Dexilant

DEXILANT- dexlansoprazole capsule, delayed release
Cardinal Health

1 INDICATIONS AND USAGE

1.1 Healing of Erosive Esophagitis

DEXILANT is 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

DEXILANT is 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

DEXILANT is 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Patients 12 Years of Age and Older

Table 1. Recommended DEXILANT Capsules Dosage Regimen by Indication in Patients 12 Years of Age and Older
Indication Dosage of DEXILANT 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-Pugh Class B), the recommended dosage is 30 mg DEXILANT once daily for up to eight weeks. DEXILANT is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)].

2.3 Important Administration Information

Take without regard to food.
Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
Swallow whole; do not chew.
For patients who have trouble swallowing capsules, DEXILANT capsules can be opened and administered with applesauce as follows:
1.
Place one tablespoonful of applesauce into a clean container.
2.
Open capsule.
3.
Sprinkle intact granules on applesauce.
4.
Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use.
Alternatively, the capsule can be administered with water via oral syringe or nasogastric (NG) tube.
Administration with Water in an Oral Syringe
5.
Open the capsule and empty the granules into a clean container with 20 mL of water.
6.
Withdraw the entire mixture into a syringe.
7.
Gently swirl the syringe in order to keep granules from settling.
8.
Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use.
9.
Refill the syringe with 10 mL of water, swirl gently, and administer.
10.
Refill the syringe again with 10 mL of water, swirl gently, and administer.
Administration with Water via a NG Tube (≥16 French)
11.
Open the capsule and empty the granules into a clean container with 20 mL of water.
12.
Withdraw the entire mixture into a catheter-tip syringe.
13.
Swirl the catheter-tip syringe gently in order to keep the granules from settling, and immediately inject the mixture through the NG tube into the stomach. Do not save the water and granule mixture for later use.
14.
Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube.
15.
Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.

3 DOSAGE FORMS AND STRENGTHS

DEXILANT delayed-release capsules

30 mg: strength is an opaque, blue and gray capsule imprinted with “TAP” and “30″.
60 mg: strength is an opaque, blue capsule imprinted with “TAP” and “60″.

4 CONTRAINDICATIONS

DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11)]. Hypersensitivity reactions, including anaphylaxis have been reported [see Adverse Reactions (6.1, 6.2)]. Acute interstitial nephritis (AIN) has been reported with other proton pump inhibitors (PPIs), including lansoprazole of which dexlansoprazole is the R-enantiomer.
PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with DEXILANT 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 Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue DEXILANT if acute interstitial nephritis develops [see Contraindications (4)].

5.3 Clostridium difficile- Associated Diarrhea

Published observational studies suggest that PPI therapy like DEXILANT may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.4 Bone Fracture

Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2), Adverse Reactions (6.2)].

5.5 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.
The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.
Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI-associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.
Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving DEXILANT, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in four to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.