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.
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.
Ranbaxy Pharmaceuticals Inc.
Jacksonville, FL 32257 USA
Principal Display Panel
Lorazepam Tablets, USP 1mg CIV
| LORAZEPAM |
|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 || |
|# ||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.
|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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