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:

Preferred Pharmaceuticals Inc.

INN (International Name):

LANSOPRAZOLE

Composition:

LANSOPRAZOLE 30 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 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 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 are either allergic or intolerant to clarithromy

Product summary:

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 68788-7385-1 Bottles of 14 NDC 68788-7385-3 Bottles of 30 NDC 68788-7385-6 Bottles of 60 NDC 68788-7385-9 Bottles of 90 NDC 68788-7385-8 Bottles of 120 Storage Store at 20ο to 25ο C (68ο to 77ο 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
Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Lansoprazole
(lan-SO-pruh-zole)
Delayed-release Capsules, USP
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 cheeks

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
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)
07/2017
Fundic Gland Polyps (5.11)
06/2018
INDICATIONS AND USAGE
Lansoprazole delayed-release capsules are proton pump inhibitors
(PPIs) indicated for the:
•
•
•
•
•
•
•
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DOSAGE AND ADMINISTRATION
Recommended Dosage:
•
Administration Instructions (2.4):
_Lansoprazole delayed-release capsules_
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
•
•
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
with