Prevacid NapraPAC® (as a combination product containing Lansoprazole, Naproxen)

Pharmacokinetics

NAPROSYN

Absorption

Naproxen is rapidly and completely absorbed from the GI tract with an in vivo bioavailability of 95%. After administration of NAPROSYN tablets, peak plasma levels are attained in 2 to 4 hours. The elimination half-life of naproxen ranges from 12 to 17 hours. Steady-state levels of naproxen are reached in 4 to 5 days, and the degree of naproxen accumulation is consistent with this half-life.

Distribution

Naproxen has a volume of distribution of 0.16 L per kg. At therapeutic levels, naproxen is greater than 99% albumin-bound. At doses of naproxen greater than 500 mg per day, there is less than proportional increase in plasma levels due to an increase in clearance caused by saturation of plasma protein binding at higher doses (average trough concentrations at steady state were 36.5, 49.2 and 56.4 mg per L with 500, 1000, and 1500 mg daily doses of naproxen, respectively).

The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of the maximum naproxen concentration in plasma (see PRECAUTIONS, Nursing Mothers).

Metabolism

Naproxen is extensively metabolized in the liver to 6-0-desmethyl naproxen, and both parent and metabolites do not induce metabolizing enzymes. Both naproxen and 6-0-desmethyl naproxen are further metabolized to their respective acylglucuronide conjugated metabolites.

Excretion

The clearance of naproxen is 0.13 mL per min per kg. Approximately 95% of the naproxen from any dose is excreted in the urine, primarily as naproxen (less than 1%), 6-0-desmethyl naproxen (less than 1%) or their conjugates (66% to 92%). The plasma half-life of the naproxen anion in humans ranges from 12 to 17 hours. The corresponding half-lives of both naproxen's metabolites and conjugates are shorter than 12 hours, and their rates of excretion have been found to coincide closely with the rate of naproxen disappearance from the plasma. Small amounts, 3% or less of the administered dose, are excreted in the feces. In patients with renal failure metabolites may accumulate (see WARNINGS, Renal Effects).

Special Populations

Pediatric Patients

The combination of naproxen and lansoprazole has not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, PREVACID Special Populations – Pediatric Use).

Geriatric Patients

Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly, although the unbound fraction is less than 1% of the total naproxen concentration. Unbound trough naproxen concentrations in elderly subjects have been reported to range from 0.12% to 0.19% of total naproxen concentration, compared with 0.05% to 0.075% in younger subjects. The clinical significance of this finding is unclear; although, it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients.

Race

Pharmacokinetic differences due to race have not been studied.

Hepatic Insufficiency

Naproxen pharmacokinetics has not been determined in subjects with hepatic insufficiency.

Renal Insufficiency

Naproxen pharmacokinetics has not been determined in subjects with renal insufficiency. Given that naproxen, its metabolites and conjugates are primarily excreted by the kidney, the potential exists for naproxen metabolites to accumulate in the presence of renal insufficiency (see CLINICAL PHARMACOLOGY, PREVACID Special Populations - Renal Insufficiency). Elimination of naproxen is decreased in patients with severe renal impairment. Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment – (creatinine clearance less than 30 mL per min – see WARNINGS, Renal Effects).

PREVACID

PREVACID Delayed-Release capsules contain an enteric-coated granule formulation of lansoprazole. Absorption of lansoprazole begins only after the granules leave the stomach. Absorption is rapid, with mean peak plasma levels of lansoprazole occurring after approximately 1.7 hours. After a single-dose administration of 15 mg to 60 mg of oral lansoprazole, the peak plasma concentrations (Cmax) of lansoprazole and the area under the plasma concentration curves (AUCs) of lansoprazole were approximately proportional to the administered dose. Lansoprazole does not accumulate and its pharmacokinetics are unaltered by multiple dosing.

Absorption

The absorption of lansoprazole is rapid, with the mean Cmax occurring approximately 1.7 hours after oral dosing, and the absolute bioavailability is over 80%. In healthy subjects, the mean (± SD) plasma half-life was 1.5 (± 1.0) hours. Both the Cmax and AUC are diminished by about 50 to 70% if lansoprazole is given 30 minutes after food, compared to the fasting condition. There is no significant food effect if lansoprazole is given before meals.

Distribution

Lansoprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 0.05 to 5 mcg per mL.

Metabolism

Lansoprazole is extensively metabolized in the liver. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole). These metabolites have very little or no antisecretory activity. Lansoprazole is thought to be transformed into two active species which inhibit acid secretion by blocking the proton pump [(H+,K+)-ATPase enzyme system] at the secretory surface of the gastric parietal cell. The two active species are not present in the systemic circulation. The plasma elimination half-life of lansoprazole is less than 2 hours while the acid inhibitory effect lasts more than 24 hours. Therefore, the plasma elimination half-life of lansoprazole does not reflect its duration of suppression of gastric acid secretion.

