Lansoprazole (Prevacid) reduces gastric acid secretion by inhibiting the proton pumps in the parietal cells. It is used to treat heartburn, peptic ulcer disease, gastroesophageal reflux disease, and dyspepsia.

Lansoprazole (Prevacid) Uses:

• Gastroesophageal reflux disease (GERD):

  • Treatment of symptomatic GERD in children ≥1 year of age and adults(up to 8 weeks); short-term (up to 12 weeks in children <12 years and adults; up to 8 weeks in children >12 yrs of age) treatment to maintain healing of erosive oesophagitis.

• Hypersecretory conditions:

  • Long term treatment of hypersecretory disorders like Zollinger-Ellison syndrome.

• Peptic ulcer disease:

  • Treatment of duodenal ulcers as a short-term therapy i.e 4 weeks.
  • As a maintenance treatment of healed duodenal ulcer.
  • Also used as a part of eradication therapy in H. pylori-induced recurrent duodenal ulcers.
  • Treatment of NSAIDs induced gastric ulcers in adults and as a short term treatment of active benign gastric ulcer in adults.
  • Relieving frequent heartburns (≥2 days/week)

• Off Label Use of Lansoprazole Adults:

  • Dyspepsia
  • Prophylactically treating stress ulcers in critically ill patients.

Lansoprazole (Prevacid) Dose in Adults:

Lansoprazole (Prevacid) Dose in the treatment of Gastroesophageal reflux disease (GERD):

Note: The drug should be administered 30 mins before meal along with lifestyle and dietary modifications.

• Initial therapy:

  • Mild and intermittent symptoms (<2 episodes/week), and no evidence of erosive esophagitis:

    • Oral: 15 mg OD for 8 weeks;
    • if symptoms persist after 8 weeks, increase to 30 mg OD;
    • continue treatment for at least 8 weeks when symptoms are controlled.
    • Discontinue while tapering the dose when asymptomatic for 8 weeks with therapy.

  • Severe or frequent symptoms (≥2 episodes/week), erosive esophagitis, or Barrett's esophagus:

    • Oral: 30 mg OD;
    • continue treatment for at least 8 weeks when symptoms are controlled.
    • In patients with severe erosive esophagitis or Barrett esophagus, long-term maintenance therapy with 30 mg once daily is advised.
    • In patients without severe erosive esophagitis or Barrett's esophagus, continue at the lowest dose for the shortest duration and discontinue therapy while tapering the dose in all asymptomatic patients.

Note: It is recommended by some experts to continue the drug if symptoms persist with a standard dose of H2 receptor antagonist.

• Refractory:

  • Persistent symptoms despite 30 mg once daily dosing regimen:

    • Oral: 30 mg twice daily (before breakfast and dinner) or
    • 15mg twice daily one dose before breakfast and one before dinner.

  • Recurrent symptoms after discontinuing acid suppression:

    • Recurrent symptoms ≥3 months:
      • Repeat an 8-week course at the previous effective dose.
    • Recurrent symptoms <3 months:
      • Long-term maintenance at the lowest effective dose necessary; upper endoscopy is also recommended (if not already performed).

Note: Referral to a specialist is recommended:

• OTC labeling (patient-guided therapy):

  • Heartburn, frequent symptoms (≥2 episodes/week):
    • 15 mg OD for 14 days;
    • if required a repeat course of 14 days every 4 months can be prescribed.

Lansoprazole (Prevacid) Dose in the treatment of Hypersecretory conditions:

• Oral: Initial: 60 mg OD;
• adjust dose based upon patient response and to reduce acid secretion to <10 mEq/hour (5 mEq/hour in patients with prior gastric surgery);
• doses of 90 mg twice daily have been used; administer doses >120 mg/day in divided doses

Lansoprazole (Prevacid) Dose in the treatment of Peptic ulcer disease:

• Duodenal ulcer:

  • Oral: Short-term treatment: 15 mg once daily for 4 weeks;
  • maintenance therapy: 15 mg once daily

• Dyspepsia (off label):

  • Oral: 15 or 30 mg once daily for up to 8 weeks.

