ESORAL DESCRIPTION
Each tablet contains 20 mg or 40 mg Esoral (as magnesium trihydrate). Each tablet contains Esoral as enteric-coated pellets (MUPS). Esoral MUPS is a proton pump inhibitor. The active ingredient in Esoral MUPS is Esoral magnesium trihydrate, a substituted benzimidazole. Esoral is the S-isomer of omeprazole. It is optically stable in vivo, with negligible conversion to the R-isomer. The chemical name is di-(S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl] sulfinyl] -1H- benzimidazole magnesium salt trihydrate. Its molecular formula is C34H36N6O6S2Mg·3H2O and has a molecular weight of 767.2 (trihydrate). Excipients/Inactive Ingredients: Glycerol monostearate 40-55, hyprolose, hypromellose, iron oxide (E 172) (Tablet 20 mg, reddish-brown CI 77491, yellow, CI 77492) (Tablet 40 mg, reddish-brown CI 77491), magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 percent, cellulose microcrystalline, synthetic paraffin, macrogols, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and maize starch), talc, titanium dioxide (E 171), triethyl citrate. Esoral 20 mg: Sucrose 28 mg. Esoral 40 mg: Sucrose 30 mg.
Usual Adult Dose for Gastroesophageal Reflux Disease:
Esoral Magnesium: -20 mg orally once a day for 4 weeks
Esoral Strontium: -24.65 mg orally once a day for 4 to 8 weeks.
Comment:Â -If symptoms do not resolve after 4 weeks, an additional 4 weeks may be considered. GERD with Erosive Esophagitis:
Esoral Sodium:Â -20 mg or 40 mg IV injection once a day, over no less than 3 minutes; or IV infusion once a day, over no less than 10 to 30 minutes Comment: Safety and efficacy of Esoral sodium IV for Injection for more than 10 days have not been demonstrated. Uses: Short term treatment of heartburn and symptomatic gastroesophageal reflux disease; short term treatment of GERD with erosive esophagitis, inclusively as an alternative to oral therapy, if unable to use oral route
Â
Usual Adult Dose for Erosive Esophagitis:
Healing:
-Esomeprazole Magnesium: 20 to 40 mg orally once a day for 4 to 8 weeks
-Esomeprazole Strontium: 24.65 to 49.3 mg orally once a day for 4 to 8 weeks -An additional 4 to 8 week course of therapy may be considered in patients not healed after initial treatment.
Maintenance of healing:
- -Esomeprazole Magnesium: 20 mg orally once a day
- -Esomeprazole Strontium: 24.65 mg orally once a daily
Comments:
- Esomeprazole Sodium injection may be used as an alternative to oral therapy, if unable to use oral route.
- Maintenance of healing: Controlled studies did not extend beyond six months.
Uses:
Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis; to maintain symptom resolution and healing of erosive esophagitis
ESORAL SIDE EFFECTS
Clinical Trials Experience with
Intravenous Esoral
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults
The safety of intravenous Esoral is based on results from clinical trials conducted in four different populations including patients having symptomatic GERD with or without a history of erosive esophagitis (n=199), patients with erosive esophagitis (n=160), healthy subjects (n=204) and patients with bleeding gastric or duodenal ulcers (n=375).
Reviews
There are no reviews yet.