Lansoprazole DR 30 mg/1
Lansoprazole · CAPSULE, DELAYED RELEASE · Advanced Rx Pharmacy of Tennessee, LLC
Lansoprazole DR is a capsule, delayed release containing lansoprazole at 30 mg/1, taken oral. Manufactured by Advanced Rx Pharmacy of Tennessee, LLC.
Key Facts
- Brand Name
- Lansoprazole DR
- Generic Name
- Lansoprazole
- NDC Code (Product)
80425-0174- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205868
- Drug Class
- Proton Pump Inhibitor [EPC]
- Marketing Start
- 06/04/2018
Recall History
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Full Prescribing Information
Indications & Usage
Indications and Usage Section 1 INDICATIONS AND USAGE 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 delayed-release capsules/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)]. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin Lansoprazole delayed-release capsules 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 on…
Dosage & Administration
Dosage and Administration Section 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment Maintenance of Healed 15 mg 15 mg Once daily for 4 weeks Once daily Eradicationof H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets Amoxicillin Clarithromycin Dual Therapy: Lansoprazole delayed-release capsules Amoxicillin 30 mg 1gram 500 mg 30 mg 1 gram Twice daily for 10 or 14 days Twice daily for 10 or 14 days Twice daily for 10 or 14 days Three times daily for 14 days Three times daily for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-Associated Gastric Ulcer Healing Risk Reduction 30 mg 15 mg Once daily for 8 weeks† Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD Short -Term Treatment of Erosive Esophagitis 15 mg 30 mg Once daily for up to 8 weeks Once daily for up to 8 weeks‡ Maintenance of Healing of Erosive Esophagitis 15 mg Once daily¶ Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndro…
Contraindications
Contraindications Section 4 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 tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2),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.
Drug Interactions
Drug 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 Coadministered 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. · 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: Rilpi…
Adverse Reactions
Adverse Reactions 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)] • 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)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Worldwide, over 10,000 patients have been treated with lansoprazole delayed-release capsules in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, lansoprazole delayed-release capsules treatment has been well-tolerated in both short-term and long-term trials…
Frequently Asked Questions
What is Lansoprazole DR used for?
Lansoprazole DR contains Lansoprazole. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.
Is Lansoprazole DR a controlled substance?
Lansoprazole DR is not classified as a controlled substance by the DEA.
What is the generic name for Lansoprazole DR?
The generic name for Lansoprazole DR is Lansoprazole. There are 12 other brand versions of Lansoprazole.
What is the NDC code for Lansoprazole DR 30 mg/1?
The NDC (National Drug Code) for Lansoprazole DR 30 mg/1 is 80425-0174, listed by Advanced Rx Pharmacy of Tennessee, LLC.