Namzaric ER 21mg-10mg Capsules

Namzaric is a combination of memantine and donepezil. Memantine is a low to moderate affinity uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. It binds to the NMDA receptor-operated cation channels, preventing the prolonged influx of Ca2+ that can lead to neuronal dysfunction and death, while allowing for normal physiological activation. Donepezil is a reversible inhibitor of acetylcholinesterase (AChE), the enzyme responsible for the hydrolysis of acetylcholine. By inhibiting AChE, donepezil increases the concentration of acetylcholine at cholinergic synapses in the central nervous system, thereby enhancing cholinergic function.

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 difficulties
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

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.

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 allergic reaction you experienced, including any symptoms that occurred.
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 identify 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 with all your other 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. 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 potential benefits and risks of this medication to both you and your baby.

• Anticholinergic agents (e.g., atropine, benztropine, oxybutynin): Donepezil may antagonize their effects.
• Succinylcholine-type muscle relaxants: Donepezil may exaggerate muscle relaxation.

• Drugs that increase urine pH (e.g., carbonic anhydrase inhibitors, sodium bicarbonate): May decrease memantine renal clearance, leading to increased memantine plasma levels.
• Drugs that are renally eliminated via active tubular secretion (e.g., cimetidine, ranitidine, quinidine, nicotine): May alter memantine excretion.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase donepezil exposure.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, itraconazole): May increase donepezil exposure.
• CYP2D6/3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease donepezil exposure.
• NSAIDs (e.g., ibuprofen, naproxen): Increased risk of peptro-ulceration/GI bleeding with donepezil.
• Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia and syncope with donepezil.

• Bradycardia
• Syncope
• Dizziness
• Headache
• Confusion
• Hallucinations
• Nausea
• Vomiting
• Diarrhea
• Dyspepsia
• Urinary incontinence
• Seizures
• Aggression
• Agitation

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.

It is not known if memantine or donepezil are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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.

Safety and effectiveness in pediatric patients have not been established. Namzaric is not indicated for use in pediatric patients.

Alzheimer's disease primarily affects the geriatric population. No specific dosage adjustment is required based solely on age. However, geriatric patients may be more susceptible to adverse effects (e.g., bradycardia, syncope, GI upset) and should be monitored closely.

• Namzaric is indicated for moderate to severe Alzheimer's disease in patients already stabilized on donepezil 10 mg.
• The extended-release formulation of memantine in Namzaric allows for once-daily dosing, which may improve adherence.
• Swallow capsules whole; do not crush, chew, or open, as this will alter the extended-release properties.
• Titration is crucial when initiating Namzaric to minimize gastrointestinal and CNS side effects.
• Monitor for signs of bradycardia, syncope, and GI bleeding, especially in patients with pre-existing cardiac conditions or those on NSAIDs.
• Educate patients and caregivers on potential side effects and when to seek medical attention.

• Donepezil (Aricept, generic)
• Memantine (Namenda, generic)
• Rivastigmine (Exelon, generic)
• Galantamine (Razadyne, generic)

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, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. 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 was taken, as this will aid in providing appropriate treatment.