Medication info

Lansoprazole Capsule 30mg (Lansoprazole Granule)

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Lansoprazole Granules›353mg / 1 capsule
Manufacturer / importer
Korea Sintax Pharmaceutical Co., Ltd.
Appearance
A hard capsule filled with white or almost white round or oval granules.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Expired

MFDS item code 202000314 · Approved 2020.01.21

This product's status changed to Expired on 2025.01.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of peptic ulcer disease (including eradication therapy), gastroesophageal reflux disease, and gastric acid hypersecretion
Who takes it
Adults · Children
Adult dose
This medication should be administered before meals. For patients who have difficulty swallowing the medication, open the capsule, mix the contents with a small amount (60 mL) of orange juice or tomato juice, and administer immediately. To ensure the entire dose is taken, rinse the glass with twice as much or more juice and drink immediately. After opening the capsule, do not chew or crush the contents before taking them. 1. Short-term treatment of active duodenal ulcers: Administer lansoprazole 15 mg orally once daily for 4 weeks. 2. Short-term treatment of active benign gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. 3. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers 1) Administer lansoprazole 30 mg with clarithromycin 250 ∼ 500 mg and amoxicillin 1,000 mg twice daily (every 12 hours) for 7 days. Treatment may be continued for up to 14 days if needed. 2) Administer lansoprazole 30 mg with amoxicillin 1,000 mg three times daily (every 8 hours) for 14 days. 4. Maintenance therapy after treatment of duodenal ulcers: Administer lansoprazole 15 mg orally once daily. The duration of comparative clinical trials did not exceed 12 months. 5. Treatment of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. The duration of comparative clinical trials did not exceed 8 weeks. 6. Reduction of the risk of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 15 mg orally once daily for 12 weeks. The duration of comparative clinical trials did not exceed 12 weeks. 7. Short-term treatment of symptoms associated with gastroesophageal reflux disease Administer lansoprazole 15 mg orally once daily for 8 weeks 8. Short-term treatment of erosive reflux esophagitis: Administer lansoprazole 30 mg orally once daily for 8 weeks. 9. Maintenance therapy after treatment of erosive reflux esophagitis: Administer lansoprazole 15 mg orally once daily. 10. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The lansoprazole dosage for pathological hypersecretory conditions should be individualized. The usual starting dose for adults is 60 mg once daily. The dose should be adjusted according to the patient's needs and may be continued as long as it is clinically effective. Doses of 90 mg per dose up to twice daily have been administered. If the daily dose exceeds 120 mg, it should be given in divided doses. Because clearance of this medication is reduced in elderly patients, dosage adjustment is necessary. Do not exceed a daily dose of 30 mg. Use with caution, including dosage adjustment, in patients with hepatic impairment, as the metabolism and excretion of this medication may be delayed.
Child dose
Children and adolescents aged 12 ∼ 17 years - Short-term treatment of symptoms associated with non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks Children and adolescents aged 12 ∼ 17 years - Short-term treatment of erosive reflux esophagitis: 30 mg once daily for 8 weeks Children aged 1 ∼ 11 years, 30 kg or less: 15 mg once daily for 12 weeks Children aged 1 ∼ 11 years, over 30 kg: 30 mg once daily for 12 weeks

Ingredients

Manufacturer
Korea Sintax Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of peptic ulcer disease (including eradication therapy), gastroesophageal reflux disease, and gastric acid hypersecretion

  • Active duodenal ulcer
  • active benign gastric ulcer
  • recurrent duodenal ulcer
  • NSAID-induced gastric ulcer
  • symptoms related to gastroesophageal reflux disease
  • erosive esophagitis
  • Zollinger-Ellison syndrome
  • pathological hypersecretion.
View approved original text

This medication is used for the short-term treatment of duodenal ulcers and gastric ulcers, and it helps prevent ulcer recurrence by eradicating Helicobacter pylori. Additionally, it is effective for treating gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs) and reducing the risk of occurrence. It is also used for the short-term treatment and maintenance therapy of gastroesophageal reflux disease and erosive esophagitis, as well as for improving symptoms in conditions characterized by excessive gastric acid production, such as Zollinger-Ellison syndrome. Overall, this medication is very useful in the treatment and management of gastrointestinal diseases.

