LANSOPRAZOLE- 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 for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)] . Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy are 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. Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy are indicated 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 clarithromycin or in whom resistance to clarithromycin is known or suspected (see the c

Product summary:

Lansoprazole Delayed-Release Capsules, USP are available containing 15 mg or 30 mg of lansoprazole, USP. The 30 mg capsule is a hard-shell gelatin capsule with a pink opaque cap and pink opaque body filled with white to off-white pellets. The capsule is axially printed with MYLAN over 8030 in black ink on both the cap and the body. They are available as follows: Bottle of 14 - 68788-9269-1 Bottle of 30 - 68788-9269-3 Bottle of 60 - 68788-9269-6 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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 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:
•
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.
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. 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 PPI 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.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body’s
i

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
Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus
(5.5) 10/2016
INDICATIONS AND USAGE
Lansoprazole delayed-release capsules are a proton pump inhibitor
(PPI) indicated for:
•
•
•
•
•
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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)
T riple
The rapy:
Lansoprazole Amoxicillin
Clarithromycin
30 mg
1 gram
500 mg
Twice daily for 10 or 14 days
Dual
The rapy:
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)
He aling
30 mg
Once daily for 8 wks
Risk Reduction
15 mg
Once daily up to 12 wks
GERD (1.7)
Short-Term Treatment of Symptomatic
GERD
15 mg
Once daily up to 8 wks
Short-Term Treatment of EE
30 mg
Once daily up to 8 wks
PEDIATRIC (8.4)
(1 to 11 Years of Age) Short-Term Treatment of Symptomatic GERD and
Short-Term Treatment of EE
≤ 30 kg
15 mg
Once daily up to 12 wks
> 30 kg
30 mg
Once daily up to 12 wks
(12 to 17 Years of Age) Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily up to 8 wks
EE
30 mg
Once daily up to 8 wks
MAINTENANCE OF HEALING OF EE (1.8)
15 mg
Once daily
PATHOLOGICAL HYPERSECRETORY CONDITIONS 60 mg
Once daily
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)