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Rabeprazole
Pronunciation
U.S. Brand Names
Synonyms
Pharmacological Index
Use
Pregnancy Risk Factor
Pregnancy/Breast-Feeding Implications
Contraindications
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Stability
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms

Pronunciation
(ra BE pray zole)

U.S. Brand Names
Aciphex™

Synonyms
Pariprazole

Pharmacological Index

Gastric Acid Secretion Inhibitor


Use

Short-term (4-8 weeks) treatment and maintenance of erosive or ulcerative gastroesophageal reflux disease (GERD); short-term (up to 4 weeks) treatment of duodenal ulcers; long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Also, possibly used for H. pylori eradication, symptomatic GERD, maintenance of healing of GERD, and maintenance of duodenal ulcer


Pregnancy Risk Factor

B


Pregnancy/Breast-Feeding Implications

Not recommended


Contraindications

Contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation


Warnings/Precautions

Severe hepatic impairment; relief of symptoms with rabeprazole does not preclude the presence of a gastric malignancy


Adverse Reactions

1% to 10%: Central nervous system: Headache

<1%:

Body as a whole: Weakness, fever, allergic reaction, chills, malaise, chest pain substernal, neck rigidity, photosensitivity reaction

Rare: Abdomen enlarged, face edema, hangover effect

Cardiovascular system: Hypertension, myocardial infarct, electrocardiogram abnormal, migraine, syncope, angina pectoris, bundle branch block, palpitation, sinus bradycardia, tachycardia

Rare: Bradycardia, pulmonary embolus, supraventricular tachycardia

Central nervous system: Insomnia, anxiety, dizziness, depression, nervousness, somnolence, hypertonia, neuralgia, vertigo, convulsions, abnormal dreams, libido decreased, neuropathy, paresthesia, tremor

Rare: Agitation, amnesia, confusion, extrapyramidal syndrome, hyperkinesia

Digestive system: Diarrhea, nausea, abdominal pain, vomiting, dyspepsia, flatulence, constipation, dry mouth, eructation, gastroenteritis, rectal hemorrhage, melena, anorexia, cholelithiasis, mouth ulceration, stomatitis, dysphagia, gingivitis, cholecystitis, increased appetite, abnormal stools, colitis, esophagitis, glossitis, pancreatitis, proctitis

Rare: Bloody diarrhea, cholangitis, duodenitis, gastrointestinal hemorrhage, hepatic encephalopathy, hepatitis, hepatoma, liver fatty deposit, salivary gland enlargement, thirst

Endocrine system: Hyperthyroidism, hypothyroidism

Hemic & lymphatic system: Anemia, ecchymosis, lymphadenopathy, hypochromic anemia

Metabolic & nutritional disorders: Peripheral edema, edema, weight gain, gout, dehydration, weight loss

Neuromuscular & skeletal: Myalgia, arthritis, leg cramps, bone pain, arthrosis, bursitis

Rare: Twitching

Respiratory system: Dyspnea, asthma, epistaxis, laryngitis, hiccups, hyperventilation

Rare: Apnea, hypoventilation

Skin & appendages: Rash, pruritus, sweating, urticaria, alopecia

Rare: Dry skin, herpes zoster, psoriasis, skin discoloration

Special senses: Cataract, amblyopia, glaucoma, dry eyes, abnormal vision, tinnitus, otitis media

Rare: Corneal opacity, blurry vision, diplopia, deafness, eye pain, retinal degeneration, strabismus

Urogenital system: Cystitis, urinary frequency, dysmenorrhea, dysuria, kidney calculus, metrorrhagia, polyuria

Rare: Breast enlargement, hematuria, impotence, leukorrhea, menorrhagia, orchitis, urinary incontinence


Overdosage/Toxicology

There has been no experience with large overdoses with rabeprazole. Seven reports of accidental overdosage with rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs of symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg/day. No specific antidote for rabeprazole is known. The single oral dose of 2000 mg/kg was not lethal to dogs.


Drug Interactions

Cytochrome P-450 inhibitor (extremely high concentrations); may alter the absorption of pH-dependent drugs (eg, ketoconazole, digoxin)


Stability

Rapidly degraded in acid conditions; may give antacid with rabeprazole


Mechanism of Action

Potent proton pump inhibitor; suppresses gastric acid secretion by inhibiting the parietal cell H+/K+ ATP pump


Pharmacodynamics/Kinetics

Onset of action: 1 hour

Peak effect: Peak plasma concentrations occur within 2-5 hours

Duration: 24 hours

Absorption: Well absorbed following oral administration by 1 hour

Distribution: 96.3%

Protein binding, serum: 94.8% to 97.5%

Metabolism: Metabolized by CYP3A and 2C19 in the liver to inactive metabolites

Bioavailability: Oral: 52%

Half-life, elimination: 0.85-2 hours (dose-dependent)

Time to peak serum concentration: 2-5 hours

Elimination: 90% eliminated in urine, primarily as thioether carboxylic acid; remainder of dose found in feces


Usual Dosage

Adults >18 years and Elderly:

Duodenal ulcer: 20 mg/day after breakfast for 4 weeks

Hypersecretory conditions: 60 mg once daily; dose may need to be adjusted as necessary. Doses as high as 100 mg and 60 mg twice daily have been used.


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects or complications reported


Patient Information

Swallow whole - do not crush, chew, or split tablet; take before eating


Nursing Implications

Do not crush tablet


Dosage Forms

Tablet, delayed release (enteric coated): 20 mg


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