"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
(memantine hydrochloride) Oral Solution
Read this Patient Information that comes with NAMENDA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is NAMENDA?
NAMENDA is a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer's disease. NAMENDA belongs to a class of medicines called NMDA (N-methyl-Daspartate) inhibitors.
It is not known if NAMENDA is safe and effective in children.
Who should not take NAMENDA?
Do not take NAMENDA if you are allergic to memantine or any of the ingredients in NAMENDA. See the end of this leaflet for a complete list of ingredients in NAMENDA.
What should I tell my doctor before taking NAMENDA?
Before you take NAMENDA, tell your doctor if you:
- have or have had seizures
- have or have had problems passing urine
- have or have had bladder or kidney problems
- have liver problems
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if NAMENDA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if NAMENDA passes into your breast milk. You and your doctor should decide if you will take NAMENDA or breastfeed.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Taking NAMENDA with certain other medicines may affect each other. Taking NAMENDA with other medicines can cause serious side effects.
Especially tell your doctor if you take:
- other NMDA antagonists such as amantadine, ketamine, and dextromethorphan
- medicines that make your urine alkaline such as carbonic anhydrase inhibitors and sodium bicarbonate
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take NAMENDA?
- See the step-by-step instructions for taking NAMENDA at the end of this Patient Information.
- Your doctor will tell you how much NAMENDA to take and when to take it.
- Your doctor may change your dose if needed.
- NAMENDA can be taken with food or without food.
- If you forget to take one dose of NAMENDA, do not double up on the next dose. You should take only the next dose as scheduled.
- If you have forgotten to take NAMENDA for several days, you should not take the next dose until you talk to your doctor.
- If you take too much NAMENDA, call your doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
What are the possible side effects of NAMENDA?
NAMENDA may cause side effects, including:
The most common side effects of NAMENDA include:
These are not all the possible side effects of NAMENDA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store NAMENDA?
- Store NAMENDA at room temperature between 68°F to 77°F (20°C to 25°C).
What are the ingredients in NAMENDA?
Active ingredients: memantine hydrochloride
Inactive ingredients: sorbitol solution (70%), methyl paraben, propylparaben, propylene glycol, glycerin, natural peppermint flavor #104, citric acid, sodium citrate, and purified water
Keep NAMENDA and all medicines out of the reach of children.
General information about the safe and effective use of NAMENDA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take NAMENDA for a condition for which it was not prescribed. Do not give NAMENDA to other people, even if they have the same condition. It may harm them.
This Patient Information leaflet summarizes the most important information about NAMENDA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about NAMENDA that was written for healthcare professionals.
For more information about NAMENDA, go to www.namenda.com, or call Forest Laboratories, Inc. at 1-800-678-1605.
INSTRUCTIONS FOR USE
(memantine hydrochloride) Oral Solution
Directions for Using your NAMENDA Oral Solution
Read these instructions before taking NAMENDA Oral Solution and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
Preparing your dose of NAMENDA Oral Solution.
You will need the following supplies:
- NAMENDA Oral Solution bottle with Child-resistant cap
- Green syringe adaptor cap with lid
- Oral dosing syringe
- Prescribing Information
1. Remove the oral dosing syringe, the green syringe adaptor cap, and remove the plastic tube from its protective plastic bag. Attach the tube to the green syringe adaptor cap if it is not already attached.
2. The bottle comes with a child-resistant cap. To remove the cap, you should push down on the cap and at the same time; turn the cap counter-clockwise (to the left).
3. Carefully remove the seal from the bottle and throw away.
4. Insert the green syringe adaptor cap, with the attached tube, all the way into the bottle and tightly screw the cap onto the bottle by turning the cap clockwise (to the right).
5. The green syringe adaptor cap has an opening with an attached lid. The adaptor is used to withdraw the correct dose of medicine from the bottle with the syringe. The attached adaptor lid should be closed in between doses.
6. Keep the bottle upright on a table. Open the syringe adaptor lid and insert the tip of syringe into the syringe adaptor opening
- Make sure the syringe is pushed firmly into the adaptor opening.
7. While holding the syringe in place, gently pull the plunger of the syringe until you get to the correct mL (amount) of medicine you need.
- Do not worry about a few tiny bubbles. This will not affect your dose.
8. Remove the syringe from the syringe adaptor cap.
9. Remove the syringe from the bottle and slowly squirt the NAMENDA Oral Solution into the corner of you or the patient's mouth. Do not mix NAMENDA Oral Solution with any other liquid.
10. After use, reseal the bottle by snapping the attached syringe adaptor lid closed.
11. Rinse the empty syringe by inserting the open end of the syringe into a glass of water, pulling the plunger out to draw in water, and pushing the plunger in to remove the water. Repeat several times. Allow the syringe to air dry.
12. Store the bottle upright.
Last reviewed on RxList: 9/25/2014
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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