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Pharmacologic class: Proton pump inhibitor
Therapeutic class: GI agent
Pregnancy risk category B
Suppresses gastric acid secretion by specific inhibition of (H+, K+)-ATPase in the gastric parietal cell.
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
• Moderate hepatic impairment
• Hypersensitivity to drug or its components
Use cautiously in:
• moderate renal impairment
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).
• Administer with or without food.
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
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
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
• Monitor renal function tests closely.
• 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.
ClassificationTherapeutic: antiulcer agents
Pharmacologic: proton pump inhibitors
Time/action profile (blood levels)
|PO||unknown||1–2 hr (1st); 4–5 hr (2nd)||24 hr|
Adverse Reactions/Side Effects
- pseudomembranous colitis (life-threatening)
- abdominal pain (most frequent)
- diarrhea (most frequent)
Fluid and Electrolyte
- hypomagnesemia (especially if treatment duration ≥3 mo)
- bone fracture
Drug-Drug interaction↓ levels of atazanavir ; do not administer concurrently.May ↓ absorption of drugs requiring acid pH for absorption, including ampicillin, iron salts, digoxin, erlotinib, and ketoconazole.May ↑ effect of warfarin.May ↑ tacrolimus and methotrexate levels.Hypomagnesemia ↑ risk of digoxin toxicity.
Hepatic ImpairmentOral (Adults) Moderate hepatic impairment—daily dose should not exceed 30 mg.
- Assess patient routinely for epigastric or abdominal pain and for frank or occult blood in stool, emesis, or gastric aspirate.
- Monitor bowel elimination. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis.
- Lab Test Considerations: May cause abnormal liver function tests, including ↑AST, ALT, and ↑ or ↓ serum bilirubin.
- May cause ↑ serum creatinine and BUN, ↑ blood glucose, and ↑ serum potassium, and ↓ serum magnesium levels.
- May cause ↓ platelet levels.
- May also cause ↑ gastrin and total protein levels.
- Monitor INR and prothrombin time in patients taking warfarin.
Potential Nursing DiagnosesAcute pain (Indications)
- Oral: May be administered without regard to food. Swallow capsules whole or may be opened and sprinkled on 1 tbsp of applesauce and swallowed immediately, without crushing or chewing, for patients with difficulty swallowing.
- Capsules may be opened and granules emptied into 20 mL water. Withdraw entire mixture into syringe; swirl gently to mix. Administer mixture into mouth or NG tube immediately; do not save for later. Rinse syringe with 10 mL or water twice to ensure all medication administered.
- Instruct patient to take medication as directed for the full course of therapy, even if feeling better. Take missed doses as soon as remembered. Brand name was formerly Kapidex.
- 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.
- 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.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Decrease in abdominal pain, heartburn, gastric irritation, and bleeding in patients with GERD; may require up to 4 wk of therapy.
- Healing in patients with erosive esophagitis; may require up to 8 wk of therapy for healing and 6 mo of therapy for maintenance.