Medication info
Monolitum Plus Tablet 30 mg (Lansoprazole)

Monolitum Plus Tablet 30 mg (Lansoprazole)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Lansoprazole›30mg / 1 tablet
Manufacturer / importer
(주)태준제약
Appearance
White, round tablet with gray speckles
Packaging
28 tablets (7 tablets/PTP x 4 PTP/carton)
Approval status
Active

MFDS item code 201404060 · Approved 2014.08.29 · Insurance code 650102690

Summary

Main use
Treatment of active duodenal ulcers and gastric ulcers (NSAID-induced), eradication of Helicobacter pylori, short-term and maintenance treatment of gastroesophageal reflux disease (including erosive), and improvement of hypersecretion conditions.
Who takes it
Adults · Children
Adult dose
This drug should be administered before meals. Place on the tongue to dissolve with saliva or take with water. Do not chew or crush before taking. 1. Short-term treatment of active duodenal ulcer: Lansoprazole 15 mg orally once daily for 4 weeks. 2. Short-term treatment of active benign gastric ulcer: Lansoprazole 30 mg orally once daily for 8 weeks. 3. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers: 1) Lansoprazole 30 mg, with clarithromycin 250 - 500 mg and amoxicillin 1,000 mg, administered twice daily (every 12 hours) for 7 days; can be extended to 14 days if necessary. 2) Lansoprazole 30 mg, with amoxicillin 1,000 mg, administered three times daily (every 8 hours) for 14 days. 4. Maintenance therapy after treatment of duodenal ulcers: Lansoprazole 15 mg orally once daily. The duration of comparative clinical trials did not exceed 12 months. 5. Treatment of NSAID-induced gastric ulcers: 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 NSAID-induced gastric ulcer: 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 related to gastroesophageal reflux disease: Lansoprazole 15 mg orally once daily for 8 weeks. 8. Short-term treatment of erosive esophagitis: Lansoprazole 30 mg orally once daily for 8 weeks. 9. Maintenance therapy after treatment of erosive esophagitis: Lansoprazole 15 mg orally once daily. 10. Pathological hypersecretion states, including Zollinger-Ellison syndrome: Dosage of Lansoprazole for pathological hypersecretion states varies by individual patient. Typically, treatment starts at 60 mg once daily for adults. Dosage should be adjusted based on patient needs and can continue as long as clinically effective. It has been administered in doses up to 90 mg twice daily. Doses exceeding 120 mg per day must be split into separate doses.
Child dose
Children and adolescents aged 12 to 17 years: 1. Short-term treatment of symptoms related to non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks. 2. Short-term treatment of erosive esophagitis: 30 mg once daily.

Ingredients

Importer
(주)태준제약

Efficacy & effects

Treatment of active duodenal ulcers and gastric ulcers (NSAID-induced), eradication of Helicobacter pylori, short-term and maintenance treatment of gastroesophageal reflux disease (including erosive), and improvement of hypersecretion conditions.

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

This medication is used for the short-term treatment of active duodenal ulcers and benign gastric ulcers. It is also effective in eradicating Helicobacter pylori to prevent recurrence of duodenal ulcers and is helpful for maintenance therapy after treatment. This drug is used for the treatment of gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs) and to reduce the risk of developing such ulcers. It is useful for the short-term treatment and maintenance therapy of symptoms related to gastroesophageal reflux disease and erosive esophagitis. Additionally, it is used to treat pathological hypersecretion conditions such as Zollinger-Ellison syndrome. Therefore, it is used to effectively improve various gastric-related conditions.

