Medication info
Azilas Injection 0.5 mg (Rasagiline Mesylate)

Azilas Injection 0.5 mg (Rasagiline Mesylate)

Prescription medicationTabletOral
Ingredient · strength
Rasagiline Mesylate›0.78mg / 1 tablet
Manufacturer / importer
Daewoong Bio Co., Ltd.
Appearance
White round tablet
Packaging
Domestic use - bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201907987 · Approved 2019.11.19 · Insurance code 694002700

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 1 mg orally once daily. 2) Adjunctive therapy to levodopa: The recommended initial dose for patients taking levodopa is 0.5 mg once daily. If well tolerated but 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 Bio Co., Ltd.

Efficacy & effects

Treatment of idiopathic Parkinson's disease

  • Idiopathic Parkinson's disease
  • motor fluctuation symptoms
View approved original text

This medication is used for the treatment of idiopathic Parkinson's disease. Initially, it can be used as a monotherapy or as an adjunct therapy with dopamine agonists. Additionally, it can also be utilized as an adjunct therapy to levodopa for patients experiencing motor fluctuation symptoms known as 'end of dose fluctuations'. This medication helps effectively improve the symptoms of Parkinson's disease.

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 1 mg orally once daily. 2) Adjunctive therapy to levodopa: The recommended initial dose for patients taking levodopa is 0.5 mg once daily. If well tolerated but 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 taken by individuals with hypersensitivity to specific components. Concurrent use with other MAO inhibitors or certain analgesics and cough medicines can be dangerous; hence, such combinations should be avoided. Patients with moderate to severe hepatic impairment should avoid taking this medication. Side effects such as headache, dizziness, depression, skin rash, dyspepsia, and myalgia may occur upon ingestion. Particularly in Parkinson's patients, symptoms such as hallucinations, movement disorders, hypotension, and drowsiness may develop, hence caution is necessary. While taking this medication, there may be occurrences of impulse control disorders; thus, symptoms should be closely monitored. Caution is needed during pregnancy or breastfeeding. The safety and efficacy in children have not been established, so it is not recommended. The elderly can use it without special dosage adjustments. Serious side effects may occur in case of overdose; therefore, the prescribed dosage must be strictly followed. This medication may affect driving or machinery operation, so caution is necessary after taking it. Additionally, it is advisable not to take it with alcohol or other central nervous system depressants. During storage, keep it in a cool place out of reach of children.

Side effects

  • Influenza
  • skin cancer
  • leukopenia
  • allergy
  • loss of appetite
  • depression
  • hallucinations
  • headache
  • cerebrovascular accident
  • conjunctivitis
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  • dizziness
  • angina
  • myocardial infarction
  • rhinitis
  • abdominal distension
  • dermatitis
  • vesicular rash
  • musculoskeletal pain
  • cervical pain
  • arthritis
  • urgency
  • fever
  • fatigue
  • peripheral edema
  • falls
  • arthralgia
  • cough
  • insomnia
  • nausea
  • constipation
  • vomiting
  • dry mouth
  • diarrhea
  • abdominal pain
  • dyspepsia
  • hernia
  • infection
  • gingivitis
  • accidental injuries
  • weight loss
  • tendinitis
  • dyskinesia
  • drowsiness
  • sensory disturbances
  • ataxia
  • muscle tone abnormalities
  • myasthenia
  • decreased appetite
  • abnormal dreams
  • respiratory distress
  • rash
  • hyperhidrosis
  • orthostatic hypotension
  • petechiae
  • bleeding
  • melanoma
  • confusion
  • carpal tunnel syndrome
  • balance disorder
  • hypotension
  • acute renal failure
  • urinary difficulty
  • malignant hyperthermia
  • generalized weakness
  • pulmonary tuberculosis
  • semi-coma
  • gait disorder
  • ocular movement seizure
  • facial paralysis
  • spinal canal stenosis
  • exacerbation of Parkinson's disease
  • subdural hematoma
  • pneumonia
  • spinal fracture
  • rib fracture
  • ligament injury
  • pelvic fracture
  • leg fracture
  • upper limb fracture
  • low back pain
  • knee arthroplasty
  • herniated disc
  • hypoglycemia
  • weight loss
  • vaginitis
  • conjunctival injection
  • diplopia
  • floaters
  • visual impairment
  • skin hypertrophy
  • palpitations
  • arrhythmia
  • heartburn
  • generalized weakness
  • fatigue
  • delusion
  • sleep disorder
  • aggression
  • amnesia
  • memory impairment
  • lethargy
  • sleep talking
  • psychosexual disorders
  • skin paresthesia
  • tremors
  • freezing phenomenon
  • limb tremors
  • idiopathic muscle cramps
  • leg cramps
  • polyuria
  • tremors
  • stuttering
  • vocal cord dysfunction
  • speech disorders
  • localized inflammation
  • itching
  • hives
  • boils
  • hair loss
  • contusion
  • sputum abnormalities
  • increased sputum
  • common cold
  • bronchitis

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

Storage

This medication is sensitive to air and moisture; therefore, it should be stored in a sealed container. Moreover, it is important to keep it at a cool temperature between 1 degree and 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

White round tablet

Package unit

Domestic use - bottle - 30 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.