Memantine
Regulatory sources consulted
- EMA/H/C/002660
- AEMPS/77539
- AEMPS CIMA · nº registro 77539 ↗
- EMA EPAR · EMEA/H/C/002660 ↗
- RxNorm rxcui 6719 ↗
Approved indications
- Treatment of patients with moderate to severe Alzheimer’s disease.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Caution is recommended in patients with epilepsy, a history of convulsions or patients with predisposing factors for epilepsy. — EMA
- Factors that may raise urine pH (changes in diet, renal tubular acidosis, severe urinary tract infections) may necessitate careful monitoring of the patient, as they decrease the elimination of memantine. — EMA
Drug interactions
- HighAmantadineN04BB01
Mechanism: Pharmacodynamic antagonism at the NMDA-receptor. Concomitant use may lead to an increased incidence and severity of CNS adverse effects (pharmacotoxic psychosis).
Recommendation: The concomitant use of memantine and amantadine, ketamine or dextromethorphan should be avoided.
EMA SPC
- ModerateHydrochlorothiazideC03AA03
Mechanism: Unknown mechanism. Memantine may reduce the exposure of hydrochlorothiazide (HCT).
Recommendation: Monitor for efficacy of hydrochlorothiazide. Dose adjustment may be necessary.
EMA SPC
Adverse events
Common (≥1%)
dizziness · headache · somnolence · hypertension · dyspnoea · constipation · balance disorder
Rare but serious
seizures · cardiac failure · pancreatitis · hepatitis · psychotic reactions
Pregnancy and lactation
There are no clinical data on exposed pregnancies available for memantine. It should not be used during pregnancy unless clearly necessary. Breast-feeding is not recommended during treatment.