Pronunciation:

lan-SOE-pra-zole, na-PROX-en

Brand Names:

• Prevacid NapraPAC

Dosage Forms:

• Tablet
• Capsule, Delayed Release

Warnings:

• CARDIOVASCULAR RISK
  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk

• Naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery .

• GASTROINTESTINAL RISK
  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events .

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Uses of This Medicine:

Lansoprazole and naproxen combination is used to relieve the symptoms of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. It is used for patients who have had stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis.

Lansoprazole is a proton pump inhibitor (PPI) that is used to treat certain conditions (e.g., duodenal and gastric ulcers) where there is too much acid in the stomach. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain and the symptoms of arthritis, such as inflammation, swelling, stiffness, and joint pain.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of lansoprazole and naproxen combination in the pediatric population. Safety and efficacy have not been established.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lansoprazole and naproxen combination in the elderly. However, elderly patients may be more sensitive to the effects of lansoprazole and naproxen combination than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ardeparin
• Atazanavir
• Beta Glucan
• Certoparin
• Clopidogrel
• Dalteparin
• Danaparoid
• Dasatinib
• Delavirdine
• Desirudin
• Enoxaparin
• Erlotinib
• Ginkgo
• Methotrexate
• Mycophenolate Mofetil
• Nadroparin
• Nelfinavir
• Parnaparin
• Pemetrexed
• Reviparin
• Tacrolimus
• Tinzaparin
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Acetohexamide
• Alacepril
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amiloride
• Azosemide
• Bemetizide
• Benazepril
• Bendroflumethiazide
• Benzthiazide
• Bumetanide
• Buthiazide
• Calcium Carbonate
• Candesartan Cilexetil
• Canrenoate
• Captopril
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cilazapril
• Citalopram
• Clopamide
• Clopidogrel
• Clovoxamine
• Cranberry
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Delapril
• Desvenlafaxine
• Dicumarol
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Duloxetine
• Enalaprilat
• Enalapril Maleate
• Eprosartan
• Escitalopram
• Ethacrynic Acid
• Femoxetine
• Flesinoxan
• Fluoxetine
• Fluvoxamine
• Fosinopril
• Furosemide
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Hydrochlorothiazide
• Hydroflumethiazide
• Imidapril
• Indapamide
• Irbesartan
• Lisinopril
• Losartan
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Methyclothiazide
• Metolazone
• Milnacipran
• Moexipril
• Nefazodone
• Olmesartan Medoxomil
• Paroxetine
• Pentopril
• Perindopril
• Phenprocoumon
• Piretanide
• Polythiazide
• Quinapril
• Quinethazone
• Ramipril
• Sertraline
• Spirapril
• Spironolactone
• Tasosartan
• Telmisartan
• Temocapril
• Tolazamide
• Tolbutamide
• Torsemide
• Trandolapril
• Triamterene
• Trichlormethiazide
• Valsartan
• Venlafaxine
• Warfarin
• Xipamide
• Zimeldine
• Zofenopril

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Bleeding problems or
• Congestive heart failure or
• Crohn's disease, history of or
• Edema (fluid retention or body swelling) or
• Heart attack, history of or
• Heart disease or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease or
• Stomach ulcers or bleeding, history of or
• Stroke, history of or
• Ulcerative colitis, history of Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or
• Aspirin sensitivity, history of Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG]) Should not be used to relieve pain right before or after the surgery.

Proper Use of This Medicine:

Use this medicine exactly as ordered by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is packaged as a kit. The kit contains two different medicines that are used together for 7 days or 28 days. Each daily dose consists of one Prevacid® capsule and two Naprosyn® tablets.

It is best to take this medicine on an empty stomach, but take your medicine with a glass of water.

Swallow the Prevacid® capsule whole. Do not break, crush, or chew it. If you are also taking sucralfate, take the Prevacid® capsule 30 minutes before sucralfate.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules and tablets):
  • For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
    • Adults One Prevacid® capsule and one Naprosyn® tablet in the morning before eating. Take the second Naprosyn® tablet in the evening.
    • Children Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Naproxen may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

Naproxen may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.