How to take

Adult dose

This drug should be administered before meals. Place on the tongue to dissolve with saliva or take with water. Do not chew or crush before taking. 1. Short-term treatment of active duodenal ulcer: Lansoprazole 15 mg orally once daily for 4 weeks. 2. Short-term treatment of active benign gastric ulcer: Lansoprazole 30 mg orally once daily for 8 weeks. 3. Eradication of Helicobacter pylori to prevent recurrence of duodenal ulcers: 1) Lansoprazole 30 mg, with clarithromycin 250 - 500 mg and amoxicillin 1,000 mg, administered twice daily (every 12 hours) for 7 days; can be extended to 14 days if necessary. 2) Lansoprazole 30 mg, with amoxicillin 1,000 mg, administered three times daily (every 8 hours) for 14 days. 4. Maintenance therapy after treatment of duodenal ulcers: Lansoprazole 15 mg orally once daily. The duration of comparative clinical trials did not exceed 12 months. 5. Treatment of NSAID-induced gastric ulcers: 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 NSAID-induced gastric ulcer: 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 related to gastroesophageal reflux disease: Lansoprazole 15 mg orally once daily for 8 weeks. 8. Short-term treatment of erosive esophagitis: Lansoprazole 30 mg orally once daily for 8 weeks. 9. Maintenance therapy after treatment of erosive esophagitis: Lansoprazole 15 mg orally once daily. 10. Pathological hypersecretion states, including Zollinger-Ellison syndrome: Dosage of Lansoprazole for pathological hypersecretion states varies by individual patient. Typically, treatment starts at 60 mg once daily for adults. Dosage should be adjusted based on patient needs and can continue as long as clinically effective. It has been administered in doses up to 90 mg twice daily. Doses exceeding 120 mg per day must be split into separate doses.

Child dose

Children and adolescents aged 12 to 17 years: 1. Short-term treatment of symptoms related to non-erosive gastroesophageal reflux disease: 15 mg once daily for 8 weeks. 2. Short-term treatment of erosive esophagitis: 30 mg once daily.

Precautions

This drug should not be used in patients with specific allergic reactions. For example, individuals who are hypersensitive to this drug, its components, or have experienced such reactions to benzimidazoles should avoid it. Caution is also necessary for patients allergic to penicillin or macrolide antibiotics. It is safest for women who are pregnant or breastfeeding not to use this medication; if it must be used, consultation with a professional is advised. Patients with impaired liver function, elderly individuals, and children or nursing mothers should also be administered this drug with caution. While taking this medication, rare but serious allergic reactions, liver dysfunction, blood abnormalities, skin reactions, etc., may occur, so consult a doctor immediately if any unusual symptoms appear. Long-term use may lead to nutrient deficiencies such as vitamin B12 deficiency or hypomagnesemia, so regular monitoring is necessary. Furthermore, this drug inhibits gastric acid secretion, which may increase the risk of bacterial overgrowth in the gastrointestinal tract; therefore, if symptoms such as diarrhea persist, medical advice should be sought. Interactions may occur when taken with other medications, so any current medications being taken must be disclosed, especially when combined with HIV treatments, antibiotics, anticoagulants, etc. Although severe side effects are rare with overdose, if suspected, immediate hospital visit for appropriate treatment is necessary. When storing, keep it out of the reach of children and do not transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, rash all over the body, facial edema, shortness of breath, shock, agranulocytosis, aplastic anemia, hemolytic anemia, granulocytopenia, thrombocytopenia, anemia, jaundice, toxic liver dysfunction accompanied by elevated AST and ALT, toxic epidermal necrolysis (Lyell syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), DRESS syndrome, interstitial pneumonia, interstitial nephritis.

Mild side effects

  • Headache
  • diarrhea
  • taste disturbance
  • abdominal pain
  • nausea
  • vomiting
  • abdominal distension
  • stomatitis
  • glossitis
  • thirst
Show 28 more
  • heartburn
  • gastroesophageal reflux
  • appetite loss
  • rash
  • itching
  • candidiasis
  • malaise
  • chills
  • fatigue
  • neck stiffness/pain
  • pelvic pain
  • angina
  • arrhythmia
  • bradycardia/tachycardia
  • hypertension/hypotension
  • migraine
  • palpitations
  • vasodilation
  • syncope
  • constipation
  • dyspepsia
  • dysphagia
  • belching
  • esophageal stricture
  • esophageal ulcer
  • esophagitis
  • bloating
  • gastric nodules/gastritis.

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius to preserve the effectiveness and safety of the drug.

Appearance and packaging

Appearance

White, round tablet with gray speckles

Package unit

28 tablets (7 tablets/PTP x 4 PTP/carton)

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.