Virazole | Ribavirin Powder, For Solution Breastfeeding
American Academy of Pediatrics and other medical experts exclusively recommend to breastfeed the baby for first 6 months. Once you introduce baby to other foods it is recommended to breastfeed for at least first year of babys life. Taking medication while breastfeeding could be tricky as most drugs pass in breast milk. In this article we will evaluate Virazole | Ribavirin Powder, For Solution for its safety in breastfeeding.

What is Virazole | Ribavirin Powder, For Solution used for?


VIRAZOLE® (Ribavirin for Inhalation Solution, USP) is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with VIRAZOLE. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of VIRAZOLE aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with VIRAZOLE should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection. Use of aerosolized VIRAZOLE in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used (see WARNINGS and DOSAGE AND ADMINISTRATION). Diagnosis RSV infection should be documented by a rapid diagnostic method such as demonstration of viral antigen in respiratory tract secretions by immunofluorescence3,4 or ELISA5 before or during the first 24 hours of treatment. Treatment may be initiated while awaiting rapid diagnostic test results. However, treatment should not be continued without documentation of RSV infection. Non-culture antigen detection techniques may have false positive or false negative results. Assessment of the clinical situation, the time of year and other parameters may warrant reevaluation of the laboratory diagnosis. Description of Studies Non-Mechanically Ventilated Infants: In two placebo-controlled trials in infants hospitalized with RSV lower respiratory tract infection, aerosolized VIRAZOLE treatment had a therapeutic effect, as judged by the reduction in severity of clinical manifestations of disease by treatment day 3.3,4 Treatment was most effective when instituted within the first 3 days of clinical illness. Virus titers in respiratory secretions were also significantly reduced with VIRAZOLE in one of these original studies.4 Additional controlled studies conducted since these initial trials of aerosolized VIRAZOLE in the treatment of RSV infection have supported these data. Mechanically Ventilated Infants: A randomized, double-blind, placebo-controlled evaluation of aerosolized VIRAZOLE at the recommended dose was conducted in 28 infants requiring mechanical ventilation for respiratory failure caused by documented RSV infection.6 Mean age was 1.4 months (SD, 1.7 months). Seven patients had underlying diseases predisposing them to severe infection and 21 were previously normal. Aerosolized VIRAZOLE treatment significantly decreased the duration of mechanical ventilation required (4.9 vs. 9.9 days, p=0.01) and duration of required supplemental oxygen (8.7 vs. 13.5 days, p=0.01). Intensive patient management and monitoring techniques were employed in this study. These included endotracheal tube suctioning every 1 to 2 hours; recording of proximal airway pressure, ventilatory rate, and FlO2 every hour; and arterial blood gas monitoring every 2 to 6 hours. To reduce the risk of VIRAZOLE precipitation and ventilator malfunction, heated wire tubing, two bacterial filters connected in series in the expiratory limb of the ventilator (with filter changes every 4 hours), and water column pressure release valves to monitor internal ventilator pressures were used in connecting ventilator circuits to the SPAG®-2. Employing these techniques, no technical difficulties with VIRAZOLE administration were encountered during the study. Adverse events consisted of bacterial pneumonia in one case, staphylococcus bacteremia in one case and two cases of post-extubation stridor. None were felt to be related to VIRAZOLE administration.

What are the risk associated with Virazole | Ribavirin Powder, For Solution usage while breastfeeding? What precautions shall I take while using it in breastfeeding?

Virazole | Ribavirin Powder, For Solution low risk for breastfeeding
Ribavirin is the one and only active ingredient present in Virazole | Ribavirin Powder, For Solution. Ribavirin in itself is a low risk drug for lactation so it is easy to understand that Virazole | Ribavirin Powder, For Solution also comes in category of Low Risk item while breastfeeding. Below is the summary of Ribavirin in breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
Lactation VIRAZOLE has been shown to be toxic to lactating animals and their offspring. It is not known if VIRAZOLE is excreted in human milk.

Virazole | Ribavirin Powder, For Solution Breastfeeding Analsys


Ribavirin while Breastfeeding

Low Risk

CAS Number: 36791-04-5

Synthetic drug and nucleoside analogue which is structurally related to guanine with antiviral activity. It is used in infants and newborns for treatment of respiratory syncytial virus (RSV) and adenovirus. Along with interferon for treatment of hepatitis C (authorized on these cases from the 3 years of life). At latest update no published data on excretion into breast milk were found. Its large volume of distribution makes it unlikely that may occur the passage of significant amounts to the milk. Its low oral bioavailability hinder the passage toward infant’s plasma from ingested milk, except in preterm milk and immediate neonatal period, for which there may be an increased intestinal permeability. Since it is used as treatment on infants and its pharmacokinetic data are favorable, it should be regarded as compatible with breastfeeding for short-term exposures, however, to be cautiously used on long-term treatments.


Virazole | Ribavirin Powder, For Solution Breastfeeding Analsys - 2


Ribavirin while Breastfeeding

CAS Number: 36791-04-5

Ribavirin has not been studied in nursing mothers being treated for hepatitis C infection. However, ribavirin is given directly to infants by inhalation to treat respiratory syncytial virus (RSV) infection. The amount in milk is likely to be lower than the doses received by infants treated with ribavirin for RSV infection. Hepatitis C is not transmitted through breastmilk[1][2] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[3][4] However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C. Infants born to mothers with HCV infection should be tested for HCV infection; because maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.[1][2]



I already used Virazole | Ribavirin Powder, For Solution 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 Virazole | Ribavirin Powder, For Solution then you shall inform your doctor, But you should not be worried too much as Virazole | Ribavirin Powder, For Solution comes in category of low risk drug.


My health care provider has asked me to use Virazole | Ribavirin Powder, For Solution, what to do?

Though Virazole | Ribavirin Powder, For Solution dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.


If I am using Virazole | Ribavirin Powder, For Solution, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Virazole | Ribavirin Powder, For Solution 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