This medicine may cause some people to become dizzy, drowsy, depressed, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal or stomach pain, cramping, or burning

black, tarry stools

bruising

constipation

diarrhea

difficult or labored breathing

heartburn

indigestion

large, flat, blue, or purplish patches in the skin

nausea

pale skin

shortness of breath

skin blisters

swelling

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

wheezing

Less common

Irregular heartbeat

pinpoint red or purple spots on the skin

sweating

thirst

Rare

Abdominal or stomach fullness

abdominal or stomach pain with gas

ankle, knee, or great toe joint pain

anxiety

arm, back, or jaw pain

back, leg, or stomach pains

bladder pain

bleeding from rectum or bloody stools

bleeding gums

blistering, burning, crusting, dryness, or flaking of the skin

blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bloody nose

bloody or cloudy urine

blue lips and fingernails

blurred vision

body aches or pain

burning while urinating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

canker sores

change in consciousness

changes in menstrual periods

chest pain, discomfort, or burning

chest tightness or heaviness

clay-colored stools

cold, clammy skin

cold sweats

confusion

congestion

cool, pale skin

cough increased

cough or hoarseness

cough producing mucus

coughing or spitting up blood

coughing that sometimes produces a pink frothy sputum

cracks in the skin

dark-colored urine

decrease in the amount of urine

decreased frequency or amount of urine

decreased sexual ability in males

decreased urination

decreased urine output

depression

difficult or troubled breathing

difficult, burning, or painful urination

difficult, fast, or noisy breathing, sometimes with wheezing

difficulty with swallowing

dilated neck veins

dizziness

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

dry cough

dry mouth

dry skin and hair

dry, puffy skin

dryness or soreness of the throat

extreme fatigue

fainting

fast, irregular, pounding, or racing heartbeat or pulse

fast, weak pulse feeling

feeling of warmth or heat

fever with or without chills

fluid-filled skin blisters

flushed, dry skin

flushing or redness of the skin, especially on the face and neck

frequent strong or increased urge to urinate

frequent urge to defecate or urinate

fruit-like breath odor

general body swelling

general feeling of discomfort or illness

general feeling of tiredness or weakness

greatly decreased frequency of urination or amount of urine

hair loss

headache

high blood pressure

high fever

hives

inability to speak

increase in heart rate

increased blood pressure

increased clear or white vaginal discharge

increased hunger

increased need to urinate

increased sweating

increased thirst

increased urination

irregular, fast or slow, or shallow breathing

itching, scaling, severe redness, soreness, or swelling of the skin

joint or muscle pain

joint stiffness or swelling

kidney pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

lightheadedness, dizziness, or fainting

loss of appetite

loss of consciousness

loss of heat from the body

lower back or side pain

muscle cramps and stiffness

neck pain

nervousness

nightmares

noisy breathing

nosebleeds

numbness or tingling in the hands, feet, or lips

pain

pain in the ankles or knees

pain in the groin or genitals

pain or burning in the throat

pain or discomfort in the arms, jaw, back, or neck

pain or tenderness around the eyes and cheekbones

pain with swallowing

painful, red lumps under the skin, mostly on the legs

pains in the stomach, side, or abdomen, possibly radiating to the back

pale or blue lips, fingernails, or skin

passing of gas

passing urine more often

pounding in the ears

rapid weight gain

rapid, shallow breathing

rash

rectal bleeding

recurrent fever

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

redness, soreness, or itching skin

runny nose

scaly skin

seizures

sensitivity to the sun

severe and continuing nausea

severe or continuing stomach pain

severe or sudden headache

severe stomach pain, cramping, or burning

shakiness in the legs, arms, hands, or feet

sharp back pain just below ribs

shivering

skin thinness

slurred speech

sneezing

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

sores, welting, or blisters

stiff neck or back

stomach pain, continuing

stomach pain, fullness, or discomfort

straining while passing stool

sudden decrease in amount of urine

sunken eyes

swelling of the face, fingers, feet, or lower legs

swelling of the front part of the neck

swollen, painful, or tender lymph glands in the neck, armpit, or groin

