Medication info

Nokshimja Rasagiline Tablets 0.5 mg (Rasagiline Mesylate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Rasagiline Mesylate›0.78mg / 1 tablet
Manufacturer / importer
Nokshimja Co., Ltd.
Appearance
Flat round tablets with a white or almost white appearance
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202002209 · Approved 2020.03.31

This product's status changed to Approval withdrawn on 2024.06.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Ingredients

Manufacturer
Nokshimja Co., Ltd.

Efficacy & effects

Treatment of idiopathic Parkinson's disease

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

This is for the treatment of idiopathic Parkinson's disease. Initially, treatment begins with either monotherapy of a dopamine agonist or as an adjunct to a dopamine agonist. Subsequently, for patients exhibiting motor fluctuations, i.e., end of dose fluctuations, levodopa is used as an adjunct to manage symptoms. These treatments help improve the symptoms of Parkinson's disease and enhance the quality of life for patients.

How to take

Adult dose

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

Precautions

This medication should not be used by patients with an allergy to certain components. Additionally, patients who are currently taking or have recently stopped other MAO inhibitors, certain pain relievers, or cold medicines should not use this medication. Patients with moderate to severe liver impairment should also avoid this medication. This medication can cause various side effects, common symptoms include headache, dizziness, dermatitis, dyspepsia, insomnia, and arthralgia. Occasionally, severe symptoms such as depression, hallucinations, and blood pressure changes may also occur, so caution is necessary. If unusual skin reactions occur during treatment, consulting a specialist is recommended. Drowsiness or sudden sleep may occur while driving or operating machinery, so precaution is advised. Due to many potential drug interactions, any ongoing medications should be disclosed to a doctor or pharmacist. Caution is particularly warranted when taking this medication alongside antihypertensives, antidepressants, and pain relievers. Caution is also advised for use during pregnancy or breastfeeding, and consulting a specialist is important. Its safety and efficacy have not been established in children, so it is advisable not to use it. Serious side effects may occur in case of overdose, so it is important to adhere strictly to the prescribed dosage. Store in a cool place out of reach of children and do not transfer to another container.

Side effects

  • Influenza
  • skin cancer
  • leukopenia
  • allergy
  • decreased appetite
  • depression
  • hallucinations
  • headache
  • cerebrovascular accident
  • conjunctivitis
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  • dizziness
  • angina pectoris
  • myocardial infarction
  • rhinitis
  • abdominal distention
  • dermatitis
  • vesicular rash
  • musculoskeletal pain
  • neck pain
  • arthritis
  • urinary urgency
  • fever
  • malaise
  • peripheral edema
  • falls
  • arthralgia
  • lower back pain
  • cough
  • insomnia
  • upper respiratory infection
  • orthostatic hypotension
  • nausea
  • constipation
  • vomiting
  • dry mouth
  • diarrhea
  • abdominal pain
  • dyspepsia
  • hernia
  • infection
  • gingivitis
  • accidental injury
  • weight loss
  • tendinitis
  • dyskinesia
  • drowsiness
  • sensory disturbances
  • ataxia
  • muscle tone abnormalities
  • myasthenia
  • anorexia
  • abnormal dreams
  • respiratory disorders
  • rash
  • hyperhidrosis
  • petechiae
  • melanoma
  • confusion
  • carpal tunnel syndrome
  • balance disorders
  • hypotension
  • pathological gambling
  • increased libido
  • hypersexuality
  • compulsive spending
  • buying
  • binge eating
  • compulsive eating
  • impulse control disorders
  • excessive drowsiness
  • acute renal failure
  • malignant hyperthermia
  • general weakness
  • pulmonary tuberculosis
  • semicoma
  • gait disorders
  • ocular motor 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 limb fracture
  • back pain
  • knee joint replacement
  • herniated disc
  • hypoglycemia
  • dysuria
  • palpitations
  • arrhythmia
  • heartburn
  • general weakness
  • fatigue
  • delusions
  • sleep disorders
  • aggression
  • amnesia
  • memory impairment
  • lethargy
  • sleep talking
  • psychosexual disorders
  • skin paresthesia
  • tremor
  • freezing phenomenon
  • limb tremor
  • myotonic dystrophy
  • leg cramps
  • polyuria
  • tremor
  • stuttering
  • dysphonia
  • vocal cord paralysis
  • speech disorder
  • localized inflammation
  • itching
  • hives
  • eyelid skin disorders
  • abscess
  • hair loss
  • bruise
  • abnormal sputum
  • increased sputum
  • common cold
  • bronchitis

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, ideally at room temperature between 1 and 25 degrees Celsius. This will help maintain the medication's efficacy and ensure safe use.

Appearance and packaging

Appearance

Flat round tablets with a white or almost white appearance

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 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

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

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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.