First - Lansoprazole (Oral)

Lansoprazole is used to treat certain conditions where there is too much acid in the stomach. It treats duodenal and gastric ulcers, gastric ulcers caused by NSAID use, 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 with antibiotics (for example, amoxicillin, clarithromycin) to treat ulcers linked to an infection caused by H. pylori bacteria.

Lansoprazole is also used to treat Zollinger-Ellison syndrome (ZES), which is a condition where the stomach makes too much acid.

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

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

It is important for your doctor to check the progress of you or your child during regular visits. This allows your doctor to see if the medicine is working correctly and to decide if you should continue taking it. Blood, urine, and other lab tests may be needed to check for unwanted effects. If you or your child's condition does not improve, or if it worsens, discuss this with your doctor.

Do not take this medicine if you are also using products that contain rilpivirine (Complera®, Edurant®). Using these medicines together may cause unwanted side effects.

Lansoprazole may cause a serious allergic reaction in patients with conditions treated with antibiotics. Call your doctor right away if you or your child has itching, trouble breathing or swallowing, or any swelling of the hands, face, or mouth.

Check with your doctor right away if you have a change in how often you urinate or the amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body or feet and ankles, unusual tiredness or weakness, or unusual weight gain. These could be signs of a serious kidney problem called acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you are worried about vitamin B12 deficiency.

Serious stomach problems may happen while taking this medicine alone or with antibiotics. Check with your doctor immediately if you or your child has stomach cramps, a bloated feeling, watery and severe diarrhea that may sometimes be bloody, fever, nausea or vomiting, or unusual tiredness or weakness.

Lansoprazole may increase your risk of fractures of the hip, wrist, and spine. This is more likely if you have osteoporosis, are 50 years of age or older, are taking high doses of this medicine, or are using it for one year or more. Call your doctor right away if you have severe bone pain or cannot walk or sit normally.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Cutaneous or systemic lupus erythematosus may occur or worsen in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that worsens with sun exposure.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely if you are taking this medicine for more than one year, or if you are taking this medicine with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), a fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are taking this medicine for more than 1 year. Talk to your doctor if you have concerns.

Do not stop taking this medicine without first checking with your doctor, or unless your doctor tells you to do so.

Before you have any medical tests, inform 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 (e.g., atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to think about the risks of taking the medicine compared to the benefits it will provide. Here are some important things to consider:

Allergies

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

Pediatric

Studies so far have not shown any specific problems in children aged 1 to 17 years that would limit the use of lansoprazole to treat GERD and erosive esophagitis. However, safety and effectiveness have not been established in children younger than 1 year of age. This medicine may increase the risk of heart problems (for example, heart valve thickening) in children younger than 1 year of age.

Geriatric

Studies conducted to date have not identified any specific problems in elderly patients that would limit the usefulness of lansoprazole. However, elderly patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all. In other cases, two different medicines may be used together, even if there is a chance of interaction. In these situations, your doctor may want to change the dose, or other precautions may be needed. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following 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 is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Acalabrutinib
• Amphetamine
• Atazanavir
• Atezolizumab
• Belumosudil
• Benzphetamine
• Bosutinib
• Capecitabine
• Cefuroxime Axetil
• Cilostazol
• Citalopram
• Clopidogrel
• Dabrafenib
• Dacomitinib
• Dasatinib
• Delavirdine
• Dextroamphetamine
• Erlotinib
• Eslicarbazepine Acetate
• Fedratinib
• Fluconazole
• Gefitinib
• Infigratinib
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Mavacamten
• Methamphetamine
• Methotrexate
• Methylphenidate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Nilotinib
• Octreotide
• Palbociclib
• Pazopanib
• Pexidartinib
• Phenobarbital
• Pirtobrutinib
• Primidone
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• Sunitinib
• Tocilizumab
• Velpatasvir
• Vismodegib
• Voriconazole

Using this medicine with any of the following may increase the risk of certain side effects, but taking both may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Acenocoumarol
• Dicumarol
• Levothyroxine
• Phenprocoumon
• Tacrolimus
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime, as interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following may increase the risk of certain side effects, but may be unavoidable in some situations. If used together, your doctor may adjust the dose or frequency for this medicine or give you specific instructions regarding food, alcohol, or tobacco use.

• Cranberry

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to inform your doctor about any other medical conditions, especially:

• Diarrhea or
• Hypomagnesemia (low magnesium in the blood), history of or
• Osteoporosis (bone problem) or
• Seizures, history of or
• Systemic lupus erythematosus (SLE)—Use with caution. May worsen these conditions.

• Liver disease—Use with caution. Effects may be stronger due to slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can worsen this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Diarrhea
• itching, skin rash

Less common

• Increased or decreased appetite
• joint pain
• nausea
• stomach pain
• vomiting

Rare

• Anxiety
• blurred vision
• chest pain or discomfort
• colds
• constipation
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• increased cough
• lightheadedness, dizziness or fainting
• mental depression
• muscle pain
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• rectal bleeding
• slow or irregular heartbeat
• sweating
• unusual bleeding or bruising

Incidence not known

• Back or leg pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• bloody, black, or tarry stools
• change in mental status
• chest tightness
• chills
• clay colored stools
• confusion
• cough
• dark or bloody urine
• difficulty with swallowing
• drowsiness
• fast heartbeat
• fever
• general body swelling
• hives
• hoarseness
• indigestion
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching seizures
• nosebleeds
• numbness and tingling around the mouth, fingertips, or feet
• 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 skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach tenderness
• swelling of the feet or lower legs
• swollen or painful glands
• trembling
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Also, your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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

• Bad, unusual, or unpleasant (after) taste
• bad breath
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• difficulty in moving
• double vision
• feeling of heat or warmth
• flushing or redness of the skin, especially on the face and neck
• lack or loss of strength
• loss or thinning of the hair
• mild diarrhea
• mild headache
• mild vomiting
• persistent non-healing sore
• reddish patch or irritated area
• shiny bump
• stomach discomfort or upset
• swollen joints
• white, yellow or waxy scar-like area

Incidence not known

• Decrease in passing urine (dribbling)
• decrease in the frequency of urination
• decrease in urine volume
• 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. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• First - Lansoprazole
• Prevacid
• Prevacid SoluTab

Available Dosage Forms:

• Capsule, Delayed Release
• Tablet Disintegrating, Delayed Release
• Powder for Suspension

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

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.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 (eg, amoxicillin, clarithromycin) at the same time of day.

To use the delayed-release 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 delayed-release 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 as 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 2 or 3 times a day. The dose is usually taken together with amoxicillin or clarithromycin plus amoxicillin. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. To treat erosive esophagitis: Adults—30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed. Children 12 years of age and older—30 mg once a day before a meal. Your doctor may adjust your dose as 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 as 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 as needed. Children younger than 1 year of age—Use and dose must be determined by your doctor. To treat benign gastric ulcers: Adults—30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. To treat gastric ulcers caused by NSAID use: Adults—15 to 30 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. To treat gastroesophageal reflux disease (GERD): Adults and children 12 years of age and older—15 milligrams (mg) once a day before a meal. Your doctor may adjust your dose as needed. Children 1 to 11 years of age and weighing 30 kg or more—30 mg once a day before a meal. Your doctor may adjust your dose as 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 as 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 as 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.