Namenda XR

(Memantine Hydrochloride ER)

The active ingredient in Namenda XR is memantine hydrochloride, which is an N-methyl-D-aspartate (NMDA) receptor antagonist (also called an NMDA inhibitor). In Alzheimer’s disease, the brain chemical glutamate may overstimulate NMDA receptors over time. Memantine’s mechanism of action involves blocking this NMDA receptor activity in a specific way (an “open-channel” blocker), which may help with symptoms of Alzheimer’s disease. It is not proven to prevent or slow the underlying disease process.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Namenda XR. However, the following is a synopsis of the general guidelines for the use of Namenda XR:

• Namenda XR is taken by mouth 1 time per day (once daily), with or without food.
• Many people start at 7 mg once daily. Your healthcare professional may increase the dose in 7 mg steps (titration) up to the typical maintenance dose of 28 mg/day (28 mg once daily). The minimum time between dose increases is 1 week, and the dose is usually increased only if the previous dose was well tolerated.
• Swallow the extended-release capsules whole. Do not divide the capsule contents. Do not crush, chew, or split the capsule. If needed, the capsule may be opened and sprinkled on applesauce, and the entire contents should be swallowed right away. If you have trouble taking it this way, memantine is also available in an oral solution.
• Do not use capsules that are damaged or look tampered with.
• Missed dose: If you miss 1 dose, do not take 2 doses at the next dose time. Take your next dose as scheduled. If you have missed Namenda XR for several days, do not restart on your own—contact your healthcare professional, because you may need to restart at a lower dose and retitrate.
• If you are switching from immediate-release memantine (for example, 10 mg twice daily), talk to your healthcare professional about how to switch to Namenda XR.

Some mild or common side effects of Namenda XR include:

• Headache
• Diarrhea
• Dizziness
• Constipation
• Back pain
• Sleepiness (somnolence)
• Stomach pain
• Nausea and vomiting

Some individuals may experience serious side effects while using Namenda XR. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a serious allergic reaction (hypersensitivity), such as swelling, rash, hives, or trouble breathing (do not take Namenda XR if you are allergic to memantine or any ingredient).
• Seizure (especially if you have a history of seizures).
• New or worsening kidney problems, including acute renal failure (may show up as changes in urination or abnormal kidney tests).
• Severe skin reactions such as Stevens-Johnson syndrome (blistering, peeling, or painful rash).
• Unusual bruising or bleeding, severe weakness, or signs of blood problems (postmarketing reports include low white blood cell counts such as leukopenia or neutropenia, low platelets, and rare conditions like thrombotic thrombocytopenic purpura).
• Severe stomach pain that may not go away (postmarketing reports include pancreatitis).
• Mood or behavior changes, including suicidal ideation (reported after approval).

These are not all of the possible adverse reactions of Namenda XR. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Namenda XR, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Seizures (or a history of seizures)
• Problems passing urine or urinary tract issues
• Bladder or kidney problems, including renal impairment
• Liver problems
• Also, tell your healthcare professional if you are pregnant or breastfeeding.

Yes. Namenda XR is contraindicated in people with a known hypersensitivity (allergy) to memantine hydrochloride or any of the excipients (inactive ingredients) in the formulation.

Namenda XR is used as an ongoing daily treatment for moderate to severe Alzheimer’s disease. If you or your caregiver do not notice any improvement or you see worsening symptoms of Alzheimer’s disease, talk with your healthcare professional. They can explain what to expect in terms of the effect of memantine and whether your dose (mg/day) or treatment plan needs review.

When Namenda XR is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Medicines that make urine more alkaline can reduce the clearance of memantine and raise memantine levels. Examples include carbonic anhydrase inhibitors (such as acetazolamide or methazolamide) and sodium bicarbonate. Some diets and certain urinary tract conditions (such as renal tubular acidosis or severe urinary tract infections) can also raise urine pH.
• Other NMDA receptor antagonists (NMDA antagonists) such as amantadine, ketamine, and dextromethorphan. Combining these with Namenda XR has not been well studied and should be approached with caution.
• Always check with your doctor or pharmacist before starting anything new, including supplements.

Namenda XR is available in these strengths and dosage forms: 7 mg, 14 mg, 21 mg, and 28 mg extended-release capsules. A 28-day titration pack is also available with 7 capsules each of 7 mg, 14 mg, 21 mg, and 28 mg.

Store Namenda XR at controlled room temperature (25°C/77°F), with allowed excursions to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.

Namenda XR is manufactured by Allergan.

Namenda XR is the brand name. The drug’s generic name is memantine hydrochloride extended-release capsules.

Do not stop Namenda XR or change your dose unless your healthcare professional tells you to. If you have missed Namenda XR for several days, do not restart on your own; contact your healthcare professional because you may need to restart at a lower dose and retitrate.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. The label notes that it is not known if Namenda XR will harm your unborn baby.

The label notes that it is not known if memantine passes into breast milk during lactation, and your doctor can help you decide the best way to feed your baby while taking Namenda XR.