Medication info
Boryeong Rasagiline 1mg Tablets (Rasagiline Mesylate)

Boryeong Rasagiline 1mg Tablets (Rasagiline Mesylate)

Prescription medicationTabletOral
Ingredient · strength
Rasagiline Mesylate›1.56mg / 1 tablet
Manufacturer / importer
Boryeong Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/box [10 tablets/PTP*3]
Approval status
Active

MFDS item code 201907627 · Approved 2019.10.31

Summary

Main use
Treatment of idiopathic Parkinson's disease
Who takes it
Adults
Adult dose
This medicine is administered orally once daily to adults as monotherapy or adjunctive therapy. 1) Monotherapy or adjunctive therapy to a dopamine agonist: Administer 1mg orally once daily. 2) Adjunctive therapy to levodopa: The recommended initial dose for patients taking levodopa is 0.5mg once daily. If it is well tolerated and an adequate clinical response is not achieved, the dose may be increased to 1mg once daily. This medicine may be taken with or without food.

Ingredients

Manufacturer
Boryeong Co., Ltd.

Efficacy & effects

Treatment of idiopathic Parkinson's disease

  • Idiopathic Parkinson's disease
  • motor dyskinesia
View approved original text

This medication is used for the treatment of idiopathic Parkinson's disease. Initially, it is used as monotherapy or as an adjunct therapy with dopamine agonists to alleviate symptoms. Additionally, it is administered as adjunct therapy to levodopa in patients with motor dyskinesia to aid in symptom control. This treatment contributes to the improvement of the patient's motor function.

How to take

Adult dose

This medicine is administered orally once daily to adults as monotherapy or adjunctive therapy. 1) Monotherapy or adjunctive therapy to a dopamine agonist: Administer 1mg orally once daily. 2) Adjunctive therapy to levodopa: The recommended initial dose for patients taking levodopa is 0.5mg once daily. If it is well tolerated and an adequate clinical response is not achieved, the dose may be increased to 1mg once daily. This medicine may be taken with or without food.

Precautions

This medication should not be administered to patients who are allergic to its active ingredient or other components. Also, it should not be used in conjunction with other MAO inhibitors or natural medicines without a prescription, or if discontinued within the last 2 weeks. Especially, patients who are using or have discontinued medications such as pethidine, tramadol, or dextromethorphan within 2 weeks should not be treated with this medication. This medication should not be used in patients with moderate to severe liver impairment. Various adverse reactions may occur during the use of this medication, with common symptoms including headache, dizziness, nausea, arthralgia, and insomnia. Additionally, infections, dermatitis, musculoskeletal pain, blood pressure changes, psychiatric symptoms (depression, hallucinations), gastrointestinal symptoms (vomiting, constipation, diarrhea) have been reported. If adverse reactions are severe or persistent, consult a physician. Exceeding the recommended dosage may reduce selectivity and increase the risk of side effects, so it is essential to adhere to the prescribed dosage. For patients with Parkinson's disease, regular monitoring of skin conditions is advisable due to an increased risk of skin cancer. Additionally, those with pre-existing movement disorders or hypotension may find symptoms worsen when taking this medication. Mental or behavioral changes such as impulse control disorders, obsessive behaviors, and pathological gambling may occur while taking this medication; thus, both the patient and caregivers should recognize and closely monitor these symptoms. Patients with liver impairment may have elevated concentrations of this medication in their blood, so even patients with mild liver dysfunction should be treated with caution, and individuals with moderate to severe liver dysfunction should not use this medication. Patients with mild or moderate kidney dysfunction do not require dosage adjustments, but safety has not been established for patients with severe kidney impairment. This medication may cause drowsiness or sudden sleep, so it is advisable to avoid driving or operating hazardous machinery while taking it. Patients with a history of drowsiness or sleep attacks should exercise extra caution. Due to numerous drug interactions, especially with other MAO inhibitors, pethidine, tramadol, dextromethorphan, antidepressants, and sympathomimetics, serious side effects may occur when taken together; therefore, consultation with a physician or pharmacist is essential. There is insufficient safety information regarding the use of this medication in pregnant or breastfeeding women, so caution is advised when taking it, especially during breastfeeding as it may affect nursing. The safety and efficacy of this medication in children under 18 years of age have not been confirmed, so it is advisable not to use it. In the case of overdose, serious side effects may occur, and there is no specific antidote, so appropriate treatment should be sought immediately at a medical institution. This medication should be kept out of the reach of children and should be stored at a temperature between 1 and 25 degrees Celsius. Transferring the medication to other containers should be avoided as it may result in a decrease in quality or risk of accidents.

