Namzaric 28mg/10mg Capsules
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; Acetylcholinesterase inhibitor
Pregnancy Category
Category C
FDA Approved
Apr 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Namzaric is a medication used to treat moderate to severe Alzheimer's disease. It contains two different medicines: memantine and donepezil. Memantine helps by blocking certain brain chemicals that can be overactive in Alzheimer's. Donepezil helps by increasing levels of another brain chemical called acetylcholine, which is important for memory and thinking. Together, they aim to improve or maintain mental function and daily activities.
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 normal 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 normal 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 once daily, preferably in the evening, with or without food.
- Swallow the capsule whole; do not chew, crush, or divide it. If unable to swallow, the capsule can be opened and the contents sprinkled on a spoonful of applesauce and swallowed immediately without chewing.
- Take consistently at the same time each day.
- Do not stop taking this medication suddenly without consulting your doctor, as it may worsen symptoms.
- Report any new or worsening side effects to your doctor promptly.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One 28mg/10mg capsule orally once daily
Dose Range:
7 - 28 mg
Condition-Specific Dosing:
initial_titration:
Patients should be titrated to the 28mg/10mg dose using lower strengths (7mg/10mg, 14mg/10mg, 21mg/10mg) over a period of at least 4 weeks, or as directed by physician. The 28mg/10mg strength is for patients stabilized on memantine ER 28mg and donepezil 10mg.
switching_from_donepezil:
Patients on donepezil 10mg can be switched directly to Namzaric 7mg/10mg once daily and then titrated.
switching_from_memantine_er:
Patients on memantine ER 28mg can be switched directly to Namzaric 7mg/10mg once daily and then titrated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl 50-80 mL/min)
Moderate:
Reduce dose to Namzaric 14mg/10mg once daily (CrCl 30-49 mL/min)
Severe:
Not recommended (CrCl < 30 mL/min)
Dialysis:
Not recommended
Hepatic Impairment:
Mild:
No dosage adjustment needed
Moderate:
Caution advised, monitor for adverse effects. Donepezil exposure may be increased.
Severe:
Not recommended due to increased donepezil exposure and lack of data.
Pharmacology
Mechanism of Action
Namzaric combines two active ingredients: Memantine and Donepezil. Memantine is an N-methyl-D-aspartate (NMDA) receptor antagonist. It is thought to exert its therapeutic effect by blocking the effects of abnormally elevated levels of glutamate, which may contribute to the pathophysiology of Alzheimer's disease. Donepezil is a reversible inhibitor of the enzyme acetylcholinesterase (AChE). It is thought to exert its therapeutic effect by enhancing cholinergic function through increasing the concentration of acetylcholine at cholinergic synapses in the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
Memantine: ~100%; Donepezil: ~100%
Tmax:
Memantine: 9-12 hours (ER); Donepezil: 3-7 hours
FoodEffect:
Food does not affect the absorption of either memantine or donepezil from Namzaric capsules.
Distribution:
Vd:
Memantine: 9-11 L/kg; Donepezil: 12 L/kg
ProteinBinding:
Memantine: ~45%; Donepezil: ~96%
CnssPenetration:
Yes
Elimination:
HalfLife:
Memantine: 60-80 hours (ER); Donepezil: ~70 hours
Clearance:
Memantine: Primarily renal; Donepezil: Hepatic
ExcretionRoute:
Memantine: Urine (primarily unchanged); Donepezil: Urine (57%), Feces (14%)
Unchanged:
Memantine: 48% (unchanged in urine); Donepezil: ~17% (unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Memantine: Days to weeks; Donepezil: Weeks (for clinical effect)
PeakEffect:
Memantine: Weeks to months; Donepezil: Weeks to months
DurationOfAction:
Memantine: Prolonged due to long half-life; Donepezil: ~24 hours (once daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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. Although many people do not experience any side effects or only have mild ones, it is 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 do not go away, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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. Although many people do not experience any side effects or only have mild ones, it is 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 do not go away, 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 nausea, vomiting, or diarrhea
- Slow heartbeat (bradycardia)
- Fainting or feeling lightheaded (syncope)
- New or worsening seizures
- Difficulty urinating or increased urination
- Severe dizziness or confusion
- Unusual bleeding or bruising
- Signs of liver problems (e.g., yellowing skin/eyes, dark urine, severe stomach pain)
- Muscle weakness or cramps
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 identify potential interactions between this medication and other substances.
* 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 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 identify potential interactions between this medication and other substances.
* 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 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 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 breastfeeding, be sure to discuss this with your doctor, as you will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting
- Excessive salivation
- Sweating
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Respiratory depression
- Muscle weakness or paralysis
- Seizures
- Severe dizziness
- Confusion
- Agitation
- Hallucinations
- Coma
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222). Treatment is supportive and may include atropine for cholinergic symptoms, gastric lavage, and activated charcoal.
