Lansoprazole

What is Lansoprazole?

• Lansoprazole (Prevacid; Prevacid SoluTab; Prevacid 24HR) is a proton pump inhibitor (PPI) which reduces stomach acid.

Lansoprazole

Lansoprazole 3D

What are the uses of this medicine?

• Lansoprazole (Prevacid; Prevacid SoluTab; Prevacid 24HR) is used:

In Adults:

• 4 weeks for the healing and symptom relief of duodenal ulcers.
• 10 to 14 days with certain antibiotics to treat an infection caused by bacteria called H. pylori.
• maintaining healing of duodenal ulcers. Lansoprazole delayed-release capsules have not been studied beyond 12 months for this purpose.
• up to 8 weeks for the healing and symptom relief of stomach ulcers.
• up to 8 weeks for the healing of stomach ulcers in people taking pain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Lansoprazole delayed-release capsules have not been studied beyond 8 weeks for this purpose.
• reducing the risk of stomach ulcers in people who are at risk of developing stomach ulcers with NSAIDs. Lansoprazole delayed-release capsules have not been studied beyond 12 weeks for this purpose.
• up to 8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping.
• up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 to 16 weeks of lansoprazole delayed-release capsules for patients whose EE does not improve or whose symptoms return.
• maintaining healing of EE. Lansoprazole delayed-release capsules have not been studied beyond 12 months for this purpose.
• the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

In children 1 to 11 years of age, lansoprazole delayed-release capsules are used for:

• up to 12 weeks to treat heartburn and other symptoms that can happen with GERD.
• up to 12 weeks for the healing and symptom relief of EE.

In children 12 to 17 years of age, lansoprazole delayed-release capsules are used for:

• up to 8 weeks to treat heartburn and other symptoms that can happen with GERD.
• up to 8 weeks for the healing and symptom relief of EE.

• Lansoprazole delayed-release capsules are not recommended for treating the symptoms of GERD in children less than 1 year of age and may harm them.

How does this medicine work?

• Lansoprazole (lan soe' pra zole), like other PPIs, binds to and inactivates the hydrogen/ potassium (H+/K+) ATPase of gastric parietal cells, causing inhibition of the proton pump that transports H+ into the gastric lumen, the final common step in gastric acid production.
• Lansoprazole is a prodrug and is converted to the active form in the acidic secretory canaliculi of parietal cells.
• Because the inhibition is irreversible, acid secretion is suppressed for 24 to 48 hours, until new proton pump molecules have been synthesized and transported to the cell membrane.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• known hypersensitivity to any component of the formulation.
• with rilpivirine-containing products.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• rilpivirine (Edurant, in Cabenuva, Complera, Juluca, Odefsey)
• certain antibiotics
• anticoagulants (blood thinners) such as warfarin (Jantoven)
• atazanavir (Reyataz, in Evotaz)
• dasatinib (Sprycel)
• digoxin (Lanoxin)
• diuretics ('water pills')
• erlotinib (Tarceva)
• iron supplements
• itraconazole (Sporonox, Tolsura), ketoconazole
• methotrexate (Trexall, Xatmep)
• mycophenolate mofetil (Cellcept, Myfortic)
• nelfinavir (Viracept)
• nilotinib (Tasigna)
• rifampin (Rifadin, Rimactane)
• ritonavir (Norvir, in Kaletra)
• saquinavir (Invirase)
• tacrolimus (Astagraf, Envarsus, Prograf)
• theophylline (Theo-24)
• voriconazole (Vfend)

• If you are taking sucralfate (Carafate), take it at least 30 minutes after you take lansoprazole.

Is this medicine FDA approved?

• Lansoprazole was the second PPI approved for use in the United States (1995) and dexlansoprazole, a stereoisomer, was approved for use in 2009.
• Lansoprazole is available in 15 and 30 mg delayed release capsules and tablets, as well as granules for oral suspension and in vials for parenteral use under the brand name of Prevacid.
• Over-the-counter formulations have also become available.
• Dexlansoprazole is available by prescription only in capsules of 30 or 60 mg under the brand name Dexilant.

How should this medicine be used?

Recommended dosage:

Recommended Adult Dosage:

In Duodenal Ulcers:

• Short-Term Treatment: 15 mg Once daily for 4 weeks.
• Maintenance of Healed: 15 mg Once daily.

For Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence:

Triple Therapy:

• Lansoprazole 30 mg twice daily for 10 or 14 days.
• Amoxicillin:1 gram twice daily for 10 or 14 days.
• Clarithromycin: 500 mg twice daily for 10 or 14 days.

Dual Therapy:

• Lansoprazole 30 mg three times daily for 14 days.
• Amoxicillin: 1 gram three times daily for 14 days.

For Benign Gastric Ulcer:

• Short-Term Treatment: 30 mg Once daily for up to 8 weeks.

For NSAID-Associated Gastric Ulcer:

• Healing: 30 mg Once daily for 8 weeks.
• Risk Reduction: 15 mg once daily for up to 12 weeks.

For Gastroesophageal Reflux Disease (GERD):

• Short-Term Treatment of Symptomatic GERD: 15 mg once daily for up to 8 weeks.
• Short-Term Treatment of Erosive Esophagitis: 30 mg once daily for up to 8 weeks.
• Maintenance of Healing of Erosive Esophagitis: 15 mg Once daily.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome:

• 60 mg once daily.

