Namzaric ER Titration Pack
It is used to treat dementia in people with Alzheimer's disease.
Drug Class
Agents for Alzheimer's Disease
Pharmacologic Class
N-methyl-D-aspartate (NMDA) receptor antagonist; Cholinesterase inhibitor
Pregnancy Category
Category C
FDA Approved
Apr 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Namzaric is a combination medicine containing two drugs, memantine and donepezil, used to treat moderate to severe Alzheimer's disease. Memantine works by affecting a chemical in the brain called glutamate, which is involved in memory and learning. Donepezil works by increasing the levels of another brain chemical called acetylcholine, which is also important for memory. Together, they help improve memory, awareness, and the ability to function in people with Alzheimer's.
How to Use This Medicine
Taking Your Medication
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the evening, with or without food. Swallow the capsule whole - do not chew or crush it. If you notice any capsules that appear abnormal or are damaged, do not take them.
If you have difficulty swallowing the capsule whole, you can sprinkle the contents onto applesauce. If you do this, swallow the mixture immediately without chewing.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep it in its original container or a light-protective container to maintain its effectiveness.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the evening, with or without food. Swallow the capsule whole - do not chew or crush it. If you notice any capsules that appear abnormal or are damaged, do not take them.
If you have difficulty swallowing the capsule whole, you can sprinkle the contents onto applesauce. If you do this, swallow the mixture immediately without chewing.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep it in its original container or a light-protective container to maintain its effectiveness.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take Namzaric exactly as prescribed by your doctor, usually once daily in the evening.
- Swallow the capsule whole; do not chew, crush, or divide it.
- Namzaric can be taken with or without food.
- If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take two doses at once.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products, as interactions can occur.
- Be aware of potential side effects like dizziness, headache, nausea, and diarrhea. Report any severe or persistent side effects to your doctor.
- Avoid sudden changes in position to prevent dizziness and falls.
- Regularly attend follow-up appointments to monitor your condition and the effectiveness of the medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial titration using Namzaric ER Titration Pack: Week 1: Memantine 7 mg/Donepezil 10 mg once daily in the evening. Week 2: Memantine 14 mg/Donepezil 10 mg once daily in the evening. Week 3: Memantine 21 mg/Donepezil 10 mg once daily in the evening. Week 4 and beyond: Memantine 28 mg/Donepezil 10 mg once daily in the evening. Maintenance dose is typically Memantine 28 mg/Donepezil 10 mg once daily, or Memantine 14 mg/Donepezil 10 mg once daily if the higher dose is not tolerated or clinically indicated.
Dose Range:
7 - 28 mg
Condition-Specific Dosing:
moderateToSevereAlzheimer'sDisease:
Titrate as described above to a maintenance dose of Memantine 28 mg/Donepezil 10 mg once daily, or Memantine 14 mg/Donepezil 10 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required (CrCl 50-80 mL/min).
Moderate:
No dosage adjustment required (CrCl 30-49 mL/min).
Severe:
For patients with severe renal impairment (CrCl 5-29 mL/min), the recommended target dose of memantine is 14 mg once daily. If the patient is on the 28 mg/10 mg dose, reduce to 14 mg/10 mg. If already on 14 mg/10 mg, no change.
Dialysis:
Not specifically studied; memantine is partially dialyzable, donepezil is not significantly dialyzable. Use with caution and monitor closely.
Hepatic Impairment:
Mild:
No dosage adjustment required.
Moderate:
Use with caution; monitor for adverse effects. Donepezil exposure may be increased.
Severe:
Not studied; use with caution and monitor closely. Donepezil exposure is expected to be significantly increased.
Pharmacology
Mechanism of Action
Namzaric is a combination of memantine and donepezil. Memantine is a low-to-moderate affinity, uncompetitive (open-channel) N-methyl-D-aspartate (NMDA) receptor antagonist. It is thought to exert its therapeutic effect by blocking the effects of abnormally elevated tonic levels of glutamate, which may contribute to neuronal dysfunction in Alzheimer's disease. Donepezil is a reversible inhibitor of the enzyme acetylcholinesterase, which is responsible for the hydrolysis of acetylcholine. By inhibiting acetylcholinesterase, donepezil increases the concentration of acetylcholine at cholinergic synapses in the central nervous system, thereby enhancing cholinergic function.
