Rabeprazole is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1H–benzimidazole sodium salt. It has an empirical formula of C18H20N3NaO3S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of Rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions.
Prompton ® 20mg capsule contains Rabeprazole Sodium INN 20mg in enteric coated pellets.
Prompton® capsule should be swallowed whole. Prompton® capsule can be taken with or without food. Healing of Erosive or Ulcerative GERD The recommended adult oral dose is Prompton® capsule to be taken once daily for four to eight weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Prompton® capsule may be considered. Maintenance of Healing of Erosive or Ulcerative GERD The recommended adult oral dose is one Prompton® capsule once daily. Treatment of Symptomatic GERD The recommended adult oral dose is one Prompton® capsule once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. Healing of Duodenal Ulcers The recommended adult oral dose is one Prompton® capsule once daily after the morning meal for a period up to 4 weeks. Most patients with duodenal ulcer heal within 4 weeks. A few patients may require additional therapy to achieve healing. Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Prompton® 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg Twice daily with the morning and evening meals for 7 days Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome The dosage of Prompton® capsule in patients with pathological hypersecretory conditions varies with the individual patient The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patients needs and should continue for as long as clinically indicated. Some patients may require divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Prompton® capsule for up to one year.
Rabeprazole capsules are generally well tolerated. The observed undesirable effects have been generally mild/moderate and transient in nature. The most common adverse events are headache, diarrhoea and nausea. The less common adverse effects are abdominal pain, asthenia, flatulence, rash, dry mouth etc.
Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole or to any component of the formulation.
Pregnancy category B. There are no adequate well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Since many drugs are excreted in milk, and becasue of the 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.
Rabeprazole like other PPIs is metabolized through Cytochrome P450 drug metabolizing enzyme system. But Rabeprazole does not have clinically significant interaction with other drugs metabolized by CYP P450 system, such as warfarin, theophylline, diazepam and phenytoin. Rabeprazole inhibits gastric acid secretion and may interfere with absorption of drugs where gastric pH is an important determinant of bioavailability e.g. ketoconazole, iron salts and digoxin. In studies no interaction with liquid antacid or foods was observed.
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. There has been no experience with large overdoses with Rabeprazole. Seven reports of accidental over dosage with Rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg Rabeprazole QD. No specific antidote for Rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable. In the event of over dosage, treatment should be symptomatic and supportive.
Single oral doses of Rabeprazole at 786 mg/kg and 1024 mg/kg were lethal to mice and rats, respectively. The single oral dose of 2000 mg/kg was not lethal to dogs. The major symptoms of acute toxicity were hypo activity, labored respiration, lateral or prone position, and convulsion in mice and rats and watery diarrhea, tremor, convulsion, and coma in dogs.
high air pressure DTH bit below 30ºC, away from light & moisture.Keep out of reach of children.
Prompton® 20 mg capsule: Each box contains 6 x 10’s capsules in Alu-Alu blister pack.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.