First - Lansoprazole

Name: First - Lansoprazole

First - Lansoprazole Side Effects

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 or leg 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 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
  • swelling of the feet or lower legs
  • swollen or painful glands
  • tightness in the chest
  • trembling
  • unusual tiredness or weakness
  • yellow 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
  • Acid or sour stomach
  • bad, unusual or unpleasant (after) taste
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • feeling faint, dizzy, or lightheaded
  • feeling of heat or warmth
  • flushing or redness of the skin, especially on the face and neck
  • mild diarrhea
  • mild headache
  • mild vomiting
  • stomach discomfort or upset
  • sweating
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.

What should I discuss with my healthcare provider before taking First Lansoprazole (lansoprazole)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medicine if you are allergic to lansoprazole.

Ask a doctor or pharmacist if it is safe for you to use lansoprazole if you have other medical conditions, especially:

  • liver disease;

  • low levels of magnesium in your blood;

  • osteoporosis or low bone mineral density (osteopenia).

Do not use over-the-counter lansoprazole (Prevacid OTC) without the advice of a doctor if you have:

  • trouble or pain with swallowing;

  • bloody or black stools; vomit that looks like blood or coffee grounds;

  • heartburn that has lasted for over 3 months;

  • frequent chest pain, heartburn with wheezing;

  • unexplained weight loss;

  • nausea or vomiting, stomach pain; or

  • an electrolyte imbalance or metabolic disorder.

Taking a proton pump inhibitor such as lansoprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether lansoprazole is the actual cause of an increased risk of fracture.

Some conditions are treated with a combination of lansoprazole and antibiotics. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether lansoprazole passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Some forms of lansoprazole may contain phenylalanine. Tell your doctor if you have phenylketonuria.

Do not give lansoprazole to a child younger than 1 year old. Prevacid OTC is not approved for use by anyone younger than 18 years old.

Before taking this medicine

You should not use this medicine if you are allergic to lansoprazole.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Ask a doctor or pharmacist if it is safe for you to use lansoprazole if you have other medical conditions, especially:

  • liver disease;

  • low levels of magnesium in your blood; or

  • osteoporosis or low bone mineral density (osteopenia).

Do not use over-the-counter lansoprazole (Prevacid OTC) without the advice of a doctor if you have:

  • trouble or pain with swallowing;

  • bloody or black stools; vomit that looks like blood or coffee grounds;

  • heartburn that has lasted for over 3 months;

  • frequent chest pain, heartburn with wheezing;

  • unexplained weight loss;

  • nausea or vomiting, stomach pain; or

  • an electrolyte imbalance or metabolic disorder.

Some forms of lansoprazole may contain phenylalanine. Tell your doctor if you have phenylketonuria.

Taking a proton pump inhibitor such as lansoprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether lansoprazole is the actual cause of an increased risk of fracture.

Some conditions are treated with a combination of lansoprazole and antibiotics. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether lansoprazole passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not give lansoprazole to a child younger than 1 year old. Prevacid OTC is not approved for use by anyone younger than 18 years old.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking lansoprazole?

If you also take sucralfate (Carafate), avoid taking it at the same time you take lansoprazole. Wait at least 30 minutes after taking lansoprazole before you take sucralfate.

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Lansoprazole dosing information

Usual Adult Dose of Lansoprazole for Erosive Esophagitis:

Treatment: 30 mg orally once a day
-Duration of therapy: Up to 8 weeks

Maintenance: 15 mg orally once a day

Comments:
-Controlled studies did not extend beyond 12 months.
-If patients are not healed after 8 weeks or erosive esophagitis recurs, treatment for another 8 weeks may be considered.

Uses:
-Short-term treatment for healing and symptom relief of all grades of erosive esophagitis
-Maintain healing of erosive esophagitis

Usual Adult Dose for Duodenal Ulcer:

Treatment: 15 mg orally once a day
-Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled studies did not extend beyond 12 months.

Uses:
-Short-term treatment for healing and symptom relief of active duodenal ulcers
-Maintain healing of duodenal ulcers

Usual Adult Dose Dose of Lansoprazole for Duodenal Ulcer Prophylaxis:

Treatment: 15 mg orally once a day
-Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled studies did not extend beyond 12 months.

Uses:
-Short-term treatment for healing and symptom relief of active duodenal ulcers
-Maintain healing of duodenal ulcers

Usual Adult Dose for Duodenal Ulcer Maintenance:

Treatment: 15 mg orally once a day
-Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled studies did not extend beyond 12 months.