Pharmacokinetics
Absorption:
Bioavailability:
Memantine: Approximately 100%; Donepezil: Approximately 100%
Tmax:
Memantine: 3-7 hours; Donepezil: 3-4 hours
FoodEffect:
Absorption of both memantine and donepezil is not affected by food.
Distribution:
Vd:
Memantine: 9-11 L/kg; Donepezil: Approximately 12 L/kg
ProteinBinding:
Memantine: Approximately 45%; Donepezil: Approximately 96%
CnssPenetration:
Yes
Elimination:
HalfLife:
Memantine: 60-80 hours; Donepezil: Approximately 70 hours
Clearance:
Memantine: Primarily renal; Donepezil: Hepatic
ExcretionRoute:
Memantine: Urine (primarily unchanged); Donepezil: Urine (57%) and feces (14%)
Unchanged:
Memantine: 48% (in urine); Donepezil: Not available
Pharmacodynamics
OnsetOfAction:
Memantine: Days to weeks; Donepezil: Weeks (clinical effect)
PeakEffect:
Memantine: Weeks (clinical effect); Donepezil: Weeks (clinical effect)
DurationOfAction:
Memantine: Prolonged due to long half-life; Donepezil: Prolonged due to long half-life (once daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Urination problems
Severe dizziness or fainting
Fever, chills, or sore throat
New or worsening breathing difficulties
Seizures
Stomach pain or heartburn
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Slow heartbeat
Abnormal heartbeat
Bruising
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness or headache
Muscle cramps
Fatigue or weakness
* Sleep disturbances
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Urination problems
Severe dizziness or fainting
Fever, chills, or sore throat
New or worsening breathing difficulties
Seizures
Stomach pain or heartburn
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Slow heartbeat
Abnormal heartbeat
Bruising
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness or headache
Muscle cramps
Fatigue or weakness
* Sleep disturbances
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (syncope)
- Slow or irregular heartbeat (bradycardia)
- New or worsening confusion
- Seizures
- Severe nausea, vomiting, or diarrhea that leads to dehydration
- Signs of stomach bleeding (black, tarry stools; vomit that looks like coffee grounds)
- Difficulty urinating
- Muscle cramps or weakness
- Unusual tiredness or weakness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug does not cure Alzheimer's disease, and you should continue to receive regular care from your doctor. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor, as you will need to carefully weigh the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Excessive sweating
- Salivation (drooling)
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Respiratory depression (slow, shallow breathing)
- Muscle weakness or paralysis
- Seizures
- Collapse
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Anticholinergic agents (e.g., atropine, scopolamine, benztropine): Donepezil may antagonize their effects.
- Succinylcholine-type muscle relaxants: Donepezil may exaggerate muscle relaxation.
- Other NMDA antagonists (e.g., amantadine, ketamine, dextromethorphan): Increased risk of CNS toxicity with memantine.
Moderate Interactions
- Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia and syncope with donepezil.
- NSAIDs (e.g., ibuprofen, naproxen): Increased risk of GI bleeding with donepezil.
- Drugs that alter urinary pH (e.g., carbonic anhydrase inhibitors, sodium bicarbonate): May alter memantine excretion.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase donepezil exposure.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase donepezil exposure.
- CYP2D6/3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease donepezil exposure.
Monitoring
Baseline Monitoring
Cognitive function (e.g., MMSE, ADAS-Cog)
Rationale: To establish baseline cognitive status and track disease progression/response to therapy.
Timing: Prior to initiation of therapy
Heart rate and rhythm (ECG if clinically indicated)
Rationale: Donepezil can cause bradycardia and QT prolongation.
Timing: Prior to initiation, especially in patients with pre-existing cardiac conditions
Renal function (CrCl)
Rationale: Memantine dose adjustment is required in severe renal impairment.