temporary blindness

tenderness

thirst

tiredness

trouble with sleeping

trouble with swallowing

troubled breathing with exertion

unexplained bleeding or bruising

unexplained weight loss

unpleasant breath odor

unusual weight gain or loss

upper right abdominal pain

voice changes

vomiting

watery or bloody diarrhea

weakness in the arm or leg on one side of the body, sudden and severe

weakness or heaviness of the legs

weight gain or loss

wrinkled skin

yellow eyes and skin

Incidence not known

Change in mental status

clay colored stools

decrease in frequency of urination

decreased appetite

difficulty in passing urine (dribbling)

difficulty with speaking

difficulty with swallowing

greatly decreased frequency of urination or amount of urine

nosebleeds

pains in the stomach, side, or abdomen, possibly radiating to the back

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Absent missed or irregular menstrual periods

belching

continuing ringing or buzzing or other unexplained noise in the ears

excess air or gas in the stomach or intestines

hearing loss

pain in the chest below the breastbone

passing gas

sleepiness

stopping of menstrual bleeding

Less common

Acid or sour stomach

change in hearing

disturbed color perception

double vision

feeling of constant movement of self or surroundings

loss of hearing

night blindness

overbright appearance of lights

seeing halos around lights

sensation of spinning

swelling or inflammation of the mouth

tunnel vision

Rare

Abnormal dreams

abnormal menses

abnormal stools

bad breath

blemishes on the skin

bone deformity

breast enlargement, pain, or tenderness

breath odor

burning feeling in the chest or stomach

burning, dry, or itching eyes

change in ability to see colors, especially blue or yellow

change in color vision

change in hearing

changes in vision

cold sweats

coma

continuing ringing or buzzing or other unexplained noise in the ears

cool, pale skin

cramps

crying

deafness

decrease in height

decrease or change in vision

decreased interest in sexual intercourse

decreased vision

depersonalization

difficulty seeing at night

discharge, excessive tearing

discoloration of the fingernails or toenails

discouragement

double vision

drooping upper eyelids

dysphoria

earache

enlarged abdomen

euphoria

excessive muscle tone

eye pain

fear

fecal discoloration

feeling of constant movement of self or surroundings

feeling of unreality

feeling sad or empty

fruit-like breath odor

hair loss or thinning of the hair

headache, severe and throbbing

heavy bleeding

hiccup

hostility

hyperventilation

impaired vision

inability to concentrate

inability to have or keep an erection

inability to move the legs or arms

increase in body movements

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased salivation

increased sensitivity of the skin to sunlight

irritability

itching of the vagina or genital area

lack of appetite

lack of feeling or emotion

lack or loss of strength

leg cramps

longer or heavier menstrual periods

loss of interest or pleasure

loss of memory

loss of strength or energy

mood or mental changes

mouth ulceration

muscle aching or cramping

muscle or bone pain

muscle tension or tightness

muscle weakness

neck pain or rigidity

nightmares

pain during sexual intercourse

pain in the back, ribs, arms, or legs

paralysis of one side of the body

paranoia

passing gas

pelvic pain

persistent non-healing sore

pimples

poor insight and judgment

problems with memory or speech

quick to react or overreact emotionally

rapidly changing moods

rash with flat lesions or small raised lesions on the skin

red-green color blindness

reddish patch or irritated area

redness or other discoloration of the skin

redness or swelling in the arms or legs

redness or swelling in the ear

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

redness, swelling, or soreness of the tongue

restlessness

seeing double

seeing, hearing, or feeling things that are not there

seizures

sensation of spinning

sense of detachment from self or body

severe sunburn

shiny bump

skin disorder

sleep disorder

swelling of the breasts or breast soreness in both females and males

swelling or inflammation of the mouth

taste loss

tearing

thick, white vaginal discharge with no odor or with a mild odor

tiredness

transient, mild, pleasant aromatic odor

trouble performing routine tasks, recognizing objects, thinking and planning, or walking

uncaring

unexplained weight loss

urethral pain

white patches with diaper rash

white, yellow, or waxy scar-like area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.