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
Prevpac Indications, Dosage, Storage, Stability - Lansoprazole, Amoxicillin And Clarithromycin
Prevpac Indications, Dosage, Storage, Stability - Lansoprazole, Amoxicillin And Clarithromycin
INDICATIONS
AND USES
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
The components in PREVPAC (PREVACID, amoxicillin, and clarithromycin) are indicated
for the treatment of patients with H. pylori infection and duodenal ulcer
disease (active or one-year history of a duodenal ulcer) to eradicate H.
pylori . Eradication of H. pylori has been shown to reduce the risk
of duodenal ulcer recurrence (See CLINICAL STUDIES and DOSAGE AND
ADMINISTRATION ).
DOSAGE AND ADMINISTRATION
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
The recommended adult oral dose is 30 mg PREVACID, 1 g amoxicillin, and 500
mg clarithromycin administered together twice daily (morning and evening) for
10 or 14 days. (See INDICATIONS
AND USAGE .)
PREVPAC is not recommended in patients with creatinine clearance less than
30 mL/min.
HOW SUPPLIED
PREVPAC is supplied as an individual daily administration pack, each containing:
PREVACID:
- two opaque, hard gelatin, black and pink PREVACID 30-mg capsules, with
the TAP logo and "PREVACID 30" imprinted on the capsules.
TRIMOX:
- four maroon and light pink amoxicillin 500-mg capsules, USP, with "BRISTOL
7279" imprinted on the capsules.
BIAXIN Filmtab:
- two yellow oval film-coated clarithromycin 500-mg tablets, USP, debossed
with the Abbott logo on one side and "KL" on the other side of the tablets.
NDC 0300-3702-01 Daily administration pack
NDC 0300-3702-11 Daily administration card
Storage: Protect from light and moisture.
Store at a controlled room temperature between 20°C and 25°C (68°F and 77°F).
Rx only
U.S. Patent No. 5,013,743
PREVPAC is distributed by TAP Pharmaceuticals Inc.
PREVACID ® (lansoprazole) Delayed-Release Capsules
Manufactured for TAP Pharmaceuticals Inc.
Lake Forest, Illinois 60045, U.S.A.
by Takeda Chemical Industries Limited
Osaka, Japan 541
TRIMOX ® (amoxicillin, USP)
Manufactured by APOTHECON ® A Bristol-Myers Squibb Company Princeton,
NJ 08540, U.S.A.
BIAXIN ® Filmtab ® (clarithromycin tablets, USP)
Manufactured by Abbott Laboratories North Chicago, IL 60064, U.S.A.
Jul 2000
© 1997-2000 TAP Pharmaceutical Products Inc.
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