• Gastric ulcer:

  • Oral: Short-term treatment: 30 mg once daily for up to 8 weeks.
  • Some clinical trial data suggest a dose of 15 mg once daily for up to 8 weeks may also be effective.

• Helicobacter pylori eradication:

  • Oral: 30 mg 3 times daily administered with amoxicillin 1,000 mg 3 times daily for 14 days or 30 mg twice daily administered with amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 10 to 14 days

• American College of Gastroenterology guidelines:

  • Clarithromycin triple regimen:
    • 30 to 60 mg twice daily in combination with clarithromycin 500 mg twice daily and either amoxicillin 1 g twice daily or metronidazole 500 mg 3 times per day for 14 days.

Note:

• Avoid the use of clarithromycin triple therapy in patients with risk factors for macrolide resistance (eg, prior macrolide exposure, local clarithromycin resistance rates ≥15%, eradication rates with clarithromycin-based regimens ≤85%).
  • Sequential regimen:
    • 30 mg twice daily plus amoxicillin 1 g twice daily for 5 to 7 days;
    • then follow with clarithromycin 500 mg twice daily, either metronidazole or tinidazole 500 mg twice daily, and lansoprazole 30 mg twice daily for 5 to 7 days
  • Levofloxacin triple regimen:
    • 30 mg twice daily in combination with amoxicillin 1 g twice daily and levofloxacin 500 mg once daily for 10 to 14 days
  • Bismuth quadruple regimen:
    • 30 mg twice daily in combination with tetracycline 500 mg 4 times daily, metronidazole 250 mg 4 times daily or 500 mg 3 or 4 times daily, and either bismuth subcitrate 120 to 300 mg 4 times daily or bismuth subsalicylate 300 mg 4 times daily for 10 to 14 days
  • Concomitant regimen:
    • 30 mg twice daily in combination with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 10 to 14 days
  • Hybrid regimen:
    • 30 mg twice daily plus amoxicillin 1 g twice daily for 7 days;
    • then follow with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, either metronidazole or tinidazole 500 mg twice daily, and lansoprazole 30 mg twice daily for 7 days

Lansoprazole (Prevacid) Dose in the treatment of NSAID-associated gastric ulcer (healing):

• Oral: 30 mg OD for 8 weeks.

Lansoprazole (Prevacid) Dose in the treatment of NSAID-associated gastric ulcer (to reduce risk):

• Oral: 15 mg OD for up to 12 weeks;

Lansoprazole (Prevacid) Dose in the treatment of stress ulcer prophylaxis in critically ill patients (off-label):

• Oral: 30 mg once daily.
• Note: Intended for patients with associated risk factors (eg, coagulopathy, mechanical ventilation for >48 hours, sepsis/septic shock);
• discontinue use once risk factors have resolved.

• Discontinuation of therapy:

  • Oral: Some experts recommend a step-down approach in order to avoid worsening or rebound symptoms.
  • One strategy is to decrease the dose by 50% over 2 to 4 weeks.
  • If the patient is already on the lowest possible dose, alternate-day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patients should be reevaluated.

Lansoprazole (Prevacid) Dose in Childrens:

Lansoprazole (Prevacid) Dose in the treatment of Symptomatic Gastroesophageal reflux disease (GERD):

Note: Guidelines recommend a 4to 8-week treatment course; if improvement seen after 4 to 8 weeks, consider possible wean; if no response after 4 to 8 weeks, reevaluate diagnosis and consider referral to pediatric GI specialist.

• Weight-based dosing:

  • Infants:
    • Oral: 2 mg/kg/day.
    • a dose of 1 mg/kg/day has also been shown to increase gastric pH in infants and decrease the frequency of GERD symptoms (eg, regurgitation/vomiting, feeding refusal, crying, back arching) from baseline.
  • Children and Adolescents:
    • Oral: 0.7 to 3 mg/kg/day
    • maximum daily dose: 30 mg/day.

• Fixed dosing:

  • Infants ≥3 months:
    • 5 mg twice daily or 15 mg once daily was shown to provide better symptom relief compared to dietary management in 68 patients.

  • Children ≤11 years:

    • ≤30 kg: 15 mg once daily.
    • >30 kg: 30 mg once daily.
  • Children ≥12 years and Adolescents: Oral:
    • 15 mg once daily.