Side effects

  • Influenza
  • skin cancer
  • leukopenia
  • allergy
  • decreased appetite
  • depression
  • hallucination
  • headache
  • cerebrovascular accident
  • conjunctivitis
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  • dizziness
  • angina
  • myocardial infarction
  • rhinitis
  • abdominal distension
  • dermatitis
  • vesicular rash
  • musculoskeletal pain
  • neck pain
  • arthritis
  • urgency
  • fever
  • fatigue
  • peripheral edema
  • falls
  • arthralgia
  • cough
  • insomnia
  • nausea
  • constipation
  • vomiting
  • dry mouth
  • diarrhea
  • abdominal pain
  • indigestion
  • hernia
  • infection
  • gingivitis
  • traumatic injury
  • weight loss
  • tendinitis
  • dyskinesia
  • drowsiness
  • sensory disturbance
  • ataxia
  • muscle tension disorder
  • myasthenia
  • anorexia
  • abnormal dreams
  • respiratory distress
  • rash
  • hyperhidrosis
  • orthostatic hypotension
  • petechiae
  • bleeding
  • melanoma
  • confusion
  • carpal tunnel syndrome
  • balance disorder
  • hypertension
  • pathological gambling
  • increased libido
  • hypersexuality
  • compulsive buying or spending
  • binge eating
  • compulsive eating
  • hypotension
  • excessive drowsiness
  • acute renal failure
  • malignant hyperthermia
  • general weakness
  • pulmonary tuberculosis
  • semicoma
  • gait disorder
  • oculomotor seizures
  • facial paralysis
  • spinal canal stenosis
  • worsening of Parkinson's disease
  • subdural hematoma
  • pneumonia
  • vertebral fracture
  • rib fracture
  • tendon injury
  • pelvic fracture
  • leg fracture
  • upper extremity fracture
  • back pain
  • knee joint replacement
  • herniated disc
  • hypoglycemia
  • weight loss
  • urinary difficulty
  • hematuria
  • frequent urination
  • insufficient urine output
  • nocturia
  • urinary incontinence
  • vaginitis
  • conjunctival congestion
  • diplopia
  • visual impairment
  • skin hypertrophy
  • palpitations
  • arrhythmia
  • gastrointestinal discomfort
  • gas reflux
  • excessive salivation
  • irritable bowel syndrome
  • fissured tongue
  • increased bowel movements
  • unspecified intestinal disease
  • esophagitis
  • hyperacidity
  • gastroesophageal reflux
  • gastric irritation
  • gastritis
  • intestinal motility disorder
  • periodontitis
  • Helicobacter pylori gastritis
  • anemia
  • leg pain
  • chest pain
  • syncope
  • periorbital edema
  • facial flushing
  • pain
  • hallucination
  • sleep disorder
  • aggression
  • amnesia
  • memory impairment
  • lethargy
  • sleep talking
  • psychosexual disorder
  • skin tingling
  • tremor
  • freezing phenomenon
  • limb tremor
  • idiopathic muscle cramp syndrome
  • leg cramps
  • polyuria
  • shaking
  • stuttering
  • phonation disorder
  • vocal cord paralysis
  • speech disorder
  • localized inflammation
  • itching
  • urticaria
  • eyelid skin disease
  • abscess
  • hair loss
  • contusion
  • abnormal sputum
  • increased sputum
  • cold
  • bronchitis

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. A cool place with a temperature between 1 and 25 degrees Celsius is suitable for storage.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets/box [10 tablets/PTP*3]

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.