Medication info

Bearect 1mg (Rasagiline Mesilate)

Prescription medicationApproval withdrawn
Ingredient · strength
Rasagiline Mesylate›Strength being verified
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
White, round tablet
Packaging
10 tablets/PTP [10 tablets/PTP*3]
Approval status
Approval withdrawn

MFDS item code 201907856 · Approved 2019.11.11

This product's status changed to Approval withdrawn on 2023.03.22. 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 uses it
Adults
Adult dosage
This medicine 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 well tolerated and an adequate clinical response is not achieved, the dose may be increased to 1 mg once daily. This medicine may be taken with or without food.

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of idiopathic Parkinson's disease

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

This medication is used for the treatment of patients with idiopathic Parkinson's disease. In the early stages, it can be administered as monotherapy or as an adjunct therapy with dopamine agonists, and for patients exhibiting 'end of dose fluctuations', it may also be utilized as an adjunct therapy to levodopa. This effectively manages the symptoms of Parkinson's disease and improves the quality of life for patients.

Dosage and Administration

Adult dosage

This medicine 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 well tolerated and an adequate clinical response is not achieved, the dose may be increased to 1 mg once daily. This medicine may be taken with or without food.

Precautions

This medication should not be administered to patients who are allergic to specific ingredients. Patients currently or recently treated with other MAO inhibitors, certain analgesics, or cough medications should also avoid using this drug. It is not administered to patients with moderate to severe liver impairment. This medication can cause various side effects, with headaches, dizziness, dermatitis, depression, hallucinations, dyspepsia, and muscle pain being commonly reported. Hallucinations and confusion may particularly occur in patients with Parkinson's disease, so caution is required. There is a risk of sudden increases in blood pressure during treatment, so it is advisable to avoid foods high in tyramine. Patients taking dopamine-related medications may be at risk for impulse control disorders or excessive drowsiness, and they require regular monitoring. The drug concentration may increase in patients with liver impairment, so caution should be exercised. Drowsiness or decreased attention may occur while driving or operating machinery, so caution is advised. There are many interactions with other medications, so consultation with a physician or pharmacist is essential, especially when taken with antidepressants, analgesics, or cold medicines. Women who are pregnant or breastfeeding should be cautious when taking this medication, and safety for children has not been established. Serious side effects may occur in cases of overdose, so prescribed dosages must be strictly followed. When storing, keep in a cool, dry place out of reach of children, and avoid transferring it to another container.

Side effects

  • Influenza
  • skin cancer
  • leukopenia
  • allergy
  • loss of appetite
  • depression
  • hallucinations
  • headache
  • cerebrovascular accident
  • conjunctivitis
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  • dizziness
  • angina pectoris
  • myocardial infarction
  • rhinitis
  • abdominal distension
  • dermatitis
  • vesicular rash
  • musculoskeletal pain
  • cervical pain
  • arthritis
  • urinary urgency
  • fever
  • lethargy
  • nausea
  • peripheral edema
  • falls
  • arthralgia
  • low back pain
  • cough
  • insomnia
  • upper respiratory tract infection
  • orthostatic hypotension
  • constipation
  • vomiting
  • dry mouth
  • diarrhea
  • abdominal pain
  • dyspepsia
  • hernia
  • infection
  • gingivitis
  • accidental injury
  • weight loss
  • tendinitis
  • movement disorders
  • drowsiness
  • sensory disturbances
  • ataxia
  • muscle tone abnormalities
  • myasthenia gravis
  • appetite loss
  • abnormal dreams
  • respiratory distress
  • rash
  • hyperhidrosis
  • petechiae
  • melanoma
  • confusion
  • carpal tunnel syndrome
  • balance disorders
  • semi-consciousness
  • gait disturbances
  • ocular motor seizures
  • facial paralysis
  • spinal canal stenosis
  • worsening of Parkinson's disease
  • subdural hematoma
  • pneumonia
  • spinal fracture
  • rib fracture
  • tendon injury
  • pelvic fracture
  • leg fracture
  • upper limb fracture
  • back pain
  • knee arthroplasty
  • herniated disc
  • hypoglycemia
  • acute renal failure
  • dysuria
  • malignant hyperthermia
  • systemic weakness
  • pulmonary tuberculosis
  • delirium
  • sleep disorders
  • aggression
  • amnesia
  • memory disorders
  • lethargy
  • sleep talking
  • psychosexual disorders
  • skin paresthesia
  • tremor
  • freezing phenomenon
  • limb tremors
  • myotonia
  • leg cramps
  • polyuria
  • tremors
  • stuttering
  • speech disorders
  • language disorders
  • localized inflammation
  • itching
  • urticaria
  • abscess
  • hair loss
  • palpitations
  • arrhythmia
  • abnormal sputum
  • increased sputum
  • cold
  • bronchitis
  • heartburn
  • fatigue
  • leg pain
  • chest pain
  • syncope
  • periorbital edema
  • facial flushing
  • pain

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress, with an appropriate storage temperature between 1 to 25 degrees. It is important to avoid direct sunlight and not to place it in excessively hot or cold environments.

Appearance and packaging

Appearance

White, round tablet

Package unit

10 tablets/PTP [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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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.