Lansoprazole (Prevacid) Dose in the treatment of Erosive esophagitis:

Note: Duration of therapy is dependent on age: Children ≤11 years recommended duration is up to 12 weeks and for children ≥12 years and adolescent duration is up to 8 weeks.

• Children ≤11 years:

  • ≤30 kg: 15 mg once daily.
  • >30 kg: 30 mg once daily.

• Children ≥12 years and Adolescents:

  • Oral: 30 mg once daily.

• Discontinuation of therapy:

  • Oral: Based on experience in adults, some experts recommend a step-down approach in order to avoid worsening or rebound symptoms.
  • One recommendation is to decrease the dose by 50% over 2 to 4 weeks.
  • If the patient is already on the lowest possible dose, alternate day therapy may be considered.
  • If symptoms worsen during treatment or after discontinuation, patients should be reevaluated.

Lansoprazole (Prevacid) Pregnancy Risk Category: B

• Data available do not show an increase in the risk of major birth defects due to maternal use of Lansoprazole during pregnancy.
• There are many recommendations for treating GERD during pregnancy.
• Lifestyle modifications, followed by medication, are the first treatment for non-pregnant women.
• Proton pump inhibitors can be used when clinically indicated based on the available data.

Lansoprazole use during breastfeeding:

• It is unknown if lansoprazole can be found in breast milk.
• Before prescribing any drug, it is important to weigh the benefits to the mother and the baby of breastfeeding.

Lansoprazole (Prevacid) Dose in Kidney Disease:

No dosage adjustment is necessary.

Lansoprazole (Prevacid) Dose in Liver disease:

• Mild or moderate impairment (Child-Pugh class A or B):
  • No dosage adjustment is necessary.
• Severe impairment (Child-Pugh class C):
  • 15 mg once daily.

Note:

• The dosage recommendation is based on pharmacokinetic data using a single 30 mg dose.

Side Effects of Lansoprazole (Prevacid):

• Central nervous system:

  • Headache
  • Dizziness

• Gastrointestinal:

  • Diarrhea
  • Abdominal pain
  • Constipation
  • Nausea

Side effects of lansoprazole (frequency not defined):

• Endocrine & Metabolic:

  • Abnormal Albumin-Globulin Ratio
  • Albuminuria
  • Decreased Serum Cholesterol
  • Hyperlipidemia
  • Increased Gamma-Glutamyl Transferase
  • Increased Gastrin
  • Increased Lactate Dehydrogenase
  • Increased Serum Glucocorticoids
  • Increased Serum Potassium

• Gastrointestinal:

  • Occult Blood In Stools

• Genitourinary:

  • Crystalluria
  • Hematuria

• Hematologic & Oncologic:

  • Abnormal Erythrocytes
  • Blood Platelet Disorder (Abnormal Platelets)
  • Leukocyte Disorder
  • Leukocytosis

• Hepatic:

  • Abnormal Hepatic Function Tests
  • Hyperbilirubinemia
  • Increased Serum Alkaline Phosphatase
  • Increased Serum ALT
  • Increased Serum AST

• Immunologic:

  • Increased Serum Globulins

• Renal:

  • Acute Interstitial Nephritis
  • Increased Blood Urea Nitrogen
  • Increased Serum Creatinine

Contraindications to Lansoprazole Include:

• Hypersensitivity to lansoprazole and any component thereof (eg anaphylaxis.
• concomitant use with products that contain rilpivirine.

Warnings and precautions

• Carcinoma

  • No reports of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia has occurred.

• Clostridium difficile-associated diarrhea (CDAD), formerly Clostridium, is now Clostridioides

  • Proton pump inhibitors (PPIs), especially when used in hospitals, may increase the risk for CDAD.
  • Patients with persistent diarrhea should be diagnosed with CDAD if their condition does not improve.
  • The best PPI therapy for your condition is the one that has the lowest dosage and longest duration.

