LANSOPRAZOLE capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

LANSOPRAZOLE

Composition:

LANSOPRAZOLE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lansoprazole is 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 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/amoxicillin Lansoprazole 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 duodena

Product summary:

Lansoprazole Delayed-release Capsules USP, 15 mg are enteric-coated pellets filled in size '3' hard gelatin capsules with standard pink opaque colored cap printed with "ZA -50" in black ink and white opaque body printed with "15mg" in black ink and are supplied as follows: NDC 50268-465-15   10 capsules per card, 5 cards per carton. Lansoprazole Delayed-release Capsules USP, 30 mg are enteric-coated pellets filled in size '1' hard gelatin capsules with standard pink opaque colored cap printed with "ZA -51" in black ink and white opaque body printed with "30 mg" in black ink and are supplied as follows: NDC 50268-466-15   10 capsules per card, 5 cards per carton. Dispensed in Unit Dose Package. For Institutional Use Only. Storage Store at 20 ο to 25 ο C (68 ο to 77 ο F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
AvPAK
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MEDICATION GUIDE
MEDICATION GUIDE
Lansoprazole
(lan-SO-pruh-zole)
Delayed-release Capsules, USP
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 is lansoprazole delayed-release capsule?
Lansoprazole delayed-release capsule is a prescription medicine called
a proton pump inhibitor (PPI).
Lansoprazole delayed-release capsule reduces the amount of acid in
your stomach.
Lansoprazole delayed-release capsule is used in adults:
•
for 4 weeks for the healing and symptom relief of duodenal ulcers. T

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
LANSOPRAZOLE DELAYED-RELEASE CAPSULES, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANSOPRAZOLE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR:
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 capsules, USP are 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
INDICATION
DOSE
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
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 ( 1.4) Short-Term Treatment
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-