Names and pronunciation
(rah-bep′rah-zole) Aciphex, Aciphex Sprinkle, Pariet
Source page 1120
Loading InternPractice…
Individual generic drug information
Extracted information for RABEprazole only.
(rah-bep′rah-zole) Aciphex, Aciphex Sprinkle, Pariet
Source page 1120
Func. class.: Antiulcer, proton pump inhibitor
Source page 1120
Chem. class.: Benzimidazole
Source page 1120
Do not confuse: Aciphex/Aricept/Accupril RABEprazole/ARIPiprazole
Source page 1120
ACTION: Suppresses gastric secretion by inhibiting hydrogen/potassium ATPase enzyme system in the gastric parietal cells; characterized as a gastric acid pump inhibitor because it blocks the final step of acid production
Source page 1120
USES: Gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive systemic GERD, pathologic hypersecretory conditions (Zollinger-Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas); treatment of active duodenal ulcers with/without antiinfectives for Helicobacter pylori; daytime, nighttime heartburn
Source page 1120
Unlabeled uses: Gastric ulcer, heart- burn, H. pylori eradication in children
Source page 1120
Extracted information for RABEprazole only.
CONTRAINDICATIONS: Hyper- sensitivity to this product or proton pump inhibitors (PPIs) Precautions: Pregnancy, breastfeeding, children, Asian patients, diarrhea, geriatric patients, gastric cancer, hepatic/ GI disease, IBS, osteoporosis, CDAD, ulcerative colitis, vit B12 deficiency
Source page 1120
SIDE EFFECTS CNS: Headache, dizziness EENT: Tinnitus, taste perversion GI: Diarrhea, abdominal pain, vomiting, nausea, constipation, flatulence, acid regurgitation, abdominal swelling, anorexia, hepatitis, hepatic encephalopathy, Clostridium difficile–associated diarrhea GU: UTI, proteinuria, hematuria MS: Back pain, arthralgia, myalgia, os- teoporosis, fractures MISC: Infection, Stevens-Johnson syndrome
Source page 1120
INTERACTIONS Increase: bleeding risk—warfarin, clop- idogrel Increase: serum levels of RABEpra- zole—benzodiazepines, phenytoin, cla rithromycin, antacids, other proton pump inhibitors, H2 blockers Increase: levels of—digoxin, nelfinavir/ omeprazole, methotrexate Decrease: levels of RABEprazole—sucral- fate, calcium carbonate, vit B12 Decrease: levels of ketoconazole, itracon- azole, iron salts, atazanavir/ritonavir, ampi- cillin, cycloSPORINE, protease inhibitors Drug/Herb Decrease: RABEprazole—St. John’s wort Drug/Lab Test Decrease: magnesium
Source page 1121
Extracted information for RABEprazole only.
DOSAGE AND ROUTES Healing of duodenal ulcers • Adult: PO 20 mg/day × ≤4 wk; to be taken after breakfast Healing of erosive esophagitis or ulcerative GERD • Adult: PO 20 mg/day × 4-8 wk; may use an additional course • Adolescent and child ≥12 yr: PO 20 mg/day up to 8 wk • Child 1-11 yr (≥15 kg): PO (sprinkle) 10 mg daily up to 12 wk • Child 1-11 yr (<15 kg): PO 5 mg daily up to 12 wk; may increase to 10 mg daily if needed H. pylori eradication • Adult: PO 20 mg bid × 7 days with amoxicillin 1 g bid × 7 days with clarithro- mycin 500 mg bid × 7 days Pathologic hypersecretory conditions • Adult: PO 60 mg/day; may increase to 120 mg in 2 divided doses Gastric ulcer (unlabeled) • Adult: PO 20 mg/day after AM meal × 3-6 wk Dyspepsia/heartburn (unlabeled) • Adult: PO 20 mg/day × ≤14 days
Source page 1120
Available forms: Del rel tabs 20 mg; del rel caps 5, 10 mg
Source page 1120
Administer: PO route • Do not break, crush, chew del-rel tab; after breakfast daily with full glass of water, without regard to food • Delayed-release capsule: open, use on spoonful of applesauce or liquid, give dose immediately (within 15 min), ½ hr before a meal; do not crush, chew delayed-release product
Source page 1120
Extracted information for RABEprazole only.