Elimination

Following single-dose oral administration of PREVACID, virtually no unchanged lansoprazole was excreted in the urine. In one study, after a single oral dose of 14C-lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the lansoprazole metabolites.

Special Populations

Pediatric Use

The combination of lansoprazole and naproxen has not been studied in pediatric patients (see CLINICAL PHARMACOLOGY, NAPROSYN Special Populations – Pediatric Use).

Geriatric Use

The clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50% to 100%. Because the mean half-life in the elderly remains between 1.9 to 2.9 hours, repeated once daily dosing does not result in accumulation of lansoprazole. Peak plasma levels were not increased in the elderly.

Gender

In a study comparing 12 male and 6 female human subjects who received lansoprazole, no gender differences were found in pharmacokinetics and intragastric pH results (see PRECAUTIONS, PREVACID Use in Women).

Renal Insufficiency

In patients with severe renal insufficiency, plasma protein binding decreased by 1% to 1.5% after administration of 60 mg of lansoprazole. Patients with renal insufficiency had a shortened elimination half-life and decreased total AUC (free and bound). The AUC for free lansoprazole in plasma, however, was not related to the degree of renal impairment; and the Cmax and Tmax (time to reach the maximum concentration) were not different than the Cmax and Tmax from subjects with normal renal function (see CLINICAL PHARMACOLOGY, NAPROSYN Special Populations - Renal Insufficiency).

Hepatic Insufficiency

In patients with various degrees of chronic hepatic disease, the mean plasma half-life of lansoprazole was prolonged from 1.5 hours to 3.2 to 7.2 hours. An increase in the mean AUC of up to 500% was observed at steady state in hepatically-impaired patients compared to healthy subjects. Dose reduction in patients with severe hepatic disease should be considered.

Race

The pooled mean pharmacokinetic parameters of PREVACID from twelve U.S. Phase I studies (N=513) were compared to the mean pharmacokinetic parameters from two Asian studies (N=20). The mean AUCs of PREVACID in Asian subjects were approximately twice that seen in pooled U.S. data; however, the inter-individual variability was high. The Cmax values were comparable.

Pharmacodynamics

NAPROSYN

Naproxen is a NSAID with analgesic and antipyretic properties. The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

PREVACID

Mechanism of Action

PREVACID (lansoprazole) belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

Antisecretory Activity

After oral administration, lansoprazole was shown to significantly decrease the basal acid output and significantly increase the mean gastric pH and percent of time the gastric pH was greater than 3 and greater than 4. Lansoprazole also significantly reduced meal-stimulated gastric acid output and secretion volume, as well as pentagastrin-stimulated acid output. In patients with hypersecretion of acid, lansoprazole significantly reduced basal and pentagastrin-stimulated gastric acid secretion. Lansoprazole inhibited the normal increases in secretion volume, acidity and acid output induced by insulin.

The intragastric pH results of a five-day, pharmacodynamic, crossover study of 15 mg and 30 mg of once daily lansoprazole are presented in Table 1.

Table 1: Mean Antisecretory Effects after single and multiple daily PREVACID dosing
		PREVACID
Parameter	Baseline Value	15 mg		30 mg
		Day 1	Day 5	Day 1	Day 5
NOTE: An intragastric pH of greater than 4 reflects a reduction in gastric acid by 99%.
* (p<0.05) versus baseline only. † (p<0.05) versus baseline and lansoprazole 15 mg.
Mean 24-Hour pH	2.1	2.7*	4.0*	3.6†	4.9†
Mean Nighttime pH	1.9	2.4	3.0*	2.6	3.8†
% Time Gastric pH>3	18	33*	59*	51†	72†
% Time Gastric pH>4	12	22*	49*	41†	66†

After the initial dose in this study, increased gastric pH was seen within 1 to 2 hours with 30 mg of lansoprazole and 2 to 3 hours with 15 mg of lansoprazole. After multiple daily dosing, increased gastric pH was seen within the first hour post-dosing with 30 mg of lansoprazole and within 1 to 2 hours post-dosing with 15 mg of lansoprazole.

The inhibition of gastric acid secretion as measured by intragastric pH gradually returned to normal over two to four days after multiple doses. There was no indication of rebound gastric acidity.

Enterochromaffin-like (ECL) Cell Effects

During lifetime exposure of rats with up to 150 mg per kg per day of lansoprazole dosed seven days per week, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats (see PRECAUTIONS, PREVACID Carcinogenesis, Mutagenesis, Impairment of Fertility).

Gastric biopsy specimens from the body of the stomach from approximately 150 patients treated continuously with lansoprazole for at least one year did not show evidence of ECL cell effects similar to those seen in rat studies. Longer term data are needed to rule out the possibility of an increased risk of the development of gastric tumors in patients receiving long-term therapy with lansoprazole.

