Viramune | Nevirapine Suspension Breastfeeding

Do you know that important immune protective proteins are present in breast milk? Breast milk also contains required vitamins, minerals, saturated and un saturated fats. These things are extremely important for development of healthy brain. If you are taking any medicine for short term or for the chronic reason then that passes in breast milk as well, that is why you should always check the drug with your health care provider. Here at DrLact we try to analyze drugs based on available researches and in this sheet we will present our analysis for Viramune | Nevirapine Suspension.

What is Viramune | Nevirapine Suspension used for?


VIRAMUNE is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)]. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, VIRAMUNE is not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4+ cell counts greater than 250 cells/mm3 or adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)]. VIRAMUNE is an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. (1) Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, VIRAMUNE is not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4+ cell counts greater than 250 cells/mm3 adult males with CD4+ cell counts greater than 400 cells/mm3 (1, 5.1)

Viramune | Nevirapine Suspension while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?

Viramune | Nevirapine Suspension low risk for breastfeeding
Viramune | Nevirapine Suspension contains only one active ingredient that is Nevirapine. We have analyzed the usage of Nevirapine in breastfeeding and our analysis suggest that Nevirapine poses Low risk for infant while breastfeeding and hence Viramune | Nevirapine Suspension itself shall be considered Low risk item for breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.2 Lactation Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Published data report that nevirapine is present in human milk [see Data]. There are limited data on the effects of nevirapine on the breastfed infant. There is no information on the effects of nevirapine on milk production. Because of the potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving VIRAMUNE. Data Based on five publications, immediate-release nevirapine was excreted in breast-milk at median concentrations ranging from 4080 to 6795 ng/mL, and the median maternal breast-milk to maternal plasma concentration ratio range was 59 to 88%. Reported infant nevirapine median plasma concentrations were low, ranging from 734 to 1140 ng/mL. The estimated nevirapine dose of 704 to 682 µg/kg/day for infants fed exclusively with breast-milk was lower than the daily recommended nevirapine dose for infants. Published literature indicates that rash and hyperbilirubinemia have been seen in infants exposed to nevirapine through breastmilk.

Viramune | Nevirapine Suspension Breastfeeding Analsys


Nevirapine while Breastfeeding

Low Risk

CAS Number: 129618-40-2

Anti-HIV drug. It has been used to treat neonates for vertical transmission risk lowering. Mothers must be adviced that transmission of HIV infection through breastfeeding has been documented.

Viramune | Nevirapine Suspension Breastfeeding Analsys - 2


Nevirapine while Breastfeeding

CAS Number: 129618-40-2

Viramune | Nevirapine Suspension and breastfeeding

In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. Nevirapine has been well studied in nursing mothers. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, World Health Organization guidelines recommend that all women with an HIV infection who are pregnant or breastfeeding should be maintained on antiretroviral therapy for at least the duration of risk for mother-to-child transmission. Mothers should exclusively breastfeed their infants for the first 6 months of life; breastfeeding with complementary feeding should continue through 12 months of life. The first choice regimen for nursing mothers is tenofovir, efavirenz and either lamivudine or emtricitabine. If these drugs are unavailable, alternative regimens include: 1) zidovudine, lamivudine and efavirenz; 2) zidovudine, lamivudine and nevirapine; or 3) tenofovir, nevirapine and either lamivudine or emtricitabine. Exclusively breastfed infants should also receive 6 weeks of prophylaxis with nevirapine.[1][2] Because of the long half-life of nevirapine, subtherapeutic nevirapine concentrations can persist in breastmilk and infant serum for relatively long periods, potentially increasing the risk of development of nevirapine-resistant HIV infections when it is used alone for prophylaxis in the mother.[3][4][5][6][7][8]

Is Viramune | Nevirapine Suspension safe while breastfeeding

I already used Viramune | Nevirapine Suspension and meanwhile I breastfed my baby should I be concerned?

During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Viramune | Nevirapine Suspension then you shall inform your doctor, But you should not be worried too much as Viramune | Nevirapine Suspension comes in category of low risk drug.


I am nursing mother and my doctor has suggested me to use Viramune | Nevirapine Suspension, is it safe?

Viramune | Nevirapine Suspension comes in category of low risk and if your doctor is aware that you are breastfeeding it should be ok to use without much concerns.


If I am using Viramune | Nevirapine Suspension, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Viramune | Nevirapine Suspension in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week