耐信说明书

[Common name]:

[Product name]: Nexium

[All names]: esomeprazole, Nexium, esomeprazole, Nexium

[Nexium Indications]:

1. Nexium is used for the treatment of gastroesophageal reflux disease (GERD), including the treatment of erosive reflux esophagitis, long-term maintenance treatment to prevent recurrence of cured esophagitis patients, and symptom control of gastroesophageal reflux disease (GERD).

2. Nexium combined with appropriate antibacterial therapy can eradicate Helicobacter pylori, heal duodenal ulcers related to Helicobacter pylori infection, and prevent the recurrence of peptic ulcers related to Helicobacter pylori infection. 

[Reliable usage and dosage]:

1. Treatment of erosive reflux esophagitis: 40 mg once a day for 4 weeks. For patients whose esophagitis is not cured or whose symptoms persist, a further 4 weeks of treatment is recommended.

2. Long-term maintenance treatment for cured esophagitis patients to prevent recurrence: 20 mg once a day.

3. Symptom control of GERD (gastroesophageal reflux disease): patients without esophagitis take 20 mg once a day. If symptoms are not controlled after 4 weeks of medication, the patient should undergo further examination. After the symptoms disappear, immediate therapy can be used (ie, 20 mg orally, once a day if necessary).

4. Combined antimicrobial therapy to eradicate Helicobacter pylori: Use a combined medication regimen of 20 mg of this drug once, 1 g of amoxicillin once, and 500 mg of clarithromycin once, twice a day for 7 days.

Tablets should be swallowed whole with liquid and should not be chewed or crushed.

For patients with difficulty swallowing, put it into boiled water until the tablet is completely disintegrated and take it within 30 minutes. 

[Nexium Adverse Reactions]:

>10%:

Central nervous system: headache (2%-11%)

1%-10%:

Central nervous system: irritability (infants: ≥5%), dizziness (intravenous injection: ≤3%; oral administration: <1%), vertigo (intravenous injection: ≤3%), somnolence (children: 2%; adults: <1%)

Dermatology: Pruritus (IV: 1%; Oral: <1%)

Endocrine and metabolism: changes in thyroid hormone levels (increased thyroxine: ≤1%), decreased serum potassium (≤1%), decreased serum sodium (≤1%), decreased thyroid hormone (decreased thyroxine: ≤1%), increased gastrin (≤1%), increased serum potassium (≤1%), increased serum sodium (≤1%), increased thyroid-stimulating hormone (≤1%), increased uric acid (≤1%)

Gastrointestinal: Flatulence (IV: 10%; PO: ≥1%), diarrhea (2%-4%), abdominal pain (1%-6%), nausea (IV: 6%; PO: ≥1%-2%), vomiting (infants: 1% to ≥5%; adults: <1%), dry mouth (IV: 4%; PO: ≥1%), constipation (IV: 3%; PO: ≥1%)

Hematology and Oncology: Platelet count disorders (≤1%)

Liver: elevated serum alkaline phosphatase (≤1%), elevated serum alanine aminotransferase (≤1%), elevated serum aspartate aminotransferase (≤1%)

Local: injection site reaction (intravenous injection: 2%-4%)

Kidney: Elevated serum creatinine (≤1%)

<1%:

Post-marketing or case reports: Acne vulgaris, acute interstitial nephritis, aggressive behavior, restlessness, agranulocytosis, proteinuria, alopecia, olfactory changes, anaphylactic shock, allergic reaction, anemia, angioedema, anorexia, apathy, aphtha, arthralgia, arthritis, fatigue, back pain, blurred vision, fractures, bronchospasm, candidiasis, etc. 

【Nexium Taboo】:

Hypersensitivity reaction (e.g., anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to Nexium, other substituted benzimidazole proton pump inhibitors, or any component of the formulation; use with products containing rilpivirine. 

[Notes on Nexium]:

Carcinoma: There have been no reports of enterochromaffin-like (ECL) cell carcinoid tumors, dysplasia, or tumor formation.

Clostridium difficile-associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase the risk of CDAD (Clostridium difficile-associated diarrhea), particularly in hospitalized patients; patients with persistent diarrhea do not feel improved by a CDAD (Clostridium difficile-associated diarrhea) diagnosis. Use the lowest dose and shortest duration of PPI (proton pump inhibitor) therapy appropriate to treat the disease.

Cutaneous and systemic lupus erythematosus: New onset or exacerbations of autoimmune diseases have been reported; most cases are cutaneous lupus erythematosus (CLE), most commonly subacute CLE (occurring within weeks to years after continued treatment). Systemic lupus erythematosus (SLE) is less common (usually occurring within days to years after starting treatment) and occurs primarily among young and older adults. If symptoms of CLE or SLE occur, stop treatment and seek evaluation by a specialist; most patients improve within 4 to 12 weeks after stopping treatment.

[Nexium Storage]:

Seal and store below 30℃.