Namzaric 14mg/10mg Capsules

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 abnormal glutamate levels, which are believed to contribute to the symptoms 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 by increasing the concentration of acetylcholine at cholinergic synapses in the central nervous system.

Urgent 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 notice any of the following symptoms, contact your doctor or seek immediate 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
Trouble passing urine
Severe dizziness or fainting
Fever, chills, or sore throat
New or worsening trouble breathing
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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness or headache
Muscle cramps
Fatigue or weakness
* Trouble sleeping

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

It is essential to inform all 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.

• Anticholinergic agents (e.g., atropine, scopolamine, benztropine): Donepezil may antagonize their effects.
• Succinylcholine and other neuromuscular blocking agents: Donepezil may exaggerate neuromuscular blockade.
• Drugs that increase urine pH (e.g., carbonic anhydrase inhibitors, sodium bicarbonate): May decrease memantine renal clearance, leading to increased memantine levels.
• Drugs eliminated by renal tubular secretion (e.g., cimetidine, ranitidine, quinidine, procainamide): May increase memantine levels.

• Beta-blockers and other agents that slow heart rate (e.g., digoxin, diltiazem, verapamil): Increased risk of bradycardia and syncope due to donepezil's cholinergic effects.
• NSAIDs: Increased risk of peptic ulcers/GI bleeding with donepezil (though not a direct interaction, caution advised in patients with history).
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase donepezil exposure.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin): May increase donepezil exposure.
• CYP2D6/3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease donepezil exposure.

• Dizziness
• Headache
• Nausea
• Vomiting
• Diarrhea
• Dyspepsia
• Anorexia
• Bradycardia
• Syncope
• Muscle cramps
• Fatigue
• Confusion
• Agitation
• Urinary incontinence

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.

L3 (Moderately Safe). Donepezil is excreted in human milk. It is unknown if memantine is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants from donepezil (e.g., cholinergic 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.

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.

Namzaric is primarily used in the geriatric population. No specific dosage adjustment is required based solely on age. However, geriatric patients may have age-related decreases in renal function, which necessitates dosage adjustment for memantine component based on creatinine clearance. Increased susceptibility to adverse effects like bradycardia, syncope, and GI disturbances should be considered.

• Namzaric is a fixed-dose combination for patients already stabilized on individual memantine and donepezil doses.
• Always swallow the extended-release capsule whole. If swallowing is difficult, the capsule can be opened and contents sprinkled on applesauce, but must be swallowed immediately without chewing.
• Monitor for cholinergic side effects (e.g., nausea, vomiting, diarrhea, bradycardia, syncope), especially during dose titration.
• Caution is advised in patients with a history of cardiac conduction abnormalities (e.g., sick sinus syndrome) or those taking other drugs that slow heart rate due to donepezil's effects.
• Memantine excretion is pH-dependent; avoid drugs that significantly increase urine pH (e.g., sodium bicarbonate) as they can increase memantine levels.
• Regularly assess cognitive function to monitor treatment efficacy and disease progression.

• Memantine (Namenda, Namenda XR) as monotherapy
• Donepezil (Aricept) as monotherapy
• Rivastigmine (Exelon, Exelon Patch)
• Galantamine (Razadyne, Razadyne ER)
• Aducanumab (Aduhelm) - for early Alzheimer's, different mechanism
• Lecanemab (Leqembi) - for early Alzheimer's, different mechanism

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 safe use, never share your medication with others, and do not take medication prescribed to 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 otherwise, 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 advice. Many communities offer 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 occurred, as this will aid in receiving appropriate treatment.