Kapidex

It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus .

Dexlansoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

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

This product is available in the following dosage forms:

• Capsule, Delayed Release

Before Using

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexlansoprazole in the elderly.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Atazanavir


• Clopidogrel


• Mycophenolate Mofetil

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.

• Warfarin

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:

• Liver diseasea€”Use with caution. The effects may be increased because of slower removal from the body .

Proper Use

Take this medicine only as directed 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 your doctor ordered.

You may take this medicine with or without food.

Swallow the delayed-release capsule whole. If you cannot swallow the capsule whole, you may open it and pour the medicine into a tablespoon of soft food such as applesauce, pudding, or yogurt. Stir this mixture well and swallow it right away without chewing.

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 form (delayed-release capsules):
  
  
  
  • For erosive esophagitis (EE):
    
    
    
    • Adultsa€”60 milligrams (mg) once a day for up to 8 weeks. To prevent erosive esophagitis from coming back, your doctor may want you to take 30 mg once a day for up to 6 months.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For gastroesophageal reflux disease (GERD):
    
    
    
    • Adultsa€”30 milligrams (mg) once a day for 4 weeks.
    
    
    • Childrena€”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

It is important that your doctor check your progress at regular visits. If your condition does not improve, or if it become worse, check with your doctor .

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

Side Effects

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:

Less common

• Acid or sour stomach


• Belching


• Black, tarry stools


• Bleeding after defecation


• Bleeding from the rectum or bloody stools


• Bloated, full feeling


• Blurred vision


• Burning feeling in the chest or stomach


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


• Chest pain or discomfort


• Chest tightness or heaviness


• Confusion


• Constipation


• Continuing diarrhea


• Continuing stomach pain


• Convulsions


• Cracked lips


• Decreased urine


• Deep or fast breathing with dizziness


• Depression


• Diarrhea


• Difficult or labored breathing


• Difficulty in swallowing


• Dry mouth


• Excess air or gas in the stomach


• Fast, irregular, pounding, or racing heartbeat or pulse


• Feeling of heat


• Fever


• Gaseous abdominal pain


• Headache


• Headache, severe and throbbing


• Heartburn


• Hives


• Hoarseness


• Incoherent speech


• Increased thirst


• Increased urination


• Indigestion


• Irritation


• Itching


• Joint pain, stiffness, or swelling


• Lightheadedness, dizziness, or fainting


• Loss of appetite


• Metallic taste


• Mood changes


• Muscle pain or cramps


• Muscle weakness


• Nausea or vomiting


• Nervousness


• Numbness or tingling in the hands, feet, or lips


• Pain


• Pain or burning in the throat


• Pain or discomfort in the arms, jaw, leg, back, or neck


• Pale skin


• Passing of gas


• Pounding in the ears


• Rash


• Recurrent fever


• Redness of the skin


• Right upper abdominal pain and fullness


• Seizures


• Shakiness in the legs, arms, hands, or feet


• Sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• Stomach cramps


• Stomach discomfort, fullness, upset, or pain


• Sweating


• Swelling


• Swelling of the eyelids, face, lips, hands, or feet


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Tenderness in the stomach area


• Thirst


• Troubled breathing with exertion


• Uncomfortable swelling around the anus


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vomiting of blood or material that looks like coffee grounds


• Watery or bloody diarrhea


• Weight loss


• Wheezing


• Yellow eyes or skin

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:

Less common

• Abnormal dreams


• Blemishes on the skin


• Blistering, crusting, irritation, itching, or reddening of the skin


• Body aches or pain


• Bumps on the skin


• Burning or itching around the anus


• Burning while urinating


• Change in taste or bad, unusual, or unpleasant (after) taste


• Changes in appetite


• Changes in menstrual periods


• Chills


• Congestion


• Continuing ringing or buzzing or other unexplained noise in the ears


• Cough


• Cracked, dry, scaly skin


• Decreased interest in sexual intercourse


• Decreased sexual ability in males


• Difficult or painful urination


• Difficulty in moving


• Dry, puffy skin


• Ear congestion


• Ear pain


• Excess air or gas in the stomach or intestines


• Falls


• Feeling cold


• Feeling of constant movement of self or surroundings


• Feeling of warmth


• Frequent strong or increased urge to urinate


• General feeling of discomfort or illness


• Hearing loss


• Heavy bleeding


• Hiccups


• Hives or welts


• Inability to have or keep an erection


• Lack or loss of strength


• Longer or heavier menstrual periods


• Loss in sexual ability, desire, drive, or performance


• Loss of voice


• Muscle or bone pain


• Muscle stiffness


• Nasal congestion


• Noisy breathing


• Pain around the anus


• Pain or tenderness around the eyes and cheekbones


• Pain, swelling, or redness in the joints


• Painful sexual intercourse


• Pimples


• Red, sore eyes


• Redness of the face, neck, arms, and occasionally, upper chest


• Sensation of spinning


• Shivering


• Sleeplessness


• Sneezing


• Sore throat


• Stuffy or runny nose


• Sudden sweating


• Sunburn


• Thick, white, or curd-like vaginal discharge


• Trouble remembering


• Trouble sleeping


• Unable to sleep


• Voice changes


• Weight gain

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.