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Compared with conventional proton pump inhibitors (PPIs), Tegoprazan Tablets features a faster onset of action, more stable gastric acid inhibition, a lower risk of drug-drug interactions, and minimal impact on hepatic and renal function.
AuthenticGuaranteeFast DeliveryPrivacy As the first domestically developed P-CAB in China, Tegoprazan Tablets offers a novel therapeutic option for patients with acid-related diseases in China, and clinical studies for its additional indications are currently underway.
1.Reflux esophagitis.
2.Duodenal ulcer.
3.In combination with appropriate antibiotics for the eradication of Helicobacter pylori.
This product may be taken on an empty stomach or after meals.
Adults: 50mg once daily, for a continuous treatment of 8 weeks.
Adults: 50mg once daily, for a continuous treatment of 6 weeks.
Tegoprazan: 50mg twice daily. It is usually administered in combination with amoxicillin 1000mg, clarithromycin 500mg, and bismuth potassium citrate 240mg (calculated as bismuth oxide)- all twice daily - for 14 consecutive days.
This product is contraindicated in the following patients:
Patients with hypersensitivity or a history of hypersensitivity to this product, its components, or benzimidazole drugs.
Patients taking atazanavir, nelfinavir, or rilpivirine.
Pregnant and lactating women.
For information on the contraindications of drugs co-administered with tegoprazan (clarithromycin, amoxicillin and bismuth potassium citrate), refer to the contraindication section in their respective package inserts.
1. Metabolism and nutrition disorders
Common: Hyperlipidemia, hyperuricemia
Uncommon: Hypocalcemia, hypermagnesemia, anorexia
2. Gastrointestinal disorders
Uncommon: Nausea, reflux esophagitis, diarrhea, abdominal distension, constipation, abdominal discomfort, dry mouth, epigastric pain, gastric emptying disorder
3. Hepatobiliary disorders
Common: Abnormal liver functiona
Uncommon: Hepatic steatosis
4. Infections and infestations
Uncommon: Urinary tract infection, upper respiratory tract infection, viral infection, gastroenteritis, periodontitis, asymptomatic bacteriuria, bronchitis
5. Nervous system disorders
Very common: Headache
Uncommon: Dizziness, motor dysfunction
6. Renal and urinary disorders
Uncommon: Renal impairmentb, hematuria
7. Blood and lymphatic system disorders
Uncommon: Anemia, leukopenia, lymphadenitis, coagulation disorder
8. General disorders and administration site conditions
Uncommon: Asthenia, pyrexia
9. Cardiac disorders
Uncommon: Sinus bradycardia, sinus arrhythmia
10. Ear and labyrinth disorders
Uncommon: Tinnitus
11. Musculoskeletal and connective tissue disorders
Uncommon: Limb pain
12. Respiratory, thoracic and mediastinal disorders
Uncommon: Paranasal sinus cyst
13. Psychiatric disorders
Uncommon: Agitation
14. Skin and subcutaneous tissue disorders
Uncommon: Allergic dermatitis
Pregnancy
No clinical data on the use of this product in pregnant women are available. Animal studies have shown that when pregnant rats were administered 100 and 500 mg/kg/day (AUC approximately 98 and 369 times that of the clinical dose in humans), short supernumerary ribs were observed in fetal rats. Therefore, this product is contraindicated during pregnancy.
Lactating Women
Whether this product is excreted in human milk has not been determined. In animal studies, this product was detected in the milk of lactating rats after administration. Therefore, this product is contraindicated during lactation.
No clinical data on the use of this product in children or adolescents under 18 years of age are available.
Clinical experience with this product in elderly patients (aged 65 years and older) is limited.
In two Phase III clinical trials for the treatment of reflux esophagitis and duodenal ulcer, 10 elderly patients each received tegoprazan tablets 50 mg once daily. In the Phase III clinical trial for Helicobacter pylori eradication, a total of 10 elderly patients received tegoprazan tablets 50 mg twice daily. Results from these three Phase III clinical studies showed that the efficacy, incidence of adverse events, and common adverse reactions in elderly patients were similar to those in the overall population.
Due to the decline in overall physiological functions (such as hepatic and renal function) in elderly patients, this product should be used only after assessment.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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