Medication info

Citus Suspension Tablet 50mg (Franlucast Hydrate)

Prescription medicationOralApproval withdrawn
Ingredient · strength
Pranlukast Hydrate›50mg / 1 tablet
Manufacturer / importer
Sama Pharmaceutical Co., Ltd.
Appearance
White to pale yellow heart-shaped suspension tablet
Packaging
60 tablets (6 tablets/Alu-Alu x 10)
Approval status
Approval withdrawn

MFDS item code 201110491 · Approved 2011.11.29 · Insurance code 645702430

This product's status changed to Approval withdrawn on 2025.12.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of bronchial asthma and perennial allergic rhinitis
Who takes it
Children
Child dose
Children: Administer pranlukast hydrate orally at a dose of 7 mg/kg of body weight per day, divided into 2 doses after breakfast and dinner. Do not swallow or divide this medicine; dissolve it in a small amount of water before taking. Place a small amount of water in a spoon and add 1 tablet of this medicine. Wait for the tablet to disintegrate, then stir and take promptly. The maximum daily dose of this medicine is 10 mg/kg of body weight and should not exceed 450 mg per day. The standard dose per administration by body weight is as follows; administer twice daily after breakfast and dinner. 12 kg or more and less than 18 kg: 1 50 mg dispersible tablet (50 mg of pranlukast hydrate) 18 kg or more and less than 25 kg: 1 70 mg dispersible tablet (70 mg of pranlukast hydrate) 25 kg or more and less than 35 kg: 1 100 mg dispersible tablet (100 mg of pranlukast hydrate) 35 kg or more and less than 45 kg: 1 140 mg dispersible tablet (140 mg of pranlukast hydrate)

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: Administer pranlukast hydrate orally at a dose of 7 mg/kg of body weight per day, divided into 2 doses after breakfast and dinner. Do not swallow or divide this medicine; dissolve it in a small amount of water before taking. Place a small amount of water in a spoon and add 1 tablet of this medicine. Wait for the tablet to disintegrate, then stir and take promptly. The maximum daily dose of this medicine is 10 mg/kg of body weight and should not exceed 450 mg per day. The standard dose per administration by body weight is as follows; administer twice daily after breakfast and dinner. 12 kg or more and less than 18 kg: 1 50 mg dispersible tablet (50 mg of pranlukast hydrate) 18 kg or more and less than 25 kg: 1 70 mg dispersible tablet (70 mg of pranlukast hydrate) 25 kg or more and less than 35 kg: 1 100 mg dispersible tablet (100 mg of pranlukast hydrate) 35 kg or more and less than 45 kg: 1 140 mg dispersible tablet (140 mg of pranlukast hydrate)

