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Is Proxym Gel Application Safe During Lactation?

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Posted on Thu, 29 May 2014
Question: I had leg and heel pain due to vitamin D deficiency. I consulted an orthopedician and he suggested "Proxym" gel. I am feeding my 5 months old.
In the manual, it says
Pregnancy and lactation:
Although it had been shown that plasma levels following the application of the gel are extremely low, unknown risk is associated with the use of the gel during pregnancy and lactation.

Please let me know the meaning of this.
doctor
Answered by Dr. Vaibhav Gandhi (31 minutes later)
Brief Answer:
studies do not label as 100 percent safe in lactat

Detailed Answer:
Hello,

I have studied your case history.

Proxym contains etodolac.
It is a COX 2 inhibitor

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from etodolac extended-release tablets, 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.
And proxym gel has very less penetration through skin.

So in conclusion studies do not label it as 100 percent safe in lactation, and if you have choice you can avoid it. But gel has very less adverse effect.
I may advise my patient plain dolo 650 mg tablet which is very safe in lactation also.

Hope this answers your query. If you have additional questions or follow up queries then please do not hesitate in writing to us. I will be happy to answer your queries.

Wishing you good health.

Take care.

Above answer was peer-reviewed by : Dr. Vinay Bhardwaj
doctor
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Follow up: Dr. Vaibhav Gandhi (37 minutes later)
Actually, I am not understanding how can the application of gel on the surface of skin affect lactation? Or is it the smell which will affect the infant?
Yesterday night I applied the gel and soaked my leg in hot water. Later, happened to read the manual. What reaction it may cause the baby?
doctor
Answered by Dr. Vaibhav Gandhi (40 minutes later)
Brief Answer:
Explained below

Detailed Answer:
Hello XXXXXXX

Gel acts through two mechanism

1 Local counter irritant action leads to pain relief by giving more signals through alternate pathway.

2 By absorption from skin it goes into blood and by cox 2 channel inhibition attains pain relief which is locally and systemically.This medicine in blood can cross plasma barrier and enter into lactating milk in breast.So small/unknown amount of medication can reach to baby through lactation.

Side effects to baby can be same as all cox 2[Painkiller NSAIDS]inhibitors.
Safety and effectiveness of proxym in pediatric patients below the age of 6 have not been established[Not studied]
Unfortunately, large randomized clinical trials of selective COX-2 inhibitors in adult detected an increased incidence of adverse cardiovascular events. This risk likely due to permanent blockade of COX-2 dependent prostaglandins.

Hope this answers your query. If you have additional questions or follow up queries then please do not hesitate in writing to us. I will be happy to answer your queries.

Wishing you good health.

Take care.
Note: For further queries, consult a joint and bone specialist, an Orthopaedic surgeon. Book a Call now.

Above answer was peer-reviewed by : Dr. Vinay Bhardwaj
doctor
Answered by
Dr.
Dr. Vaibhav Gandhi

Orthopaedic Surgeon

Practicing since :1998

Answered : 5164 Questions

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Is Proxym Gel Application Safe During Lactation?

Brief Answer: studies do not label as 100 percent safe in lactat Detailed Answer: Hello, I have studied your case history. Proxym contains etodolac. It is a COX 2 inhibitor It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from etodolac extended-release tablets, 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. And proxym gel has very less penetration through skin. So in conclusion studies do not label it as 100 percent safe in lactation, and if you have choice you can avoid it. But gel has very less adverse effect. I may advise my patient plain dolo 650 mg tablet which is very safe in lactation also. Hope this answers your query. If you have additional questions or follow up queries then please do not hesitate in writing to us. I will be happy to answer your queries. Wishing you good health. Take care.