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Lansoprazole

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Overview

What is Lansoprazole?

The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is CHFNOS with a molecular weight of 369.37. Lansoprazole USP has the following structure:

Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water.

Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0.

Lansoprazole USP is supplied as delayed-release capsules for oral administration.

The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide.

Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.



What does Lansoprazole look like?



What are the available doses of Lansoprazole?

Delayed-release capsules: 15 mg and 30 mg. ()

What should I talk to my health care provider before I take Lansoprazole?

How should I use Lansoprazole?

Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer

* Please refer to amoxicillin and clarithromycin full prescribing information for Contraindications and Warnings and Precautions sections, and for information regarding dosing in elderly and renally-impaired patients.

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What interacts with Lansoprazole?

Sorry No Records found


What are the warnings of Lansoprazole?

Sorry No Records found


What are the precautions of Lansoprazole?

Sorry No Records found


What are the side effects of Lansoprazole?

Sorry No records found


What should I look out for while using Lansoprazole?

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What might happen if I take too much Lansoprazole?

Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole delayed-release capsules with no adverse reaction. Oral lansoprazole delayed-release capsules doses up to 5000 mg/kg in rats [approximately 1300 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.


How should I store and handle Lansoprazole?

Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.Risperidone 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green colored body, imprinted ‘RDY’ on cap and ‘LAN’ on body with white ink. They are supplied in bottles of 30’s and 90's.Bottles of 30 NDC 68001-111-04Bottles of 90 NDC 68001-111-05Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of 90's and 500’s.Bottles of 90 NDC 68001-112-05Bottles of 500 NDC 68001-112-03Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green colored body, imprinted ‘RDY’ on cap and ‘LAN’ on body with white ink. They are supplied in bottles of 30’s and 90's.Bottles of 30 NDC 68001-111-04Bottles of 90 NDC 68001-111-05Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of 90's and 500’s.Bottles of 90 NDC 68001-112-05Bottles of 500 NDC 68001-112-03Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green colored body, imprinted ‘RDY’ on cap and ‘LAN’ on body with white ink. They are supplied in bottles of 30’s and 90's.Bottles of 30 NDC 68001-111-04Bottles of 90 NDC 68001-111-05Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of 90's and 500’s.Bottles of 90 NDC 68001-112-05Bottles of 500 NDC 68001-112-03Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green colored body, imprinted ‘RDY’ on cap and ‘LAN’ on body with white ink. They are supplied in bottles of 30’s and 90's.Bottles of 30 NDC 68001-111-04Bottles of 90 NDC 68001-111-05Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of 90's and 500’s.Bottles of 90 NDC 68001-112-05Bottles of 500 NDC 68001-112-03Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green colored body, imprinted ‘RDY’ on cap and ‘LAN’ on body with white ink. They are supplied in bottles of 30’s and 90's.Bottles of 30 NDC 68001-111-04Bottles of 90 NDC 68001-111-05Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of 90's and 500’s.Bottles of 90 NDC 68001-112-05Bottles of 500 NDC 68001-112-03Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green colored body, imprinted ‘RDY’ on cap and ‘LAN’ on body with white ink. They are supplied in bottles of 30’s and 90's.Bottles of 30 NDC 68001-111-04Bottles of 90 NDC 68001-111-05Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of 90's and 500’s.Bottles of 90 NDC 68001-112-05Bottles of 500 NDC 68001-112-03


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

Non-Clinical Toxicology
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ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin

When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.

Diuretics

Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.

Lithium

Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin-type anticoagulants

Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

H-2 Antagonists

In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

In adults, symptomatic response to therapy with lansoprazole delayed-release capsules does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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