lansoprazole

BEERS REMS

Erosive esophagitis.
Duodenal ulcers (with or without anti-infectives for Helicobacter pylori).
Active benign gastric ulcer.
Short-term treatment of symptomatic GERD.
Healing and risk reduction of NSAID-associated gastric ulcer.
Pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.

OTC

Heartburn occurring ≥twice/wk.

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.
Healing of duodenal ulcers and esophagitis.

Pharmacokinetics ⬆ ⬇

Absorption: 80% absorbed after oral administration.

Distribution: Unknown.

Protein Binding: 97%.

Metabolism/Excretion: Extensively metabolized by the liver to inactive compounds. Converted intracellularly to at least two other antisecretory compounds.

Half-Life: Children: 1.2–1.5 hr; Adults: 1.3–1.7 hr (↑ in geriatric patients and patients with impaired hepatic function).

Time/Action Profile ⬆ ⬇

(acid suppression)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	1.7 hr	more than 24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to lansoprazole or related drugs (benzimidazoles);
Concurrent use of rilpivirine-containing products.

Use Cautiously in:

Phenylketonuria (solutabs contain aspartame);
Severe hepatic impairment (do not exceed 30 mg/day);
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;
Lactation: Safety not established in breastfeeding;
Pedi: Children <1 yr (↑ risk of heart valve thickening);
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), rash, 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: diarrhea, abdominal pain, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), fundic gland polyps, nausea

GU: acute tubulointerstitial nephritis

Hemat: vitamin B₁₂ deficiency

MS: bone fracture

Neuro: dizziness, headache

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

Interactions ⬆ ⬇

Drug-drug:

May ↓ rilpivirine levels and ↑ risk of resistance; concurrent use contraindicated.
Sucralfate↓ absorption of lansoprazole (take 30 min before sucralfate).
May ↓ absorption of drugs requiring acid pH, including ketoconazole, itraconazole, atazanavir, nelfinavir, ampicillin esters, iron salts, erlotinib, and mycophenolate mofetil; avoid concurrent use with atazanavir and nelfinavir.
May ↑ levels of digoxin tacrolimus, and methotrexate.
May ↑ risk of bleeding with warfarin (monitor INR/PT).
Hypomagnesemia and hypokalemia ↑ risk of digoxin toxicity.

Route/Dosage ⬆ ⬇

PO (Adults ): Short-term treatment of duodenal ulcer: 15 mg once daily for 4 wk; H. pylori eradication to reduce the risk of duodenal ulcer recurrence: 30 mg twice daily with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 10–14 days (triple therapy) or 30 mg 3 times daily with 1000 mg amoxicillin 3 times daily for 14 days (dual therapy); Maintenance of healed duodenal ulcers: 15 mg once daily; Short-term treatment of gastric ulcers/healing of NSAID-associated gastric ulcer: 30 mg once daily for up to 8 wk; Risk reduction of NSAID-associated gastric ulcer: 15 mg once daily for up to 12 wk; Short-term treatment of symptomatic GERD: 15 mg once daily for up to 8 wk; Short-term treatment of erosive esophagitis: 30 mg once daily for up to 8 wk (8 additional wk may be necessary); Maintenance of healing of erosive esophagitis: 15 mg once daily; Pathologic hypersecretory conditions: 60 mg once daily initially, up to 90 mg twice daily (daily dose >120 mg should be given in divided doses).
PO (Adults ): OTC: 15 mg once daily for up to 14 days (14 day course may be repeated every 4 mo).
PO (Children 12–17 yr): Non-erosive GERD: 15 mg once daily for up to 8 wk; Erosive esophagitis: 30 mg once daily for up to 8 wk.
PO (Children 1–11 yr and >30 kg): GERD and Erosive Esophagitis: 30 mg once daily for up to 12 wk.
PO (Children 1–11 yr and ≤30 kg): GERD and Erosive Esophagitis: 15 mg once daily for up to 12 wk.

Availability ⬆ ⬇

(Generic available)

Delayed-release capsules: 15 mg^{Rx, OTC}; 30 mg
Delayed-release orally disintegrated tablets (SoluTabs): 15 mg^{Rx, OTC}; 30 mg
In combination with: amoxicillin and clarithromycin as part of a compliance package (Prevpac). See Appendix [not included in this PDA edition].

Assessment ⬆ ⬇

Assess patient routinely for epigastric or abdominal pain and for frank or occult blood in stool, emesis, or gastric aspirate.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of CDAD. May begin up to several wk following cessation of therapy.
Monitor for severe cutaneous reactions (SJS, TEN, DRESS, acute generalized exanthematous pustulosis). Discontinue lansoprazole at first signs of severe cutaneous reactions or hypersensitivity.

Lab Test Considerations:

May cause abnormal liver function tests, including ↑ AST, ALT, alkaline phosphatase, LDH, and bilirubin.
- May cause ↑ serum creatinine and ↑ or ↓ electrolyte levels.
- May alter RBC, WBC, and platelet levels.
- May also cause ↑ gastrin levels, abnormal A/G ratio, hyperlipidemia, and ↑ or ↓ cholesterol.
- Monitor INR and prothrombin time in patients taking warfarin.
- May cause hypomagnesemia. Monitor serum magnesium prior to and periodically during therapy.
- May cause vitamin B₁₂ deficiency with long term use (>3 yrs).
- May ↑ serum chromogranin levels which may interfere with diagnosis of neuroendocrine tumors.

Implementation ⬆ ⬇

PO: Delayed-release capsules: Administer before meals. DNC: Swallow whole; do not crush or chew capsule contents. Capsules may be opened and sprinkled on 1 tbsp of applesauce, Ensure, pudding, cottage cheese, yogurt, or strained pears and swallowed immediately for patients with difficulty swallowing. Capsule contents may also be sprinkled with intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – 2 oz.). Mix briefly and administer immediately.
- For patients with a nasogastric (NG) tube, capsules may be opened and intact granules may be mixed in 40 mL of apple juice and injected through the NG tube into stomach. Flush NG tube with additional apple juice to clear tube.
- Orally disintegrating tablets may be placed on tongue, allowed to disintegrate and swallowed with or without water. Do not cut or break tablet. For administration via oral syringe or NG tube, Prevacid SoluTab can be administered by placing a 15-mg tablet in oral syringe and drawing up 4 mL of water, or a 30-mg tablet in oral syringe and drawing up 10 mL of water. Shake gently to allow for a quick dispersal. After tablet has dispersed, administer the contents within 15 min. Refill syringe with 2 mL (5 mL for the 30-mg tablet) of water, shake gently, and administer any remaining contents and flush NG tube.
- Antacids may be used concurrently.

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 unless almost time for next dose; do not double doses. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
May occasionally cause dizziness. Caution patient to avoid driving and other activities that require alertness until response to medication is known.
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. Instruct patient to notify health care professional immediately if rash, diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professional.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in abdominal pain or prevention of gastric irritation and bleeding. Healing of duodenal ulcers can be seen on x-ray examination or endoscopy. Therapy is continued for at least 2–4 wk. Therapy for pathologic hypersecretory conditions may be long term.
Healing in patients with erosive esophagitis. Therapy is continued for up to 8 wk, and an additional 8-wk course may be used for patients who do not heal in 8 wk or whose ulcer recurs.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