Medication info
Citus Chewable Tablet 53.0 mg (Franlukast Hydrate)

Citus Chewable Tablet 53.0 mg (Franlukast Hydrate)

Prescription medicationChewable TabletOral
Ingredient · strength
Pranlukast Hydrate›53mg / 1 tablet
Manufacturer / importer
Sama Pharmaceutical Co., Ltd.
Appearance
White or light yellow chewable round tablet
Packaging
60 tablets/box [(10 tablets/Alu-Alu x 6)]
Approval status
Active

MFDS item code 202401991 · Approved 2024.08.14 · Insurance code 645702910

Summary

Main use
Treatment of bronchial asthma and perennial allergic rhinitis
Who takes it
Children
Child dose
Children: The standard dose per administration by body weight is as follows. Administer twice daily, after breakfast and dinner. Chew thoroughly before swallowing. 25kg or more to less than 35kg: 1 chewable tablet 53.0 mg (53.0 mg) 35kg or more to less than 45kg: 1 chewable tablet 74.2 mg (74.2 mg)

Ingredients

Manufacturer
Sama Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of bronchial asthma and perennial allergic rhinitis

  • Bronchial asthma
  • perennial allergic rhinitis
View approved original text

This medication is used for bronchial asthma and perennial allergic rhinitis.

How to take

Child dose

Children: The standard dose per administration by body weight is as follows. Administer twice daily, after breakfast and dinner. Chew thoroughly before swallowing. 25kg or more to less than 35kg: 1 chewable tablet 53.0 mg (53.0 mg) 35kg or more to less than 45kg: 1 chewable tablet 74.2 mg (74.2 mg)

Precautions

This medication contains the artificial sweetener aspartame, and should not be administered to patients with the hereditary disease phenylketonuria. Care should be taken not to exceed the daily maximum allowable amount of aspartame, which is 2.4 grams for adults. Patients who are hypersensitive to this medication or who have a genetic issue with lactose digestion should not take this medication. During the use of this medication, serious allergic reactions such as shock or anaphylaxis may occur, so if symptoms such as low blood pressure, loss of consciousness, difficulty breathing, or skin rashes appear, the administration should be stopped immediately and medical attention should be sought. Since there may be a decrease in white blood cell or platelet count, patients should consult a doctor quickly if symptoms of fever or bleeding occur. Liver dysfunction may occur, so if jaundice symptoms or elevated liver enzymes are observed, administration should be stopped, and treatment should be sought. If respiratory distress, cough, or fever occurs, there may be a risk of pneumonia, so medication should be stopped and appropriate treatment should be administered. If symptoms such as muscle pain, weakness, or muscle destruction appear, administration should be stopped immediately, and caution should be taken regarding kidney function abnormalities. If hypersensitivity reactions such as skin rashes, hives, or itching occur, administration should be stopped, and treatment should be sought. Mental and nervous system symptoms may occur, such as insomnia, anxiety, headache, or drowsiness, so the condition should be closely monitored. Gastrointestinal symptoms may include nausea, vomiting, diarrhea, or abdominal pain, so if discomfort is severe, consulting a doctor is advisable. Symptoms such as irregular heartbeat or palpitations and flushing may occur; caution is warranted. There may be a decrease in urine output or urination difficulties, and any abnormal symptoms should be reported. Additionally, symptoms like edema, hair loss, lethargy, or menstrual irregularities have been reported, so patients should inform the doctor of any abnormal symptoms. This medication is not one that immediately relieves asthma attacks, so patients must be adequately informed to use bronchodilators or steroids during an attack. Patients undergoing long-term steroid therapy should gradually reduce the dosage of steroids under the supervision of a doctor when using this medication. If a patient reduces the steroid maintenance dose and then stops this medication, there is a possibility that the original condition may worsen, so caution is needed. Rarely, serious immune reactions such as vasculitis may occur, so monitoring for symptoms like numbness, joint pain, fever, or lung abnormalities is necessary. Since this medication may affect mental health, if symptoms such as depression, suicidal thoughts, or aggressive behavior occur, a doctor should be consulted immediately. If there is no effect, caution should be exercised against prolonged use, especially in children who may not express symptoms well, so caregivers should closely monitor the condition. This medication is metabolized by a specific enzyme in the liver (CYP3A4), so caution is required when taken with other drugs that affect this enzyme due to potential interactions. Safety has not been established during pregnancy, so women who are pregnant or may become pregnant should consult their doctor before administration. Due to a lack of safety data, it is advisable not to administer this medication to infants under one year of age. Because elderly patients may have reduced bodily functions, the dosage should be reduced, with caution exercised during administration. This medication should be stored in a safe place out of the reach of children, and transferring it to another container may pose a risk of accidents and deterioration of quality, so caution is necessary.

Side effects

  • Shock
  • anaphylaxis-like symptoms
  • hypotension
  • altered consciousness
  • dyspnea
  • rash
  • leukopenia
  • fever
  • sore throat
  • general malaise
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  • thrombocytopenia
  • purpura
  • epistaxis
  • gum bleeding
  • jaundice
  • liver dysfunction
  • elevated bilirubin
  • elevated ALP
  • interstitial pneumonia
  • eosinophilic pneumonia
  • rhabdomyolysis
  • myalgia
  • fatigue
  • elevated CK
  • increased myoglobin
  • acute renal impairment
  • arthralgia
  • urticaria
  • polymorphic exudative erythema
  • pruritus
  • insomnia
  • paresthesia
  • tremor
  • anxiety
  • taste disturbance
  • seizures
  • headache
  • drowsiness
  • dizziness
  • excitability
  • abdominal discomfort
  • anorexia
  • heartburn
  • abdominal distension
  • stomatitis
  • glossitis
  • tongue paralysis
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • constipation
  • arrhythmia
  • palpitations
  • flushing
  • decreased urine output
  • frequent urination
  • dysuria
  • hematuria
  • proteinuria
  • pleural effusion
  • edema
  • alopecia
  • malaise
  • menstrual irregularities
  • elevated triglycerides
  • thirst
  • tinnitus
  • hemorrhage
  • increased sputum
  • fever
  • headache
  • enteritis
  • gastroenteritis
  • pneumonia
  • pharyngitis
  • sinusitis
  • otitis media
  • rhinitis
  • bronchitis
  • viral infection
  • conjunctivitis
  • upper respiratory tract infection
  • laceration
  • synovitis

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at room temperature between 1 degree to 30 degrees Celsius to maintain the medication's effectiveness.

Appearance and packaging

Appearance

White or light yellow chewable round tablet

Package unit

60 tablets/box [(10 tablets/Alu-Alu x 6)]

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.