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:

NuCare 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) ]. Triple Therapy: Lansoprazole/amoxicillin/clarithromycin Lansoprazole 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/amoxicillin Lansoprazole in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori

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 68071-3019-3 bottle of 30 NDC 68071-3019-7 bottle of 7 NDC 68071-3019-6 bottle of 60 Storage Store at 20 ο to 25 ο C (68 ο to 77 ο 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
NuCare Pharmaceuticals, Inc.
----------
Advise the patient to read the FDA-approved patient labeling
(Medication Guide and Instructions for
Use).
Adverse Reactions
Advise patients to report to their healthcare provider if they
experience any signs or symptoms consistent
with:
•
Hypersensitivity Reactions [see Contraindications
•
Acute Interstitial Nephritis [see Warnings and Precautions > ]
•
Clostridium difficile-Associated Diarrhea [see Warnings and
•
Bone Fracture [see Warnings and Precautions ( ]
•
Cutaneous and Systemic Lupus Erythematosus [see Warnings and
•
Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions
•
Hypomagnesemia [see Warnings and Precautions ( 5.7) ]
Administration
Lansoprazole is available as capsules in 15 mg and 30 mg strengths.
Direction for use specific to the route
and available methods of administration of this dosage form is
presented below [see Dosage and
Administration ( 2.3) ].
•
Lansoprazole should be taken before eating.
•
Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED.
Administration Options
Lansoprazole Delayed-release Capsules – Oral Administration
•
Lansoprazole delayed-release capsules should be swallowed whole.
•
Alternatively, for patients who have difficulty swallowing capsules,
lansoprazole delayed-release
capsules can be opened and administered as follows:
о Open capsule.
о Sprinkle intact granules on one tablespoon of either applesauce,
ENSURE pudding, cottage cheese,
yogurt or strained pears.
о Swallow immediately.
•
Lansoprazole delayed-release capsules may also be emptied into a small
volume of either apple
juice, orange juice or tomato juice and administered as follows:
о Open capsule.
о Sprinkle intact granules into a small volume of either apple juice,
orange juice or tomato juice (60
mL – approximately two ounces).
о Mix briefly.
о Swallow immediately.
о To ensure complete delivery of the dose, the glass should be rinsed
with t

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
NUCARE 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
INDICATIONS AND USAGE
Lansoprazole delayed-release capsules are 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 nonsteroidal 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)
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
Amoxicillin
Clarithromycin
30 mg
1 gram
500 mg
Twice daily for 10 or 14 days
Dual Therapy:
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)
Healing
Risk Reduction
30 mg
15 mg
Once daily for 8 wks
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