Medication info
Neximazole Tablets 20mg (Esomeprazole Magnesium Trihydrate)

Neximazole Tablets 20mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Esomeprazole Magnesium Trihydrate (Micronized)›22.25mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Light pink round film-coated tablets
Packaging
28 tablets/box [14 tablets x 2 PTP]
Approval status
Active

MFDS item code 201707493 · Approved 2017.10.17 · Insurance code 649103700

Summary

Main use
Treatment of gastroesophageal reflux, gastrointestinal disorders (such as ulcers and Helicobacter pylori infection), and Zollinger-Ellison syndrome
Who uses it
Adults · Children
Adult dosage
This medicine should be swallowed with a liquid such as water. Do not chew or crush it. Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, take it for an additional 4 weeks. Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. Once symptoms have resolved, subsequent recurring symptoms are controlled by administering 20 mg once daily. In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurring symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. Administer this medicine 20 mg together with amoxicillin 1 g and clarithromycin 500 mg, twice daily for 7 days. 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. Clinical trials exceeding 4 weeks have not been conducted. Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The treatment period is 4∼8 weeks. Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The recommended initial dose is 40 mg twice daily. The subsequent dose should be adjusted for each patient, and treatment should continue while clinical symptoms are present. Clinical data indicate that most patients can be controlled with doses of 80 ∼ 160 mg daily. Doses greater than 80 mg daily should be divided into 2 doses. Administer 40 mg once daily for 4 weeks following induction of prevention of recurrent bleeding due to gastric or duodenal ulcers with intravenous administration. Renal impairment: No dose adjustment is necessary. Use with caution in patients with severe renal failure because there is limited experience with administration in these patients. Hepatic impairment: No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose of this medicine must not exceed 20 mg. Older adults: No dose adjustment is necessary.
Children's dosage
Adolescents aged 12 years and older — Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, take it for an additional 4 weeks. Adolescents aged 12 years and older — Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. Adolescents aged 12 years and older — Symptomatic treatment of gastroesophageal reflux disease without esophagitis: Once symptoms have resolved, subsequent recurring symptoms are controlled by administering 20 mg once daily. Children under 12 years: There is no experience with administration of this medicine to children under 12 years.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastroesophageal reflux, gastrointestinal disorders (such as ulcers and Helicobacter pylori infection), and Zollinger-Ellison syndrome

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • Helicobacter pylori positive duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease and erosive reflux esophagitis, and for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is also effective in alleviating symptoms of gastroesophageal reflux disease without esophagitis. The drug is utilized in combination therapy with antibiotics for the treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers and duodenal ulcers. It assists in treating upper gastrointestinal symptoms associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), as well as in the treatment and prevention of related gastric and duodenal ulcers. It is also used for the treatment of Zollinger-Ellison syndrome and for maintenance therapy following the prevention of rebleeding due to gastric or duodenal ulcers. This medication is effective in treating gastrointestinal diseases and improving symptoms.

Dosage and Administration

Adult dosage

This medicine should be swallowed with a liquid such as water. Do not chew or crush it. Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, take it for an additional 4 weeks. Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. Once symptoms have resolved, subsequent recurring symptoms are controlled by administering 20 mg once daily. In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurring symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. Administer this medicine 20 mg together with amoxicillin 1 g and clarithromycin 500 mg, twice daily for 7 days. 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. Clinical trials exceeding 4 weeks have not been conducted. Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The treatment period is 4∼8 weeks. Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The recommended initial dose is 40 mg twice daily. The subsequent dose should be adjusted for each patient, and treatment should continue while clinical symptoms are present. Clinical data indicate that most patients can be controlled with doses of 80 ∼ 160 mg daily. Doses greater than 80 mg daily should be divided into 2 doses. Administer 40 mg once daily for 4 weeks following induction of prevention of recurrent bleeding due to gastric or duodenal ulcers with intravenous administration. Renal impairment: No dose adjustment is necessary. Use with caution in patients with severe renal failure because there is limited experience with administration in these patients. Hepatic impairment: No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose of this medicine must not exceed 20 mg. Older adults: No dose adjustment is necessary.

Children's dosage

Adolescents aged 12 years and older — Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, take it for an additional 4 weeks. Adolescents aged 12 years and older — Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. Adolescents aged 12 years and older — Symptomatic treatment of gastroesophageal reflux disease without esophagitis: Once symptoms have resolved, subsequent recurring symptoms are controlled by administering 20 mg once daily. Children under 12 years: There is no experience with administration of this medicine to children under 12 years.

Precautions

This medication should not be used in patients with specific allergic reactions or those who have previously experienced hypersensitivity to this medication or to benzimidazole derivatives, penicillin, or macrolide antibiotics. Furthermore, patients with certain heart diseases, nursing women, and those taking some antiviral or cardiac medications should also avoid this medication. This medicine may cause a range of adverse reactions, from gastrointestinal symptoms like headache, abdominal pain, nausea, and diarrhea to skin rashes, myalgia, and, rarely, severe blood abnormalities or neurological symptoms. Especially with prolonged use, electrolyte imbalances such as hypomagnesemia may occur, necessitating regular blood tests. This drug suppresses gastric acid secretion and may cause bacterial overgrowth in the gastrointestinal tract, leading to an increased risk of diarrhea or infection. Prolonged use may increase the risk of fractures, so osteoporosis patients should be cautious. This medication contains certain sugars, so patients with certain genetic disorders should avoid it. This drug may interact with several other medications, so inform healthcare providers if taking other medications. Caution is advised when using this drug during pregnancy, and it is better not to take it while nursing. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and it should be stored out of the reach of children.

Side effects

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, paresthesia, drowsiness, taste disorder, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, increased liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, polymorphic eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, epileptic nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distention, allergic reaction, back pain, chest pain, substernal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, thyroid goiter, irritable bowel syndrome, exacerbation of constipation, dyspepsia, dysphagia, gastrointestinal motility disorders, epigastric pain, belching, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, melena, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, increased serum gastrin, tongue disorders, tongue edema, ulcerative stomatitis, earache, tinnitus, anemia, hypopigmented anemia, cervicofacial lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, xerostomia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, polymyalgia rheumatica, anorexia, apathy, increased appetite, confusion, exacerbation of depression, hypertonia, sensory loss, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremor, visual field defect, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal pruritus, erythematous rash, papulovesicular rash, otitis media, abnormal smell, taste loss, taste distortion, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infection, hematuria, urinary frequency, candidiasis, genital candidiasis, polyuria, conjunctivitis, visual disturbances, duodenitis, esophagitis, esophageal stricture, esophageal ulcer, esophageal varices, gastric ulcer, gastritis, benign polyp or nodule, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric gland polyp, hypocalcemia, hypokalemia, rhabdomyolysis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container that prevents air and moisture from entering. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Light pink round film-coated tablets

Package unit

28 tablets/box [14 tablets x 2 PTP]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.