LANSOPRAZOLE capsule, delayed release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

Lansoprazole (UNII: 0K5C5T2QPG) (Lansoprazole - UNII:0K5C5T2QPG)

Inapatikana kutoka:

Rebel Distributors Corp

INN (Jina la Kimataifa):

Lansoprazole

Tungo:

Lansoprazole 15 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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/amoxicillin/clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy 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 (14)] Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: lansoprazole/amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant t

Bidhaa muhtasari:

Lansoprazole Delayed-Release Capsules, 15 mg, are opaque, hard gelatin, colored pink and green with "TAP" and "PREVACID 15" imprinted on the capsules. The 30 mg capsules are opaque, hard gelatin, colored pink and black with "TAP" and "PREVACID 30" imprinted on the capsules. They are available as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).[See USP Controlled Room Temperature].

Idhini hali ya:

New Drug Application

Tabia za bidhaa

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANSOPRAZOLE DELAYED-RELEASE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR:
LANSOPRAZOLE DELAYED-RELEASE CAPSULES
FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Contraindications (4)
April 2008
Warnings and Precautions (5)
April 2008
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
Indication
Dose
Fre que ncy
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
Amoxicillin
Clarithromycin
30 mg
1 gram
500 mg
Twice daily for 10 or 14 days
Dual Therapy: Lansoprazole
Amoxicillin
30 mg
1 gram
Three times daily for 14 days
BENIGN GASTRIC ULCER
SHORT-TERM TREATMENT (1.4)
30 mg
Once daily up to 8 wks
NSAID-ASSOCIATED GASTRIC ULCER (1.6)
Healing
Risk Reduction
30 mg
15 mg
Once daily for 8 wks
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 patients with known severe hypersensitivity to any
component of the lansoprazole delayed-release
capsule formulation