Namenda XR Titration Pack (Oral)

Memantine is used to treat moderate to severe Alzheimer's disease. Memantine is not a cure for Alzheimer's disease but it can help people with the disease. Memantine will not cure Alzheimer's disease, and it will not stop the disease from getting worse.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to ensure that this medicine is working properly and to look for any unwanted effects.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There haven't been appropriate studies on how memantine affects children.

Geriatric

There is no information on how memantine affects older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be prescribed together, even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are using any of the following medicines. The following interactions are significant but may not be all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or the frequency of one or both medicines.

• Acetazolamide
• Amantadine
• Brinzolamide
• Bupropion
• Dextromethorphan
• Dorzolamide
• Ketamine
• Levoketoconazole
• Methazolamide
• Methotrexate
• Sodium Bicarbonate

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Epilepsy or seizures or
• Urinary tract problems (e.g., bladder problems, difficulty with urination)—Use with caution. This may worsen these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger because the body removes the medicine more slowly.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away if you notice any of the following side effects:

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• rapid weight gain
• slow or fast heartbeat
• tingling of the hands or feet
• unusual weight gain or loss

Incidence not known

• Abdominal or stomach pain
• agitation
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chest pain
• coma
• constipation
• ongoing vomiting
• convulsions
• dark-colored urine
• decreased urine output
• depression
• fainting
• fast, pounding, or irregular heartbeat or pulse
• general feeling of tiredness or weakness
• high fever
• high or low blood pressure
• hostility
• increased sweating
• indigestion
• infection from breathing foreign substances into the lungs
• itching
• lethargy
• light-colored stools
• lip smacking or puckering
• loss of consciousness
• muscle twitching
• no blood pressure
• no breathing
• no pulse
• numbness or tingling in the face, arms, or legs
• pain in the stomach, side, or abdomen, possibly radiating to the back
• pain or swelling in the arms or legs without any injury
• pain, tension, and weakness while walking that goes away during rest
• pinpoint red spots on the skin
• pounding, slow heartbeat
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• rapid weight gain
• recurrent fainting
• red irritated eyes
• red skin lesions, often with a purple center
• seizures
• severe constipation
• severe headache
• severe muscle stiffness
• severe vomiting
• sores, ulcers, or white spots in the mouth or on the lips
• stupor
• sudden severe weakness
• swelling of the face, ankles, or hands
• total body jerking
• trouble with speaking or walking
• troubled breathing
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled chewing movements
• unusual bleeding or bruising
• unusually pale skin
• vomiting
• yellow eyes and skin

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Confusion

Less common

• Anxiety
• back pain
• bladder pain
• bloody or cloudy urine
• change in walking and balance
• chills
• clumsiness or unsteadiness
• cough producing mucus
• coughing
• diarrhea
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with moving
• discouragement
• dry mouth
• fear
• feeling sad or empty
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• hyperventilation
• insomnia
• irritability
• joint pain
• loss of appetite
• loss of bladder control
• loss of interest or pleasure
• lower back or side pain
• muscle pain or stiffness
• nausea
• nervousness
• pain
• pain in the joints
• restlessness
• seeing, hearing, or feeling things that are not there
• shortness of breath
• sleepiness or unusual drowsiness
• sore throat
• tightness in the chest
• tiredness
• trouble with concentrating
• trouble with sleeping
• unusual tiredness or weakness
• vomiting
• wheezing

Incidence not known

• Burning feeling in the chest or stomach
• burning, numbness, pain, or tingling in all fingers except the smallest finger
• cold sweats
• cool pale skin
• decreased interest in sexual intercourse
• difficulty with swallowing
• general feeling of discomfort or illness
• heartburn
• inability to have or keep an erection
• increased hunger
• large amounts of fat in the blood
• loss in sexual ability, desire, drive, or performance
• nightmares
• shakiness
• slurred speech
• stomach cramps
• upset stomach
• tenderness in the stomach area
• watery or bloody diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Namenda
• Namenda XR
• Namenda XR Titration Pack

Available Dosage Forms:

• Tablet
• Solution
• Capsule, Extended Release

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: N-Methyl-D-Aspartate Receptor Antagonist

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the extended-release capsules whole. Do not break, crush, or chew them.

If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of soft food such as applesauce. Stir this mixture well and swallow it without chewing.

For patients taking the oral liquid:

• Remove the oral dosing syringe along with the cap and plastic tube from the bag and attach to tube to the cap.
• Open the child-resistant cap on the bottle by pushing down on the cap while turning the cap counter-clockwise (to the left) and remove the cap and seal from the bottle.
• Insert the plastic tube fully into the bottle and screw the cap tightly onto the bottle by turning the cap clockwise (to the right).
• Keeping the bottle upright on the table, remove the lid to uncover the opening on the top of the cap. With the plunger fully depressed, insert the tip of the syringe firmly into the opening of the cap.
• While holding the syringe, gently pull the plunger of the syringe up to draw medicine into the syringe.
• Remove the syringe from the cap opening. Invert the syringe (point tip upwards) and slowly press the plunger to a level that pushed out any large air bubbles that may be present. Keep the plunger in this position.
• Re-insert the tip of the syringe into the cap opening. While holding the syringe, continue to gently pull out the plunger until the bottom of the black ring of the plunger reaches the appropriate mark on the syringe that corresponds to the dose prescribed.
• Remove the syringe from the bottle and swallow the oral solution directly from the syringe. Do not mix with any other liquid.
• After use, reseal the bottle by snapping the attached lid closed.
• 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.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of Alzheimer's disease: For oral dosage form (extended-release capsules): Adults—At first, 7 milligrams (mg) once a day. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 28 mg per day. Children—Use and dose must be determined by your doctor. For oral dosage form (solution and tablets): Adults—At first, 5 milligrams (mg) once a day. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 10 mg two times a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What drugs can help improve or slow down memory loss?
• How does Namenda work?