How to take

Adult dose

This medication should be administered before meals. For patients who have difficulty swallowing the medication, open the capsule, mix the contents with a small amount (60 mL) of orange juice or tomato juice, and administer immediately. To ensure the entire dose is taken, rinse the glass with twice as much or more juice and drink immediately. After opening the capsule, do not chew or crush the contents before taking them. 1. Short-term treatment of active duodenal ulcers: Administer lansoprazole 15 mg orally once daily for 4 weeks. 2. Short-term treatment of active benign gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. 3. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers 1) Administer lansoprazole 30 mg with clarithromycin 250 ∼ 500 mg and amoxicillin 1,000 mg twice daily (every 12 hours) for 7 days. Treatment may be continued for up to 14 days if needed. 2) Administer lansoprazole 30 mg with amoxicillin 1,000 mg three times daily (every 8 hours) for 14 days. 4. Maintenance therapy after treatment of duodenal ulcers: Administer lansoprazole 15 mg orally once daily. The duration of comparative clinical trials did not exceed 12 months. 5. Treatment of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. The duration of comparative clinical trials did not exceed 8 weeks. 6. Reduction of the risk of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Administer lansoprazole 15 mg orally once daily for 12 weeks. The duration of comparative clinical trials did not exceed 12 weeks. 7. Short-term treatment of symptoms associated with gastroesophageal reflux disease Administer lansoprazole 15 mg orally once daily for 8 weeks 8. Short-term treatment of erosive reflux esophagitis: Administer lansoprazole 30 mg orally once daily for 8 weeks. 9. Maintenance therapy after treatment of erosive reflux esophagitis: Administer lansoprazole 15 mg orally once daily. 10. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The lansoprazole dosage for pathological hypersecretory conditions should be individualized. The usual starting dose for adults is 60 mg once daily. The dose should be adjusted according to the patient's needs and may be continued as long as it is clinically effective. Doses of 90 mg per dose up to twice daily have been administered. If the daily dose exceeds 120 mg, it should be given in divided doses. Because clearance of this medication is reduced in elderly patients, dosage adjustment is necessary. Do not exceed a daily dose of 30 mg. Use with caution, including dosage adjustment, in patients with hepatic impairment, as the metabolism and excretion of this medication may be delayed.

Child dose

Children and adolescents aged 12 ∼ 17 years - Short-term treatment of symptoms associated with non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks Children and adolescents aged 12 ∼ 17 years - Short-term treatment of erosive reflux esophagitis: 30 mg once daily for 8 weeks Children aged 1 ∼ 11 years, 30 kg or less: 15 mg once daily for 12 weeks Children aged 1 ∼ 11 years, over 30 kg: 30 mg once daily for 12 weeks

Precautions

This medication should not be administered to patients with hypersensitivity to certain components. For example, symptoms can be severe if allergic to this drug or benzimidazole derivatives. Patients allergic to penicillin and macrolide antibiotics should also exercise caution when using this medication in combination, as the risk of adverse effects may increase with certain antibiotics. It is safer for pregnant or breastfeeding women to avoid using this medication, as it can affect the fetus or infant. Patients with liver dysfunction, elderly individuals, children, or those with a history of drug allergies should be particularly cautious when using this medication. Serious allergic reactions, blood abnormalities, liver dysfunction, or severe skin reactions can rarely occur while taking this medication; therefore, it is important to closely monitor one’s health condition. If symptoms such as rash, difficulty breathing, facial swelling, severe diarrhea, or abdominal pain occur, one should consult with healthcare professionals immediately. This medication can suppress gastric acid secretion, which may affect the absorption of other drugs; therefore, consultation with a doctor or pharmacist is essential if there are other medications to take concurrently. Long-term use may lead to vitamin B12 deficiency or magnesium deficiency, so regular testing is required. Moreover, long-term administration of this medication may increase the risk of fractures, hence caution is warranted. Dizziness, drowsiness, or visual disturbances may occur while taking this medication, necessitating caution when driving or operating machinery. There is no specific antidote for overdose, but gastric lavage or symptomatic treatment may be needed if necessary. Finally, keep this medication out of reach of children and do not transfer it to another container.

