Dexlansoprazole 30 mg/1
Dexlansoprazole · CAPSULE, DELAYED RELEASE · Par Health USA, LLC
Dexlansoprazole is a capsule, delayed release containing dexlansoprazole at 30 mg/1, taken oral. Manufactured by Par Health USA, LLC.
Key Facts
- Brand Name
- Dexlansoprazole
- Generic Name
- Dexlansoprazole
- NDC Code (Product)
49884-147- Manufacturer
- Par Health USA, LLC
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202294
- Drug Class
- Proton Pump Inhibitor [EPC]
- Marketing Start
- 06/10/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: • Healing of all grades of erosive esophagitis (EE). ( 1.1 ) • Maintenance of healed EE and relief of heartburn. ( 1.2 ) • Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3 ) 1.1 Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. 1.3 Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage in patients 12 years of age and older: • See full prescribing information for complete dosing information for dexlansoprazole delayed-release capsules by indication and age group and dosage adjustment in patients with hepatic impairment. ( 2.1 , 2.2 ) Administration Instructions ( 2.3 ): • Take without regard to food. • Swallow whole; do not chew. • See full prescribing information for alternative administration options. 2.1 Recommended Dosage in Patients 12 Years of Age and Older Table 1. Recommended Dexlansoprazole Delayed-Release Capsules Dosage Regimen by Indication in Patients 12 Years of Age and Older Indication Dosage of Dexlansoprazole Delayed-Release Capsules Duration Healing of EE One 60 mg capsule once daily. Up to 8 weeks. Maintenance of Healed EE and Relief of Heartburn One 30 mg capsule once daily. Controlled studies did not extend beyond 6 months in adults and 16 weeks in patients 12 to 17 years of age. Symptomatic Non-Erosive GERD One 30 mg capsule once daily. 4 weeks. 2.2 Dosage Adjustment in Patients with Hepatic Impairment for the Healing of Erosive Esophagitis For patients with moderate hepatic impairment (Child-Pug…
Contraindications
4 CONTRAINDICATIONS • Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11)] . Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)]. • PPIs, including dexlansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products [see Drug Interactions (7)]. • Patients with known hypersensitivity to any component of the formulation. ( 4 ) • Patients receiving rilpivirine-containing products. ( 4 , 7 )
Drug Interactions
7 DRUG INTERACTIONS Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with dexlansoprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3. Clinically Relevant Interactions Affecting Drugs Coadministered with Dexlansoprazole 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 dexlansoprazole may reduce antiviral effect and promote the development of drug resistance . Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with dexlansoprazole may increase toxicity of the antiretroviral drugs. There are other antiretroviral drugs which do not result in clinically relevant interactions with dexlansoprazole. Intervention: Rilpivirine-containing products : Concomita…
Adverse Reactions
6 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)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6)] • Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions (5.7)] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8)] • Fundic Gland Polyps [see Warnings and Precautions (5.11)] • Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age [see Warnings and Precautions (5.12)] The most common adverse reactions are: • Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. ( 6.1 ) • Patients 12 to 17 years of age (≥5%): headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Tr…
Frequently Asked Questions
What is Dexlansoprazole used for?
Dexlansoprazole contains Dexlansoprazole. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.
Is Dexlansoprazole a controlled substance?
Dexlansoprazole is not classified as a controlled substance by the DEA.
What is the generic name for Dexlansoprazole?
The generic name for Dexlansoprazole is Dexlansoprazole. There are 4 other brand versions of Dexlansoprazole.
What is the NDC code for Dexlansoprazole 30 mg/1?
The NDC (National Drug Code) for Dexlansoprazole 30 mg/1 is 49884-147, listed by Par Health USA, LLC.