Xanax XR® 3mg (Alprazolam Extended-Release) – Sustained Anxiolytic Therapy
1. High-Dose, Extended-Release Formulation
Active Ingredient: Alprazolam 3mg
Formulation:
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Triple-layer matrix tablet (ER technology)
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Color: Yellow (branded), Blue (generic variants)
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Non-scorable – Must swallow whole
FDA-Approved Indications:
✔ Panic Disorder Maintenance (daily management)
✔ Treatment-Resistant GAD (severe, chronic cases)
✔ Benzodiazepine-Tolerant Patients Only
2. Advanced Pharmacokinetics
🧠 Mechanism:
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GABA-A superagonist (α1-α3 subunit targeting)
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12-hour controlled release via osmotic pump
⏳ Clinical Kinetics:
| Parameter | Value | Clinical Relevance |
|---|---|---|
| Onset | 1-2 hr | Slower than IR forms |
| Peak | 5-7 hr | Steady anxiolysis |
| Duration | 10-12 hr | Bid dosing required |
| Half-life | 10-15 hr | Accumulation risk |
3. Strict Dosing Protocol
| Patient Profile | Regimen | Max Duration |
|---|---|---|
| Stable Panic Disorder | 3mg QAM + 1mg QPM | 8 weeks |
| Benzodiazepine-Tolerant | 3mg BID | 4 weeks max |
| Cross-Taper from IR | 3mg XR + 0.5mg IR PRN | 2-week transition |
Critical Administration Rules:
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Never crush/chew – Risk of dose dumping
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Morning + Noon dosing – Avoids next-day sedation
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Hepatic Adjustment: Max 2mg/day
4. Black Box Warnings
⚠ Dependence Potential:
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50% incidence with 12-week use
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Protracted withdrawal syndrome
⚠ Overdose Fatality:
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LD50 = 331mg/kg (but fatal with 2mg + opioids)
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Respiratory arrest risk
⚠ Cognitive Risks:
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Anterograde amnesia (40% incidence)
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Complex sleep behaviors
5. Safety-Engineered Packaging
🔐 Controlled Dispensing:
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7-day starter packs with alarm caps
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Biometric lock bottles
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UV-reactive lot coding
⚠ Storage: 15-30°C in narcotics safe
6. Mandatory REMS Protocol
Before Prescribing:
✓ Urine drug screen
✓ C-SSRS suicide assessment
✓ Pulmonary function test
Monitoring Requirements:
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Weekly prescription pickups
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Biweekly cognitive testing
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Monthly respiratory checks
Rx Only | Schedule IV Controlled Substance
DEA Triplicate Form Required
Patient Contract Stipulations:
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No driving/machinery operation
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Mandatory monthly psychotherapy
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Pill dispenser with facial recognition
Available Clinical Tools:
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Benzodiazepine Equivalency Calculator
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Withdrawal Seizure Protocol
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ER-to-IR Transition Guide
