dexlansoprazole

Contraindicated in:

Hypersensitivity to dexlansoprazole or related drugs (benzimidazoles)
Severe hepatic impairment
Concurrent use of rilpivirine.

Use Cautiously in:

Moderate hepatic impairment
Patients using high doses for >1 yr (↑ risk of hip, wrist, or spine fractures and fundic gland polyps)
Patients using therapy for >3 yr (↑ risk of vitamin B₁₂ deficiency)
Pre-existing risk of hypocalcemia
OB: Safety not established in pregnancy
Lactation: Safety not established in breastfeeding
Pedi: Children <12 yr (safety and effectiveness not established); ↑ risk of heart valve thickening in children <2 yr
Geri: Appears on Beers list. ↑ risk of Clostridioides difficile infection, pneumonia, GI malignancies, bone loss, and fractures in older adults. Avoid scheduled use for >8 wk in older adults unless for high-risk patients (e.g. oral corticosteroid or chronic NSAID use) or patients with erosive esophagitis, Barrett's esophagitis, pathological hypersecretory condition, or demonstrated need for maintenance therapy (e.g. failure of H₂ antagonist).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, cutaneous lupus erythematosus, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

F and E: hypocalcemia (especially if treatment duration ≥3 mo), hypokalemia (especially if treatment duration ≥3 mo), hypomagnesemia (especially if treatment duration ≥3 mo).

GI: abdominal pain, diarrhea, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), flatulence, fundic gland polyps, nausea, vomiting.

GU: acute tubulointerstitial nephritis.

Hemat: vitamin B₁₂ deficiency.

MS: bone fracture.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, OR ACUTE TUBULOINTERSTITIAL NEPHRITIS), systemic lupus erythematosus.

Interactions ⬆ ⬇

Drug-Drug:

May ↓ absorption of drugs requiring acid pH, including ketoconazole, itraconazole, atazanavir, nelfinavir, rilpivirine, ampicillin esters, iron salts, erlotinib, and mycophenolate mofetil; concurrent use with rilpivirine contraindicated; avoid concurrent use with atazanavir and nelfinavir.
May ↑ levels of digoxin, methotrexate, and tacrolimus.
May ↑ effect of warfarin.
Hypomagnesemia and hypokalemia ↑ risk of digoxin toxicity.

Availability ⬆ ⬇

(Generic available)

Delayed-release capsules: 30 mg; 60 mg;

Route/Dosage ⬆ ⬇

PO (Adults and Children ≥12 yr): Healing of erosive esophagitis: 60 mg once daily for up to 8 wk; Maintenance of healed erosive esophagitis: 30 mg once daily for up to 6 mo (adults) and up to 16 wk (12–17 yr old); GERD: 30 mg once daily for 4 wk.

Hepatic Impairment

PO (Adults): Moderate hepatic impairment: Not to exceed 30 mg/day.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to an enzyme in the presence of acidic gastric pH, preventing the final transport of hydrogen ions into the gastric lumen.

Therapeutic Effects:

Diminished accumulation of acid in the gastric lumen, with lessened acid reflux.

Classifications ⬆ ⬇

Therapeutic Classification: antiulcer agents

Pharmacologic Classification: proton pump inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: 96–99%.

Metabolism/Excretion: Extensively metabolized by the liver, primarily by the CYP2C19 and CYP3A4 isoenzymes); the CYP2C19 isoenzyme exhibits genetic polymorphism (15–20% of Asian patients and 3–5% of Caucasian and Black patients may be poor metabolizers and may have significantly ↑ dexlansoprazole concentrations and an ↑ risk of adverse effects); no active metabolites. No renal elimination.

Half-life: 1–2 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK*	DURATION
PO	unknown	1–2 hr (1st); 4–5 hr (2nd)	24 hr

*Reflects effects of delayed release capsule.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed for the full course of therapy, even if feeling better. Take missed doses as soon as remembered but not if just before next scheduled dose; do not double doses.
Advise patient to avoid alcohol, products containing aspirin or NSAIDs, and foods that may cause an increase in GI irritation.
Advise patient to report onset of black, tarry stools; diarrhea; or abdominal pain to health care professional promptly, especially if accompanied by fever or bloody stools. Do not treat with antidiarrheals without consulting health care professional.
Advise patient to notify health care professional if signs and symptoms of hypomagnesemia (seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking [tremors], muscle weakness, spasms of the hands and feet, cramps or muscle aches, spasm of the voice box) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

dex-lan-SOE-pra-zole

Code ⬆

NDC Code^*

50090- A-S Medication Solutions
50090-4374- Dexilant 50090-4374-0- 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4374-0)

55154- Cardinal Health
55154-5154- Dexilant 55154-5154-8- 1800 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55154-5154-8)

64764- Takeda Pharmaceuticals America, Inc.
64764-171- Dexilant 64764-171-00- 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-00)

64764- Takeda Pharmaceuticals America, Inc.
64764-171- Dexilant 64764-171-01- 5 BLISTER PACK in 1 TRAY (64764-171-01) > 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

64764- Takeda Pharmaceuticals America, Inc.
64764-171- Dexilant 64764-171-03- 1 BOTTLE in 1 CARTON (64764-171-03) > 5 CAPSULE, DELAYED RELEASE in 1 BOTTLE

64764- Takeda Pharmaceuticals America, Inc.
64764-171- Dexilant 64764-171-11- 10 BLISTER PACK in 1 CARTON (64764-171-11) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

64764- Takeda Pharmaceuticals America, Inc.
64764-171- Dexilant 64764-171-19- 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-19)

64764- Takeda Pharmaceuticals America, Inc.
64764-171- Dexilant 64764-171-30- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-30)

64764- Takeda Pharmaceuticals America, Inc.
64764-171- Dexilant 64764-171-90- 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-90)

64764- Takeda Pharmaceuticals America, Inc.
64764-175- Dexilant 64764-175-00- 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-00)

64764- Takeda Pharmaceuticals America, Inc.
64764-175- Dexilant 64764-175-01- 5 BLISTER PACK in 1 TRAY (64764-175-01) > 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

64764- Takeda Pharmaceuticals America, Inc.
64764-175- Dexilant 64764-175-02- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-02)

64764- Takeda Pharmaceuticals America, Inc.
64764-175- Dexilant 64764-175-11- 10 BLISTER PACK in 1 CARTON (64764-175-11) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

64764- Takeda Pharmaceuticals America, Inc.
64764-175- Dexilant 64764-175-19- 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-19)

64764- Takeda Pharmaceuticals America, Inc.
64764-175- Dexilant 64764-175-30- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-30)

64764- Takeda Pharmaceuticals America, Inc.
64764-175- Dexilant 64764-175-90- 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-90)

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Indications ⬇

Contraind./Precautions ⬆ ⬇