COMPOSITION
Somazole 40 capsule: Each capsule contains Esomeprazole INN 40 mg (as Esomeprazole Magnesium Trihydrate).
PHARMACOLOGY
Somazole (Esomeprazole) is the S-isomer of Omeprazole, a proton pump inhibitor that suppresses the gastric acid secretion by specific inhibition of the H+/K+ATPase (hydrogen-potassium-adenosine triphosphatase) enzyme system in the gastric parietal cell. By acting specifically on the proton pump, Somazole (Esomeprazole) blocks the final step in acid production, thus reducing gastric acidity
INDICATION
Somazole (Esomeprazole) capsules are indicated for the treatment of conditions where a reduction of gastric acid secretion is required such as: reflux esophagitis, maintenance treatment of patients with reflux esophagitis, symptomatic gastroesophageal reflux disease (i.e. heartburn and regurgitation), and H. pylori eradication.
Somazole (Esomeprazole), in combination with Clarithromycin and Amoxicillin, is indicated for the treatment of patients with duodenal ulcer disease associated with Helicobacter pylori infection to eradicate the H. pylori and heal ulcers. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
DOSE AND ADMINISTRATION
Treatment of GERD: 20 or 40 mg once daily for 4 to 8 weeks, NSAID-associated Gastric ulcer: 20 or 40 mg once daily for up to 6 months, For H.pylori eradication: 40 mg once daily for 10 days in combination with Amoxicillin and Clarithromycin.
CONTRAINDICATION
Hypersensitivity to Somazole (Esomeprazole), substituted benzimidazoles or any of the components of this medication. When used for eradication of Helicobacter pylori, the contraindications for Amoxicillin and Clarithromycin as found in the corresponding product monographs should be taken into consideration.
WARNING AND PRECAUTION
In the presence of any alarm symptom (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis or melena) and/or when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.
SIDE EFFECTS
Somazole (Esomeprazole) is well-tolerated. Most adverse events have been mild and transient, showing no consistent relationship with treatment. Only headache, diarrhea, flatulence, abdominal pain, nausea, vomiting, dizziness and dry mouth are thought to be associated with the use of Somazole (Esomeprazole).
USE IN PREGNANCY AND LACTATION
The safety of Somazole (Esomeprazole) in pregnancy has not been established. Somazole (Esomeprazole) capsule should not be administered to pregnant women unless the expected benefits outweigh the potential risks. No studies in lactating women have been performed. Therefore, Somazole (Esomeprazole) should not be given to nursing mothers unless its use is considered essential.
DRUG INTERACTION
There are no clinically significant interactions between Somazole (Esomeprazole) and Diazepam, Phenytoin, Warfarin, Quinidine or Cisapride
STORAGE
Store in a cool and dry place below 300C. Protect from light and moisture. Keep out of the reach of children.
PACKING
Box containing 5×6’s capsules in alu-alu pack.
