Florinef Update

[Never Give Up]

We made a shocking, but wonderful discovery last week and are passing it on in case it might help you.

Florinef is an all generic POTS drug now called Fludrocortisone. My son's first prescription fill was manufactured by Barr Laboratories(now owned by TEVA), was a yellow rounded diamond shaped pill, and worked wonders.

The second prescription fill was a round white pill manufactured by Impax(Global), and was about 1/3 as effective as the one made by Barr.

He switched back to the Barr manufactured Fludrocortisone and it is again working wonders.

 

[Hutan]

Thanks for posting this @Never Give Up and I'm so pleased to hear your son has a useful medication again.

My son and I have been taking fludrocortisone for about 3 weeks now. It is labelled Florinef, 'sponsored' in Australia by Aspen Pharma. The pills are small, round and white.

We have not noticed any significant improvement, certainly it was not 'working wonders'. I think it is possible that heart rates and blood pressure have been a bit more normal but that hasn't translated to any noticeable improvement in well-being. I had substantial rectal bleeding last weekend with no obvious cause so I have stopped taking all medication and supplements except Valtrex until I get to see my doctor.

My son is underwhelmed with the Florinef and isn't bothering to take it anymore.

The pills have to be stored in the fridge. I wonder if poor storage somewhere in the supply chain results in ineffective tablets.

 

[WillowJ]

Generics are allowed to differ from the brand by a given percentage point. Since one might be higher and another might be lower, they might differ from each other even more.

The statistics may be difficult to understand, but to be determined bioequivalent the 90% confidence interval of the ratios of the mean bioavailability, or “area under the curve” (AUC), of the two drugs and their peak concentrations (Cmax) must be in the ranges of 80 to 125%.

http://www.kevinmd.com/blog/2013/02/generic-drugs-safe-effective-brand-drugs.html
(most straightforward explanation I could find)

This would be averages across many people.

Besides the main ingredient, extra ingredients can be different and can also affect how a given person absorbs a particular make.

People won't necessarily find that the same one works for them, as works for their neighbor (although it's possible there are several brands that are better for most people).

There are always some drugs made in less good facilities where quality control is not great. I'm not sure how to tell which is which. I finally just got a pharmacy that doesn't change my brand all the time and hope they know what they are doing.

I'm also glad your son found the brand that worked for him, @Never Give Up

 

[Never Give Up]

Thanks for posting this @Never Give Up and I'm so pleased to hear your son has a useful medication again.

Thank you. We're so pleased, but trying not to get our hopes up. His heart rate is much more stable and much lower, his temperature regulation has improved, his cognitive function is improving, pain levels are down, nausea is reduced, and energy levels are up. He still has PEM, etc., so it's not the cure, it's just a major improvement.

We have not noticed any significant improvement, certainly it was not 'working wonders'. I think it is possible that heart rates and blood pressure have been a bit more normal but that hasn't translated to any noticeable improvement in well-being. I had substantial rectal bleeding last weekend with no obvious cause so I have stopped taking all medication and supplements except Valtrex until I get to see my doctor.

Oh, I'm sorry to hear that. I hope it turns out to be nothing, or something with a simple fix that also improves the rest of your health.

My son is underwhelmed with the Florinef and isn't bothering to take it anymore.

That's too bad. I hope that you two will continue to persue treatment for your POTS. There are a handful of other meds to try out there. One of them could make a significant difference in your quality of life.

The pills have to be stored in the fridge. I wonder if poor storage somewhere in the supply chain results in ineffective tablets.

That could be a factor. Neither of the Fludrocortisone tabs that my son took required refrigeration.

 

[Hutan]

Interesting about the various storage requirements. It seems the branded Florinef was reformulated with the result that it now requires storage in the fridge. So, clearly there are significant differences in the formulation. Something to be aware of if you change brand.

The following is from http://www.addisons-network.co.uk/new_florinef.html

NEW FORMULATION FOR FLORINEF MEANS CHANGES IN THIS DRUG'S STORAGE NEEDED.

PLEASE SEE '§' BELOW FOR LATEST UPDATE ON STORAGE INFORMATION: Received 10 Jan 2008

The formulation of 'Florinef™' brand of fludrocortisone sold in some countries has been changed by the manufacturers, Bristol-Myers Squibb Pharmaceuticals Ltd. (B-M S) of Uxbridge, Middlesex, UK.

The new formulation requires Florinef to now be stored at a temperature of between 2-8ºcelcius.

• FLORINEF™ (FLUDROCORTISONE ACETATE)- CHANGES TO MY TABLETS
  
  It is extremely important that you understand how to identify and store your Florinef tablets correctly. Failure to do so may result in your Florinef tablets not working correctly.
  
  Florinef tablets contain fludrocortisone acetate which is a member of the group of medicines known as steroids. The tablets contain 0.1mg fludrocortisone acetate.
  
  Florinef is used to replace hormones normally produced by glands attached to your kidneys.
  These hormones are missing if you suffer from Addison's disease. Florinef tablets are also used to treat salt losing adrenogenital syndrome, which is a different form of hormone imbalance.
  
  Why have my tablets and their storage changed?
  There are minor changes in the formulation of Florinef due to a change in the manufacturing site of Florinef. There is no change to the effectiveness of the Florinef tablets though.
  
  How do I identify my Florinef tablets?
  The colour of Florinef tablets has changed from pink to WHITE. The tablets are round in shape. They are scored on one side and have the markings 'SQUIBB' and '429' on the other side.
  
  What are the changes in formulation of Florinef?
  Erythrosine (E127) and industrial methylated spirits are no longer present in the tablet.
  Dibasic calcium phosphate and lactose anhydrous and monohydrate are not new excipients but are specified as per the guidelines.
  
  How do I store my Florinef tablets?
  Florinef tablets should be stored in a refridgerator between 2 and 8 degrees celcius.