Medication info
Colazal Capsule (Balsalazide Sodium Trihydrate)

Colazal Capsule (Balsalazide Sodium Trihydrate)

Prescription medicationHard capsuleOral
Ingredient · strength
Balsalazide Disodium Hydrate›750mg / 1 capsule
Manufacturer / importer
JonggeunDang Co., Ltd.
Appearance
A yellow to light orange powder contained in an off-white hard capsule.
Packaging
Bottle - 30 capsules/bottle, Bottle - 280 capsules/bottle
Approval status
Active

MFDS item code 200500130 · Approved 2005.06.27 · Insurance code 643303520

Summary

Main use
Treatment and maintenance of remission of mild to moderate active ulcerative colitis
Who takes it
Adults · Children
Adult dose
Induction therapy: Take 2.25g (3 capsules) 3 times daily until remission is achieved or for up to 12 weeks (6.75g per day). Maintenance therapy: The initial recommended dose is 1.5g (2 capsules) twice daily (3g per day). The dose may be adjusted according to the patient's response, and additional benefit may be achieved by increasing the dose to 6g per day. The capsules may be swallowed whole with water, or carefully opened and the contents mixed with applesauce. If a capsule is opened, the contents should be mixed with applesauce and taken immediately; the contents may be chewed if necessary. Do not leave this medicine mixed with applesauce for an extended period. Do not store the mixture for the next dose. When a capsule is opened, the contents may change color to orange-yellow due to a color change in the active ingredient. Taking the contents of an opened capsule may temporarily cause staining of the teeth or tongue.
Child dose
Children aged 5 to 17 years: Take 2.25g (3 capsules) 3 times daily for up to 8 weeks (6.75g per day). Children aged 5 to 17 years: Take 750mg (1 capsule) 3 times daily for up to 8 weeks (2.25g per day). Safety and efficacy have not been established for treatment lasting longer than 8 weeks.

Ingredients

Manufacturer
JonggeunDang Co., Ltd.

Efficacy & effects

Treatment and maintenance of remission of mild to moderate active ulcerative colitis

  • Active ulcerative colitis
View approved original text

This medication is used to treat active ulcerative colitis of mild to moderate severity and to maintain a state of remission after treatment. It helps patients alleviate symptoms and maintain ongoing gut health.

How to take

Adult dose

Induction therapy: Take 2.25g (3 capsules) 3 times daily until remission is achieved or for up to 12 weeks (6.75g per day). Maintenance therapy: The initial recommended dose is 1.5g (2 capsules) twice daily (3g per day). The dose may be adjusted according to the patient's response, and additional benefit may be achieved by increasing the dose to 6g per day. The capsules may be swallowed whole with water, or carefully opened and the contents mixed with applesauce. If a capsule is opened, the contents should be mixed with applesauce and taken immediately; the contents may be chewed if necessary. Do not leave this medicine mixed with applesauce for an extended period. Do not store the mixture for the next dose. When a capsule is opened, the contents may change color to orange-yellow due to a color change in the active ingredient. Taking the contents of an opened capsule may temporarily cause staining of the teeth or tongue.

Child dose

Children aged 5 to 17 years: Take 2.25g (3 capsules) 3 times daily for up to 8 weeks (6.75g per day). Children aged 5 to 17 years: Take 750mg (1 capsule) 3 times daily for up to 8 weeks (2.25g per day). Safety and efficacy have not been established for treatment lasting longer than 8 weeks.

Precautions

This medication contains mesalamine, which may cause specific allergic reactions; therefore, individuals who are hypersensitive to this drug or mesalamine should not take it. Patients with severe liver damage or moderate to severe kidney impairment should also avoid using this medication. This drug should not be taken by patients with bleeding disorders or peptic ulcers, and by pregnant or nursing women. Asthma patients or persons with bleeding disorders, as well as those with mild kidney or liver disease, should use this drug with caution. During the use of this medication, regular blood tests, kidney function tests, and urine tests should be conducted. If any adverse symptoms such as bleeding, bruising, sore throat, fever, or fatigue occur, you should contact a doctor immediately. This medication may cause side effects primarily derived from mesalamine, including blood abnormalities, headaches, heart inflammation, shortness of breath, digestive disorders, liver function abnormalities, skin rashes, muscle pain, kidney inflammation, among others. Particularly, side effects similar to these may also occur in children aged 5 to 17, so caution is advised. It is recommended to take this medication with food as it favors absorption, and it may alter drug concentrations when taken with certain medications, so consultation with a doctor or pharmacist is necessary. It is safer for pregnant or nursing women to avoid taking this medication, and its use in children is only recommended for those over 5 years old. In cases of overdose, symptoms similar to salicylate poisoning may occur, so appropriate treatment is required based on the symptoms. Keep this medication out of reach of children, and do not transfer it to other containers to maintain its quality.

Side effects

Blood disorders, aplastic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, headache, neuropathy, myocarditis, pericarditis, bronchospasm, allergic alveolitis, abdominal pain, diarrhea, nausea, vomiting, exacerbation of ulcerative colitis, acute pancreatitis, hepatitis, cholelithiasis, hepatotoxicity, jaundice, cholestatic jaundice, cirrhosis, hepatic necrosis, liver failure, alopecia, rash, systemic lupus erythematosus-like syndrome, arthralgia, myalgia, interstitial nephritis, epigastric pain, nasopharyngitis, fever, hematochezia, influenza, fatigue, gastritis, cough, sore throat, dysmenorrhea, nausea, rectal carcinoma

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 sealed container. The recommended storage temperature is between 1°C and 30°C at room temperature to prolong the drug's effectiveness.

Appearance and packaging

Appearance

A yellow to light orange powder contained in an off-white hard capsule.

Package unit

Bottle - 30 capsules/bottle, Bottle - 280 capsules/bottle

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.