Pama Esomeprazole Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is unresolved or symptoms persist, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent relapse in patients with esophagitis: 20 mg once daily. - Treatment of GERD symptoms without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further examination is necessary. · Once symptoms are alleviated, subsequently persistent symptoms are managed with 20 mg once daily. · For adults, 20 mg can be given once daily as needed. It is not recommended for continuous symptomatic control for patients at high risk of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug use. 2) Combination therapy for eradicating Helicobacter pylori Administer 20 mg of this medication along with 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning) associated with non-steroidal anti-inflammatory drug (non-selective and selective COX-2) administration - 20 mg once daily. If symptoms are not controlled after 4 weeks, further examination is necessary. Clinical trials extending beyond 4 weeks have not been conducted. 4) For patients requiring continuous administration of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drug administration: 20 mg once daily for a treatment duration of 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug administration: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted based on the patient, and treatment should continue for as long as clinical symptoms are present. According to clinical data, most patients can be managed at doses of 80 to 160 mg daily. Doses exceeding 80 mg daily should be divided into two administrations. 6) Maintenance therapy following intravenous prevention of rebleeding from gastric or duodenal ulcers Following intravenous prevention of rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents over 12 years 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is unresolved or symptoms persist, continue for an additional 4 weeks. - Treatment of GERD symptoms without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further examination is necessary. · Once symptoms are alleviated, subsequently persistent symptoms are managed with 20 mg once daily. · For adults, 20 mg can be given once daily as needed. It is not recommended for continuous symptomatic control for patients at high risk of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug use. 3. For children under 12 years There is no experience administering this medication to children under 12 years. 4. Renal impairment There is no need to adjust the dosage. Due to limited cases in patients with severe renal failure, it should be administered with caution. 5. Hepatic impairment There is no need to adjust the dosage in patients with mild to moderate liver impairment. In patients with severe liver impairment, this medication should not exceed a dose of 20 mg. 6. Elderly There is no need to adjust the dosage.

Children's dosage

Adolescents over 12 years use the adult dosage. - Treatment for erosive reflux esophagitis: 40 mg once daily for 4 weeks. If not improved, take for an additional 4 weeks. - Treatment for GERD symptoms without esophagitis.

This medication should not be used in patients who are hypersensitive to this medication or any of its constituents, or to benzimidazole derivatives. Patients with hypersensitivity to some antibiotics used in combination with this medication for the eradication of Helicobacter pylori should also not receive this medication. It should not be administered to patients taking certain heart-related medications, or those with a history of myocardial infarction, or nursing mothers. This medication contains the dye Yellow No. 5, so patients with allergic reactions or hypersensitivity to this ingredient should use it cautiously. This medication can cause various adverse reactions, including headaches, abdominal pain, diarrhea, rash, myalgia, etc., affecting multiple body areas, and any unusual symptoms should be reported to healthcare professionals immediately. Long-term use may lead to electrolyte imbalances such as hypomagnesemia, necessitating regular blood tests. This medication suppresses gastric acid secretion which may increase bacterial proliferation in the gastrointestinal tract, potentially raising the risk of certain infections, so if symptoms like diarrhea persist, it is essential to inform a doctor. Due to the high potential for drug interactions, patients should inform healthcare professionals of any medications they are currently taking, especially when combined with anticoagulants, antiviral agents, antibiotics, etc. Data on the use of this medication during pregnancy is limited, so it should only be administered to pregnant women if necessary and with caution; during breastfeeding, it is considered safer not to use this medication. In case of overdose, there are no specific antidotes, so symptomatic treatment should be provided, and the medication should be kept out of reach of children to prevent accidents.

Serious side effects

Hives, angioedema, anaphylactic reactions/shock, jaundice, hepatitis, liver failure, encephalopathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, Clostridium difficile-associated diarrhea, severe allergic reactions, severe cutaneous adverse reactions, respiratory issues, liver abnormalities (jaundice),

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorders, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distention, allergic reactions, back pain,

This medication should be stored in a tightly sealed container to avoid contact with air or moisture, and it is safe to store at room temperature between 1 degree and 30 degrees Celsius. Maintaining appropriate temperature and container conditions can preserve the efficacy and safety of the medication over time.

Appearance

Light pink oval film-coated tablets

Package unit

28 tablets (14 tablets/Alu-Alu x 2)