A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Prevacid NapraPAC Indications, Dosage, Storage, Stability - Naproxen and Lansoprazole
Prevacid NapraPAC Indications, Dosage, Storage, Stability - Naproxen and Lansoprazole
INDICATIONS AND USAGE
PREVACID® NapraPACTM (375 or 500)
is indicated for reducing the risk of NSAID-associated gastric ulcers in patients
with a history of documented gastric ulcer who require the use of an NSAID for
treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis,
and ankylosing spondylitis. (See CLINICAL STUDIES and DOSAGE
AND ADMINISTRATION.) Controlled studies did not extend beyond 12
weeks.
DOSAGE AND ADMINISTRATION
Risk Reduction of NSAID-Associated Gastric Ulcers in the Treatment
of Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
Each convenience package of PREVACID® NapraPACTM
(375 or 500) contains sufficient product for seven days of treatment. Each daily
dose consists of one PREVACID 15 mg capsule and two NAPROSYN tablets, either
375 mg or 500 mg. Take the PREVACID capsule and one NAPROSYN tablet in the morning
before eating with a glass of water. Take the second NAPROSYN tablet in the
evening with a glass of water.
The maximum daily naproxen dose of PREVACID®
NapraPACTM (375, or 500) is 1000 mg. Controlled studies for PREVACID®
NapraPACTM did not extend beyond 12 weeks.
For PREVACID® NapraPACTM (375 or
500), no adjustment of the 15 mg PREVACID component is necessary in patients
with renal insufficiency or for the elderly. Dosage adjustment for the NAPROSYN
component should be considered for patients with renal insufficiency, liver
disease or the elderly (see PRECAUTIONS
- Renal Effects and Hepatic Function).
PREVACID Delayed-Release Capsules should be swallowed whole.
The capsule should not be chewed or crushed.
HOW SUPPLIED
PREVACID® NapraPACTM 375 is supplied
as a weekly blister card packaged as a monthly (28 days) course of therapy.
Each weekly blister card contains:
NAPROSYN
- fourteen pink, biconvex oval tablets, engraved with NPR LE
375 on one side.
PREVACID
- seven opaque, hard gelatin, pink and green PREVACID 15 mg
capsules, with the TAP logo and "PREVACID 15" imprinted on the capsules.
PREVACID® NapraPACTM 500 is supplied
as a weekly blister card packaged as a monthly (28 days) course of therapy.
Each weekly blister card contains:
NAPROSYN
- fourteen yellow, capsule-shaped tablets, engraved with NPR
LE 500 on one side and scored on the other.
PREVACID
- seven opaque, hard gelatin, pink and green PREVACID 15 mg
capsules, with the TAP logo and "PREVACID 15" imprinted on the capsules.
|
NDC 0300-1545-07
|
Weekly Blister Card, 375 mg
|
|
NDC 0300-1546-07
|
Weekly Blister Card, 500 mg
|
|
NDC 0300-1545-30
|
One Month Administration Pack,
375 mg
|
|
NDC 0300-1546-30
|
One Month Administration Pack,
500 mg
|
Storage: Protect from light and moisture.
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
[See USP Controlled Room Temperature] Store and dispense in original container.
U.S. Patent No. 6,047,829
Distributed by TAP Pharmaceuticals Inc. Lake
Forest, Illinois 60045, U.S.A.
ALEVE® is a registered trademark
of Bayer-Roche L.L.C.
ANAPROX®/ANAPROX DS®,
EC-NAPROSYN®, NAPROSYNÒ,
and NAPROSYN® SUSPENSION are registered trademarks of and NapraPACTM
is a trademark of Syntex Pharmaceuticals International Ltd., A Bermuda Corporation
PREVACID® is a registered trademark
of TAP Pharmaceuticals Inc. 3646-R3, Rev. November, 2003 © 2003 TAP Pharmaceutical
Products Inc.
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