Rabeprazole sodium INN 20mg/tablet
Indication:
1. Short-term treatment (4 to 8 weeks) in the healing & symptomatic relief of 'erosive or ulcerative gastro·esophageal reflux diseases (GERD)'.
2. Treatment for maintaining healing and reduction in relapse rates of heart burn symptoms in patients with 'erosive or ulcerative gastroesophageal reflux diseases (GERD)' .
3. Healing of duodenal ulcers: Short·term (up to 4 weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within 4 weeks.
4. Long-term treatment of pathological hypersecretory conditions including Zollinger· Ellison syndrome. CII: Known hypersensitivity to the drug or substituted benzimidazoles. Symptomatic response to therapy does not preclude the presence of gastric malignancy.
Side Effects: Generally rabeprazole is well tolerated in both short-term and long-term trials. The following adverse events were reported with rabeprazole in both short term and long term treatments . Body as a whole asthenia, fever, allergic reaction, chills, malaise, chest pain (substernal), neck rigidity, photosensitivity reaction. Rarely, 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, thrombophlebitis, vasodilation, QTC prolongation and ventricular tachycardia.
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.
Hematinic & lymphatic system: anemia, ecchymosis, lymphadenopathy, hypochromic anemia. Metabolic & nutritional diorders: peripheral edema, edema, weight gain, gout, dehydration, weight loss. Musculo-skeletal system: myalgia, arthritis, leg cramps, bone pain, arthrosis, bursitis. Raretwitching.
Nervous system: insomnia, anxiety, dizziness, depression, nervousness, somnolence, hypertonia, neuralgia, vertigo, convulsion, abnormal dreams, libido decreased, neuropathy, paresthesia, tremor. Rare-agitation, amnesia, confusion, extrapyramidal syndrome, hyperkinesia. Respiratory system: dyspnea, asthma, epistaxis, laryngitis, hiccup, hyperven-tilation. Rareapnea, hypo ventilation.
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.
Caution & Warnings: No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised.
Pregnancy & lactation: No adequate and wellcontrolled studies in pregnant worrien. In animal studies have revealed no evidence of impaired fertility or harm to the fetus due to rabeprazole. Since many drugs are excreted in the milk, and there are potential for adverse reactions to nursing infants from rabeprazole, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Dosage & administration: Healing of 'erosive or ulcerative gastro-esophageal reflux diseases (GERD)': The recommended dose is 20mg daily for 4 to 8 weeks. Patients who have not healed after 8 weeks of treatment, an additional 8-weeks course may be considered. Maintaining healing & reduction in relapse rates of heart burn symptoms in patients with 'erosive or ulcerative gastro-esophageal reflux diseases (GERD),: The recommended dose is 20mg daily Healing of duodenal ulcers: The recommended dose is 20mg daily in the morning for 4 weeks Treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome. The dosage of rabeprazole in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended starting dose is 60mg once day. Doses should be adjuster to individual patient's need and continued for as long as clinically indicated. Some patients may require divided doses Doses up to 100mg divided in to 4 times and 60mg in to 2 times daily may be administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with rabeprazole for up to one year. Rabeprazole tablets should be swallowed whole, and not be chewed crushed, or split.
Drug interaction: Rabeprazole is metabolized by the cytochrome P450 drug metabolizing enzyme system, but it does not have clinically significant interactions with other drugs metabolized by the CYP450 enzyme system, such as warfarin, theophylline, diazepam, phenytoin etc.
Indication:
1. Short-term treatment (4 to 8 weeks) in the healing & symptomatic relief of 'erosive or ulcerative gastro·esophageal reflux diseases (GERD)'.
2. Treatment for maintaining healing and reduction in relapse rates of heart burn symptoms in patients with 'erosive or ulcerative gastroesophageal reflux diseases (GERD)' .
3. Healing of duodenal ulcers: Short·term (up to 4 weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within 4 weeks.
4. Long-term treatment of pathological hypersecretory conditions including Zollinger· Ellison syndrome. CII: Known hypersensitivity to the drug or substituted benzimidazoles. Symptomatic response to therapy does not preclude the presence of gastric malignancy.
Side Effects: Generally rabeprazole is well tolerated in both short-term and long-term trials. The following adverse events were reported with rabeprazole in both short term and long term treatments . Body as a whole asthenia, fever, allergic reaction, chills, malaise, chest pain (substernal), neck rigidity, photosensitivity reaction. Rarely, 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, thrombophlebitis, vasodilation, QTC prolongation and ventricular tachycardia.
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.
Hematinic & lymphatic system: anemia, ecchymosis, lymphadenopathy, hypochromic anemia. Metabolic & nutritional diorders: peripheral edema, edema, weight gain, gout, dehydration, weight loss. Musculo-skeletal system: myalgia, arthritis, leg cramps, bone pain, arthrosis, bursitis. Raretwitching.
Nervous system: insomnia, anxiety, dizziness, depression, nervousness, somnolence, hypertonia, neuralgia, vertigo, convulsion, abnormal dreams, libido decreased, neuropathy, paresthesia, tremor. Rare-agitation, amnesia, confusion, extrapyramidal syndrome, hyperkinesia. Respiratory system: dyspnea, asthma, epistaxis, laryngitis, hiccup, hyperven-tilation. Rareapnea, hypo ventilation.
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.
Caution & Warnings: No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised.
Pregnancy & lactation: No adequate and wellcontrolled studies in pregnant worrien. In animal studies have revealed no evidence of impaired fertility or harm to the fetus due to rabeprazole. Since many drugs are excreted in the milk, and there are potential for adverse reactions to nursing infants from rabeprazole, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Dosage & administration: Healing of 'erosive or ulcerative gastro-esophageal reflux diseases (GERD)': The recommended dose is 20mg daily for 4 to 8 weeks. Patients who have not healed after 8 weeks of treatment, an additional 8-weeks course may be considered. Maintaining healing & reduction in relapse rates of heart burn symptoms in patients with 'erosive or ulcerative gastro-esophageal reflux diseases (GERD),: The recommended dose is 20mg daily Healing of duodenal ulcers: The recommended dose is 20mg daily in the morning for 4 weeks Treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome. The dosage of rabeprazole in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended starting dose is 60mg once day. Doses should be adjuster to individual patient's need and continued for as long as clinically indicated. Some patients may require divided doses Doses up to 100mg divided in to 4 times and 60mg in to 2 times daily may be administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with rabeprazole for up to one year. Rabeprazole tablets should be swallowed whole, and not be chewed crushed, or split.
Drug interaction: Rabeprazole is metabolized by the cytochrome P450 drug metabolizing enzyme system, but it does not have clinically significant interactions with other drugs metabolized by the CYP450 enzyme system, such as warfarin, theophylline, diazepam, phenytoin etc.