Omeprazole
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omeprazole (oh me' pray zol) Losec (CAN), Prilosec Pregnancy Category C Drug classes
Antisecretory agent Proton pump inhibitor Therapeutic actions
Gastric acid-pump inhibitor: Suppresses gastric acid secretion by specific inhibition of the hydrogen-potassium ATPase enzyme system at the secretory surface of the gastric parietal cells; blocks the final step of acid production. Indications
• • • • • • • •
Short-term treatment of active duodenal ulcer First-line therapy in treatment of heartburn or symptoms of gastroesophageal reflux disease (GERD) Short-term treatment of active benign gastric ulcer GERD, severe erosive esophagitis, poorly responsive symptomatic GERD Long-term therapy: Treatment of pathologic hypersecretory conditions (ZollingerEllison syndrome, multiple adenomas, systemic mastocytosis) Eradication of H. pylori with amoxicillin or metronidazole and clarithromycin Prilosec OTC: Treatment of frequent heartburn (2 or more days per wk) Unlabeled use: Posterior laryngitis; enhance efficacy of pancreatin for the treatment of steatorrhea in cystic fibrosis
Contraindications and cautions
• •
Contraindicated with hypersensitivity to omeprazole or its components. Use cautiously with pregnancy, lactation.
Available forms
DR capsules—10, 20, 40 mg; DR tablets—20 mg (OTC) Dosages ADULTS
• • •
Active duodenal ulcer: 20 mg PO daily for 4–8 wk. Should not be used for maintenance therapy. Active gastric ulcer: 40 mg PO daily for 4–8 wk. Severe erosive esophagitis or poorly responsive GERD: 20 mg PO daily for 4–8 wk. Do not use as maintenance therapy. An additional 4–8 wk course can be considered if needed.
• •
Pathologic hypersecretory conditions: Individualize dosage. Initial dose is 60 mg PO daily. Doses up to 120 mg tid have been used. Administer daily doses of > 80 mg in divided doses. Frequent heartburn (2 or more days/wk): 20 mg (Prilosec OTC tablet) PO once daily before eating in the AM for 14 days. May repeat the 14-day course q 4 mo.
PEDIATRIC PATIENTS
Safety and efficacy not established. Pharmacokinetics Route Oral
Onset Varies
Peak 0.5–3.5 hr
Metabolism: Hepatic; T1/2: 0.5–1 hr Distribution: Crosses placenta; may enter breast milk Excretion: Urine and bile Adverse effects
• • • • •
CNS: Headache, dizziness, asthenia, vertigo, insomnia, apathy, anxiety, paresthesias, dream abnormalities Dermatologic: Rash, inflammation, urticaria, pruritus, alopecia, dry skin GI: Diarrhea, abdominal pain, nausea, vomiting, constipation, dry mouth, tongue atrophy Respiratory: URI symptoms, cough, epistaxis Other: Cancer in preclinical studies, back pain, fever
Interactions
Drug-drug • Increased serum levels and potential increase in toxicity of benzodiazepines, phenytoin, warfarin; if these combinations are used, monitor patient very closely • Decreased absorption with sucralfate; give these drugs at least 30 min apart Nursing considerations Assessment
• •
History: Hypersensitivity to omeprazole or any of its components; pregnancy, lactation Physical: Skin lesions; T; reflexes, affect; urinary output, abdominal exam; respiratory auscultation
Interventions
• • •
Administer before meals. Caution patient to swallow capsules whole—not to open, chew, or crush them. Arrange for further evaluation of patient after 8 wk of therapy for gastroreflux disorders; not intended for maintenance therapy. Symptomatic improvement does not rule out gastric cancer, which did occur in preclinical studies. Administer antacids with omeprazole, if needed.
Teaching points
• • •
•
Take the drug before meals. Swallow the capsules whole; do not chew, open, or crush them. This drug will need to be taken for up to 8 wk (short-term therapy) or for a prolonged period (> 5 yr in some cases). Have regular medical follow-up visits. These side effects may occur: Dizziness (avoid driving or performing hazardous tasks); headache (request medications); nausea, vomiting, diarrhea (maintain proper nutrition); symptoms of upper respiratory tract infection, cough (do not self-medicate; consult with your health care provider if uncomfortable). Report severe headache, worsening of symptoms, fever, chills.
