Alprazolam tablets for anxiety and panic disorder in adults

Alprazolam tablets are a benzodiazepine medication approved for the short-term acute treatment of generalized anxiety disorder and panic disorder, including panic disorder with agoraphobia, in adult patients. It is taken orally in tablet form available in 0.25 mg, 0.5 mg, 1 mg, and 2 mg strengths.

Alprazolam tablets are used in adults for:

• The acute management of generalized anxiety disorder (GAD).
• Treatment of panic disorder (PD), with or without agoraphobia.

Alprazolam

Alprazolam works as a benzodiazepine by enhancing the effect of gamma-aminobutyric acid (GABA), a natural chemical in the brain that produces calming effects. This mechanism helps reduce excessive brain activity associated with anxiety and panic symptoms.

Generalized Anxiety Disorder (GAD)

Starting dose: 0.25 mg to 0.5 mg orally three times a day. Dose may be adjusted every 3 to 4 days based on response. Maximum recommended daily dose is 4 mg, given in divided doses. Use the lowest effective dose and reassess regularly.

Panic Disorder (PD)

Starting dose: 0.5 mg orally three times a day. Dose can be increased every 3 to 4 days by no more than 1 mg per day. Controlled trials used doses from 1 mg to 10 mg daily; average was 5 to 6 mg, with some patients needing up to 10 mg daily. Patients on doses over 4 mg per day should have periodic reassessment and dose reduction considered when possible.

Tapering and Discontinuation

To avoid withdrawal reactions, taper the dose gradually by reducing no more than 0.5 mg every 3 days. Some patients may require an even slower taper. If withdrawal symptoms occur, pause or increase the dose before continuing with a slower taper.

Special Populations

• Geriatric patients: start at 0.25 mg two or three times daily; increase cautiously.
• Patients with hepatic impairment: start at 0.25 mg two or three times daily; adjust slowly based on tolerance.
• Patients using ritonavir: reduce alprazolam dose by half at initiation; increase dose after 10-14 days of combined use. Dose adjustment is not necessary if ritonavir has been used for more than 10-14 days.

• Known hypersensitivity to alprazolam or other benzodiazepines (including a history of angioedema).
• Concomitant use with strong CYP3A inhibitors except ritonavir (e.g., ketoconazole, itraconazole).

Serious Warnings

• Concomitant use with opioids: May cause profound sedation, respiratory depression, coma, and death. Use together only if alternative treatments are inadequate, at the lowest effective doses and shortest duration.
• Abuse, misuse, and addiction: Alprazolam carries risks of abuse that can lead to overdose or death. Patients should be carefully assessed for addiction risk before and during treatment.
• Dependence and withdrawal: Physical dependence can develop; abrupt discontinuation or rapid dose reduction may cause life-threatening withdrawal including seizures. Taper gradually.

Additional Precautions

• Patients should avoid driving or operating machinery until effects are known, especially with concomitant CNS depressants or alcohol.
• Use caution in patients with depression and limit prescription quantities to reduce overdose risk.
• Monitor neonates exposed to alprazolam in utero for sedation or withdrawal symptoms.
• Patients with severe pulmonary disease should be monitored closely for respiratory depression.
• Contraindicated with strong CYP3A inhibitors except ritonavir due to increased alprazolam levels.

Common Side Effects

• Drowsiness
• Dizziness
• Tiredness
• Impaired coordination

Serious Side Effects

• Respiratory depression (especially with opioids)
• Seizures (particularly on withdrawal)
• Withdrawal symptoms including increased anxiety, insomnia, sensory disturbances, muscle cramps, and gastrointestinal symptoms
• Angioedema (allergic reaction)
• Hypomania or mania in patients with depression

Alprazolam metabolism is primarily via CYP3A. Concomitant use with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, fluvoxamine, cimetidine) increases alprazolam plasma levels and risk of toxicity and is contraindicated except for ritonavir.

When starting or stopping ritonavir, alprazolam dosage adjustments are required.

Concurrent use with opioids increases risks of sedation and respiratory depression; doses of both drugs should be minimized and patients monitored closely.

Pregnancy

Use late in pregnancy can cause neonatal sedation and withdrawal symptoms. Neonates exposed during pregnancy or labor should be closely monitored and managed as needed.

Lactation

No specific information provided in label.