| Oral hypoglycemic, Hypolipidemic, Proton Pump inhibitor, B.ComplexVitamin |
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Esomeprazole
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| INFORMATION FOR USE OF A MEDICAL PRACTITIONER, HOSPITAL OR LABORATORY |
Each enteric coated tablet contains: Esomeprazole Magnesium Trihydrate eq. to Esomeprazole…20 |
| Each enteric coated tablet contains: Esomeprazole Magnesium Trihydrateeq. to Esomeprazole…40 |
PHARMACOLOGICAL CLASSIFICATION |
| Esomeprazole is in a class of drugs called proton pump inhibitors (PPIs) which block the production of acid by the stomach. |
Absorption of esomeprazole in healthy subjects results in peak plasma levels occurring 1 to 2 hours after dosing. The systemic bioavailability is 64% after a single 40 mg dose and 89% after repeated once daily oral administration (40 mg for 5 days). The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 L/kg body weight. Esomeprazole is 97% protein bound and optically stable in vivo, with negligible inversion to the other isomer.Esomeprazole is completely metabolized by the cytochrome P-450 system, mainly in the liver (via CYP 2C19 and CYP 3A4). The major metabolites of esomeprazole (hydroxy and desmethyl metabolites) have no effect on gastric acid secretion. The CYP 2C19 isozyme, which is involved in the metabolism of all available proton pump inhibitors, exhibits polymorphism. Some 3% of Caucasians and 15-20% of Asians lack CYP 2C19 and are termed "poor metabolizers." At steady state (40 mg for 5 days), the ratio of AUC in poor metabolizers to AUC in the rest of the population is approximately 2. Almost 80% of an oral dose of esomeprazole is excreted as metabolites in urine with the remainder recovered in feces. Less than 1% of the parent drug is found in urine. Total recovery from urine and feces is 92 to 96% within 48 hours of a single oral dose. ESAMIZOL is indicated for the treatment of: |
| · Gastroesophageal reflux disease (GERD)· Stomach ulcers caused by a certain type of bacteria (H. pylori) · NSAIDs induced peptic ulcer · Zollinger-Ellison Syndrome |
| Make sure you have told your doctor if you: · Have or have ever had liver disease. · Are pregnant, plan to become pregnant, or are breast-feeding. · If you are allergic to esomeprazole, lansoprazole omeprazole, pantoprazole rabeprazole, or any other medications. |
You must take your medicine as the doctor tells you. It is important to take ESAMIZOL Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. Esomeprazole 20 or 40 is usually taken once a day at least 1 hour before a meal. When esomeprazole is used to treat some conditions in which the stomach makes too much acid, it is taken twice a day. Take esomeprazole at around the same time(s) every day. Take the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed. WHAT TO DO IF AN OVERDOSE IS TAKEN |
In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. Symptoms of overdose may include confusion, extreme sweating, blurred vision, or unusually fast heartbeat. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of ESAMIZOL if you are taking: · Anticoagulants (blood thinners) such as warfarin · Atazanavir· Antifungal such as ketoconazole· Digoxin · Iron supplements |
Common side effects of ESAMIZOL include headache |
- diarrhea
- nausea
- gas
- stomach pain
- constipation
- dry mouth
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Serious side effects which may require medical attention include: · blisters or peeling skin · hives · rash · itching · difficulty breathing or swallowing · swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs · hoarseness |
· Keep all medicines out of the reach of children · Store it at room temperature and away from excess heat and moisture |
| Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice. |
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