LANSOPRAZOLE- lansoprazole capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

LANSOPRAZOLE

Composition:

LANSOPRAZOLE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1)] . Triple Therapy: Lansoprazole/amoxicillin/clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults 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 (14.2)]. 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 is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who

Product summary:

Lansoprazole delayed-release capsules, USP are available as follows: 15 mg are white hypromellose capsules printed with "GG637" with green ink on body and cap. NDC 68788-6389-4, bottle of 14 capsules NDC 68788-6389-2, bottle of 20 capsules NDC 68788-6389-3, bottle of 30 capsules NDC 68788-6389-6, bottle of 60 capsules NDC 68788-6389-9, bottle of 90 capsules NDC 68788-6389-1, bottle of 100 capsules NDC 68788-6389-8, bottle of 120 capsules NDC 68788-6389-7, bottle of 40 Capsules 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Lansoprazole Delayed-Release Capsules, for oral use
(lanz-AH-pray-zol)
What is the most important information that I should know about
lansoprazole delayed-release capsules?
You should take lansoprazole delayed-release capsules exactly as
prescribed, at the lowest dose possible
and for the shortest time needed.
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:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including lansoprazole delayed-release capsules, may
develop a kidney problem
called acute interstitial nephritis that can happen at any time during
treatment with PPI medicines
including lansoprazole delayed-release capsules. Call your doctor
right away if you have a decrease
in the amount that you urinate or if you have blood in your urine.
•
Diarrhea caused by an infection (Clostridium difficile) in your
intestines. Call your doctor right
away if you have watery stools or stomach pain that does not go away.
You may or may not have a
fever.
•
Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in people
who take multiple daily doses of PPI medicines and for a long period
of time (a year or longer). Tell
your doctor if you have a bone fracture, especially in the hip, wrist,
or spine.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body’s
immune cells attack other cells or organs in the body). Some people
who take PPI medicines,
including lansoprazole delayed-release capsules, may develop certain
types of lupus erythematosus
or have worsening of the lupus they already have. Call your doctor
right away if you have new or
worsening joint pain or a rash on your chee

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
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.
LANSOPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Dosage and Administration
Recommended Pediatric Dosage (2.2)
06/2018
Contraindications (4)
07/2017
Warnings and Precautions
Interactions with Investigations for Neuroendocrine Tumors (5.8)
Fundic Gland Polyps (5.11)
07/2017
06/2018
INDICATIONS AND USAGE
Lansoprazole delayed-release capsules are proton pump inhibitors
(PPIs) indicated for the:
•
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•
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•
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DOSAGE AND ADMINISTRATION
Recommended Dosage:
•
Administration Instructions (2.4)
_Lansoprazole delayed-release capsules_
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DOSAGE FORMS AND STRENGTHS
Delayed-release capsules: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
Treatment of active duodenal ulcer in adults. (1.1)
Eradication of _H. pylori_ to reduce the risk of duodenal ulcer
recurrence in adults. (1.2)
Maintenance of healed duodenal ulcers in adults. (1.3)
Treatment of active benign gastric ulcer in adults. (1.4)
Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated
gastric ulcer in adults. (1.5)
Risk reduction of NSAID-associated gastric ulcer in adults. (1.6)
Treatment of symptomatic gastroesophageal reflux disease (GERD) in
adults and pediatric patients 1 year of age and
older. (1.7)
Treatment of erosive esophagitis (EE) in adults and pediatric patients
1 year of age and older. (1.8)
Maintenance of healing of EE in adults. (1.9)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome (ZES) in adults. (1.10)
See full prescribing information for complete dosing information for
lansoprazole delayed-release capsules by
indication and age group and dosage adjustment in patients w