Medication info
COTUS 50mg Tablet (Pranlukast Hydrate (Unhydrous))

COTUS 50mg Tablet (Pranlukast Hydrate (Unhydrous))

Prescription medicationTabletOral
Ingredient · strength
Pranlukast Hydrate›50mg / 1 tablet
Manufacturer / importer
Kolon Pharmaceutical Co., Ltd.
Appearance
White or pale yellow, rectangular film-coated tablet with a score line
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202502976 · Approved 2025.11.18

Summary

Main use
Treatment of bronchial asthma and allergic rhinitis
Who takes it
Adults
Adult dose
Adults: Administer pranlukast hydrate 50mg orally twice daily, after breakfast and dinner. Adjust the dose appropriately according to symptoms.

Ingredients

Manufacturer
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of bronchial asthma and allergic rhinitis

  • Bronchial asthma
  • allergic rhinitis
View approved original text

This medicine is used for bronchial asthma and allergic rhinitis.

How to take

Adult dose

Adults: Administer pranlukast hydrate 50mg orally twice daily, after breakfast and dinner. Adjust the dose appropriately according to symptoms.

Precautions

This medication should not be used by individuals allergic to this medication or its components. Additionally, this medication contains lactose, so it should not be administered to patients with a genetic inability to digest lactose. During the course of this medication, serious allergic reactions such as shock or anaphylaxis may occur; therefore, if symptoms such as low blood pressure, altered consciousness, difficulty breathing, or skin rash arise, discontinue use immediately and seek medical attention. Blood-related issues may lead to decreased white blood cell or platelet counts, so consult a physician if you experience fever, sore throat, or feelings of lethargy. Liver function abnormalities may lead to jaundice or increased liver enzymes; hence, liver health should be closely monitored, and if any abnormalities occur, medication should be ceased and treatment sought. Respiratory issues such as fever, cough, shortness of breath, and lung inflammation may occur, so if these symptoms arise, stop taking the medication and obtain appropriate treatment. Muscle pain, weakness, or muscle damage may occur; thus, discontinue use and see a doctor if such symptoms appear. Skin rashes, hives, or itching may occur, so if any abnormal symptoms arise, stop taking the medication and seek treatment. Psychiatric symptoms such as tremors, seizures, anxiety, headache, drowsiness, or dizziness may occur, thus consult a physician if these symptoms arise. Gastrointestinal symptoms like nausea, abdominal pain, diarrhea, vomiting, or loss of appetite may occur; if symptoms are severe, discontinue use and visit a hospital. Rarely, symptoms such as arrhythmia or palpitations and facial flushing may occur, so care is needed. Urinary abnormalities or urinary disorders may occur; hence, inform your doctor if you experience such symptoms. Various side effects such as muscle stiffness, weight gain, hair loss, or irregular menstruation may occur, so if there are abnormal symptoms, consult a professional immediately. This medication is not intended to provide immediate relief from asthma attacks, so it is essential to explain this to patients. If asthma symptoms worsen while taking this medication, bronchodilators or steroids may need to be used. If undergoing long-term steroid treatment, adjustments in steroid dosage while using this medication should be done gradually and under medical supervision. Care must be taken when reducing or discontinuing steroid dosages, as the original condition may worsen. The medication may cause inflammatory diseases like vasculitis during treatment; thus, be aware of symptoms such as fever, joint pain, skin anomalies, or lung issues. Moreover, psychiatric symptoms such as depression, suicidal thoughts, or aggressive behavior may arise, necessitating close monitoring of the patient’s condition. If no effects are seen, caution should be taken to avoid long-term use. Since this medication is metabolized by specific liver enzymes, concurrent use with other drugs affecting these enzymes may alter blood concentration; thus, inform your physician. Women who are pregnant or may become pregnant should only take this medication after carefully considering its benefits and risks. Safety in children or newborns has not been sufficiently established, so caution is necessary. Elderly individuals may have diminished physiological function; therefore, it is advisable to reduce the dosage when administering this medication. Lastly, this medication should be kept out of the reach of children and stored in its original container, as transferring it to another container may affect its quality.

Side effects

  • Shock
  • symptoms resembling anaphylaxis
  • hypotension
  • altered consciousness
  • dyspnea
  • rash
  • leukopenia
  • fever
  • sore throat
  • generalized malaise
Show 68 more
  • thrombocytopenia
  • purpura
  • epistaxis
  • gingival bleeding
  • jaundice
  • hepatic dysfunction
  • elevated bilirubin
  • elevated ALP
  • interstitial pneumonia
  • eosinophilic pneumonia
  • myalgia
  • weakness
  • elevated CK
  • elevated myoglobin
  • rhabdomyolysis
  • acute kidney injury
  • arthralgia
  • urticaria
  • itching
  • erythema multiforme
  • tremors
  • convulsions
  • agitation
  • anxiety
  • headache
  • drowsiness
  • dizziness
  • insomnia
  • paresthesia
  • taste disturbances
  • nausea
  • abdominal pain
  • upper abdominal discomfort
  • diarrhea
  • vomiting
  • heartburn
  • loss of appetite
  • constipation
  • abdominal distension
  • stomatitis
  • glossitis
  • tongue paralysis
  • arrhythmia
  • palpitations
  • flushing
  • proteinuria
  • hematuria
  • frequent urination
  • decreased urine output
  • urinary obstruction
  • rigidity
  • weight gain
  • overflow incontinence
  • hyperhidrosis
  • increased sputum
  • cough
  • gastroenteritis
  • hair loss
  • menstrual irregularities
  • chest discomfort
  • edema
  • malaise
  • elevated triglycerides
  • bleeding
  • eosinophilia
  • pharyngeal discomfort
  • thirst
  • tinnitus

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 exposure to air or moisture, at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication and ensure safe use.

Appearance and packaging

Appearance

White or pale yellow, rectangular film-coated tablet with a score line

Package unit

30 tablets/bottle, 300 tablets/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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.