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PREVACID (lansoprazole) Delayed-Release Capsules

2015-08-22 04:39:47 来源: 作者: 【大中小】浏览:361次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for:

PREVACID (lansoprazole) Delayed-Release Capsules
PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

For oral administration
Initial U.S. Approval: 1995
RECENT MAJOR CHANGES

WARNINGS AND PRECAUTIONS

Concomitant Use of PREVACID with Methotrexate (5.4)

5/2012

INDICATIONS AND USAGE

PREVACID is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (below) for indications and usage. (1)

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:	PREVACID Amoxicillin Clarithromycin	30 mg 1 gram 500 mg	Twice daily for 10 or 14 days
Dual Therapy:	PREVACID 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		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 and Tablets: 15 mg and 30 mg. (3)
CONTRAINDICATIONS

Contraindicated in patients with known severe hypersensitivity to any component of the PREVACID formulation. (4)
WARNINGS AND PRECAUTIONS

Symptomatic response with PREVACID does not preclude the presence of gastric malignancy. (5.1)
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.2)
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. (5.3)

ADVERSE REACTIONS

Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Atazanavir: Do not co-administer with atazanavir. (7.1)
Drugs with pH-Dependent Absorption: May interfere with the absorption of drugs where gastric pH is important for bioavailability. (7.1)
Warfarin: Concomitant warfarin use may require monitoring for increases in INR and prothrombin time. (7.2)
Tacrolimus: Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. (7.3)
Theophylline: Titration of theophylline dosage may be required when concomitant PREVACID use is started or stopped. (7.4)
Methotrexate: PREVACID may increase serum levels of methotrexate. (7.6)

USE IN SPECIFIC POPULATIONS

Consider dose adjustment in patients with severe liver impairment. (8.7)
PREVACID is not effective in patients with symptomatic GERD 1 month to less than 1 year of age. (8.4)

Revised: 8/2012

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Short-Term Treatment of Active Duodenal Ulcer

1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

1.3 Maintenance of Healed Duodenal Ulcers

1.4 Short-Term Treatment of Active Benign Gastric Ulcer

1.5 Healing of NSAID-Associated Gastric Ulcer

1.6 Risk Reduction of NSAID-Associated Gastric Ulcer

1.7 Gastroesophageal Reflux Disease (GERD)

1.8 Maintenance of Healing of Erosive Esophagitis (EE)

1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

2.2 Special Populations

2.3 Important Administration Information

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Gastric Malignancy

5.2 Bone Fracture

5.3 Hypomagnesemia

5.4 Concomitant Use of PREVACID with Methotrexate

6 ADVERSE REACTIONS

6.1 Clinical

6.2 Postmarketing Experience

6.3 Combination Therapy with Amoxicillin and Clarithromycin

6.4 Laboratory Values

7 DRUG INTERACTIONS

7.1 Drugs with pH-Dependent Absorption Kinetics

7.2 Warfarin

7.3 Tacrolimus

7.4 Theophylline

7.5 Clopidogrel

7.6 Methotrexate

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Gender

8.9 Race

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

1.1 Short-Term Treatment of Active Duodenal Ulcer

PREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)].

1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: PREVACID/amoxicillin/clarithromycin

PREVACID 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: PREVACID/amoxicillin

PREVACID 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-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 clarithromycin package insert, MICROBIOLOGY section). 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.

1.3 Maintenance of Healed Duodenal Ulcers

PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies (14)].

1.4 Short-Term Treatment of Active Benign Gastric Ulcer

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14)].

1.5 Healing of NSAID-Associated Gastric Ulcer

PREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [see Clinical Studies (14)].

1.6 Risk Reduction of NSAID-Associated Gastric Ulcer

PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies (14)].

1.7 Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14)].

Short-Term Treatment of Erosive Esophagitis

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered [see Clinical Studies (14)].

1.8 Maintenance of Healing of Erosive Esophagitis (EE)

PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [see Clinical Studies (14)].

1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

PREVACID is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. PREVACID should be taken before eating. PREVACID products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with PREVACID.

2.1 Recommended Dose

Indication

Recommended Dose

Frequency

*: Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†: Controlled studies did not extend beyond indicated duration.
‡: For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of PREVACID may be considered.