Action

Suppresses gastric acid secretion by specific inhibition of (H+, K+)-ATPase in the gastric parietal cell.

Availability

Capsule: 30 mg, 60 mg

Indications and dosages

➣ Healing of all grades of erosive esophagitis (EE)

Adults: 60 mg P.O. daily for up to 8 weeks

➣ Maintaining healing of EE

Adults: 30 mg P.O. daily for up to 6 months

➣ Symptomatic nonerosive gastro-esophageal reflux disease (GERD)

Adults: 30 mg P.O. daily for up to 4 weeks

Dosage adjustment

• Moderate hepatic impairment

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:

• moderate renal impairment

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).

Administration

• Administer with or without food.

Adverse reactions

CNS: asthenia, dizziness, headache, migraine headache, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia, abnormal dreams, anxiety, depression, insomnia, seizures

CV: angina, bradycardia, chest pain, palpitations, tachycardia, hypertension, deep vein thrombosis, arrhythmias, myocardial infarction

EENT: eye irritation, eye swelling, ear pain, tinnitus, vertigo, nasopharyngitis, pharyngitis, sinusitis

GI: nausea; vomiting; diarrhea; abdominal pain, discomfort, tenderness; flatulence; abnormal feces; anal discomfort; Barrett's esophagus; bezoar; abnormal bowel sounds; breath odor; microscopic colitis; colon and gastric polyps; constipation; dry mouth; duodenitis; dyspepsia; dysphagia; enteritis; eructation; esophagitis; gastritis; gastroenteritis; GI disorders; GI hypermotility disorders; GERD; ulcers and perforation; hematemesis; hematochezia; hemorrhoids; impaired gastric emptying; irritable bowel syndrome; mucus stools; oral mucosa blistering; painful defecation; proctitis; oral paresthesia; oral herpes; rectal hemorrhage

GU: vulvovaginal infection, libido changes, dysuria, micturition urgency, dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder

Hematologic: anemia, lymphadenopathy

Hepatic: biliary colic, cholelithiasis, hepatomegaly

Metabolic: goiter

Musculoskeletal: arthralgia, arthritis, cramps, musculoskeletal pain, myalgia; hip, wrist, spine fracture (with long-term daily use)

Respiratory: upper respiratory tract infection, aspiration, asthma, bronchitis, cough, dyspnea, hyperventilation, respiratory tract congestion, sore throat

Skin: rash, sunburn, acne, dermatitis, erythema, pruritus, lesions, urticaria

Other: edema, chills, abnormal feeling, inflammation, mucosal inflammation, nodule, pain, pyrexia, candidal infection, viral infection, influenza, falls, overdose, procedural pain, weight gain, appetite changes, altered taste, hiccups, hot flushes, hypersensitivity

Interactions

Drug-drug. Atazanavir: decreased atazanavir level

Drugs with pH-dependent absorption (such as ampicillin esters, digoxin, iron salts, ketoconazole): interference with absorption of these drugs

Tacrolimus: increased tacrolimus whole blood concentration

Warfarin: increased International Normalized Ratio and prothrombin time

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood glucose, gastrin, potassium, serum creatinine, total protein: increased levels

Bilirubin: increased or decreased level

Liver function tests: abnormal results

Platelets, serum calcium: decreased levels

Patient monitoring

• Monitor renal function tests closely.

Patient teaching

• Instruct patient to take drug with or without food.

• Tell patient to swallow capsule whole or open capsule and sprinkle contents on 1 tablespoon of applesauce and swallow immediately.

• Instruct patient to report allergic reactions (such as rash or itching) to prescriber.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.