Alprazolam XR
ALPRAZOLAM XR- alprazolam tablet, extended release
Greenstone LLC
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
- 1.
- Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for 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 [see Warnings and Precautions (5.1), Drug Interactions (7.1)].
- 2.
- The use of benzodiazepines, including Alprazolam XR, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Alprazolam XR and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2) ] .
- 3.
- The continued use of benzodiazepines, including Alprazolam XR, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Alprazolam XR after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Alprazolam XR or reduce the dosage [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] .
1 INDICATIONS AND USAGE
Alprazolam XR is indicated for the treatment of panic disorder with or without agoraphobia, in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Administer Alprazolam XR orally once daily, preferably in the morning. Swallow tablets whole; do not divide, crush, or chew.
The recommended starting oral dosage for Alprazolam XR is 0.5 mg to 1 mg once daily. Depending on the response, the dosage may be adjusted at intervals of every 3 to 4 days in increments of no more than 1 mg daily. The recommended dosage range is 3 mg to 6 mg once daily.
Controlled trials of Alprazolam XR for the treatment of panic disorder included dosages in the range of 1 mg to 10 mg per day. Most patients showed a response in the dosage range of 3 mg to 6 mg per day. Occasional patients required as much as 10 mg per day.
The longer-term efficacy of Alprazolam XR has not been systematically evaluated. If Alprazolam XR is used for periods longer than 8 weeks, the healthcare provider should periodically reassess the usefulness of the drug for the individual patient.
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 (2.2), Warnings and Precautions (5.2)].
2.2 Discontinuation or Dosage Reduction of Alprazolam XR
To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Alprazolam XR 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) ].
Reduce the dosage by no more than 0.5 mg every three 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.
2.3 Dosage Recommendations in Geriatric Patients
In geriatric patients, the recommended starting dosage of Alprazolam XR is 0.5 mg once daily. This may be gradually increased if needed and tolerated. Geriatric patients may be sensitive to the effects of benzodiazepines [see Use in Specific Populations (8.5), Clinical Pharmacology (12.3)].
2.4 Dosage Recommendations in Patients with Hepatic Impairment
In patients with hepatic impairment, the recommended starting dosage of Alprazolam XR is 0.5 mg once daily. This may be gradually increased if needed and tolerated [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Dosage Modifications for Drug Interactions
Alprazolam XR should be reduced to half of the recommended dosage when a patient is started on ritonavir and Alprazolam XR together, or when ritonavir is added to a patient treated with Alprazolam XR. Increase Alprazolam XR dosage to the target dose after 10 to 14 days of dosing ritonavir and Alprazolam XR together. It is not necessary to reduce Alprazolam XR dosage in patients who have been taking ritonavir for more than 10 to 14 days.
Alprazolam XR is contraindicated with concomitant use of all strong CYP3A inhibitors, except ritonavir [see Contraindications (4), Warnings and Precautions (5.5), Drug Interactions (7.1)].
2.6 Switching Patients from Alprazolam Tablets to Alprazolam XR Tablets
Patients who are currently being treated with divided doses of alprazolam may be switched to Alprazolam XR at the same total daily dose taken once daily. If the clinical response after switching is inadequate, titrate the dosage as outlined above.
3 DOSAGE FORMS AND STRENGTHS
Alprazolam XR extended-release tablets are available as:
- •
- 0.5 mg: white, pentagonal shaped tablets debossed with an “G” on one side and “0.5” on the other side
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- 1 mg: yellow, square shaped tablets debossed with an “G” on one side and “1” on the other side
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- 2 mg: blue, round shaped tablets debossed with an “G” on one side and “2” on the other side
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- 3 mg: green, triangular shaped tablets debossed with an “G” on one side and “3” on the other side
4 CONTRAINDICATIONS
Alprazolam XR is contraindicated in patients:
- •
- with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see Adverse Reactions (6.2)].
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- taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.5), Warnings and Precautions (5.5), Drug Interactions (7.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Risks from Concomitant Use with Opioids
Concomitant use of benzodiazepines, including Alprazolam XR, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs 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 opioids alone. If a decision is made to prescribe Alprazolam XR concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Alprazolam XR than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Alprazolam XR, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when Alprazolam XR is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Drug Interactions (7.1)].
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