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PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

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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

Dosage and Administration:
Important Administration Information (2.3)	June 2009
Warnings and Precautions:
Bone Fracture (5.2)	August 2010

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 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 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)

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

Do not co-administer with atazanavir. (7)
May interfere with the absorption of drugs where gastric pH is important for bioavailability. (7)
Concomitant warfarin use may require monitoring for increases in INR and prothrombin time. (7)
Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. (7)
Titration of theophylline dosage may be required when concomitant PREVACID use is started or stopped. (7)

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)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2010

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

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

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

12.4 Specific Populations

12.5 Drug-Drug Interactions

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. § The PREVACID dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with PREVACID for more than 4 years.
Duodenal Ulcers
Short-Term Treatment	15 mg	Once daily for 4 weeks
Maintenance of Healed	15 mg	Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
PREVACID	30 mg	Twice daily (q12h) for 10 or 14 days
Amoxicillin	1 gram	Twice daily (q12h) for 10 or 14 days
Clarithromycin	500 mg	Twice daily (q12h) for 10 or 14 days
Dual Therapy:
PREVACID	30 mg	Three times daily (q8h) for 14 days
Amoxicillin	1 gram	Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment	30 mg	Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing	30 mg	Once daily for 8 weeks†
Risk Reduction	15 mg	Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD	15 mg	Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis	30 mg	Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg	15 mg	Once daily for up to 12 weeks§
> 30 kg	30 mg	Once daily for up to 12 weeks§
(12 to 17 years of age) Short-Term Treatment of Symptomatic GERD
Nonerosive GERD	15 mg	Once daily for up to 8 weeks
Erosive Esophagitis	30 mg	Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis	15 mg	Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome	60 mg	Once daily¶

2.2 Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].

2.3 Important Administration Information

Administration Options

PREVACID Delayed-Release Capsules – Oral Administration

PREVACID Delayed-Release Capsules should be swallowed whole.
Alternatively, for patients who have difficulty swallowing capsules, PREVACID Delayed-Release Capsules can be opened and administered as follows:
- Open capsule.
- Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
- Swallow immediately.
PREVACID Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
- Open capsule.
- Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
- Mix briefly.
- Swallow immediately.
- To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

PREVACID Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration

For patients who have a nasogastric tube in place, PREVACID Delayed-Release Capsules can be administered as follows:
- Open capsule.
- Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
- Inject through the nasogastric tube into the stomach.
- Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets

PREVACID SoluTab should not be broken or cut.
PREVACID SoluTab should not be chewed.
- Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
- The tablet typically disintegrates in less than 1 minute.
- Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be delivered in two different ways.
  
  PREVACID SoluTab – Oral Syringe
  For administration via oral syringe, PREVACID SoluTab can be administered as follows:
  
  PREVACID SoluTab – Nasogastric Tube (≥ 8 French) Administration
  For administration via a nasogastric tube, PREVACID SoluTab can be administered as follows:
  - Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
  - Shake gently to allow for a quick dispersal.
  - After the tablet has dispersed, administer the contents within 15 minutes.
  - Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.

3 DOSAGE FORMS AND STRENGTHS

15 mg capsules are opaque, hard gelatin, colored pink and green with the TAP logo and "PREVACID 15" imprinted on the capsule.
30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and "PREVACID 30" imprinted on the capsule.
15 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with "15" debossed on one side of the tablet.
30 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with "30" debossed on one side of the tablet.

4 CONTRAINDICATIONS

PREVACID is contraindicated in patients with known severe hypersensitivity to any component of the formulation of PREVACID. For information on contraindications for amoxicillin or clarithromycin, refer to their full prescribing information, CONTRAINDICATIONS sections.

5 WARNINGS AND PRECAUTIONS

5.1 Gastric Malignancy

Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.

5.2 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2)].

For information on warnings and precautions for amoxicillin or clarithromycin, refer to their full prescribing information, WARNINGS and PRECAUTIONS sections.

6 ADVERSE REACTIONS

6.1 Clinical

Worldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of PREVACID-treated patients and occurred at a greater rate in PREVACID-treated patients than placebo-treated patients in Table 1.

Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled PREVACID Studies
Body System/Adverse Event	PREVACID (N= 2768) %	Placebo (N= 1023) %
Body as a Whole
Abdominal Pain	2.1	1.2
Digestive System
Constipation	1.0	0.4
Diarrhea	3.8	2.3
Nausea	1.3	1.2

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of PREVACID for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with PREVACID, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with PREVACID included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:

Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain

Cardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine System – diabetes mellitus, goiter, hypothyroidism

Hemic and Lymphatic System – anemia, hemolysis, lymphadenopathy

Metabolic and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss

Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis

Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo

Respiratory System – asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor

Skin and Appendages – acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria

Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect

Urogenital System – abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.