• Cutaneous and systemic Lupus Erythematosus

  • This condition has been described as a new onset of or an exacerbation autoimmune disease.
  • Most cases were cutaneous lupus erythematosus, but subacute CLE was more common.
  • Systemic lupus is less common and usually occurs within days to many years of starting treatment.
  • It mostly affects young adults, but can also occur in older patients.
  • If you notice any signs or symptoms of CLE/SLE, discontinue treatment and consult a specialist.
  • Most patients feel better within 4 to 12 weeks.

• Fractures

  • Proton pump inhibitor (PPI), therapy may increase the incidence of osteoporosis-related fractures of bones in the hip, spine and wrist.
  • Monitor patients receiving long-term or high-dose therapy.
  • To reduce fractures, you should use the lowest possible dose for the shortest time.

• Polyps of the fundic gland:

  • Long-term PPI use for more than one year increases the risk of fundic polyps.
  • It may not be apparent, but it may cause nausea, vomiting, abdominal pain, and GI bleeding.
  • A diagnosis of polyps can increase the likelihood of small intestinal obstruction.
  • The best PPI therapy for your condition is the one that has the lowest dosage and longest duration.

• Hypomagnesemia:

  • Rarely reported, often with prolonged PPI usage of >=3 month (most cases of therapy >1 year).
  • Hypomagnesemia can be either symptomatic, or asymptomatic.
  • Severe cases can cause seizures, tetany, and heart arrhythmias.
  • It is important to obtain serum magnesium levels before you begin long-term treatment, particularly if you are taking digoxin, diuretics or any other drugs that can cause hypomagnesemia.
  • Also, it is important to check your blood regularly thereafter.
  • Magnesium supplementation may be used to correct hypomagnesemia.
  • However, discontinuation of lansoprazole might be necessary. Magnesium levels usually return to normal within one week.

• Interstitial nephritis:

  • Patients taking PPIs have been known to experience acute interstitial nephritis.
  • This can occur at any stage of therapy and is usually due to an idiopathic hypersensitivity reaction.
  • If acute interstitial Nephritis occurs, discontinue use.

• Vitamin B deficiency:

  • Long-term treatment (>=2 year) can lead to vitamin B malabsorption or subsequent vitamin B deficiency.
  • The severity of the deficiency depends on the dose. It is more common in women than in men (30 years old) and it is less common after stopping therapy.

• Gastric cancer:

  • Gastric malignancy can still be present despite symptoms being relieved.

• Gastrointestinal infection (eg, Salmonella, Campylobacter):

  • These infections may be more likely if you use PPIs.

• Hepatic impairment

  • Patients suffering from severe liver dysfunction might need to reduce their dosage.

Lansoprazole: Drug Interaction

Monitoring parameters:

• Patients with Zollinger-Ellison syndrome should be monitored for gastric acid output, which should be maintained at ≤10 mEq/hour during the last hour before the next lansoprazole dose;
• bone loss and fractures,
• CBC,
• CDAD,
• liver function,
• renal function,
• magnesium (baseline and periodically thereafter), and
• serum gastrin levels

How to administer Lansoprazole (Prevacid)?

Oral:

• Dosage: 30 minutes before eating if you are on a daily dose.
• You should take the first dose at breakfast and the second at dinner.
• You should not chew the granules.
• Other options may be available if the patient is unable or unwilling to swallow the capsule.
• Open the capsule and sprinkle 1 tbsp cottage yogurt or applesauce with the granules.
• Capsules can be opened and emptied into approximately 60 mL orange juice or apple juice. Mix and then swallow.
• To ensure complete delivery, rinse the glass with at least 2 ounces of juice.

Tablets that can be taken orally:

• Do not swallow whole, break, chew, or chew the tablet. Allow the tablet to dissolve on your tongue, with or without water, until it is swallowable.
• Orally-disintegrating tablets may also be administered via an oral syringe:
  • Oral syringes can be used to draw up the 15 mg tablet.
  • Once the tablet is dispersed, you can administer it within 15 minutes.
  • Fill the syringe up with water (2 mL to take the 15 mg tablet, 5 mL to take the 30 mg tablet), shake the container gently, and then give any remaining contents.

