ALPRAZOLAM ER (Page 6 of 6)

Switch from Alprazolam (immediate-release) Tablets to Alprazolam Extended-Release Tablets

Patients who are currently being treated with divided doses of alprazolam (immediate-release) tablets, for example 3 to 4 times a day, may be switched to alprazolam extended-release tablets at the same total daily dose taken once daily. If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.

HOW SUPPLIED

Alprazolam extended-release tablets 0.5 mg are white, round compressed tablets debossed cor over 187 on one side and other side is plain. They are supplied as follows:

Bottles of 60 (NDC 64980-140-06)
Bottles of 100 (NDC 64980-140-01)
Bottles of 1000 (NDC 64980-140-10)

Alprazolam extended-release tablets 1 mg are yellow, round compressed tablets debossed cor over 188 on one side and other side is plain. They are supplied as follows:

Bottles of 60 (NDC 64980-141-06)
Bottles of 100 (NDC 64980-141-01)
Bottles of 1000 (NDC 64980-141-10)

Alprazolam extended-release tablets 2 mg are blue, round compressed tablets debossed cor over 189 on one side and other side is plain. They are supplied as follows:

Bottles of 60 (NDC 64980-142-06)
Bottles of 100 (NDC 64980-142-01)
Bottles of 1000 (NDC 64980-142-10)

Alprazolam extended-release tablets 3 mg are green, round compressed tablets debossed cor over 190 on one side and other side is plain. They are supplied as follows:

Bottles of 60 (NDC 64980-143-06)
Bottles of 100 (NDC 64980-143-01)
Bottles of 1000 (NDC 64980-143-10)

Store at 20° — 25°C (68° — 77°F); excursions permitted to 15° — 30°C (59° — 86°F) [see USP Controlled Room Temperature].

Dispense in a tight light-resistant container as defined in the USP.

Keep container tightly closed.

Keep this and all drugs out of the reach of children.

ANIMAL STUDIES

When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.


Manufactured by:
Corepharma LLC
Middlesex, NJ 08846


Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
February 2007MF # 539-01

ALPRAZOLAM ER 2MG LABEL IMAGE
(click image for full-size original)
ALPRAZOLAM ER alprazolam tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-588(NDC:64980-142)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPRAZOLAM (ALPRAZOLAM) ALPRAZOLAM 2 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (Blue) Score no score
Shape ROUND (round) Size 10mm
Flavor Imprint Code cor;189
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-588-30 30 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:16590-588-60 60 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
3 NDC:16590-588-72 120 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
4 NDC:16590-588-90 90 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077996 03/28/2007
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 repack, relabel

Revised: 03/2010 STAT RX USA LLC

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