Nexipra Tablets 40 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medication should be swallowed with water or other liquids and must not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: administer 40 mg once daily for 4 weeks. - For patients with persistent symptoms or incomplete healing, an additional 4 weeks of treatment is recommended. - Maintenance therapy to prevent recurrence in patients with esophagitis: administer 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: administer 20 mg once daily; if symptoms do not improve after 4 weeks, further evaluation is needed. - Once symptoms improve, continuous symptoms should be managed with 20 mg once daily. - For adults, the dosage of 20 mg once daily can be administered on an as-needed basis. It is not recommended to administer it on an as-needed basis for patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori Administer this medication 20 mg with amoxicillin 1 g and clarithromycin 500 mg twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory drug use (non-selective and selective COX-2) - Administer 20 mg once daily; if symptoms do not improve after 4 weeks, further evaluation is necessary. Trials exceeding 4 weeks have not been conducted. 4) For patients requiring continuous non-steroidal anti-inflammatory drug therapy - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drug use: administer 20 mg once daily for a treatment duration of 4-8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug use: administer 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended starting dosage is 40 mg administered twice daily. The dosage should be adjusted for each patient, and treatment should continue while clinical symptoms are present. According to clinical data, most patients can be managed with a dosage range of 80 to 160 mg per day. For doses exceeding 80 mg per day, it should be divided and taken twice daily. 6) Maintenance therapy for the prevention of re-bleeding from gastric or duodenal ulcers following intravenous induction Administer 40 mg once daily for 4 weeks following intravenous induction for prevention of re-bleeding from gastric or duodenal ulcers. 2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: administer 40 mg once daily for 4 weeks. If treatment is ineffective or symptoms persist, an additional 4 weeks is recommended. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · Administer 20 mg once daily; if symptoms do not improve after 4 weeks, further evaluation is necessary. · Once symptoms improve, ongoing symptoms should be managed with 20 mg once daily. · For adults, the dosage of 20 mg once daily can be administered as needed. It is not recommended to administer it on an as-needed basis for patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug use. 3. Children under 12 years: There is no experience administering this medication to children under 12. 4. Renal dysfunction: No dose adjustment is necessary. Caution is advised, as there are limited cases in patients with severe renal failure. 5. Liver dysfunction: No dose adjustment is necessary for patients with mild to moderate liver impairment. Patients with severe liver impairment should not exceed a dosage of 20 mg. 6. Elderly: No dose adjustment is necessary.

Children's dosage

For adolescents aged 12 years and older, the same dosing as adults applies. However, there is no experience administering this medication to children under 12 years old.

This medication should not be administered to certain patients. For example, it should not be used by those allergic to this medication or its ingredients, or who have a hypersensitivity to certain antibiotics. Additionally, patients with heart-related diseases or breastfeeding women are advised to avoid this medication. This drug can cause various side effects, such as headache, dizziness, nausea, vomiting, skin rash, and other symptoms. Regular check-ups are necessary during long-term use, and if symptoms change while using this medication, it is crucial to consult a physician. This medication can interact with other drugs, so it is important to inform healthcare providers of any medications being taken. Specifically, this medication reduces gastric acid secretion, which may promote bacterial growth in the digestive tract, increasing the risk of infections such as diarrhea. There may also be an increased risk of fractures, so patients at risk of osteoporosis should exercise caution. Long-term use of this medication may lead to low blood magnesium levels, thus magnesium supplementation and regular blood tests are recommended. Additionally, there may be rare occurrences of severe skin reactions or autoimmune diseases, so if unusual symptoms arise, the patient should cease use immediately and consult a specialist. The safety of this medication during pregnancy has not been adequately established; therefore, pregnant women must consult a doctor before use, and it is recommended that breastfeeding women do not take this medication. In case of overdose, there are no specific antidotes, so appropriate treatment should be provided based on symptoms, and safe storage, such as keeping out of reach of children, is necessary.

Serious side effects

• Urticaria, angioedema, anaphylaxis, shock, severe allergic reactions
• Severe rash, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS syndrome, serious skin adverse reactions
• Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, bronchospasm
• Skin or eyes turning yellow (jaundice), hepatitis, liver.

Mild side effects

• Headache
• dizziness
• paresthesia
• drowsiness
• taste disorders
• blurred vision
• bronchospasm
• abdominal pain
• constipation
• diarrhea

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, the medication should be kept away from extremely hot or cold places, ideally stored at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Pink circular film-coated tablets

Package unit

28 tablets (14 tablets/PTP × 2)