Memantine Hydrochloride 5 Fl 00591 3870 60 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( 1) Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
What should I know before taking it?
Risk Summary There are no adequate data on the developmental risk associated with the use of memantine in pregnant women. Adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the maximum recommended daily dose of memantine [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated.
What important warnings are listed?
Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. ( 5.1, 7.1)
How is this medication usually taken?
See FDA-approved patient labeling (Patient Information and Instructions for Use). To assure safe and effective use of memantine hydrochloride, the following information and instructions provided in the patient information section should be discussed with patients and caregivers. Patients/caregivers should be instructed to follow the dose titration schedule provided by their physician or healthcare professional for memantine hydrochloride. They should be warned not to use any tablets of memantine hydrochloride that are damaged or show signs of tampering. If a patient misses a single dose of memantine hydrochloride, that patient should not double up on the next dose. The next dose should be.
What side effects are listed?
Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion and constipation. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What interactions are listed?
The FDA/DailyMed label should be reviewed for complete details.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbfd9d95-f50b-45ff-9857-9f1712c45e56
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.