Namzaric 7mg-10mg Capsules

Manufacturer ACTAVIS Active Ingredient Memantine and Donepezil(me MAN teen & doh NEP e zil) Pronunciation NAM-zah-rik (mem-AN-teen & doh-NEP-eh-zil)
It is used to treat dementia in people with Alzheimer's disease.
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Drug Class
Agents for Alzheimer's Disease
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Pharmacologic Class
N-methyl-D-aspartate (NMDA) receptor antagonist; Acetylcholinesterase inhibitor
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Pregnancy Category
Category C
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FDA Approved
Apr 2014
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Namzaric is a combination medicine used to treat moderate to severe Alzheimer's disease. It contains two drugs: memantine and donepezil. Memantine helps by blocking certain brain chemicals that are overactive in Alzheimer's. Donepezil works by increasing another brain chemical called acetylcholine, which is important for memory and thinking. Together, they help improve memory, awareness, and the ability to perform daily activities.
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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 its contents onto applesauce. If you choose this method, be sure to swallow the mixture immediately without chewing. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry location, avoiding storage in a bathroom. Store it in its original container or in another container that protects it from light.

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.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the evening.
  • Can be taken with or without food.
  • Swallow the capsule whole; do not chew, crush, or divide.
  • If you have trouble swallowing, the capsule can be opened and the contents sprinkled on a small amount of applesauce and swallowed immediately.
  • Do not stop taking this medication suddenly without consulting your doctor, as it may worsen symptoms.
  • Maintain regular follow-up appointments with your doctor to monitor your condition and side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol or use with caution, as it may worsen dizziness or confusion.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 7 mg memantine / 10 mg donepezil once daily in the evening. Titrate weekly to target maintenance dose.
Dose Range: 7 - 28 mg

Condition-Specific Dosing:

maintenance_dose: 28 mg memantine / 10 mg donepezil once daily (achieved by weekly titration from initial dose)
mild_to_moderate_alzheimers: Not indicated for this specific stage, typically for moderate to severe AD.
moderate_to_severe_alzheimers: Initial: 7 mg memantine / 10 mg donepezil once daily. Titrate weekly to 14 mg/10 mg, then 21 mg/10 mg, then 28 mg/10 mg (maintenance).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (CrCl 50-80 mL/min)
Moderate: Maximum dose 14 mg memantine / 10 mg donepezil once daily (CrCl 30-49 mL/min)
Severe: Maximum dose 7 mg memantine / 10 mg donepezil once daily (CrCl 5-29 mL/min)
Dialysis: Not specifically studied, but memantine is partially dialyzable. Use with caution, consider 7 mg/10 mg dose.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: No dosage adjustment needed
Severe: Use with caution; donepezil exposure may be increased. Specific recommendations not available, consider lower doses.

Pharmacology

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Mechanism of Action

Namzaric combines two active ingredients: Memantine and Donepezil. Memantine is an N-methyl-D-aspartate (NMDA) receptor antagonist. It blocks the effects of abnormally high levels of glutamate, which is thought to contribute to neuronal dysfunction in Alzheimer's disease. Donepezil is a reversible inhibitor of acetylcholinesterase, the enzyme responsible for the hydrolysis of acetylcholine. By inhibiting acetylcholinesterase, donepezil increases the concentration of acetylcholine in the synaptic cleft, thereby enhancing cholinergic neurotransmission in the central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Memantine: ~100%; Donepezil: ~100%
Tmax: Memantine: 3-7 hours; Donepezil: 3-5 hours
FoodEffect: Food does not affect the absorption of either memantine or donepezil.

Distribution:

Vd: Memantine: 9-11 L/kg; Donepezil: ~12 L/kg
ProteinBinding: Memantine: ~45%; Donepezil: ~96% (primarily to albumin and alpha1-acid glycoprotein)
CnssPenetration: Yes

Elimination:

HalfLife: Memantine: 60-80 hours; Donepezil: ~70 hours
Clearance: Memantine: Primarily renal; Donepezil: Hepatic and renal
ExcretionRoute: Memantine: Urine (primarily unchanged); Donepezil: Urine (57%), Feces (14%)
Unchanged: Memantine: 48% (in urine); Donepezil: 17% (in urine)
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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: 24 hours (due to long half-life and irreversible binding to enzyme)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 or seek medical attention right away:

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 unusual 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

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe nausea, vomiting, or diarrhea
  • New or worsening dizziness or lightheadedness
  • Slow heart rate (bradycardia)
  • Fainting spells (syncope)
  • Seizures
  • Unusual bleeding or bruising
  • Black, tarry stools or vomit that looks like coffee grounds (signs of GI bleeding)
  • Difficulty urinating or increased urinary incontinence
  • Muscle weakness or cramps
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
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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 it is safe to take this medication with all your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. While this drug can help manage symptoms, it is not a cure for 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.
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Overdose Information

Overdose Symptoms:

  • Severe nausea, vomiting, diarrhea
  • Excessive sweating
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Respiratory depression
  • Muscle weakness or paralysis
  • Seizures
  • Increased salivation
  • Miosis (pinpoint pupils)
  • Severe dizziness or fainting

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include atropine for cholinergic symptoms.

