Namzaric 7mg-10mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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
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.
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.
Minor Interactions
- NSAIDs: Increased risk of GI bleeding with cholinesterase inhibitors, though not specifically for donepezil.
Monitoring
Baseline Monitoring
Rationale: To establish baseline cognitive status and track disease progression/response to treatment.
Timing: Prior to initiation
Rationale: To determine appropriate starting and maintenance doses, especially for memantine component.
Timing: Prior to initiation
Rationale: To assess baseline liver health, especially for donepezil component which is hepatically metabolized.
Timing: Prior to initiation
Rationale: Donepezil can cause bradycardia and QT prolongation in susceptible individuals.
Timing: Prior to initiation, especially in patients with cardiac conditions
Routine Monitoring
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.
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.
Frequency: Periodically
Target: Stable weight
Action Threshold: Significant weight loss may indicate GI side effects or other issues.
Frequency: Periodically, or if symptoms of bradycardia occur
Target: Normal sinus rhythm, HR > 60 bpm
Action Threshold: Bradycardia (<50 bpm) or symptomatic bradycardia.
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
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:
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.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
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
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.
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