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ADARIGILINE
Generic Name: ADARIGILINE
ABSTRACT -
Adarigiline is an investigational small-molecule monoamine oxidase B (MAO-B) inhibitor candidate. MAO-B inhibition can increase synaptic monoamines such as dopamine by reducing oxidative deamination, a mechanism relevant to neurologic disorders such as Parkinson disease. Adarigiline was not marketed and should be considered an investigational or research-stage drug candidate.
DOSAGE -
An approved, universally established dosage regimen is not available for this investigational or limited-use substance.
- Administration, dose level, schedule, and treatment duration should follow the applicable neurology clinical-trial protocol.
- Dose escalation, dose interruption, and discontinuation should be determined only by the investigator or treating specialist.
- Do not use for self-medication or outside an approved protocol, prescription, or specialist-supervised setting.
- Monitoring should include clinical assessment and laboratory testing appropriate to the drug class and patient condition.
SIDE EFFECTS -
Reported or potential side effects may include:
- Headache
- Dizziness
- Nausea
- Dry mouth
- Insomnia
- Sleepiness
- Orthostatic hypotension
- Palpitations
- Anxiety or agitation
- Confusion
- Hallucinations in susceptible patients
- Hypertension if combined with interacting sympathomimetic or serotonergic medicines
- Rash
- Allergic or hypersensitivity reactions
ALLRGIC REACTIONS–
(These symptoms may indicate an allergic reaction to the drug.)
- Skin rash
- Itching
- Hives
- Swelling of face, lips, tongue, or throat
- Difficulty breathing
- Wheezing
- Severe dizziness
- Rapid heartbeat
- Chest tightness
- Anaphylaxis
- Severe hypersensitivity reactions
DRUG INTERACTIONS–
The full drug-interaction profile has not been completely established. Use caution with:
- Other MAO inhibitors
- Serotonergic medicines including SSRIs, SNRIs, TCAs, MAOIs, linezolid, methylene blue, tramadol, meperidine, or St. John's wort
- Sympathomimetics, decongestants, stimulants, or certain migraine medicines
- Dopaminergic medicines or levodopa when neurologic adverse effects may be increased
- High-tyramine dietary exposure if clinically relevant to MAO inhibition
- Other investigational medicines or therapies used in the same protocol
- Medicines that increase the risk of overlapping organ toxicity
- Immunosuppressive, anticancer, antiviral, cardiovascular, or neurologic medicines when clinically relevant
- Herbal products and supplements with uncertain pharmacologic effects
PREAUTIONS–
- Assess psychiatric history, blood pressure, cardiovascular disease, and concomitant serotonergic or sympathomimetic medicines before use.
- Monitor for serotonin syndrome, hypertensive reaction, orthostatic symptoms, hallucinations, impulse-control symptoms, and sleep disturbance.
- Use only in settings where qualified healthcare professionals can assess eligibility, monitor response, and manage adverse reactions.
- Review baseline medical history, organ function, concomitant medicines, pregnancy status, and allergy history before use.
- Monitor clinical symptoms and laboratory values as directed by the clinical protocol or treating specialist.
- Use caution in patients with severe hepatic, renal, cardiovascular, infectious, immune, or neurologic disease unless specifically allowed by protocol.
- Use during pregnancy or breastfeeding only if the potential benefit justifies the potential risk and as directed by a physician.
- Safety and effectiveness in pediatric patients may not be established unless specifically studied.
WARNINGS –
- MAO-B inhibitors can interact dangerously with serotonergic or sympathomimetic medicines, causing serotonin syndrome or hypertensive reactions.
- Symptoms such as severe headache, chest pain, severe hypertension, fever, agitation, muscle rigidity, confusion, or tremor require urgent medical evaluation.
- This medicine is investigational or has limited publicly established clinical-use information; safety, efficacy, optimal dose, and routine clinical role may not be fully established.
- It should not be used for self-medication or substituted for an approved therapy unless directed by a qualified specialist or clinical-trial investigator.
- Treatment should be discontinued and urgent medical care sought if severe allergic reaction, severe adverse reaction, or clinical deterioration is suspected.
- Use only under medical supervision in an appropriate specialist or clinical-trial setting.
- Keep out of reach of children.
- In case of overdose or severe adverse reaction, seek immediate emergency medical attention.
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