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Uses

Anxiety Disorders

Management of anxiety disorders or short-term relief of anxiety or anxiety associated with depressive symptoms.

Panic Disorder

Management of panic disorder, with or without agoraphobia.

Cancer Chemotherapy-induced Nausea and Vomiting

Adjunct in the management of nausea and vomiting associated with emetogenic cancer chemotherapy† (including cisplatin); currently not recommended as monotherapy.

May be useful in the management of anticipatory emesis†.

Dosage and Administration

General

• Periodically reassess usefulness of the drug.
• When discontinuing therapy or reducing daily dosage, reduce dosage gradually under close supervision. If significant withdrawal symptoms develop, reinstitute the previous dosage schedule; attempt a less-rapid schedule of dosage tapering only after stabilization. Some patients may be resistant to all discontinuance regimens.
• The manufacturers recommend that dosage be decreased by ≤0.5 mg every 3 days; some patients may require slower reduction.
• Some clinicians recommend decreasing the dosage by ≤0.25 mg every 3–7 days.

Administration

Oral Administration

Immediate-release Preparations

Administer conventional and orally disintegrating tablets and oral concentrate daily in divided doses.

Dilute oral concentrate in ≥30 mL of diluent (e.g., water, juice, carbonated or soda-like beverages) or mix with semisolid foods (e.g., applesauce, pudding) just prior to administration.

Remove orally disintegrating tablet from protective container with dry hands immediately prior to administration. Immediately place tablet on tongue, allow it to disintegrate (within a few seconds), then swallow with or without water. If a half tablet is used, discard the remaining portion because it may not remain stable.

Extended-release Tablets

Administer extended-release tablets daily as a single dose, preferably in the morning.

Swallow extended-release tablets whole; do not chew, crush, or break.

Patients with panic disorder may be switched from conventional tablets to extended-release tablets at the same total daily dosage. If the response is not sufficient, titrate dosage in a similar manner to initial therapy until an acceptable therapeutic response is achieved.

Dosage

Adults

Anxiety Disorders

Therapy with Conventional or Orally Disintegrating Tablets or Oral Concentrate

Oral

Initially, 0.25–0.5 mg 3 times daily. Increase dosage gradually at intervals of 3 or 4 days according to individual requirements and response; maximum dosage of 4 mg daily given in divided doses.

Panic Disorder

Therapy with Conventional or Orally Disintegrating Tablets

Oral

Dosages >4 mg daily have been required; dosage generally has averaged 5–6 mg daily but has ranged from 1–10 mg daily.

Initiate at low dosage; increase dosage gradually until an acceptable therapeutic response is achieved, intolerable adverse effects occur, or a maximum dosage of 10 mg daily is achieved.

Initially, 0.5 mg 3 times daily. Increase dosage as necessary at 3- or 4-day intervals in increments of ≤1 mg daily; slower titration to dosages ≥4 mg daily may be advisable so that full effects of a given dosage can be expressed.

Periodic reassessment and consideration of dosage reduction recommended in patients receiving dosages >4 mg daily.

To minimize risk of symptom emergence between doses, distribute doses evenly 3–4 times daily (while awake).

Therapy with Extended-release Tablets

Oral

Dosage of 3–6 mg daily recommended, but dosage has ranged from 1–10 mg daily.

Initiate at low dosage; increase dosage gradually until an acceptable therapeutic response is achieved, intolerable adverse effects occur, or a maximum dosage of 10 mg daily is achieved.

Initially, 0.5–1 mg daily. Increase dosage as necessary (based on response) at 3- or 4-day intervals in increments of ≤1 mg daily; slower titration may be advisable so that full effects of a given dosage can be expressed.

Prescribing Limits

Adults

Anxiety Disorders

Oral

Maximum 4 mg daily.

Panic Disorder

Oral

Maximum 10 mg daily.

Special Populations

Dosage in Hepatic Impairment

Prolonged elimination. Use the smallest effective dosage.

Initially, 0.25 mg (as an immediate-release preparation) given 2 or 3 times daily or 0.5 mg (as extended-release tablets) once daily; adjust dosage according to individual tolerance and response.

Geriatric or Debilitated Patients

Possible increased sensitivity to benzodiazepines. Use the smallest effective dosage.

Initially, 0.25 mg (as an immediate-release preparation) given 2 or 3 times daily or 0.5 mg (as extended-release tablets) once daily; adjust dosage according to individual tolerance and response.