Namzaric

THE SAFETY OF NAMZARIC DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Namzaric should not be taken during pregnancy unless the benefits of treatment outweigh the potential risks to the baby. There have been no human studies that have looked at the safety of Namzaric during pregnancy, but animal studies indicate that taking Namzaric during pregnancy may be harmful to the developing baby.

What is Namzaric?

Namzaric is a medication that is taken to control symptoms of dementia. Namzaric is currently only available as a brand name medication. The active ingredients in Namzaric are memantine and donepezil. This medication was approved by the FDA in 2014. Namzaric is available in extended release capsules and is taken daily. It is only available by prescription from your doctor.

What is Namzaric used to treat?

Namzaric is used to treat Alzheimer’s disease dementia in patients who are stabilized on 10 mg once daily of donepezil. Alzheimer’s disease is a common cause of dementia. Dementia is a brain disorder that progressively impairs memory, thinking skills, and completion of simple tasks. Namzaric controls only the symptoms of Alzheimer’s dementia and is not a cure.

How does Namzaric work?

Namzaric contains two medications, memantine and donepezil. Memantine blocks glutamate receptors in the brain to prevent overstimulation and cell death. Overstimulation by glutamate, an amino acid, is thought to contribute to Alzheimer’s disease. Donepezil is a cholinesterase inhibitor, which stops the breakdown and increases levels of acetylcholine in the brain and spinal cord. Acetylcholine is a neurotransmitter affecting memory.

If I am taking Namzaric, can it harm my baby?

There is limited information looking at the safety of this medication in human pregnancy. Animal studies suggest there may be negative side effects associated with this medication. It is unknown if memantine or donepezil cross the human placenta to reach the developing baby. Namzaric should only be used during pregnancy if the benefits to the mother outweigh the potential risks to the baby. Since Namzaric is used to treat Alzheimer’s disease, which occurs in older adults, there is minimal risk of exposure during pregnancy and studies in pregnant women are rare.

Evidence from Animal Studies with Namzaric:

When given to pregnant rats and rabbits at much larger doses than the maximum recommended human dose, Namzaric was found to cause reduced birth weight, delayed bone development, and a higher rate of stillbirths. It was not associated with a higher rate of birth defects. 

Bottom line: Namzaric should not be used during pregnancy unless the benefits of treatment outweigh potential risks to the baby. There have been no human studies that have looked at the safety of Namzaric during pregnancy. Animal studies have shown that Namzaric may be harmful to the developing baby.

If I am taking Namzaric and become pregnant, what should I do?

If you are taking Namzaric and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am taking Namzaric, can I safely breastfeed my baby?

It is unknown if Namzaric passes into human breast milk. There are an absence of studies evaluating the effects of Namzaric in nursing infants or on milk production. Caution is advised when taking this medication while breastfeeding an infant. It may be recommended to either discontinue this medication or discontinue breastfeeding.

Bottom line: In breastfeeding moms who are taking Namzaric, it is important to weigh the risks versus benefits of this medication before continuing therapy while breastfeeding. It is not known if Namzaric passes into breast milk, and the effects of the medication on the breastfed baby are unknown.

If I am taking Namzaric, will it be more difficult to get pregnant?

There have been no studies in men or women that have looked at the effects of Namzaric on fertility. Animal studies have reported no negative effects on fertility associated with memantine or donepezil. 

If I am taking Namzaric, what should I know?

Namzaric should not be used during pregnancy unless the benefits of treatment outweigh the potential risks to the baby. There have been no human studies that have looked at the effects of Namzaric in pregnancy.

In breastfeeding moms who are taking Namzaric, the risks and benefits of continuing this medication should be evaluated. It is not known if Namzaric passes into human breast milk, and its effects on the breastfed baby are unknown.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of Namzaric during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about mental health and the medications used to treat mental health conditions here, and about neurological conditions here.   Additional information can also be found in the resources below. 

For more information about Namzaric during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

Allergan:  Namzaric Prescribing Information

National Institutes of Health: Alzheimer’s Disease

Alzheimer’s Association. What is Alzheimer’s?

Alzheimer’s Association. What is dementia?

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.