Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Descriptions Lansoprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. Sometimes lansoprazole is used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat ulcers associated with an infection caused by H. pylori bacteria. Lansoprazole is also used to treat Zollinger-Ellison syndrome (ZES), which is a condition where the stomach produces too much acid. Lansoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach. This medicine is available both over-the-counter (OTC) and with your doctor’s prescription. This product is available in the following dosage forms: • Tablet Disintegrating, Delayed Release • Capsule, Delayed Release • Packet • Powder for Suspension 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lansoprazole to treat GERD and erosive esophagitis in children 1 to 17 years of age. Safety and efficacy have not been established in children younger than 1 year of age. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lansoprazole in the elderly. Pregnancy Information about this lansoprazole-oral-route Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. 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 Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. 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. • Rilpivirine 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 • Bosutinib • Citalopram • Dabrafenib • Dasatinib • Delavirdine • Erlotinib • Eslicarbazepine Acetate • Mycophenolate Mofetil • Nelfinavir • Nilotinib • Pazopanib • Ponatinib • Saquinavir • Vismodegib 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. 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: • Diarrhea or • Hypomagnesemia (low magnesium in the blood), history of or • Osteoporosis (bone problem) or • Seizures, history of—Use with caution. May make these conditions worse. • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. • Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse. 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. If you are using this medicine without a prescription, follow the instructions on the medicine label. Take this medicine before a meal and for the full time of treatment, even if you begin to feel better after a few days. If you are taking this medicine to treat an ulcer that is associated with an H. pylori infection, take it together with the antibiotics (e.g., amoxicillin, clarithromycin) at the same time of day. To use the capsule: • Swallow the capsule whole. Do not break, crush, or chew it. • If the capsule cannot be swallowed, open it and sprinkle the contents on one tablespoonful of applesauce, Ensure® pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not chew or crush the granules. • The contents of the capsule can also be mixed with 2 ounces (1/4 cup or 60 mL) of apple juice, orange juice, or tomato juice. After mixing, drink and swallow the mixture right away. Do not chew or crush the granules. Refill the cup 2 more times with juice and drink the liquid to make sure all of the medicine is taken. To use the capsule with a nasogastric (NG) tube: • Open the capsule and mix the contents with 40 mL of apple juice. Do not use any other liquids. • Inject or pour the mixture into the nasogastric tube. • Flush the tube with more apple juice to rinse all of the medicine from the tube into the stomach. To use the orally disintegrating tablet: • Make sure your hands are dry before you handle the tablet. • Do not crush, chew, break, or cut the tablet. • Place the tablet on the tongue, with or without water, and allow it to dissolve into particles. Swallow the particles right away. To use the orally disintegrating tablet with an oral syringe: • Make sure your hands are dry before you handle the tablet. • Do not crush, break, or cut the tablet. • For the 15 mg tablet: Place it in the oral syringe and add 4 mL of water. • For the 30 mg tablet: Place it in the oral syringe and add 10 mL of water. • Shake the syringe gently until the tablet dissolves and is mixed well. • Give the mixture within 15 minutes. • Refill the syringe with 2 mL (15 mg tablet) or 5 mL (30 mg tablet) of water and shake it gently. Give the mixture to make sure all of the medicine is taken. To use the orally disintegrating tablet with a nasogastric (NG) tube: • Make sure your hands are dry before you handle the tablet. • Do not crush, break, or cut the tablet. • For the 15 mg tablet: Place it in the syringe and add 4 mL of water. • For the 30 mg tablet: Place it in the syringe and add 10 mL of water. • Shake the syringe gently until the tablet dissolves and is mixed well. • Inject or pour the mixture into the nasogastric tube within 15 minutes. • Refill the syringe with 5 mL of water and shake it gently. Flush the tube with the water to rinse all of the medicine from the tube into the stomach. 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 or orally disintegrating tablets): To treat duodenal ulcers: Adults—15 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. To treat duodenal ulcers with H. pylori infection: Adults—30 milligrams (mg) before meals two or three times a day. The dose is usually taken together with amoxicillin or clarithromycin plus amoxicillin. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. To treat erosive esophagitis: Adults—15 to 30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed. Teenagers and children 12 years of age—30 mg once a day before a meal. Your doctor may adjust your dose if needed. Children 1 to 11 years of age and weighing over 30 kg—30 mg once a day before a meal. Your doctor may adjust your dose if needed. Children 1 to 11 years of age and weighing 30 kg or less—15 mg once a day before a meal. Your doctor may adjust your dose if needed. Children younger than 1 year of age—Use and dose must be determined by your doctor. To treat gastric ulcers: Adults—15 to 30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. To treat gastroesophageal reflux disease (GERD): Adults, teenagers, and children 12 years of age—15 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed. Children 1 to 11 years of age and weighing over 30 kg—30 mg once a day before a meal. Your doctor may adjust your dose if needed. Children 1 to 11 years of age and weighing 30 kg or less—15 mg once a day before a meal. Your doctor may adjust your dose if needed. Children younger than 1 year of age—Use and dose must be determined by your doctor. To treat Zollinger-Ellison syndrome (ZES): Adults—60 milligrams (mg) once a day before a meal. Your doctor may adjust your dose if needed. 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. It is important that your doctor check the progress of you or your child 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 other laboratory tests may be needed to check for unwanted effects. If your or your child’s condition does not improve, or if it becomes worse, discuss this with your doctor. Lansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you have osteoporosis, if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more. This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or “water pills”. Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness. Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine. Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor. Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine. 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. 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 or stomach tenderness • back, leg, or stomach pains • bleeding gums • blistering, peeling, or loosening of the skin • bloating • bloody, black, or tarry stools • change in mental status • chest pain • chills • clay colored stools • cough or hoarseness • dark or bloody urine • difficulty with swallowing • drowsiness • fast heartbeat • fever • general body swelling • high fever • hives • indigestion • loss of appetite • lower back or side pain • mood or mental changes • muscle spasms (tetany) or twitching seizures • nosebleeds • painful or difficult urination • pains in the stomach, side, or abdomen, possibly radiating to the back • pale skin • pinpoint red spots on the skin • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue • red, irritated eyes • red skin lesions, often with a purple center • seizures • shortness of breath • sore throat • sores, ulcers, or white spots on the lips or in the mouth • swelling of the feet or lower legs • swollen or painful glands • tightness in the chest • trembling • 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, or discoloration of the skin • mild nausea Rare 24. Acid or sour stomach 25. bad, unusual or unpleasant (after) taste 26. belching 27. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings 28. change in taste 29. feeling faint, dizzy, or lightheaded 30. feeling of heat or warmth 31. flushing or redness of the skin, especially on the face and neck 32. heartburn 33. indigestion 34. mild diarrhea 35. mild headache 36. mild vomiting 37. stomach discomfort, upset, or pain 38. sweating Incidence not known 10. Decrease in passing urine (dribbling) 11. decrease in the frequency of urination 12. decrease in urine volume 13. difficulty with speaking 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.