Lorazepam (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Lorazepam tablets, USP are 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 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

Lorazepam tablets, USP 0.5 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX7” on one side and plain on the other side. They are supplied as follows:

NDC 63304-772-30 Bottles of 30

NDC 63304-772-90 Bottles of 90

NDC 63304-772-01 Bottles of 100

NDC 63304-772-05 Bottles of 500

NDC 63304-772-10 Bottles of 1000

Lorazepam tablets, USP 1 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX” above the bisect and “773” below the bisect on one side and plain on the other side. They are supplied as follows:

NDC 63304-773-30 Bottles of 30

NDC 63304-773-90 Bottles of 90

NDC 63304-773-01 Bottles of 100

NDC 63304-773-05 Bottles of 500

NDC 63304-773-10 Bottles of 1000

Lorazepam tablets, USP 2 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX” above the bisect and “774” below the bisect on one side and plain on the other side. They are supplied as follows:

NDC 63304-774-30 Bottles of 30

NDC 63304-774-90 Bottles of 90

NDC 63304-774-01 Bottles of 100

NDC 63304-774-05 Bottles of 500

NDC 63304-774-10 Bottles of 1000

Store at 20° — 25° C (68° — 77° F) [See USP Controlled Room Temperature]. Dispense in a tight container. Keep tightly closed.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

February 2013

Principal Display Panel

Lorazepam Tablets, USP 1mg CIV
30 Tablets
NDC 10544-085-30

image description
(click image for full-size original)

LORAZEPAM
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-085(NDC:63304-773)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 1 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (flat faced beveled edged) Size 6mm
Flavor Imprint Code RX;773
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-085-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076045 09/04/2012
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-085)

Revised: 07/2015 Blenheim Pharmacal, Inc.

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