For most of the drugs advantages of taking medications overweighs the potential risks however some drugs could be really dangerous for breastfed baby hence every medication shall be considered separately. In this page we will discuss about purpose of Reclast | Zoledronic Acid Injection and its risk associated with lactation. We will also discuss the usage of Reclast | Zoledronic Acid Injection and some common side effects associated with Reclast | Zoledronic Acid Injection.
What is Reclast | Zoledronic Acid Injection used for?
Reclast is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2) Treatment to increase bone mass in men with osteoporosis (1.3) Treatment and prevention of glucocorticoid-induced osteoporosis (1.4) Treatment of Paget’s disease of bone in men and women (1.5) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.6) 1.1 Treatment of Osteoporosis in Postmenopausal Women Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Reclast reduces the incidence of new clinical fractures [see Clinical Studies (14.1)]. 1.2 Prevention of Osteoporosis in Postmenopausal Women Reclast is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.2)]. 1.3 Osteoporosis in Men Reclast is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3 )]. 1.4 Glucocorticoid-Induced Osteoporosis Reclast is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [s ee Clinical Studies (14.4)]. 1.5 Paget's Disease of Bone Reclast is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5)]. 1.6 Important Limitations of Use The safety and effectiveness of Reclast for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Reclast | Zoledronic Acid Injection while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?
Reclast | Zoledronic Acid Injection contains only one active ingredient that is Zoledronic acid anhydrous. We have analyzed the usage of Zoledronic acid anhydrous in breastfeeding and our analysis suggest that Zoledronic acid anhydrous poses Low risk for infant while breastfeeding and hence Reclast | Zoledronic Acid Injection itself shall be considered Low risk item for breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers It is not known whether Reclast is excreted in human milk. Because many drugs are excreted in human milk, and because Reclast binds to bone long-term, Reclast should not be administered to a nursing woman.
Reclast | Zoledronic Acid Injection Breastfeeding Analsys
Low RiskCAS Number: 118072-93-8
It is composed by bisphosphonates. Most bisphosphonates are acidic compounds that achieve low plasma concentration. Both features make it unlikely excretion into the milk in clinically significant amount. Intestinal absorption of bisphosphonates is very low even during fasting and is considered negligible in the presence of milk due to formation with the calcium of non absorbable compounds. Among bisphosponate preparations, Tiludronate and Zoledronate have the longest half-lives period of elimination and thus they are the less indicated to take while breastfeeding. A latest update no published data were found on excretion in the breast milk. Until more data about this drug regarding breastfeeding is available, safer known alternatives (pamidronate) should be of choice, especially in the neonatal period and in case of prematurity.
Reclast | Zoledronic Acid Injection Breastfeeding Analsys - 2
CAS Number: 118072-93-8
Because no information is available on the use of zoledronic acid during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. However, absorption of zoledronic acid by a breastfed infant is unlikely.
What should I do if I am breastfeeding mother and I am already exposed to Reclast | Zoledronic Acid Injection?
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 Reclast | Zoledronic Acid Injection then you shall inform your doctor, But you should not be worried too much as Reclast | Zoledronic Acid Injection comes in category of low risk drug.
I am nursing mother and my doctor has suggested me to use Reclast | Zoledronic Acid Injection, is it safe?
Though Reclast | Zoledronic Acid Injection 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 Reclast | Zoledronic Acid Injection, will my baby need extra monitoring?
Not much
Who can I talk to if I have questions about usage of Reclast | Zoledronic Acid Injection 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