Lansoprazole (9 brand names, 6 dosage forms, 2 routes)
Available dosage forms: CAPSULE, DELAYED REL PELLETS, CAPSULE, DELAYED REL PELLETS, TABLET, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS, FOR SUSPENSION, DELAYED RELEASE, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, INJECTABLE.
Routes of administration: ORAL, INTRAVENOUS.
Brand Names
- LANSOPRAZOLE
- LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
- PREVACID
- PREVACID 24 HR
- PREVACID IV
- PREVACID NAPRAPAC 250 (COPACKAGED)
- PREVACID NAPRAPAC 375 (COPACKAGED)
- PREVACID NAPRAPAC 500 (COPACKAGED)
- PREVPAC (COPACKAGED)
Contraindications
• Lansoprazole delayed-release capsules are 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 [see Adverse Reactions ( 6)] . • Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7)] . • 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 [see Warnings and Precautions ( 5.2)] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.3)] • Bone Fracture [see Warnings and Precautions ( 5.4)] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.5)] • Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions ( 5.6)] • Hypomagnesemia [see Warnings and Precautions ( 5.7 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.11 )]
Drug Interactions
Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 2. Clinically Relevant Interactions Affecting Drugs Co-Administered with Lansoprazole and Interactions with Diagnostics Antiretrovirals Clinical Impact: 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. Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole is contraindicated [see Contraindications ( 4)] . See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with lansoprazole. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information. Warfarin Clinical Impact: 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. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Methotrexate Clinical Impact
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.
Overdosage
Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction. Oral lansoprazole doses up to 5,000 mg/kg in rats [approximately 1,300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs. In the event of over-exposure, treatment should be symptomatic and supportive. If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information on the management of poisoning or over-exposure.