Lansoprazole Dr
Generic Name: lansoprazole dr
Brand Names:
Lansoprazole Dr
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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37.
Overview
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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37.
Uses
1.1 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 [see Clinical Studies ( 14.1]. 1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole /amoxicillin /clarithromycin Lansoprazole delayed-release capsules 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 [see Clinical Studies ( 14.2)].
Dosage
2.1 Recommended Adult Dosage by Indication * Please refer to the amoxicillin and clarithromycin full prescribing information, Contraindications and Warningsand Precautions sections, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis, an additional eight week course of lansoprazole may be considered. § Controlled studies did not extend beyond 12 months ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily.
Side Effects
The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial 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)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6)] Cyanocobalamin (Vitamin B 12) Deficiency [see Warnings and Precautions (5.7)] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8)] Fundic Gland Polyps [see Warnings and Precautions (5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clin...
Interactions
Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole delayed-release capsules 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 Delayed-Release Capsules 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.
Warnings
5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with lansoprazole 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. 5.2 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). Lansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)].
Storage
Lansoprazole delayed-release capsules, USP are available as: • 15 mg capsules are white to off white, spherical to oval pellets filled in hard gelatin capsule shells of size 3 with " [Image] " imprinted in grey ink on green opaque colored cap and "806" imprinted in black ink on white opaque colored body.
Frequently Asked Questions
What is Lansoprazole Dr used for?▼
1.1 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 [see Clinical Studies ( 14.1]. 1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole /amoxicillin /clarithromycin Lansoprazole delayed-release capsules 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 [see Clinical Studies ( 14.2)].
What are the side effects of Lansoprazole Dr?▼
The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial 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)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6)] Cyanocobalamin (Vitamin B 12) Deficiency [see Warnings and Precautions (5.7)] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8)] Fundic Gland Polyps [see Warnings and Precautions (5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clin...
What are the important warnings for Lansoprazole Dr?▼
5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with lansoprazole 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. 5.2 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). Lansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.