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AMITIFADINE
Generic Name: AMITIFADINE
ABSTRACT -
Amitifadine, also known as DOV-21,947 or EB-1010, is an investigational triple reuptake inhibitor that inhibits serotonin, norepinephrine, and dopamine transporters, with serotonin-preferring activity. It was developed for major depressive disorder and other neuropsychiatric indications but is not approved as a marketed antidepressant.
DOSAGE -
Dosage should be determined only by a qualified healthcare professional.
No approved dosage regimen exists.
Clinical studies used protocol-defined oral dosing, but these regimens should not be used outside clinical research.
Do not substitute amitifadine for approved antidepressant or smoking-cessation therapies.
SIDE EFFECTS–
Possible side effects may include:
- Nausea, dry mouth, constipation, or gastrointestinal discomfort
- Insomnia, anxiety, agitation, or tremor
- Headache or dizziness
- Increased heart rate or blood pressure
- Sexual dysfunction or sweating may occur with monoamine reuptake effects
- Possible serotonin syndrome when combined with serotonergic medicines
ALLRGIC REACTIONS–
Hypersensitivity to amitifadine or related compounds may occur. Symptoms may include:
- Rash or urticaria
- Pruritus
- Swelling of face, lips, or throat
- Breathing difficulty
- Severe allergic reaction symptoms
Important: Patients who develop an allergic reaction to Amitifadine should seek immediate medical attention and inform all future healthcare providers of the allergy.
DRUG INTERACTIONS–
Amitifadine may interact with certain medicines or substances. Caution is needed with:
- MAO inhibitors are expected to be contraindicated due to serious monoamine toxicity risk.
- SSRIs, SNRIs, TCAs, triptans, linezolid, lithium, or St John’s wort may increase serotonergic toxicity risk.
- Stimulants and sympathomimetics may increase blood pressure and heart-rate effects.
- Alcohol and CNS-active medicines may worsen impairment or mood instability.
Patients should inform healthcare providers about all prescription medicines, over-the-counter medicines, herbal products, and supplements they are using.
PREAUTIONS–
- Screen for bipolar disorder, suicidality, hypertension, seizure risk, and substance-use risk.
- Monitor mood, sleep, blood pressure, pulse, and adverse neuropsychiatric symptoms in research settings.
- Avoid abrupt discontinuation unless clinically required.
- Pregnancy and lactation safety are not established.
WARNINGS –
- Amitifadine is investigational and not approved for general clinical use.
- Serotonin syndrome, hypertension, mania, or worsening suicidality are theoretical or class-related risks.
- Any severe agitation, hyperthermia, confusion, or autonomic instability requires urgent medical care.
- Keep out of reach of children.
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