Recommended Pediatric Dosage:

In Pediatric Patients 1 to 11 Years of Age:

For Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis:

• ≤ 30 kg: 15 mg once daily for up to 12 weeks.
• > 30 kg: 30 mg once daily for up to 12 weeks.

In Pediatric Patients 12 to 17 Years of Age:

For Short-Term Treatment of Symptomatic GERD:

• Non-erosive GERD: 15 mg once daily for up to 8 weeks.
• Erosive Esophagitis: 30 mg once daily for up to 8 weeks.

Hepatic Impairment:

• The recommended dosage is 15 mg orally daily in patients with severe liver impairment.

Administration:

• Prescription lansoprazole comes as a delayed-release capsule and as a delayed-release orally disintegrating tablet to take by mouth.
• Nonprescription lansoprazole comes as a delayed-release capsule to take by mouth.
• Prescription lansoprazole is usually taken once a day, before a meal.
• When taken in combination with other medications to eliminate H. pylori, prescription lansoprazole is taken twice a day (every 12 hours) or three times a day (every 8 hours), before a meal, for 10 to 14 days.
• Nonprescription lansoprazole is usually taken once a day, in the morning before eating for 14 days.
• If needed, additional 14-day treatments may be repeated, not more often than once every 4 months.
• Swallow lansoprazole delayed-release capsules whole.
• Do not crush or chew lansoprazole delayed-release capsules.
• If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with certain foods or juices. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take lansoprazole delayed-release capsules with certain foods or juices.
• If you miss a dose of lansoprazole delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take your next dose at your regular time. Do not take 2 doses at the same time.
• Swallow the nonprescription capsules whole with a glass of water.
• Do not split, chew, or crush them.
• Do not break, cut or chew the orally disintegrating tablets.
• Place a tablet on your tongue and wait up to one minute for it to dissolve.
• After the tablet dissolves, swallow it with or without water.
• If you cannot swallow the tablet, you may place it in an oral syringe, draw up 4 mL of water for a 15 mg tablet or 10 mL of water for a 30-mg tablet, shake the syringe gently to dissolve the tablet, and squirt the contents into your mouth immediately.
• Then draw an additional 2 mL of water into the syringe, shake gently, and squirt that water into your mouth.
• Do not swallow the mixture more than 15 minutes after you dissolve the tablet.
• Do not take nonprescription lansoprazole for immediate relief of heartburn symptoms.
• It may take 1 to 4 days for you to feel the full benefit of the medication.
• Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment.
• Do not take nonprescription lansoprazole for longer than 14 days or treat yourself with lansoprazole more often than once every 4 months without talking to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a delayed-release capsule and as a delayed-release orally disintegrating tablet to take by mouth.

This medicine is available in fallowing brand namesː

• Prevacid; Prevacid SoluTab; Prevacid 24HR

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea, stomach-area (abdomen) pain, nausea and constipation.

Lansoprazole delayed-release capsules can cause serious side effects, including:

• acute tubulointerstitial nephritis
• Diarrhea caused by an infection (Clostridium difficile)
• Bone fractures (hip, wrist, or spine)
• Certain types of lupus erythematosus
• Low vitamin B12 levels
• fundic gland polyps
• Low magnesium levels in the body
• Severe skin reactions
• Skin rash

What special precautions should I follow?

• In adults, symptomatic response with lansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
• Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Discontinue lansoprazole delayed-release capsules and evaluate patients with suspected acute TIN.
• Lansoprazole delayed-release capsules may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
• Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported. Discontinue lansoprazole delayed-release capsules at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
• Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including lansoprazole. Discontinue lansoprazole and refer to specialist for evaluation.
• Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo- or achlorhydria.
• Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Consider monitoring magnesium and calcium levels prior to initiation of lansoprazole delayed-release capsules. Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing the PPI.
• Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. Healthcare providers should temporarily stop lansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.
• PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Use the shortest duration of PPI therapy appropriate to the condition being treated.
• Lansoprazole is not approved in pediatric patients less than one year of age.
• Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high-dose methotrexate administration, consider a temporary withdrawal of lansoprazole delayed-release capsules.
• Lansoprazole therapy is associated with a low rate of transient and asymptomatic serum aminotransferase elevations and is a reported, but very rare cause of clinically apparent liver injury.
• There is no information regarding the presence of lansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• no adverse reactions

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Lansoprazole is not removed from the circulation by hemodialysis.
• In the event of over-exposure, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment.
• Lansoprazole delayed-release capsules may harm your unborn baby.
• Talk to your doctor about the possible risks to an unborn baby if lansoprazole delayed-release capsules is taken during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of lansoprazole have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis.
• Lansoprazole delayed-release capsules are not recommended for treating the symptoms of GERD in children less than 1 year of age and may harm them.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lansoprazole.

• Inactive ingredients: black iron oxide, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, propylene glycol, red iron oxide, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. Additionally, 15 mg capsule contains brilliant blue FCF - FD&C blue 1.

Who manufactures and distributes this medicine?

• Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd., Kfar Saba, Israel

• Manufactured For: Teva Pharmaceuticals, Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store lansoprazole delayed-release capsules between 68°F to 77°F (20°C to 25°C).

The antiulcer agents in clinical use

Proton Pump Inhibitors

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Selective Histamine Type 2 Receptor Antagonists or H2 Blockers

• Cimetidine
• Famotidine
• Nizatidine
• Ranitidine

• Dailymed label info on Lansoprazole
• FDA Lansoprazole

Lansoprazole Resources
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