Assess: • GI system: bowel sounds, abdomen for pain, swelling, anorexia, emesis/stool for occult blood • Clostridium difficile–associated di- arrhea: may occur with most antibiotic therapy; watery diarrhea, abdominal pain, fever; may occur several weeks after treatment concludes • Vit B12/cyanocobalamin deficiency/ hypomagnesemia: may occur several weeks after treatment concludes; use magnesium, vit B12, cyanocobalamin supplement; if severe, discontinuation of product may be needed. Assess for low magnesium level: tremors, muscle sore- ness, spasms, anxiety, change in heart rate, palpitations • Hepatic studies: AST, ALT, alk phos during treatment; CBC with differential periodically • CBC with differential before, periodi- cally during treatment; blood dyscrasias may occur (rare) • Obtain susceptibility testing if H. pylori treatment is ineffective; another anti-in- fective may be needed • Osteoporosis/fractures: may occur with prolonged use (1 yr or longer) of high dose, usually in those ≥50 yr; make sure adequate vitamin D, calcium are taken • Beers: avoid scheduled use >8 wk in older adults unless for high-risk patients
Source page 1121
Evaluate: • Therapeutic response: absence of epi- gastric pain, swelling, fullness; decreased symptoms of GERD after 4-8 wk
Source page 1121
CLINICAL CONSIDERATIONS
Source page 1121
Patient and caregiver information: • CDAD to report severe diarrhea or black, tarry stools; product may have to be discontinued • To avoid hazardous activities because dizziness, drowsiness may occur • To avoid alcohol, salicylates, NSAIDs because they may cause GI irritation; to avoid other OTC, herbal products unless approved by prescriber • That osteoporosis and fractures are more common in those who take the product >1 yr • To use as directed for length of time prescribed; to take missed dose when re- membered; not to double dose; to take del-rel tab whole, do not cut, break; that cap should be opened and sprinkled on food (applesauce) to take within 15 min of being sprinkled and 30 min before meal; to take the tablet form for ulcers after meal, for H. pylori with morning/evening meals • To notify prescriber if pregnancy is planned, suspected R
Source page 1121
Extracted information for RABEprazole only.
PHARMACOKINETICS Eliminated in urine as metabolites and in feces, half-life 1-2 hr, metabolized by CYP2C19 enzyme system, protein binding 96.3%
Source page 1120
Filter the extracted dose blocks for this individual drug.
Healing of duodenal ulcers
• Adult: PO 20 mg/day × ≤4 wk; to be taken after breakfast Healing of erosive esophagitis or ulcerative GERD
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Adult: PO 20 mg/day × 4-8 wk; may use an additional course
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Adolescent and child ≥12 yr: PO 20 mg/day up to 8 wk
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Child 1-11 yr (≥15 kg): PO (sprinkle) 10 mg daily up to 12 wk
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Child 1-11 yr (<15 kg): PO 5 mg daily up to 12 wk; may increase to 10 mg daily if needed H. pylori eradication
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Adult: PO 20 mg bid × 7 days with amoxicillin 1 g bid × 7 days with clarithro- mycin 500 mg bid × 7 days Pathologic hypersecretory conditions
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Adult: PO 60 mg/day; may increase to 120 mg in 2 divided doses Gastric ulcer (unlabeled)
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Adult: PO 20 mg/day after AM meal × 3-6 wk Dyspepsia/heartburn (unlabeled)
Candidate age grouping · source page 1120
Healing of duodenal ulcers
• Adult: PO 20 mg/day × ≤14 days
Candidate age grouping · source page 1120