Precautions

This medication contains the artificial sweetener aspartame, which is broken down into phenylalanine in the body. Therefore, patients with the genetic disorder phenylketonuria should not take this medication. Care should be taken not to exceed the daily allowable amount of aspartame, and adults should adhere to the maximum daily dosage. Patients who have had allergic reactions to this medication or its ingredients should not take it, and patients with lactose intolerance or specific genetic issues should also avoid it. Severe allergic reactions like shock or anaphylaxis may occur while taking this medication, thus, if symptoms like low blood pressure, altered consciousness, difficulty breathing, or rashes appear, the medication should be stopped immediately and medical personnel should be notified. Blood-related issues may cause a decrease in white blood cells or platelets, so if symptoms like fever, sore throat, or bleeding occur, the medication should be discontinued. Liver dysfunction may occur, so if jaundice or elevated liver enzyme symptoms appear, careful observation is needed, and discontinuation may be necessary. Respiratory-related side effects such as interstitial pneumonia or eosinophilic pneumonia may occur, thus if symptoms like fever, cough, or difficulty breathing appear, it is crucial to stop taking the medication and receive appropriate treatment. Symptoms related to muscle pain, weakness, or muscle damage may occur, so if these symptoms arise, it is advised to cease taking the medication and consult medical staff. Hypersensitivity reactions such as skin rash, hives, and itching may occur, so if any unusual symptoms are present, discontinue the medication and seek treatment. This medication may affect the mental nervous system, leading to insomnia, anxiety, headache, and drowsiness, hence symptoms should be monitored. Gastrointestinal symptoms such as heartburn, nausea, vomiting, or diarrhea may occur; if symptoms are severe, consultation with medical staff is advisable. Cardiac-related side effects like arrhythmias or palpitations may occur, so caution is needed. Urinary symptoms like dysuria or hematuria may occur; report any unusual symptoms promptly. Long-term use of this medication may lead to unexpected adverse reactions, so regular check-ups are advisable. This medication is not an immediate relief medication for asthma attacks, so this point should be adequately explained to patients. In severe asthma attacks, bronchodilators or corticosteroids should be used, and it should not be relied upon solely to control symptoms. Patients on long-term steroid treatment need to gradually reduce the steroid dose while using this medication, under specialist supervision. Abruptly stopping this medication may cause the original condition to worsen, so caution is warranted. Rarely, serious side effects such as vasculitis may occur when using leukotriene antagonists, hence eosinophil counts or vasculitis symptoms should be carefully monitored. Psychological symptoms, including depression or suicidal thoughts, may appear after taking this medication, thus patient status should be closely observed. If no effects are observed, take care not to use this medication for prolonged periods. Children may have difficulty articulating their symptoms precisely, so guardians should closely monitor the child's condition and immediately inform medical staff of any abnormalities. This medication is metabolized in the liver by a specific enzyme (CYP3A4), so if taken with other drugs that affect this enzyme, blood concentration may change. Particular caution is needed when taking this medication with drugs that inhibit CYP3A4 as it may increase the concentration of this medication. The safety of this medication has not been established during pregnancy, thus women who are pregnant or may become pregnant should consult a physician before use. Safety has not been confirmed for infants under 1 year old or low birth weight newborns, hence it is preferable not to use it in this age group. Elderly patients may have reduced physical function, necessitating careful dosage adjustments and monitoring.

Side effects

  • Shock
  • anaphylaxis-like symptoms
  • hypotension
  • altered consciousness
  • dyspnea
  • rash
  • leukopenia
  • fever
  • sore throat
  • generalized weakness
Show 77 more
  • thrombocytopenia
  • purpura
  • nosebleeds
  • gingival bleeding
  • jaundice
  • liver dysfunction
  • elevated bilirubin
  • elevated ALP
  • interstitial pneumonia
  • eosinophilic pneumonia
  • rhabdomyolysis
  • myalgia
  • lethargy
  • elevated CK
  • elevated myoglobin
  • acute kidney injury
  • arthralgia
  • urticaria
  • polymorphic exudative erythema
  • pruritus
  • insomnia
  • paresthesia
  • tremor
  • anxiety
  • dysgeusia
  • convulsions
  • headache
  • drowsiness
  • dizziness
  • agitation
  • discomfort in the epigastric region
  • loss of appetite
  • heartburn
  • abdominal distension
  • stomatitis
  • glossitis
  • tongue paralysis
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • constipation
  • arrhythmia
  • palpitations
  • flushing
  • reduced urine volume
  • frequent urination
  • urination disorders
  • hematuria
  • proteinuria
  • pleural effusion
  • edema
  • hair loss
  • malaise
  • menstrual irregularities
  • elevated triglycerides
  • thirst
  • tinnitus
  • bleeding
  • fever
  • increased sputum
  • heat
  • pharyngitis
  • sinusitis
  • otitis media
  • gastroenteritis
  • rhinitis
  • bronchitis
  • viral infections
  • conjunctivitis
  • upper respiratory tract infections
  • enteritis
  • laceration
  • synovitis
  • enteritis
  • gastroenteritis
  • pneumonia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help to retain the medication's effectiveness and safety for a longer period.

Appearance and packaging

Appearance

White to pale yellow heart-shaped suspension tablet

Package unit

60 tablets (6 tablets/Alu-Alu x 10)

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.

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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.