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Esofag L Capsules (Esomeprazole + Levosulpiride).

  • Each capsule contains Esomeprazole 40 mg and Levosulpiride 75 mg SR.
  • Indicated for the short term therapy of GERD (gastroesophageal reflux disease) in patients who do not respond to PPI alone.
  • Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+ /K+ -ATPase in the gastric parietal cell. Levosulpiride is a prokinetic agent with dual mechanism of action. It blocks the enteric dopamine (D2) receptors (both neuronal & muscular) and also acts as an agonist at serotonin (5-HT4) receptor.
  • One capsule once daily before food.
  • Capsules are contraindicated in patients with a known hypersensitivity to esomeprazole, levosulpiride, or to substituted benzimidazoles or to any excipients used in the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticarial.
  • Therapy with esomeprazole does not preclude the presence of gastric malignancy. The use of proton pump inhibitors (including this medication) may increase the risk of a potentially serious condition known as Clostridium difficile-associated diarrhea (CDAD). The effects of levosulpiride on GI motility are antagonized by anticholinergic drugs and narcotic analgesics. Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
  • Pregnancy: Pregnancy Category C. Nursing mothers: Likely present in human milk. Caution should be exercised when administered to a nursing woman. Not recommended in children less than 12 years of age.
  • Co-administration of atazanavir with PPIs is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance. Avoid concomitant use of esomeprazole with St John’s wort or rifampin. Concomitant administration of esomeprazole and tacrolimus may increase the serum levels of tacrolimus.
  • The most common side effects are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
  • Anti-ulcerants_Gastroenterologicals