Timing: Prior to initiation
Hepatic function (LFTs)
Rationale: Donepezil is metabolized by the liver; caution in hepatic impairment.
Timing: Prior to initiation, especially in patients with pre-existing hepatic conditions
Routine Monitoring
Cognitive function
Frequency: Every 6-12 months or as clinically indicated
Target: Improvement or stabilization of cognitive scores
Action Threshold: Significant decline may warrant re-evaluation of therapy
Heart rate and rhythm
Frequency: As clinically indicated, especially if symptoms of bradycardia or syncope occur
Target: Normal sinus rhythm, heart rate > 60 bpm
Action Threshold: Symptomatic bradycardia, syncope, or significant ECG changes may require dose reduction or discontinuation
Gastrointestinal symptoms (nausea, vomiting, diarrhea)
Frequency: Regularly, especially during titration and dose increases
Target: Absence or mild, manageable symptoms
Action Threshold: Persistent or severe symptoms may require dose reduction or discontinuation
CNS symptoms (dizziness, headache, confusion)
Frequency: Regularly, especially during titration and dose increases
Target: Absence or mild, manageable symptoms
Action Threshold: Persistent or severe symptoms may require dose reduction or discontinuation
Symptom Monitoring
- Bradycardia
- Syncope
- Dizziness
- Headache
- Confusion
- Nausea
- Vomiting
- Diarrhea
- Anorexia
- Weight loss
- Urinary incontinence
- Seizures
- GI bleeding (melena, hematemesis)
Special Patient Groups
Pregnancy
Namzaric is classified as Pregnancy Category C. There are no adequate and well-controlled studies of Namzaric in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk to fetus based on animal studies or lack of human data. Donepezil (Category C) and Memantine (Category B).
Second Trimester:
Potential risk to fetus based on animal studies or lack of human data.
Third Trimester:
Potential risk to fetus based on animal studies or lack of human data. Donepezil may cause uterine contractions or premature labor due to its cholinergic effects.
Lactation
Donepezil is excreted in human milk and has the potential for serious adverse reactions in breastfed infants. It is not known if memantine is excreted in human milk. Due to the potential for serious adverse effects, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
High (L4 for donepezil component)
Pediatric Use
The safety and effectiveness of Namzaric in pediatric patients have not been established. Alzheimer's disease is not a condition that occurs in pediatric populations.
Geriatric Use
Namzaric is primarily used in the geriatric population for Alzheimer's disease. No specific dosage adjustment is generally required based on age alone, but caution should be exercised due to potential age-related decreases in renal function and increased susceptibility to adverse effects (e.g., bradycardia, falls, GI disturbances).
Clinical Information
Clinical Pearls
- Namzaric ER Titration Pack is designed to gradually increase the memantine dose while maintaining a stable donepezil dose, which may help improve tolerability of memantine.
- Administer once daily in the evening, with or without food. Swallowing the capsule whole is crucial for the extended-release properties.
- Monitor patients for signs of bradycardia, especially those with pre-existing cardiac conditions or those taking other heart rate-lowering medications (e.g., beta-blockers).
- Educate patients and caregivers about common GI side effects (nausea, vomiting, diarrhea) and strategies to manage them (e.g., taking with food, staying hydrated).
- Be aware of potential for increased CNS side effects (dizziness, confusion) when combining with other NMDA antagonists or anticholinergic agents.
- Regularly assess cognitive function and overall clinical status to determine the continued benefit of therapy.
Alternative Therapies
- Donepezil (Aricept, Aricept ODT)
- Memantine (Namenda, Namenda XR)
- Rivastigmine (Exelon, Exelon Patch)
- Galantamine (Razadyne, Razadyne ER)
- Aducanumab (Aduhelm) - for early AD
- Lecanemab (Leqembi) - for early AD
Cost & Coverage
Average Cost:
$300 - $600+ per 30 capsules (maintenance dose)
Insurance Coverage:
Tier 2 or 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed for someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Your pharmacist can provide this information if available. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred. This information is vital for receiving appropriate treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Your pharmacist can provide this information if available. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred. This information is vital for receiving appropriate treatment.