LANSOPRAZOLE tablet, orally disintegrating, delayed release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)

Fáanlegur frá:

Physicians Total Care, Inc.

INN (Alþjóðlegt nafn):

LANSOPRAZOLE

Samsetning:

LANSOPRAZOLE 30 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14) ]. Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is 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 (14) ]. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy is indicated for the treatmen

Vörulýsing:

Lansoprazole delayed-release orally disintegrating tablets are available as follows: 30 mg: white to off-white, flat, beveled round, artificial strawberry flavored tablet, with white to grayish speckles, debossed with “30” on one side of the tablet and plain on the other side in Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LANSOPRAZOLE - LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED
RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANSOPRAZOLE DELAYED-RELEASE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LANSOPRAZOLE DELAYED-RELEASE
ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE DELAYED-RELEASE ORALLY
DISINTEGRATING TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Dosage and Administration:
Important Administration Information (2.3) June 2009
Warnings and Precautions:
Bone Fracture (5.2) August 2010
INDICATIONS AND USAGE
Lansoprazole is a proton pump inhibitor (PPI). Refer to DOSAGE AND
ADMINISTRATION table (below) for indications
and usage. (1)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
FREQUENCY
DUODENAL ULCERS (1.1, 1.3)
Short-Term Treatment
15 mg
Once daily for 4 wks
Maintenance of Healed
15 mg
Once daily
_H. PYLORI_ ERADICATION TO REDUCE RECURRENCE OF DUODENAL ULCER (1.2)
Triple Therapy: Lansoprazole
Delayed-Release Orally
Disintegrating Tablets
Amoxicillin
Clarithromycin
30 mg
1 gram
500 mg
Twice daily for 10 or 14 days
Dual Therapy: Lansoprazole
Delayed-Release Orally
Disintegrating Tablets
Amoxicillin
30 mg
1 gram
Three times daily for 14 days
BENIGN GASTRIC ULCER (1.4)
Short-Term Treatment
30 mg
Once daily up to 8 wks
NSAID-ASSOCIATED GASTRIC ULCER (1.6)
He aling
30 mg
Once daily for 8 wks
Risk Reduction
15 mg
Once daily up to 12 wks
GERD (1.7)
Short-Term Treatment of
Symptomatic GERD
15 mg
Once daily up to 8 wks
Short-Term Treatment of EE
30 mg
Once daily up to 8 wks
PEDIATRIC (8.4)
(1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and
Short-Term Treatment of EE
≤ 30 kg
15 mg
Once daily up to 12 wks
> 30 kg
30 mg
Once daily up to 12 wks
(12 to 17 years of age) Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily up to 8 wks
EE
30 mg
Once daily up to 8 wks
MAINTENANCE OF HEALING OF EE
(1.8)
15 mg
Once daily
PATHOLOGI