Other Gastric Effects in Humans

Lansoprazole did not significantly affect mucosal blood flow in the fundus of the stomach. Due to the normal physiologic effect caused by the inhibition of gastric acid secretion, a decrease of about 17% in blood flow in the antrum, pylorus, and duodenal bulb was seen. Lansoprazole significantly slowed the gastric emptying of digestible solids. Lansoprazole increased serum pepsinogen levels and decreased pepsin activity under basal conditions and in response to meal stimulation or insulin injection. As with other agents that elevate intragastric pH, increases in gastric pH were associated with increases in nitrate-reducing bacteria and elevation of nitrite concentration in gastric juice in patients with gastric ulcer. No significant increase in nitrosamine concentrations was observed.

Serum Gastrin Effects

In over 2100 patients, median fasting serum gastrin levels increased 50% to 100% from baseline but remained within normal range after treatment with 15 to 60 mg of oral lansoprazole. These elevations reached a plateau within two months of therapy and returned to pretreatment levels within four weeks after discontinuation of therapy.

Endocrine Effects

Human studies for up to one year have not detected any clinically significant effects on the endocrine system. Hormones studied include testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), prolactin, cortisol, estradiol, insulin, aldosterone, parathormone, glucagon, thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), and somatotropic hormone (STH). Lansoprazole in oral doses of 15 to 60 mg for up to one year had no clinically significant effect on sexual function. In addition, lansoprazole in oral doses of 15 to 60 mg for two to eight weeks had no clinically significant effect on thyroid function.

In 24-month carcinogenicity studies in Sprague-Dawley rats with daily lansoprazole dosages up to 150 mg per kg, proliferative changes in the Leydig cells of the testes, including benign neoplasm, were increased compared to control rates.

Other Effects

No systemic effects of lansoprazole on the central nervous system, lymphoid, hematopoietic, renal, hepatic, cardiovascular, or respiratory systems have been found in humans. Among 56 patients who had extensive baseline eye evaluations, no visual toxicity was observed after lansoprazole treatment (up to 180 mg per day) for up to 58 months.

After lifetime lansoprazole exposure in rats, focal pancreatic atrophy, diffuse lymphoid hyperplasia in the thymus, and spontaneous retinal atrophy were seen.

Prevacid NapraPAC 500 is supplied as a weekly blister card packaged as a monthly (28 days) course of therapy. Each weekly blister card contains:

  PREVACID
-   Seven opaque, hard gelatin, pink and green PREVACID 15 mg capsules, with "TAP" and "PREVACID 15" imprinted on the capsules.   NAPROSYN
-   Fourteen yellow, capsule-shaped tablets, engraved with NPR LE 500 on one side and scored on the other.

NDC 64764-546-07 Weekly Blister Card, 500 mg
NDC 64764-546-30 One Month Administration Pack, 500 mg

Storage

Protect from light and moisture.

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]

Store and dispense in original container.

U.S. Patent No. 6,047,829

Distributed by
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

PREVACID® is a registered trademark of Takeda Pharmaceuticals North America, Inc. and used under license by Takeda Pharmaceuticals America, Inc.

ANAPROX®, EC-NAPROSYN®, NAPROSYN®, and NapraPAC® are registered trademarks of Syntex Pharmaceuticals International Limited.

All other trademark names are the property of their respective owners.

© 2003-2008 Takeda Pharmaceuticals America, Inc.

PI1040 R7, July 2008

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

  NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

  NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."   NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

  The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called "corticosteroids" and "anticoagulants"
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

  NSAID medicines should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Tell your healthcare provider:

• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include:	Other side effects include:
heart attack stroke high blood pressure heart failure from body swelling (fluid retention) kidney problems including kidney failure bleeding and ulcers in the stomach and intestine low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions liver problems including liver failure asthma attacks in people who have asthma	stomach pain constipation diarrhea gas heartburn nausea vomiting dizziness

Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

• nausea
• more tired or weaker than usual
• itching
• your skin or eyes look yellow
• stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name	Tradename
* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
Celecoxib	Celebrex
Diclofenac	Flector, Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal	Dolobid
Etodolac	Lodine, Lodine XL
Fenoprofen	Nalfon, Nalfon 200
Flurbirofen	Ansaid
Ibuprofen	Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin	Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen	Oruvail
Ketorolac	Toradol
Mefenamic Acid	Ponstel
Meloxicam	Mobic
Nabumetone	Relafen
Naproxen	Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Prevacid NapraPAC (PREVACID copackaged with NAPROSYN)
Oxaprozin	Daypro
Piroxicam	Feldene
Sulindac	Clinoril
Tolmetin	Tolectin, Tolectin DS, Tolectin 600

PREVACID® NapraPAC® (prĕv ă sĭd napră pak)
(lansoprazole delayed release capsules and naproxen tablets kit)

What is PREVACID® NapraPAC®?

