Lansoprazole (Oral Route)

It is used to treat duodenal and gastric ulcers and gastroesophageal reflux disease (GERD), a condition in which the acid in the stomach washes back up into the esophagus . Sometimes lansoprazole is used in combination with antibiotics to treat ulcers associated with infection caused by the H. pylori bacteria (germ).

Lansoprazole is also used to treat Zollinger-Ellison disease, a condition in which the stomach produces too much acid .

Lansoprazole works by decreasing the amount of acid produced by the stomach.

This product is available in the following dosage forms:

• Tablet Disintegrating, Delayed Release


• Capsule, Delayed Release


• Packet

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

There is no specific information comparing the use of oral lansoprazole in children less than 1 year of age with use in other age groups. It is safe to use oral lansoprazole to treat heartburn and erosive esophagitis in children and teenagers between 1 and 17 years of age.

Geriatric

In studies done to date that have included older adults, lansoprazole did not cause different side effects or problems than it did in younger adults.

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


• Dasatinib


• Delavirdine


• Erlotinib


• Mycophenolate Mofetil


• Nelfinavir

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


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Calcium Carbonate


• Cranberry


• Dicumarol


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Phenprocoumon


• 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.

Proper Use

Take oral lansoprazole before a meal, preferably in the morning .

For Delayed-Release Capsules: Swallow the capsule whole. Do not crush, break, or chew the capsule. If you cannot swallow the capsule whole, you may open it and sprinkle the granules contained in the capsule on one tablespoonful of applesauce and swallow it immediately; or you may mix the granules in some fruit or vegetable juice and drink it immediately. Juices you may use include apple, cranberry, grape, orange, pineapple, prune, tomato, and V-8 vegetable juice. Do not chew or crush the granules.

For Delayed-Release Oral Suspension: Empty the packet contents into a container containing 2 tablespoons of water . Stir well and drink immediately. If any of the content remains after drinking, add more water and drink immediately. If you have enteral administration tubes, do not take this medicine through them.

For Delayed-Release Orally Disintegrating Tablets: Do not chew. Place on tongue and allow to disintegrate, with or without water, until particles can be swallowed

• If you are using this medicine with an Oral Syringe:
  
  
  
  • Place a 15 mg tablet in oral syringe and fill with 4 mL of water, or place a 30 mg tablet in oral syringe and fill with 10 mL of water
  
  
  • Shake gently
  
  
  • After medicine mixes completely with the water, take the mixture within 15 minutes
  
  
  • Refill the syringe with 2 mL (5 mL for the 30 mg tablet) of water, shake gently and take any remaining contents
  
  
  
  


• If you are using this medicine with a Nasogastric Tube:
  
  
  
  • Place a 15 mg tablet in oral syringe and fill with 4 mL of water, or place a 30 mg tablet in oral syringe and fill with 10 mL of water
  
  
  • Shake gently
  
  
  • After tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes
  
  
  • Refill the syringe with approximately 5 mL of water, shake gently and administer any remaining contents
  
  
  
  

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

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 capsule, delayed-release oral suspension, or delayed-release orally disintegrating tablet):
  
  
  
  • To treat gastroesophageal reflux disease (GERD):
    
    
    
    • Adultsa€”15 to 30 milligrams (mg) once a day, preferably in the morning before a meal .
    
    
    • Teenagers and children 1 to 18 years of agea€”15 to 30 milligrams (mg) once daily for 8 to 12 weeks.
    
    
    • Children less than 1 year of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • To treat duodenal ulcers:
    
    
    
    • Adultsa€”At first, 15 milligrams (mg) once a day, preferably in the morning before a meal . Your doctor may adjust your dose if needed.
    
    
    • Teenagers and children younger than 18 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • To treat duodenal ulcers related to infection with H. pylori:
    
    
    
    • Adultsa€”30 milligrams (mg) plus amoxicillin 1000 mg (1 gram) plus clarithromycin 500 mg, taken together before meals twice a day for 10 to 14 days. Alternatively, your doctor may want you to take lansoprazole 30 mg plus amoxicillin 1000 mg (1 gram) before meals three times a day for 14 days.
    
    
    • Teenagers and children younger than 18 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • To treat gastric ulcers:
    
    
    
    • Adultsa€”15 to 30 milligrams (mg) once a day, preferably in the morning before a meal .
    
    
    • Teenagers and children younger than 18 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • To treat conditions in which the stomach produces too much acid:
    
    
    
    • Adultsa€”At first, 60 milligrams (mg) once a day, preferably in the morning before a meal . Your doctor may adjust your dose if needed.
    
    
    • Teenagers and children younger than 18 years of agea€”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.

Precautions

It is important that your doctor check your progress at regular intervals. If your condition does not improve, or if it becomes worse, discuss this with your doctor .

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:

More common

• Diarrhea


• Skin rash or itching

Less common

• Abdominal or stomach pain


• Increased or decreased appetite


• Joint pain


• Nausea


• Vomiting

Rare

• Anxiety


• Cold or flu-like symptoms


• Constipation


• Increased cough


• Mental depression


• Muscle pain


• Rectal bleeding


• Unusual bleeding or bruising

Incidence not known

• Abdominal tenderness


• Back, leg or stomach pains


• Bleeding gums


• Blistering, peeling, loosening of skin


• Bloating


• Bloody, black, or tarry stools


• Change in mental status


• Chest pain


• Chills


• Clay colored stools


• Constipation


• Cough or hoarseness


• Dark or bloody urine


• Difficulty swallowing


• Fast heartbeat


• Fatigue


• Fever


• General body swelling


• High fever


• Hives


• Indigestion


• Loss of appetite


• Lower back or side pain


• Nosebleeds


• Painful or difficult urination


• Pains in stomach, side or abdomen, possibly radiating to the back


• Pale skin


• Puffiness or swelling of the eyelids or around the eyes, face, lips or tongue


• Red irritated eyes


• Pinpoint red spots on skin


• Red skin lesions, often with a purple center


• Seizures


• Shortness of breath


• Sore throat


• Sores, ulcers or white spots on lips or in mouth


• Swelling of feet or lower legs


• Swollen or painful glands


• Tightness in chest


• Unusual tiredness or weakness


• Wheezing


• Yellowing of the 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:

More common

• Dizziness


• Headache

Less common

• Bleeding, blistering, burning, coldness, discoloration of skin


• Mild nausea

Rare

• Acid or sour stomach


• Bad, unusual or unpleasant (after) taste


• Belching


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


• Change in taste


• Feeling faint, dizzy, or light-headedness


• Feeling of heat or warmth


• Flushing or redness of skin, especially on face and neck


• Heartburn


• Indigestion


• Mild diarrhea


• Mild headache


• Mild vomiting


• Stomach discomfort, upset or pain


• Sweating

Incidence not known

• Difficulty in speaking


• Decrease in frequency of urination


• Decrease in urine volume


• Decrease in passing urine [dribbling]

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.