Administration of the naogastric tube:

• Capsule
  • You can open the capsule and mix the granules (but not crush) with 40mL of apple juice.
  • The granules can then be administered through the NG tube to the stomach. After that, flush the tube with more apple juice.
  • Mix with other liquids.
  • Thirty milligrams can also be suspended in 10mL of 8.4% sodium carbonate solution (or apple cider), or broken into four equal parts, flushed with warm water, and then administered via an NG tube.
• Tablet that can be taken orally:
  • French:
    • You can either place a 15 mg tablet into a syringe to draw up 4mL of water or the 30 mg tablet into a syringe to draw up 10mL.
    • Once the tablet is dispersed, you can administer it within 15 minutes.
    • Then, fill the syringe again with 5mL of water and shake it gently. Finally, flush the nasogastric tube.

Mechanism of action of Lansoprazole (Prevacid):

Inhibits H+ and K+ ATPase enzyme system leading to decreased acid secretion from parietal cells.

The onset of action:

• Gastric acid suppression: Oral: 1 to 3 hours

Duration:

• Gastric acid suppression: Oral: >1 day

Absorption:

• Rapid

Protein binding:

• 97%

Metabolism:

• Hepatic via CYP2C19 and 3A4 to inactive metabolites, and in parietal cells to two active metabolites that are not present in the systemic circulation

Bioavailability:

• >80%;
• decreased 50% to 70% if given 30 minutes after food

Half-life elimination:

• Children: 1.2 to 1.5 hours;
• Adults: 1.5 ± 1 hour;
• Elderly: 1.9 to 2.9 hours;
• Hepatic impairment: 4 to 7.2 hours

Time to peak, plasma:

• 1.7 hours

Excretion:

• Feces (67%);
• urine (33%; 14% to 25% as metabolites and <1% as unchanged drug)

International Brand Names of Lansoprazole:

• GoodSense Lansoprazole
• Heartburn Treatment 24 Hour
• Prevacid
• Prevacid 24HR
• Prevacid SoluTab
• APO-Lansoprazole
• DOM-Lansoprazole
• MYLAN-Lansoprazole
• PMS-Lansoprazole
• Prevacid
• Prevacid FasTab
• RAN-Lansoprazole
• RIVA-Lansoprazole
• SANDOZ Lansoprazole
• TEVALansoprazole
• Agopton
• Amdory
• Betalans
• Chexid
• Dakar
• Dapuaa
• Daxar
• Digest
• Dispepci
• Emlansa
• Estomil
• Gastevin
• Gastriben
• Gastrocure
• Gastrovex
• Hiza
• Ilsatec
• Imidex
• Inhipraz
• Julphasole
• Krovane
• Lacopen
• Lagas 30
• Lan30
• Lancerol
• Lancid
• Lanfast
• Langaton
• Lanodizol
• Lanpraz
• Lanpro
• Lanprol
• Lanproton
• Lans OD
• Lans-OD
• Lansal
• Lansale
• Lanso
• Lansodin
• Lansofast
• Lansol-30
• Lansomid
• Lansomylan
• Lansone
• Lansopep
• Lansopram
• Lansoprol
• Lansor
• Lansozole
• Lanspro-30
• Lanster
• Lanston
• Lanton
• Lanvell
• Lanxid-OD
• Lanximed
• Lanz
• Lanzap
• Lanzo
• Lanzo Melt
• Lanzol
• Lanzol-30
• Lanzole
• Lanzopra
• Lanzopral
• Lanzopran
• Lanzor
• Lanzostad
• Lanzul
• Lapraz
• Laproton
• Lasgan
• Lasoprol
• Laz
• Lazo
• Lazol
• Loprezol
• Monolitum
• Ogast
• Ogastro
• Olan
• Opiren
• Palatrin
• Prazex
• Prevacid
• Prevacid FDT/IV
• Prezal
• Prilosan
• Prolanzo
• Prosogan fd
• Protonexa
• Pysolan
• Quitulcer
• Razolager
• Safemar
• Solox
• Sopralan30
• Sopranix
• Soprazol
• Sorifran
• Takepron
• Takepron OD
• Taquidine
• Uldapril
• Ulpax
• Versacid
• Xizhixin
• Zolcer
• Zomel
• Zopral
• Zopraz
• Zoton
• Zoton Fastab

Lansoprazole Brand Names in Pakistan: