Lansoprazole

Lansoprazole is indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer, for use in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori, for use in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected, to treat nonsteroidal anti-inflammatory drug (NSAID)-associated gastric ulcer in patients who continue use NSAIDs, to reduce the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID, for short-term treatment of symptomatic gastroesophageal reflux disease (GERD), for short-term treatment of erosive esophagitis, to maintain healing of erosive esophagitis, and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

• Over-the-counter (OTC) lansoprazole is indicated to treat heartburn.
• Lansoprazole is available under the following different brand names: Prevacid, Prevacid Solu Tab, and Prevacid 24HR.

Dosages of Lansoprazole:

Dosage Forms and Strengths

Capsule/tablet

• 15 mg
• 30 mg

Tablet, oral-disintegrating (adult only)

• 15 mg
• 30 mg

Tablet, oral-disintegrating (adult only)

• 3 mg/mL

Dosage Considerations – Should be Given as Follows:

Duodenal Ulcer

• Active: 15 mg orally once/day for 4 weeks
• Maintenance: 15 mg orally once/day

Gastric Ulcer (GU)

• 30 mg orally once/day for 8 weeks

Nonsteroidal Anti-Inflammatory Drug (NSAID)-associated GU

• Treatment: 30 mg orally once/day for 8 weeks
• Prevention: 15 mg orally once/day for 12 weeks

Gastroesophageal Reflux Disease (GERD)

• Adult: 15 mg orally once/day for 8 weeks
• Children under 1 year
  • Safety and efficacy not established
• Children 1-12 years
  • Less than 30 kg: 15 mg orally once/day for 8-12 weeks
  • Greater than 30 kg: 30 mg orally once/day for 8-12 weeks
  • May increase dose to 30 mg orally every 12 hours after more than 2 weeks of initial therapy if still symptomatic

Children over 12 years

• 30 mg orally once/day for up to 8 weeks

Erosive Esophagitis

• Adult: 30 mg orally once/day for 8-16 weeks
• Adult, Maintenance: 15 mg orally once/day
• Children under 1 year
  • Less than 30 kg: 15 mg orally once/day for 8-12 weeks
  • Greater than 30 kg: 30 mg orally once/day for 8-12 weeks
  • May increase dose to 30 mg orally every 12 hours after more than 2 weeks of initial therapy if still symptomatic
• Children over 12 years
  • 30 mg orally once/day for up to 8 weeks

Non-erosive GERD, Pediatric

• Children under 12 years: Safety and efficacy not established
• Children 12 years and older: 15 mg orally once/day for up to 8 weeks
• Hypersecretory Condition (e.g., Zollinger-Ellison Syndrome)
• 60 mg orally once/day initially; up to 180 mg every 12 hours used
• If a dose greater than 120 mg/day orally, administered in divided doses every 12 hours

Helicobacter Pylori Infection

• Triple therapy: Lansoprazole 30 mg plus amoxicillin 1 g plus clarithromycin 500 mg orally every 12 hours for 10-14 days
• Dual therapy (clarithromycin resistant): Lansoprazole 30 mg plus amoxicillin 1 g orally every 8 hours for 14 days
• Penicillin allergy: Lansoprazole 30 mg plus clarithromycin 500 mg plus metronidazole 500 mg every 12 hours for 10-14 days

Heartburn

• Over-the-counter (OTC) product: 15 mg orally once/day for 14 days; may repeat every 4 months

Dosing Modifications

• Severe hepatic impairment: Administer a lower dose

Side effects of lansoprazole include:

• Headache
• Diarrhea
• Constipation
• Nausea
• Abdominal or stomach pain

Less common side effects of lansoprazole include:

• Anxiety
• Chest pain (angina)
• Palpitations
• Fainting
• Swelling (edema)
• Loss of appetite
• Dry mouth
• Cramping rectal pain/feeling the urge to defecate
• Gas (flatulence)
• Black, "tarry" feces
• Muscle pain
• Ringing in the ears (tinnitus)
• Allergic reaction

Serious side effects of lansoprazole include:

• Dizziness
• Fast or irregular heart rate
• Watery or bloody diarrhea
• Muscle cramps or weakness
• Jerky muscle movements
• Confusion
• Feeling jittery
• Seizures

Postmarketing side effects of lansoprazole reported include:

• Bone fracture

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe Interactions of lansoprazole include:
  • erlotinib
  • nelfinavir
  • rilpivirine
• Serious Interactions of lansoprazole include:
  • atazanavir
  • dapsone
  • dasatinib
  • delavirdine
  • digoxin
  • idelalisib
  • indinavir
  • itraconazole
  • ketoconazole
  • mesalamine
  • nilotinib
  • nisoldipine
  • pazopanib
  • phenytoin
  • ponatinib
  • sofosbuvir/velpatasvir
• Lansoprazole has moderate interactions with at least 48 different drugs.
• Lansoprazole has mild interactions with at least 54 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains lansoprazole. Do not take Prevacid, Prevacid Solu Tab, or Prevacid 24HR if you are allergic to lansoprazole or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to lansoprazole or other proton pump inhibitors

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Lansoprazole?"

Long-Term Effects

• Published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (greater than 1 year), high-dose therapy
• Hypomagnesemia may occur with prolonged use (i.e., greater than 1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
• Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
• See "What Are Side Effects Associated with Using Lansoprazole?"

Cautions

• Proton pump inhibitors (PPIs) are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider the diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve
• Liver disease may require dosage reduction
• Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to a specialist
• Published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (greater than 1 year), high-dose therapy
• Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels
• Hypomagnesemia may occur with prolonged use (i.e., greater than 1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
• Proton pump inhibitors (PPIs) may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite
• Relief of symptoms does not eliminate the possibility of a gastric malignancy
• Therapy increases the risk of Salmonella, Campylobacter, and other infections
• Acute interstitial nephritis was reported in patients taking proton pump inhibitors
• Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
• May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy with high dose methotrexate administration

Pregnancy and Lactation

• Lansoprazole may be acceptable for use during pregnancy
• Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk
• It is not known whether lansoprazole is distributed into breast milk; do not nurse