Prevacid NapraPAC contains two medicines:

1. PREVACID® (lansoprazole) Delayed-Release Capsules. PREVACID is a proton pump inhibitor (a medicine that reduces stomach acid); and
2. NAPROSYN® (naproxen) Tablets. NAPROSYN is a nonsteroidal anti-inflammatory drug (NSAID). Please read the above information regarding the benefits and risks of NSAIDs, including NAPROSYN.

Prevacid NapraPAC is used to lower the chance of getting another stomach ulcer in adult patients who have had stomach ulcers and who need to take an NSAID to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, and/or ankylosing spondylitis.

It is not known if Prevacid NapraPAC lowers the risk of ulcers of the intestines or if Prevacid NapraPAC reduces the risk of bleeding from stomach ulcers and ulcers of the intestines.

Prevacid NapraPAC comes in the following strength:

One PREVACID 15 mg capsule and two NAPROSYN 500 mg tablets

The lowest possible dose for the shortest time possible should be prescribed to treat your condition.

Prevacid NapraPAC has not been studied in children.

Can I take other medicines with Prevacid NapraPAC?

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Both of the medicines in Prevacid NapraPAC can affect other medicines you take and sometimes cause serious side effects. Especially, tell your doctor if you take:

• blood pressure medicines
• aspirin
• water pills (diuretics)
• lithium
• methotrexate
• warfarin (Coumadin)
• theophylline
• sucralfate
• ketoconazole
• ampicillin
• iron salts
• digoxin

How should I take Prevacid NapraPAC?

• In the morning before eating, take one PREVACID capsule and one NAPROSYN tablet with a glass of water. In the evening, take the second NAPROSYN tablet with a glass of water.
• Swallow PREVACID capsules whole. Do not crush or chew PREVACID capsules. If you take sucralfate, PREVACID should be taken 30 minutes before sucralfate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PI1040 R7, July 2008

Prevacid NapraPAC  lansoprazole and naproxen kit

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64764-546

Packaging # Item Code Package Description 1 NDC:64764-546-30 4 BLISTER PACK (4 BLISTER PACK) in 1 PACKAGE, COMBINATION 1 NDC:64764-546-07 1 KIT (1 KIT) in 1 BLISTER PACK

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 7  Part 2 14

Part 1 of 2 PREVACID  lansoprazole capsule, delayed release

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength lansoprazole (lansoprazole) lansoprazole 15 mg

Inactive Ingredients Ingredient Name Strength sugar sphere   sucrose   methacrylic acid copolymer   low substituted hydroxypropyl cellulose   starch   magnesium carbonate   talc   polyethylene glycol   titanium dioxide   polysorbate 80   hydroxypropyl cellulose   colloidal silicon dioxide   D&C Red No. 28   FD&C Blue No. 1   FD&C Green No. 3   FD&C Red No. 40

Product Characteristics Color pink, green Score no score Shape CAPSULE Size 16mm Flavor Imprint Code TAP;PREVACID;15 Contains      Coating false Symbol false

Part 2 of 2 NAPROSYN  naproxen tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength naproxen (naproxen) naproxen 500 mg

Inactive Ingredients Ingredient Name Strength croscarmellose sodium   iron oxides   povidone   magnesium stearate

Product Characteristics Color yellow Score 2 pieces Shape CAPSULE Size 16mm Flavor Imprint Code NPR;LE;500 Contains      Coating false Symbol false

Labeler - Takeda Pharmaceuticals America, Inc.

Revised: 10/2008   Takeda Pharmaceuticals America, Inc.

Prevacid NapraPAC contains a combination of naproxen and lansoprazole. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever. Lansoprazole is a proton pump inhibitor. It decreases the amount of acid produced in the stomach.

Prevacid NapraPAC is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The lansoprazole in Prevacid NapraPAC helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

Prevacid NapraPAC may also be used for purposes not listed in this medication guide.

Take Prevacid NapraPAC exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Each package of Prevacid NapraPAC contains pills for 7 days of treatment (one lansoprazole capsule and two naproxen tablets per day). In most cases, you will take one lansoprazole (Prevacid) capsule and one naproxen (Naprosyn) tablet each morning before eating. The second naproxen tablet is then taken 12 hours later, without lansoprazole. Follow your doctor's instructions.

Do not crush, chew, break, or open the lansoprazole capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

To be sure Prevacid NapraPAC is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. You may also need eye exams if you have any changes in your vision. Visit your doctor regularly.

Prevacid NapraPAC can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Prevacid NapraPAC.

Store Prevacid NapraPAC at room temperature away from moisture, heat, and light.