Uses:
-Short-term treatment for healing and symptom relief of active duodenal ulcers
-Maintain healing of duodenal ulcers

Usual Adult Dose Dose of Lansoprazole for Gastroesophageal Reflux Disease:

15 mg orally once a day
-Duration of therapy: Up to 8 weeks

Use: Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)

Usual Adult Dose for Gastric Ulcer:

30 mg orally once a day
-Duration of therapy: Up to 8 weeks

Use: Short-term treatment for healing and symptom relief of active benign gastric ulcers

Usual Adult Dose Dose of Lansoprazole for Multiple Endocrine Adenomas:

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

Usual Adult Dose for Systemic Mastocytosis:

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

Usual Adult Dose for Zollinger-Ellison Syndrome:

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

Usual Adult Dose for Helicobacter pylori Infection:

Triple Therapy: 30 mg orally 2 times a day, taken concomitantly with amoxicillin and clarithromycin
-Duration of therapy: 10 to 14 days

Dual Therapy: 30 mg orally 3 times a day, taken concomitantly with amoxicillin
-Duration of therapy: 14 days

Comments:
-Refer to the manufacturer product information for dosing for amoxicillin and clarithromycin.
-Eradication of Helicobacter pylori has been shown to reduce duodenal ulcer recurrence, and may result in duodenal/gastric ulcer healing without the need for continued therapy.

Uses:
-Triple therapy: Treatment of patients with H pylori infection and duodenal ulcer disease (active/1 year history of a duodenal ulcer) to eradicate H pylori
-Dual therapy: Treatment of patients with H pylori infection and duodenal ulcer disease (active/1 year history of a duodenal ulcer) who is either allergic/intolerant to clarithromycin or in whom resistance to clarithromycin is known/suspected

Usual Adult Dose for NSAID-Induced Gastric Ulcer:

30 mg orally once a day
-Duration of therapy: Up to 8 weeks

Comment: Studies did not extend beyond 8 weeks.

Use: Treatment of NSAID-associated gastric ulcer in patients who continue NSAID use

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

15 mg orally once a day
-Duration of therapy: Up to 12 weeks

Comment: Studies did not extend beyond 12 weeks.

Use: 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

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

1 to 11 years:
-Less than or equal to 30 kg: 15 mg orally once a day
-Greater than 30 kg: 30 mg orally once a day
-Duration of therapy: Up to 12 weeks

12 years and older: 15 mg orally once a day
-Duration of therapy: Up to 8 weeks

Comment: The dose was increased (up to 30 mg 2 times a day) in some patients who remained symptomatic after at least 2 weeks of treatment.

Use: Short-term treatment of GERD and other symptoms associated with GERD

Usual Pediatric Dose for Erosive Esophagitis:

1 to 11 years:
-Less than or equal to 30 kg: 15 mg orally once a day
-Greater than 30 kg: 30 mg orally once a day
-Duration of therapy: Up to 12 weeks

12 to 17 years: 30 mg orally once a day
-Duration of therapy: Up to 8 weeks

17 years and older: See adult dosing.

Comment: The dose was increased (up to 30 mg 2 times a day) in some patients who remained symptomatic after at least 2 weeks of treatment.

Use: Short-term treatment for healing and symptom relief of all grades of erosive esophagitis

What other drugs will affect lansoprazole?

Ask a doctor or pharmacist if it is safe for you to use lansoprazole if you are also using any of the following drugs:

  • digoxin;

  • erlotinib;

  • ketoconazole;

  • methotrexate;

  • mycophenolate mofetil;

  • tacrolimus;

  • theophylline;

  • warfarin (Coumadin, Jantoven);

  • an antibiotic - ampicillin, clarithromycin;

  • HIV medicine - atazanavir, nelfinavir; or

  • iron-containing medicines - ferrous fumarate, ferrous gluconate, ferrous sulfate, and others.

This list is not complete. Other drugs may interact with lansoprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Usual Adult Dose for Gastroesophageal Reflux Disease

15 mg orally once a day
-Duration of therapy: Up to 8 weeks

Use: Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)

Usual Adult Dose for Multiple Endocrine Adenomas

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

Usual Adult Dose for Helicobacter pylori Infection

Triple Therapy: 30 mg orally 2 times a day, taken concomitantly with amoxicillin and clarithromycin
-Duration of therapy: 10 to 14 days

Dual Therapy: 30 mg orally 3 times a day, taken concomitantly with amoxicillin
-Duration of therapy: 14 days

Comments:
-Refer to the manufacturer product information for dosing for amoxicillin and clarithromycin.
-Eradication of Helicobacter pylori has been shown to reduce duodenal ulcer recurrence, and may result in duodenal/gastric ulcer healing without the need for continued therapy.

Uses:
-Triple therapy: Treatment of patients with H pylori infection and duodenal ulcer disease (active/1 year history of a duodenal ulcer) to eradicate H pylori
-Dual therapy: Treatment of patients with H pylori infection and duodenal ulcer disease (active/1 year history of a duodenal ulcer) who is either allergic/intolerant to clarithromycin or in whom resistance to clarithromycin is known/suspected

Bottom Line

Lansoprazole decreases stomach acid production which promotes the healing of gastric and duodenal ulcers and other inflamed gastrointestinal tissue areas. Lansoprazole, like other PPIs, should only be used short-term.

Lansoprazole Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

Animal models have revealed evidence of tumorigenicity in carcinogenicity studies; there is a potential risk of serious adverse reactions to the nursing infant.

(web3)