Drug Interactions
Major Interactions
- Anticholinergics (e.g., atropine, scopolamine, benztropine): May antagonize the effects of donepezil.
- Succinylcholine, other neuromuscular blocking agents: Donepezil may exaggerate neuromuscular blockade.
- Other NMDA receptor antagonists (e.g., amantadine, ketamine, dextromethorphan): Coadministration with memantine may increase the frequency and severity of adverse reactions due to additive effects.
Moderate Interactions
- Cholinesterase inhibitors (e.g., rivastigmine, galantamine): Additive cholinergic effects, increased risk of bradycardia, syncope, and GI side effects.
- Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia and syncope due to additive vagotonic effects of donepezil.
- Drugs that increase urinary pH (e.g., carbonic anhydrase inhibitors, sodium bicarbonate): May decrease renal elimination of memantine, leading to increased plasma levels.
- Drugs metabolized by CYP2D6 or CYP3A4 (e.g., quinidine, fluoxetine, paroxetine, ketoconazole, erythromycin): Donepezil is metabolized by these enzymes; inhibitors or inducers may alter donepezil levels.
- NSAIDs: Increased risk of GI bleeding with donepezil, especially in patients with a history of ulcers.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Cognitive and functional assessment (e.g., MMSE, ADAS-Cog)
Rationale: To establish baseline disease severity and track progression/response to treatment.
Timing: Prior to initiation of therapy
Heart rate and blood pressure
Rationale: Donepezil can cause bradycardia and syncope.
Timing: Prior to initiation of therapy
Renal function (CrCl)
Rationale: Memantine dose adjustment is required in moderate to severe renal impairment.
Timing: Prior to initiation of therapy
Hepatic function (LFTs)
Rationale: Donepezil is metabolized by the liver; caution in hepatic impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Cognitive and functional assessment
Frequency: Every 6-12 months, or as clinically indicated
Target: Stabilization or slower decline
Action Threshold: Significant decline may warrant re-evaluation of treatment plan.
Heart rate and blood pressure
Frequency: Periodically, especially during dose titration or if symptoms of bradycardia/syncope occur
Target: Within normal limits for the patient
Action Threshold: Symptomatic bradycardia (<50 bpm), syncope, or significant hypotension/hypertension.
Adverse effects (e.g., GI upset, dizziness, headache, confusion, agitation, urinary retention, seizures)
Frequency: Regularly, especially during dose titration and with any change in patient status
Target: Minimization of side effects
Action Threshold: Persistent or severe adverse effects, requiring dose reduction or discontinuation.
Weight
Frequency: Periodically
Target: Stable
Action Threshold: Significant unexplained weight loss.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Confusion
- Agitation
- Hallucinations
- Bradycardia
- Syncope
- Urinary incontinence/retention
- Seizures
- Muscle cramps
- Fatigue
- Insomnia
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefits outweigh the potential risks to the fetus. Donepezil is Pregnancy Category C (animal studies show adverse effects, no adequate human studies). Memantine is Pregnancy Category B (animal studies show no risk, no adequate human studies). The combination is generally considered Category C.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects, especially with donepezil. Data are limited.
Second Trimester:
Limited data, potential for adverse effects.
Third Trimester:
Limited data, potential for adverse effects. Donepezil's cholinergic effects could theoretically affect uterine tone.
Lactation
Both memantine and donepezil are excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., bradycardia, cholinergic effects from donepezil, CNS effects from memantine), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk level L3 (Moderate Concern)
Pediatric Use
Namzaric is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.
Geriatric Use
Namzaric is primarily used in the geriatric population for Alzheimer's disease. No specific dose adjustment is required based on age alone, but dose adjustments are necessary for renal impairment, which is more common in the elderly. Elderly patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope, GI upset) and CNS side effects (e.g., dizziness, confusion).
Clinical Information
Clinical Pearls
- Namzaric is a fixed-dose combination, simplifying dosing for patients already stabilized on both memantine ER and donepezil.
- It is crucial to titrate patients up to the 28mg/10mg dose using the lower strengths to minimize side effects.
- Administering in the evening may help mitigate some side effects like dizziness or nausea, but can also contribute to sleep disturbances in some patients.
- Monitor for signs of bradycardia and syncope, especially in patients with pre-existing cardiac conditions or those on other heart rate-lowering medications.
- Educate caregivers on potential side effects and the importance of consistent administration.
- The capsule can be opened and sprinkled on applesauce for patients with swallowing difficulties, but the contents must be swallowed immediately without chewing.
Alternative Therapies
- Donepezil (Aricept)
- Memantine (Namenda, Namenda XR)
- Rivastigmine (Exelon, Exelon Patch)
- Galantamine (Razadyne)
- Aducanumab (Aduhelm) - for early AD
- Lecanemab (Leqembi) - for early AD
- Donanemab (investigational)
Cost & Coverage
Average Cost:
Varies, typically $400-$600+ per 30 capsules
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities may have designated drug take-back programs.
Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.