Ativan (Lorazepam) - Indications and Dosage

INDICATIONS AND USAGE

Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Ativan (lorazepam) is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.

The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.

For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.

For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.

For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.

The dosage of Ativan (lorazepam) should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.

HOW SUPPLIED

Ativan^® (lorazepam) Tablets are available in the following dosage strengths:

0.5 mg, white, five-sided (shield shape) tablet with a raised "A" on one side and "BPI" and "63" impressed on reverse side.
  NDC 64455-063-01 - Bottles of 100 tablets

1 mg, white, five-sided (shield shape) tablet with a raised "A" on one side and "BPI" and "64" impressed on scored reverse side.
  NDC 64455-064-01 - Bottles of 100 tablets
  NDC 64455-064-10 - Bottles of 1000 tablets

2 mg, white, five-sided (regular pentagon) tablet with a raised "A" and impressed "2" on one side and "BPI" and "65" impressed on scored reverse side.
  NDC 64455-065-01 - Bottles of 100 tablets

BOTTLES:

Keep tightly closed.

Store at 25°C (77°F); excursions permitted to 15 - 30° (59 – 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Manufactured by:
MEDA Manufacturing GmbH
Cologne, Germany D-51063

For:
BTA Pharmaceuticals, Inc.
(subsidiary of Biovail Corporation)
Bridgewater, NJ, 08807, USA

Tablets made in Germany

Ativan^® is a registered trademark of Biovail Laboratories International SRL.

LB0057-02
Rev. 10/09