Drug Interactions

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Major Interactions

  • Anticholinergics (e.g., atropine, scopolamine): Donepezil may antagonize their effects.
  • Succinylcholine, other neuromuscular blocking agents: Donepezil may exaggerate neuromuscular blockade.
  • Other acetylcholinesterase inhibitors (e.g., rivastigmine, galantamine): Increased risk of cholinergic side effects.
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Moderate Interactions

  • Drugs that increase gastric pH (e.g., antacids, H2 blockers, proton pump inhibitors): May decrease donepezil absorption (though not clinically significant for most patients).
  • Drugs eliminated by renal tubular secretion (e.g., hydrochlorothiazide, triamterene, cimetidine, ranitidine, quinidine, nicotine): Memantine is partially eliminated by tubular secretion; co-administration may alter memantine levels.
  • Carbonic anhydrase inhibitors (e.g., acetazolamide), sodium bicarbonate: May decrease memantine excretion by alkalinizing urine, leading to increased memantine levels.
  • CYP2D6 and CYP3A4 inhibitors (e.g., quinidine, fluoxetine, ketoconazole, erythromycin): May increase donepezil exposure.
  • CYP2D6 and CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease donepezil exposure.
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Minor Interactions

  • NSAIDs: Increased risk of GI bleeding with cholinesterase inhibitors, though not specifically for donepezil.

Monitoring

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Baseline Monitoring

Cognitive function assessment (e.g., MMSE, ADAS-Cog)

Rationale: To establish baseline cognitive status and track disease progression/response to treatment.

Timing: Prior to initiation

Renal function (CrCl)

Rationale: To determine appropriate starting and maintenance doses, especially for memantine component.

Timing: Prior to initiation

Hepatic function (LFTs)

Rationale: To assess baseline liver health, especially for donepezil component which is hepatically metabolized.

Timing: Prior to initiation

Heart rate and rhythm (ECG if clinically indicated)

Rationale: Donepezil can cause bradycardia and QT prolongation in susceptible individuals.

Timing: Prior to initiation, especially in patients with cardiac conditions

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Routine Monitoring

Cognitive function assessment

Frequency: Every 6-12 months or as clinically indicated

Target: Improvement or stabilization of cognitive decline

Action Threshold: Significant decline may warrant re-evaluation of treatment or dose adjustment.

Adverse effects (e.g., nausea, vomiting, diarrhea, dizziness, headache, bradycardia, syncope, seizures)

Frequency: Regularly, especially during dose titration and initial weeks of therapy

Target: Absence or mild, tolerable side effects

Action Threshold: Persistent or severe side effects may require dose reduction or discontinuation.

Weight

Frequency: Periodically

Target: Stable weight

Action Threshold: Significant weight loss may indicate GI side effects or other issues.

Heart rate

Frequency: Periodically, or if symptoms of bradycardia occur

Target: Normal sinus rhythm, HR > 60 bpm

Action Threshold: Bradycardia (<50 bpm) or symptomatic bradycardia.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Headache
  • Confusion
  • Agitation
  • Insomnia
  • Fatigue
  • Muscle cramps
  • Bradycardia (slow heart rate)
  • Syncope (fainting)
  • Seizures
  • Urinary incontinence
  • GI bleeding (black or tarry stools, coffee-ground vomit)

Special Patient Groups

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Pregnancy

Category C. There are no adequate and well-controlled studies of Namzaric in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity based on animal studies with donepezil at high doses.
Second Trimester: Not specifically studied, but continued exposure could pose risks.
Third Trimester: Not specifically studied, but continued exposure could pose risks.
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Lactation

L3 (Moderately safe). It is not known if memantine or donepezil are excreted in human milk. Donepezil is excreted in animal milk. The decision to discontinue nursing or discontinue the drug should consider the importance of the drug to the mother.

Infant Risk: Potential for cholinergic effects in the infant from donepezil. Memantine's effects on breastfed infants are unknown. Monitor for signs of cholinergic excess (e.g., bradycardia, diarrhea, vomiting) or CNS depression.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.

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Geriatric Use

Alzheimer's disease primarily affects the elderly. Dosage adjustments are typically based on renal function, not age alone. Elderly patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope) and should be monitored closely.

Clinical Information

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Clinical Pearls

  • Namzaric is a fixed-dose combination, simplifying dosing for patients already on stable doses of both memantine and donepezil, or for new patients starting combination therapy.
  • Always take Namzaric in the evening, as donepezil is typically dosed once daily in the evening to minimize sleep disturbances.
  • Titrate the dose slowly (weekly increments) to minimize gastrointestinal and CNS side effects.
  • If a dose is missed, skip it and take the next dose at the regularly scheduled time. Do not double the dose.
  • Patients should be monitored for signs of bradycardia, syncope, and GI bleeding, especially those with pre-existing cardiac conditions or a history of ulcers/NSAID use.
  • Renal impairment requires dose adjustment for the memantine component.
  • This medication treats symptoms but does not cure Alzheimer's disease.
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Alternative Therapies

  • Donepezil (Aricept)
  • Memantine (Namenda)
  • Rivastigmine (Exelon, Exelon Patch)
  • Galantamine (Razadyne)
  • Aducanumab (Aduhelm) - for early AD, different mechanism
  • Lecanemab (Leqembi) - for early AD, different mechanism
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Cost & Coverage

Average Cost: $400 - $600+ per 30 capsules (for 28/10 mg strength)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand name), Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional 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, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate care.