LANSOPRAZOLE capsule, delayed release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Physicians Total Care, Inc.

INN (Medzinárodný Name):

LANSOPRAZOLE

Zloženie:

LANSOPRAZOLE 15 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Lansoprazole delayed-release capsules 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 capsules/amoxicillin/clarithromycin Lansoprazole delayed-release capsules 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 capsules/amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duo

Prehľad produktov:

Lansoprazole delayed-release capsules USP are available as follows: 15 mg - hard gelatin capsules, with a light-blue opaque cap and flesh-colored opaque body, imprinted with “93” and “7350”, filled with off-white to beige pellets, in 30 mg - hard gelatin capsules, with a light-gray opaque cap and flesh-colored opaque body, imprinted with “93” and “7351”, filled with off-white to beige pellets, in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

LANSOPRAZOLE - LANSOPRAZOLE CAPSULE, DELAYED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP.
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS
Bone Fracture (5.2) 9/2010
Hypomagnesemia (5.3) 5/2011
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 Capsules USP
Amoxicillin
Clarithromycin
30 mg
1 gram
500 mg
Twice daily for 10 or 14 days
Dual Therapy:
Lansoprazole Delayed-Release Capsules USP
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
PATHOLOGICAL HYPERSECRETORY CONDITIONS (I.E., ZES) (1.9)
60 mg
Once daily
DOSAGE FORMS AND STRENGTHS
Capsules: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
Contraindicated in patien