LANSOPRAZOLE capsule, delayed release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

AvKARE

INN (nume internaţional):

LANSOPRAZOLE

Compoziție:

LANSOPRAZOLE 15 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Lansoprazole delayed-release capsules USP 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 USP/amoxicillin/clarithromycin Lansoprazole delayed-release capsules USP 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 USP/amoxicillin Lansoprazole delayed-release capsules USP in combination with a

Rezumat produs:

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, Bottles of 30  NDC 42291-364-30 Bottles of 100  NDC 42291-364-01 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, Bottles of 30  NDC 42291-365-30 Bottles of 100  NDC 42291-365-01 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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

LANSOPRAZOLE- lansoprazole capsule, delayed release
AvKARE
----------
MEDICATION GUIDE
Lansoprazole (lan-SOH-prə-zohl) 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 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 ar

Caracteristicilor produsului

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP
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
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 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 non-steroidal 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)
(1)
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 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