First - Lansoprazole

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction to lansoprazole: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• seizure (convulsions);

• kidney problems - urinating more or less than usual, blood in your urine, swelling, rapid weight gain; or

• symptoms of low magnesium - dizziness, confusion; fast or uneven heart rate; tremors (shaking) or jerking muscle movements; feeling jittery;muscle cramps, muscle spasms in your hands and feet; cough or choking feeling.

Common lansoprazole side effects may include:

• nausea, stomach pain;

• diarrhea, constipation; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:
-A daily dose higher than 120 mg should be given as divided doses.
-Dosage should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:
-A daily dose higher than 120 mg should be given as divided doses.
-Dosage should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES

Mild to Moderate Liver Impairment: No adjustment recommended.
Severe Liver Impairment: Dose adjustments may be required; however, no specific guidelines have been suggested. Caution is recommended.

Administration advice:
-This drug should be taken prior to eating and should not be crushed/chewed. Ideally, this drug should be taken in the morning, 30 minutes prior to breakfast.
-The oral dissolvable tablet should be placed on the tongue and allowed to disintegrate.
-The delayed-release capsule may be opened and sprinkled onto a tablespoon of applesauce, pudding, cottage cheese, yogurt, or strained pears and swallowed immediately. Do not chew or crush granules. Alternatively, it may also be emptied into a small volume (60 mL) of either apple juice, orange juice or tomato juice and swallowed immediately. Rinse glass with more juice and swallow immediately.
-This drug may be mixed with apple juice and administered via nasogastric tube.

Storage requirements:
-The manufacturer product information should be consulted.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

General:
-Children younger than 1 year of age did not show beneficial effects when treated for gastroesophageal reflux disease.
-Helicobacter pylori (H pylori) eradication rates reach 90% when this drug is combined with clarithromycin and amoxicillin/metronidazole. Lower eradication rates were seen in the combination of this drug, amoxicillin, and metronidazole.
-Treatment should be given at least an hour prior to sucralfate or antacids.
-A single, 30 mg dose inhibited stimulated acid secretion by 30%; after repeated dosing over 7 days, 90% of stimulated acid secretion was inhibited.

Monitoring:
-Magnesium levels, especially in patients taking other drugs that could result in hypomagnesemia or those on long-term therapy
-Vitamin B12 levels, especially in patients on long-term therapy
-Bone fractures, especially in patients at high risk for osteoporosis-related events

Patient advice:
-If using this drug to treat H pylori, tell patients that it is important to complete the full regimen.
-Instruct patients to seek medical attention if signs/symptoms of hypersensitivity, Clostridium difficile, or systemic cutaneous lupus erythematosus occur.
-Inform patients that this drug may cause drowsiness, dizziness, vertigo, and/or visual disturbances. They should avoid driving or operating machinery until the full effects of the drug are seen.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Diarrhea, abdominal pain, nausea, headache, and constipation have been the most common side effects reported. May also interfere with some laboratory tests.
• PPIs (including lansoprazole) have been associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. People on high-dose or long-term therapy are more at risk.
• Has also been associated with other conditions such as lupus erythematosus and magnesium deficiency.
• Prolonged treatment (greater than 24-36 months) may cause vitamin B12 deficiency. The risk is greater in women, people aged less than 30, and with higher dosages.
• Administration of PPIs (such as lansoprazole) has been associated with acute interstitial nephritis, a severe inflammation of the kidneys. May occur on medication initiation or at any point of therapy. Symptoms include fever, rash and generalized aches and pains. Discontinue lansoprazole and seek medical advice.
• Has been associated with a greater risk of Clostridium difficile-associated diarrhea. See your doctor if you develop diarrhea that does not improve.
• May interact with some other medications including methotrexate and sometimes warfarin. Lansoprazole can also reduce the absorption of drugs that are dependant on a certain gastric pH for their absorption.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Summary of Use during Lactation

No information is available on the use of lansoprazole during breastfeeding. However, lansoprazole has been used safely in newborn infants, so it is unlikely that the amount in breastmilk would be harmful.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

One case of elevated serum prolactin and galactorrhea was reported in a 21-year-old man. When omeprazole was substituted for lansoprazole, the serum prolactin decreased to the normal range and galactorrhea ceased.[1]

A 13-year-old girl with a recent history of bilateral galactorrhea and hyperprolactinemia from omeprazole and domperidone on separate occasions was given lansoprazole to prevent gastrointestinal irritation following intravenous diclofenac for a severe headache. After 3 days of lansoprazole therapy, she again developed galactorrhea and an elevated serum prolactin that returned to normal a week after discontinuing lansoprazole.[2]

Alternate Drugs to Consider

Cimetidine, Famotidine, Nizatidine, Omeprazole, Pantoprazole, Ranitidine, Sucralfate

References

1. Izquierdo Prieto OM, Moreno Alia E, Rosillo Gonzalez A. [Galactorrhea induced by lansoprazole]. Aten Primaria. 2004;34:325-6. PMID: 15491529

2. Jabbar A, Khan R, Farrukh SN. Hyperprolactinaemia induced by proton pump inhibitor. J Pak Med Assoc. 2010;60:689-90. PMID: 20726208

Substance Name

Lansoprazole

CAS Registry Number

103577-45-3

Drug Class

Anti-Ulcer Agents