Cognitive disorder 10.3% Memory impairment 5.5% Depression 5.1% Confusional state 5.0% Gastrointestinal disorders Nausea/Vomiting 16.5% Diarrhea 13.6% Decreased salivation 10.6% Metabolism and nutrition disorders Weight loss 13.3% Decreased appetite 12.8% Dermatological disorders Sweating 14.4% Cardiovascular disorders Tachycardia 12.2% Special Senses Blurred vision 10.0% There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX [see Warning and Precautions (5.2) and Drug Abuse and Dependence (9.3) ] . Paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations, and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of XANAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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

FDA lists 34 drug label records with ALPRAZOLAM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Xanax used for?
1 INDICATIONS AND USAGE XANAX is indicated for the: • acute treatment of generalized anxiety disorder (GAD) in adults. • treatment of panic disorder (PD), with or without agoraphobia in adults. XANAX is a benzodiazepine indicated for the: • Acute treatment of generalized anxiety disorder in adults. ( 1 ) • Treatment of panic disorder with or without agoraphobia in adults. ( 1 )

Who makes Xanax?
PHARMACIA & UPJOHN COMPANY LLC is the labeler of record for Xanax. 34 FDA label records share the active ingredient ALPRAZOLAM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Xanax come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Xanax prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ALPRAZOLAM?
Yes. 34 FDA drug label records list ALPRAZOLAM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Xanax been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.