Medication info
Nexium Capsule 30mg (Lansoprazole Granules)

Nexium Capsule 30mg (Lansoprazole Granules)

Prescription medicationHard capsuleOral
Ingredient · strength
Lansoprazole Granules›353mg / 1 capsule
Manufacturer / importer
Korea Union Pharmaceutical Co., Ltd.
Appearance
A hard capsule filled with white to light brown granules.
Packaging
30 capsules/bottle, 90 capsules/bottle
Approval status
Active

MFDS item code 201308053 · Approved 2013.07.05 · Insurance code 665506410

Summary

Main use
Treatment and prevention of peptic ulcers (including Helicobacter pylori eradication), gastroesophageal reflux disease, and gastric acid hypersecretion
Who takes it
Adults · Children
Adult dose
This medicine should be administered before meals. For patients who have difficulty swallowing the medicine, open the capsule, mix the contents with a small amount (60 mL) of orange juice or tomato juice, and administer immediately. To ensure the full dose is taken, rinse the glass with twice or more the amount of juice and drink immediately. Do not chew or crush this medicine after opening the capsule. Short-term treatment of active duodenal ulcers: Administer lansoprazole 15 mg orally once daily for 4 weeks. Short-term treatment of active benign gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers 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 as needed. Administer in combination with lansoprazole 30 mg and amoxicillin 1,000 mg three times daily (every 8 hours) for 14 days. Maintenance treatment following treatment of duodenal ulcers: Administer lansoprazole 15 mg orally once daily. The comparative clinical trial period did not exceed 12 months. Treatment of NSAID-induced gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. The comparative clinical trial period did not exceed 8 weeks. Reduction of the risk of NSAID-induced gastric ulcers: Administer lansoprazole 15 mg orally once daily for 12 weeks. The comparative clinical trial period did not exceed 12 weeks. Short-term treatment of symptoms associated with gastroesophageal reflux disease Administer lansoprazole 15 mg orally once daily for 8 weeks Short-term treatment of erosive reflux esophagitis: Administer lansoprazole 30 mg orally once daily for 8 weeks. Maintenance treatment following treatment of erosive reflux esophagitis: Administer lansoprazole 15 mg orally once daily. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The dosage of lansoprazole for pathological hypersecretory conditions varies for each patient. The usual starting dose in adults is 60 mg once daily. The dose should be adjusted according to the patient's needs and treatment may continue for 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 medicine is reduced in elderly patients, dose adjustment is necessary. Do not exceed a daily dose of 30 mg. As metabolism and excretion of this medicine may be delayed in patients with hepatic impairment, administer with caution, including dose adjustment.
Child dose
12 ∼ 17 years of age, pediatric and adolescent patients, short-term treatment of symptoms associated with non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks 12 ∼ 17 years of age, pediatric and adolescent patients, short-term treatment of erosive reflux esophagitis: 30 mg once daily for 8 weeks 1 ∼ 11 years of age, children weighing 30 kg or less: 15 mg once daily for 12 weeks 1 ∼ 11 years of age, children weighing more than 30 kg: 30 mg once daily for 12 weeks

Ingredients

Manufacturer
Korea Union Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of peptic ulcers (including Helicobacter pylori eradication), gastroesophageal reflux disease, and gastric acid hypersecretion

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

This medication is used for the short-term treatment of active duodenal ulcers and benign gastric ulcers. It also helps eradicate Helicobacter pylori infection to prevent the recurrence of duodenal ulcers and is effective for post-treatment maintenance therapy. It aids in the treatment of gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs) and reduces the risk of their occurrence. It is used for symptom relief and maintenance therapy in gastroesophageal reflux disease and erosive esophagitis, and is useful in the treatment of hypersecretion states like Zollinger-Ellison syndrome. Overall, it is effectively used for various ulcers and inflammatory diseases related to the gastrointestinal tract.

