Medication info
Asacol DR Tablets 1600 mg (Mesalazine)

Asacol DR Tablets 1600 mg (Mesalazine)

Prescription medicationTablet
Ingredient · strength
Mesalazine›400mg / 1 tablet
Manufacturer / importer
Daewoong Pharmaceuticals
Appearance
Brownish-red, semi-glossy, rectangular enteric-coated tablet
Packaging
60 tablets/box[((10 tablets/PTP)*6)/box], 30 tablets/box[((10 tablets/PTP)*3)/box]
Approval status
Active

MFDS item code 202007945 · Approved 2020.11.17 · Insurance code 641607450

Summary

Main use
Treatment and maintenance therapy for mild to moderate active ulcerative colitis
Who uses it
Adults
Adult dosage
•Treatment of mild to moderate active ulcerative colitis: Adults are usually given up to 4800mg daily for 8 weeks, as a single daily dose or divided into 2-3 doses, according to symptoms. •Maintenance treatment: Adults may usually be given 1600mg once daily.

Ingredients

Importer
Daewoong Pharmaceuticals

Efficacy & effects

Treatment and maintenance therapy for mild to moderate active ulcerative colitis

  • Active ulcerative colitis
View approved original text

This medication helps alleviate symptoms and control the progression of active ulcerative colitis in patients with mild to moderate symptoms. It is also used for maintenance therapy to prevent recurrence after symptoms have improved, thereby helping patients manage their daily lives more stably.

Dosage and Administration

Adult dosage

•Treatment of mild to moderate active ulcerative colitis: Adults are usually given up to 4800mg daily for 8 weeks, as a single daily dose or divided into 2-3 doses, according to symptoms. •Maintenance treatment: Adults may usually be given 1600mg once daily.

Precautions

This drug should not be used by patients who are allergic to specific ingredients, patients with severe liver or kidney dysfunction, those with peptic ulcers or blood clotting disorders, and children under the age of 2. Patients with bronchial asthma or allergies to other medications, those with liver or kidney issues, blood diseases, pregnant or breastfeeding women, and children aged 2 to 15 and the elderly should use this medication with caution. This drug can rarely cause various side effects such as skin rashes, hives, hair loss, difficulty breathing, cough, abdominal pain, diarrhea, liver dysfunction, muscle pain, changes in blood cell counts, heart inflammation, kidney impairment, dizziness, and headaches, so you should consult a physician immediately if symptoms appear. Regular blood tests and liver and kidney function tests should be performed during treatment, and especially if kidney dysfunction is discovered, the medication should be discontinued. This drug may interact with certain other medications, increasing or decreasing the drug's effectiveness, so if you are taking other medications, you must inform your doctor or pharmacist. During pregnancy, this medication may cross the placenta, so it should only be administered under a doctor's evaluation when necessary. While breastfeeding, it should also be used cautiously, considering the potential for adverse reactions in the baby. Elderly patients may have impaired kidney function, so the condition should be monitored regularly through blood tests. In the case of an overdose, general treatment methods for salicylate toxicity should be applied, such as inducing vomiting or gastric lavage, while maintaining fluid and electrolyte balance, and carefully monitoring kidney function. When taking this medication, do not crush or split the tablets; swallow them whole and keep them out of reach of children. This medication works to reduce inflammation in the colon, so it is important to take it at regular intervals and follow your doctor's instructions regarding regular check-ups.

Side effects

  • hyperpyrexia
  • alopecia
  • urticaria
  • allergic skin rash
  • photosensitivity
  • erythema multiforme syndrome
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • dyspnea
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  • cough
  • bronchospasm
  • allergic alveolitis
  • pulmonary eosinophilia
  • interstitial lung disease
  • lung infiltration
  • pneumonia
  • eosinophilic pneumonia
  • pleuritis
  • abdominal pain
  • diarrhea
  • distension
  • nausea
  • vomiting
  • abdominal bloating
  • pancreatitis
  • change in liver function tests
  • hepatitis
  • cholestatic hepatitis
  • liver dysfunction
  • myalgia
  • arthralgia
  • pericarditis
  • pleuritis
  • lupus-like syndrome
  • changes in blood cell counts
  • aplastic anemia
  • agranulocytosis
  • pancytopenia
  • neutropenia
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
  • anemia
  • myocarditis
  • pericardial effusion
  • acute and chronic interstitial nephritis
  • renal failure
  • kidney failure
  • renal impairment
  • nephrotic syndrome
  • nephrolithiasis
  • dizziness
  • headache
  • peripheral neuropathy
  • vertigo
  • idiopathic intracranial hypertension
  • reversible oligospermia
  • drug reaction (DRESS)

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Brownish-red, semi-glossy, rectangular enteric-coated tablet

Package unit

60 tablets/box[((10 tablets/PTP)*6)/box], 30 tablets/box[((10 tablets/PTP)*3)/box]

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.