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:

Proficient Rx LP

INN (International Name):

LANSOPRAZOLE

Composition:

LANSOPRAZOLE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-yea

Product summary:

Lansoprazole delayed-release capsules USP are available as follows: 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, in bottles of 30. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
Proficient Rx LP
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MEDICATION GUIDE
Lansoprazole (lan soe pra 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 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
duod

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
Lansoprazole is a proton pump inhibitor (PPI). Refer to DOSAGE AND
ADMINISTRATION table (below) for indications
and usage. (1)
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)
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-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 (I.E., ZES) (1.9)
60 mg
Once daily
DOSAGE FORMS AND STRENGTHS
Capsules: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
Contraindicated in patients with known severe hypersensitivity to any
component of the la