How to take

Adult dose

This medicine should be administered before meals. For patients who have difficulty swallowing the medicine, open the capsule, mix the contents with a small amount (60 mL) of orange juice or tomato juice, and administer immediately. To ensure the full dose is taken, rinse the glass with twice or more the amount of juice and drink immediately. Do not chew or crush this medicine after opening the capsule. Short-term treatment of active duodenal ulcers: Administer lansoprazole 15 mg orally once daily for 4 weeks. Short-term treatment of active benign gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers 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 as needed. Administer in combination with lansoprazole 30 mg and amoxicillin 1,000 mg three times daily (every 8 hours) for 14 days. Maintenance treatment following treatment of duodenal ulcers: Administer lansoprazole 15 mg orally once daily. The comparative clinical trial period did not exceed 12 months. Treatment of NSAID-induced gastric ulcers: Administer lansoprazole 30 mg orally once daily for 8 weeks. The comparative clinical trial period did not exceed 8 weeks. Reduction of the risk of NSAID-induced gastric ulcers: Administer lansoprazole 15 mg orally once daily for 12 weeks. The comparative clinical trial period did not exceed 12 weeks. Short-term treatment of symptoms associated with gastroesophageal reflux disease Administer lansoprazole 15 mg orally once daily for 8 weeks Short-term treatment of erosive reflux esophagitis: Administer lansoprazole 30 mg orally once daily for 8 weeks. Maintenance treatment following treatment of erosive reflux esophagitis: Administer lansoprazole 15 mg orally once daily. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The dosage of lansoprazole for pathological hypersecretory conditions varies for each patient. The usual starting dose in adults is 60 mg once daily. The dose should be adjusted according to the patient's needs and treatment may continue for 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 medicine is reduced in elderly patients, dose adjustment is necessary. Do not exceed a daily dose of 30 mg. As metabolism and excretion of this medicine may be delayed in patients with hepatic impairment, administer with caution, including dose adjustment.

Child dose

12 ∼ 17 years of age, pediatric and adolescent patients, short-term treatment of symptoms associated with non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks 12 ∼ 17 years of age, pediatric and adolescent patients, short-term treatment of erosive reflux esophagitis: 30 mg once daily for 8 weeks 1 ∼ 11 years of age, children weighing 30 kg or less: 15 mg once daily for 12 weeks 1 ∼ 11 years of age, children weighing more than 30 kg: 30 mg once daily for 12 weeks

Precautions

This medication should not be used by patients with specific allergic reactions. For instance, patients who are allergic to this medication or similar components, or who have allergies to penicillin or macrolide antibiotics should not receive this treatment. Pregnant women or patients with genetic metabolic disorders such as lactose intolerance should also avoid this medication. Additionally, it should be used cautiously in patients with a history of drug allergies, those with poor liver function, the elderly, nursing women, and children. Though rare, severe allergic reactions, blood abnormalities, liver dysfunction, and skin reactions may occur, so if these symptoms appear, usage should be stopped immediately and a doctor's consultation should be sought. Long-term use may result in nutritional deficiencies such as vitamin B12 deficiency or hypomagnesemia, necessitating regular check-ups. This medication inhibits gastric acid secretion, which may slightly increase the risk of bacterial infections in the gastrointestinal tract, so if diarrhea or abdominal pain persists, a hospital visit is advised. Also, interactions with other medications may occur, so if you are taking other medications, be sure to inform your doctor or pharmacist, especially when using certain antibiotics, antivirals, anticoagulants, or immunosuppressants. It is safer for pregnant or nursing women to avoid this medication, and if it must be taken, a consultation with a specialist is necessary. Dizziness, drowsiness, and vision impairment may occur, so caution is needed when performing activities like driving or operating machinery while taking this medication. In case of overdose, as there are no specific antidotes, appropriate treatment such as gastric lavage or activated charcoal administration may be required depending on symptoms. Lastly, this medication should be kept out of reach of children, and it is advisable not to transfer it to another container.