Adverse effects in Italic are most common; those in Bold are life-threatening.
Antisecretory agent Proton pump inhibitor Therapeutic actions
Gastric acid-pump inhibitor: Suppresses gastric acid secretion by specific inhibition of the hydrogen-potassium ATPase enzyme system at the secretory surface of the gastric parietal cells; blocks the final step of acid production. Indications
• • • • • • • •
Short-term treatment of active duodenal ulcer First-line therapy in treatment of heartburn or symptoms of gastroesophageal reflux disease (GERD) Short-term treatment of active benign gastric ulcer GERD, severe erosive esophagitis, poorly responsive symptomatic GERD Long-term therapy: Treatment of pathologic hypersecretory conditions (ZollingerEllison syndrome, multiple adenomas, systemic mastocytosis) Eradication of H. pylori with amoxicillin or metronidazole and clarithromycin Prilosec OTC: Treatment of frequent heartburn (2 or more days per wk) Unlabeled use: Posterior laryngitis; enhance efficacy of pancreatin for the treatment of steatorrhea in cystic fibrosis
Contraindications and cautions
• •
Contraindicated with hypersensitivity to omeprazole or its components. Use cautiously with pregnancy, lactation.
Available forms
DR capsules—10, 20, 40 mg; DR tablets—20 mg (OTC) Dosages ADULTS
• • •
Active duodenal ulcer: 20 mg PO daily for 4–8 wk. Should not be used for maintenance therapy. Active gastric ulcer: 40 mg PO daily for 4–8 wk. Severe erosive esophagitis or poorly responsive GERD: 20 mg PO daily for 4–8 wk. Do not use as maintenance therapy. An additional 4–8 wk course can be considered if needed.
• •
Pathologic hypersecretory conditions: Individualize dosage. Initial dose is 60 mg PO daily. Doses up to 120 mg tid have been used. Administer daily doses of > 80 mg in divided doses. Frequent heartburn (2 or more days/wk): 20 mg (Prilosec OTC tablet) PO once daily before eating in the AM for 14 days. May repeat the 14-day course q 4 mo.
PEDIATRIC PATIENTS
Safety and efficacy not established. Pharmacokinetics Route Oral
Onset Varies
Peak 0.5–3.5 hr
Metabolism: Hepatic; T1/2: 0.5–1 hr Distribution: Crosses placenta; may enter breast milk Excretion: Urine and bile Adverse effects
• • • • •
CNS: Headache, dizziness, asthenia, vertigo, insomnia, apathy, anxiety, paresthesias, dream abnormalities Dermatologic: Rash, inflammation, urticaria, pruritus, alopecia, dry skin GI: Diarrhea, abdominal pain, nausea, vomiting, constipation, dry mouth, tongue atrophy Respiratory: URI symptoms, cough, epistaxis Other: Cancer in preclinical studies, back pain, fever
Interactions
Drug-drug • Increased serum levels and potential increase in toxicity of benzodiazepines, phenytoin, warfarin; if these combinations are used, monitor patient very closely • Decreased absorption with sucralfate; give these drugs at least 30 min apart Nursing considerations Assessment
• •
History: Hypersensitivity to omeprazole or any of its components; pregnancy, lactation Physical: Skin lesions; T; reflexes, affect; urinary output, abdominal exam; respiratory auscultation
Interventions
• • •
Administer before meals. Caution patient to swallow capsules whole—not to open, chew, or crush them. Arrange for further evaluation of patient after 8 wk of therapy for gastroreflux disorders; not intended for maintenance therapy. Symptomatic improvement does not rule out gastric cancer, which did occur in preclinical studies. Administer antacids with omeprazole, if needed.
Teaching points
• • •
•
Take the drug before meals. Swallow the capsules whole; do not chew, open, or crush them. This drug will need to be taken for up to 8 wk (short-term therapy) or for a prolonged period (> 5 yr in some cases). Have regular medical follow-up visits. These side effects may occur: Dizziness (avoid driving or performing hazardous tasks); headache (request medications); nausea, vomiting, diarrhea (maintain proper nutrition); symptoms of upper respiratory tract infection, cough (do not self-medicate; consult with your health care provider if uncomfortable). Report severe headache, worsening of symptoms, fever, chills.
Adverse effects in Italic are most common; those in Bold are life-threatening.