Side effects

Anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, generalized rash, facial edema, dyspnea, shock, pancytopenia, agranulocytosis, hemolytic anemia, neutropenia, thrombocytopenia, anemia, jaundice, elevated AST, elevated ALT, toxic liver dysfunction, toxic epidermal necrolysis, mucocutaneous syndrome, Stevens-Johnson syndrome, interstitial pneumonia, fever, cough, abnormal lung sounds, interstitial nephritis, acute renal failure, membranous colitis, hematochezia, abdominal pain, frequent diarrhea, headache, diarrhea, abdominal distension, allergic reaction, back pain, weakness, candidiasis, carcinoma, chills, chest pain, edema, fever, flu-like symptoms, halitosis, infection, malaise, neck stiffness, pelvic pain, angina pectoris, arrhythmia, bradycardia, tachycardia, cerebrovascular accident, cerebral infarction, hypertension, hypotension, migraine, myocardial infarction, palpitations, vasodilation, syncope, abnormal stools, enteritis, gastritis, gastrointestinal abnormalities, gastrointestinal diseases, gastrointestinal bleeding, loss of appetite, bezoar, pyloric spasm, cholelithiasis, constipation, thirst, dry mouth, dyspepsia, dysphagia, belching, esophageal stricture, esophageal ulcer, esophagitis, stool discoloration, bloating, gastric nodules, gastric fundic polyps, gastroenteritis, upper gastrointestinal bleeding, hematemesis, increased appetite, increased saliva, anal bleeding, stomatitis, tongue disorders, glossitis, gum bleeding, late-onset disease, colitis, vomiting, nausea, gastric candidiasis, rectal disorders, rectal bleeding, diabetes mellitus, goiter, hypothyroidism, anemia, hemorrhage, lymphadenopathy, vitamin deficiency, gout, hyperglycemia, hypoglycemia, dehydration, weight gain, weight loss, peripheral edema, bone diseases, joint diseases, leg cramps, arthritis, arthralgia, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis, agitation, amnesia, anxiety, apathy, confusion, depression, dizziness, syncope, hallucination, unilateral paralysis, worsening hostility, decreased libido, increased libido, neurosis, sensory disturbance, abnormal thinking, convulsions, dementia, depersonalization, diplopia, hyperkinesia, hypertonia, sensory loss syndrome, insomnia, sleep disorders, drowsiness, tremor, asthma, bronchitis, increased cough, nasal bleeding, hemoptysis, hiccups, pneumonia, upper respiratory infection, laryngeal tumors, pulmonary fibrosis, pharyngitis, pleural disorders, respiratory disorders, rhinitis, sinusitis, wheezing, acne, alopecia, pruritus, rash, urticaria, contact dermatitis, dry skin, nail disorders, skin cancer, skin diseases, sweating, abnormal vision, amblyopia, blepharitis, cataract, conjunctivitis, dry eyes, ear diseases, eye diseases, glaucoma, abnormal olfaction, photophobia, retinal degeneration, loss of taste, blurred vision, deafness, ocular pain, otitis media, taste disturbance, tinnitus, visual field constriction, urinary disorders, kidney pain, penile disorders, testicular disorders, urethral pain, polyuria, frequency, urinary retention, menstrual irregularities, chest tenderness, chest expansion, gynecomastia, diabetes, hematuria, erectile dysfunction, nephrolithiasis, hepatotoxicity, pancreatitis, taste disorders, aplastic anemia, leukopenia, neutropenia, thrombotic thrombocytopenic purpura, eosinophilia, hypomagnesemia, Clostridium difficile-associated diarrhea, fracture, myositis, erythema multiforme, systemic lupus erythematosus, discoid lupus erythematosus, acute generalized pustular psoriasis, speech disorder, urinary retention, elevated AST, elevated ALT, elevated ALP, elevated LDH, elevated γ-GTP, malaise, hyponatremia, elevated total cholesterol, decreased total cholesterol, tongue paralysis, lip paralysis, limb paralysis, abdominal pain, fecal incontinence, abdominal fullness, nausea, vomiting, stomatitis, glossitis, heartburn, gastroesophageal reflux, neutropenia, leukocytosis, rash, pruritus, drowsiness, insomnia, paralysis, depressive state, elevated triglycerides, elevated uric acid, positive urinary protein, positive urinary glucose, malaise, dizziness, visual disturbances

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule filled with white or almost white round or oval granules.

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

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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.