Side effects

  • Anaphylactic reaction
  • generalized rash
  • facial swelling
  • dyspnea
  • shock
  • pancytopenia
  • agranulocytosis
  • hemolytic anemia
  • neutropenia
  • thrombocytopenia
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  • anemia
  • jaundice
  • elevated AST
  • elevated ALT
  • toxic liver dysfunction
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • DRESS syndrome
  • interstitial pneumonia
  • fever
  • cough
  • abnormal lung sounds
  • interstitial nephritis
  • acute renal failure
  • membranous colitis
  • hematochezia
  • abdominal pain
  • diarrhea
  • headache
  • abdominal enlargement
  • allergic reactions
  • back pain
  • weakness
  • candidiasis
  • malignancy
  • chills
  • chest pain
  • edema
  • fever
  • flu-like symptoms
  • halitosis
  • infection
  • lethargy
  • neck stiffness
  • pelvic pain
  • angina
  • arrhythmia
  • bradycardia
  • tachycardia
  • cerebrovascular accident
  • cerebral infarction
  • hypertension
  • hypotension
  • migraine
  • myocardial infarction
  • palpitations
  • vasodilation
  • syncope
  • asthma
  • bronchitis
  • increased coughing
  • epistaxis
  • hemoptysis
  • hiccups
  • pneumonia
  • upper respiratory infection
  • laryngeal tumor
  • pulmonary fibrosis
  • pharyngitis
  • pleural disorder
  • respiratory disorder
  • rhinitis
  • sinusitis
  • wheezing
  • acne
  • hair loss
  • pruritus
  • rash
  • urticaria
  • contact dermatitis
  • dry skin
  • nail disorders
  • skin cancer
  • skin diseases
  • sweating
  • abnormal vision
  • amblyopia
  • blepharitis
  • cataract
  • conjunctivitis
  • dry eyes
  • ear disorders
  • eye disorders
  • glaucoma
  • dysosmia
  • photophobia
  • retinal dystrophy
  • taste loss
  • blurred vision
  • deafness
  • ocular pain
  • otitis media
  • taste distortion
  • tinnitus
  • visual field constriction
  • urinary dysfunction
  • renal pain
  • penile disorders
  • testicular disorders
  • urethral pain
  • polyuria
  • urinary frequency
  • residual urine
  • menstrual irregularities
  • chest tenderness
  • chest expansion
  • gynecomastia
  • diabetes
  • hematuria
  • erectile dysfunction
  • renal calculi
  • abdominal pain
  • taste distortion
  • abdominal distension
  • nausea
  • vomiting
  • stomatitis
  • glossitis
  • thirst
  • heartburn
  • gastroesophageal reflux
  • anorexia
  • neutropenia
  • eosinophilia
  • leukocytosis
  • thrombocytopenia
  • rash
  • pruritus
  • drowsiness
  • dizziness
  • insomnia
  • paralysis
  • depressed mood
  • elevated triglycerides
  • elevated uric acid
  • elevated total cholesterol
  • reduced total cholesterol
  • positive urine protein
  • positive urine sugar
  • lethargy
  • hepatotoxicity
  • pancreatitis
  • dysgeusia
  • aplastic anemia
  • leukopenia
  • neutropenia
  • thrombotic thrombocytopenic purpura
  • eosinophilia
  • hypomagnesemia
  • Clostridium difficile diarrhea
  • fracture
  • myositis
  • erythema multiforme
  • speech disorder
  • interstitial nephritis
  • urinary retention
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated LDH
  • elevated γ-GTP
  • malaise
  • hyponatremia
  • tongue paralysis
  • lip paralysis
  • limb paralysis

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C room temperature. This will help preserve the drug's efficacy and safety over time.

Appearance and packaging

Appearance

A hard capsule filled with white to light brown granules.

Package unit

30 capsules/bottle, 90 capsules/bottle

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.

Questions about this medicine

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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.