LANSOPRAZOLE- lansoprazole capsule, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Lake Erie Medical DBA Quality Care Products LLC

INN (Nome Internazionale):

LANSOPRAZOLE

Composizione:

LANSOPRAZOLE 30 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 duode

Dettagli prodotto:

Lansoprazole delayed-release capsules 15 mg, contains white to off white coloured spherical shaped pellets filled in size '3' capsules with green colour body and pink colour cap, printed NATCO on cap and 15 on body with white ink. Lansoprazole delayed-release capsules 30 mg, contains white to off white coloured spherical shaped pellets filled in size '1' capsules with dark blue colour body and pink colour cap, printed NATCO on cap and 30 on body with white ink. They are available as follows: 55700-393-30 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Lansoprazole delayed-release capsules, USP
(lan-soe'-pra-zole)
Read this Medication Guide before you start taking lansoprazole
delayed-release capsules and each time
you get a refill. There may be new information. This information does
not take the place of talking to
your doctor about your medical condition or your treatment.
What is the most important information that I should know about
lansoprazole delayed-release capsules?
Lansoprazole delayed-release capsules may help your acid-related
symptoms, but you could still have
serious stomach problems. Talk with your doctor.
Lansoprazole delayed-release capsules can cause serious side effects,
including:
•
Diarrhea. Lansoprazole delayed-release capsules may increase your risk
of getting severe diarrhea.
This diarrhea may be caused by an infection (Clostridium difficile) in
your intestines.
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go
away.
•
Bone fractures. People who take multiple daily doses of proton pump
inhibitor medicines for a
long period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist or
spine. You should take lansoprazole delayed-release capsules exactly
as prescribed, at the lowest
dose possible for your treatment and for the shortest time needed.
Talk to your doctor about your
risk of bone fracture if you take lansoprazole delayed-release
capsules.
Lansoprazole delayed-release capsules can have other serious side
effects. See "What are the possible
side effects of lansoprazole delayed-release capsules?"
What are lansoprazole delayed-release capsules?
Lansoprazole delayed-release capsules are a prescription medicine
called a proton pump inhibitor (PPI).
Lansoprazole delayed-release capsules reduce the amount of acid in
your stomach.
Lansoprazole delayed-release capsules are used in adults:
•
for 4 weeks for the healing and symptom relief of duodenal ulcers. The
duodenal area is the area
w

Scheda tecnica

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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.
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, FOR ORAL USE
INITIAL U.S. APPROVAL : 1995
RECENT MAJOR CHANGES
Indications and Usage, Gastroesophageal Reflux Disease (GERD) (1.7)
12/2014
Dosage and Administration, Recommended Dose (2.1)
12/2014
Contraindications (4)
12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.2)
12/2014
Warnings and Precautions, Cyanocobalamin (vitamin B12) Deficiency
(5.3)
12/2014
INDICATIONS AND USAGE
Lansoprazole delayed-release capsule is a proton pump inhibitor (PPI)
indicated for:
Short-Term Treatment of Active Duodenal Ulcer (1.1)
_H. pylori _Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence (1.2)
Maintenance of Healed Duodenal Ulcers (1.3)
Short-Term Treatment of Active Benign Gastric Ulcer (1.4)
Healing of nonsteroidal anti-inflammatory drugs (NSAID)- Associated
Gastric Ulcer (1.5)
Risk Reduction of NSAID-Associated Gastric Ulcer (1.6)
Gastroesophageal Reflux Disease (GERD) (1.7)
Maintenance of Healing of Erosive Esophagitis (EE) (1.8)
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome (ZES) (1.9)
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
30 mg
Twice daily for 10 or 14 days
Amoxicillin
1 gram
Clarithromycin
500 mg
Dual Therapy: Lansoprazole delayed-release capsules
30 mg
Three times daily for 14 days
Amoxicillin
1 gram
BENIGN GASTRIC ULCER (1.4)
Short-Term Treatment
30 mg
Once daily up to 8 wks
NSAID-ASSOCIATED GASTRIC ULCER (1.6)
He aling