Lansoprazole

Mechanism of Action

Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

Drug Label Information | Brands:

Brands Of Lansoprazole in Kenya

Degastrol, Pharmaco Healthcare Limited
Lan 30mg ,Intas Pharmaceuticals Ltd
Lancid , Micro Labs Ltd
Lanop-30, Biodeal
Lanpro , Unichem Laboratories Ltd.
Lanzol-30 , Cipla Ltd
Lanzol DT Junior 15 mg Tablets, Cipla Ltd
Lasoprol, Delorbis Pharmaceuticals Limited
Lazope,Unicure RemediesPvt for Metro Pharmaceuticals Limited
Lazoton 30, Cosmos Limited
Selanz SR, The Searle Company Limited
Ulsacure , Gujarat Liqui Pharmacaps Limited
Zapacid , Win Medicare Private Limited

INDICATIONS

1.Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer
Short-Term Treatment 15 mg Once daily for 4 weeks
Maintenance of Healed 15 mg Once daily

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

a)Triple Therapy: Lansoprazole/amoxicillin/clarithromycin
Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults 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. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
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

b) Dual Therapy: Lansoprazole/amoxicillin
Lansoprazole in combination with amoxicillin as dual therapy is indicated in adults 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 . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
Lansoprazole 30 mg Three times daily for 14 days
Amoxicillin 1 gram Three times daily for 14 days

3.Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months

4.Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer
Short-Term Treatment 30 mg Once daily for up to 8 weeks

5.Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks
Healing 30 mg Once daily for 8 weeks

6.Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole is indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID
Lansoprazole 15 mg Once daily for up to 12 weeks

7.Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD

8.Treatment of Erosive Esophagitis (EE)
Lansoprazole delayed-release capsules are indicated for short-term treatment for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE.
Lansoprazole 30 mg Once daily for up to 8 weeks

9. Maintenance of Healing of EE
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months
Lansoprazole 15 mg Once daily

10.Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome(ZES)
Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome
Lansoprazole 60 mg Once daily

CONTRAINDICATIONS

Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria
Proton Pump Inhibitors (PPIs), including lansoprazole , are contraindicated with rilpivirine-containing products
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release capsules, refer to the Contraindications section of their prescribing information.

ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in labeling:

Acute Interstitial Nephritis
Clostridium difficile -Associated Diarrhea
Bone Fracture
Cutaneous and Systemic Lupus Erythematosus
Cyanocobalamin (Vitamin B-12) Deficiency
Hypomagnesemia
Fundic Gland Polyps

DRUG INTERACTIONS

Antiretrovirals:
The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.

  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with lansoprazole may reduce antiviral effect and promote the development of drug resistance.
  • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with lansoprazole may increase toxicity of the antiretroviral drugs.
  • There are other antiretroviral drugs which do not result in clinically relevant interactions with lansoprazole.

Warfarin:
Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.

Methotrexate:
Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted

Digoxin
Potential for increased exposure of digoxin.

Theophylline
Increased clearance of theophylline

Drugs Dependent on Gastric pH for Absorption (e.g. , iron salts , erlotinib , dasatinib , nilotinib , mycophe nolatemofetil , ketoconazole / itraconazole)
Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.

Combination Therapy with Clarithromycin and Amoxicillin:
Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated.
Amoxicillin also has drug interactions.

Tacrolimus
Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.