Formulation of Amlodipine Meleate

[Foston1]

For a number of years past my sister, now aged 76, has been taking Amlodipine in the form of Amlodipine Meleate manufactured by KRKA Parma. Parma have ceased to manufacture this formulation and she is finding that she has an allergic reaction to Amlodipine in the form of Besilate or other Meleate formulations tried todate..

It has been suggested that she may be in fact simply be allergic to one of the minor componds used in the different formulations and that as such we should try and locate a formulation that EXACTLY matches that previously produced by Parma. I have written to them to see whether they would be prepared to identify the compounds in their previously manufactured formulation and I am awaiting their reply.

However, even if I do obtain this information I am still left with the need to find an exactly matching formulation available in the UK today.

Can anyone advise how I might best go about resolving the above task? Are there any books available to the general public that would show the various precise formulations available?

Any helpful suggestions would be most welcome.

[admin]

Hi

When you say she has an allergic reaction, what symptoms does she have?

[Foston1]

Amlodipine Meleate

Accute indigestion and wind. She has tried taking indigestion tablets but with no effect.

As far as I can tell the only change in her lifestyle/medication has been the change in the Amlodipine Meleate formulation. Her GP suggested that it could be the caoting on the tablets that is causing the problem but I have no evidence to this effect.

She also takes Cardicor but this has not acused any problem in the past. For the past few days she has taken the Cardicor in the morning and the Amlodipine Meleate at night with an indigestion pill but this has not resulted in any relief.

[geordie1]

You could phone them and speak to there medicines information department, they can probs advise you with the best answer!

[Foston1]

Could you please clarify for me who I should phone. I have now heard from Parma who advise as follows:

"I can't provide you with the formulation as we do this only to the Regulatory Agency."

Regards

[Pharmanaut]

Parma

Could you please clarify for me who I should phone. I have now heard from Parma who advise as follows:

"I can't provide you with the formulation as we do this only to the Regulatory Agency."

Regards

If 'Parma' are an EC based company they should produce an SmPC which lists the minor ingredients. Ask them for a copy.

Then all you need to do is check out the UK SmPC documents available on the internet. http://www.medicines.org.uk/

Does your relative have any form of intolerance to lactose.
Lactose is used in pharmaceuticals as a bulking agent.

[Foston1]

Thank you for the SmPC information. I have requested Pharma to provide me with this data.

Looking at the web links provided in your reply I can see much interesting data. However, I cannot see a way to bring up a listing of all current suppliers of Amlodipine in Meleate form (in fact I cannot locate any supplier). I can see suppliers of Amlodipine in Besitate and Mesilate formulation.

Is there any way of identifying the current suppliers of Amlodipine in Meleate form?

Regards

[Zoggite]

At the risk of stating the obvious, is amlodipine meleate the same as amlodipine maleate?

[Foston1]

A rather good question - I assume that it is but the position is not that clear.

My sister lives some 100 miles from me and I have not had direct sight of the Pharma drug. In my dealings with them I have always described the drug as "Meleate" and they have responded with the same spelling. However, given your question I have re-looked at the web sites and I see that the site for Medekit.com refers to Meleate whilst the "Prescribing memo from Darlington PCT" states Maleate.

If available the SmPC from Pharma should clarify the position.

[kemzero]

Maleate or meleate

Frankly I've only heard of besilate and Maleate
Could the meleate salt be an import or possibly a typo?

As pharmanault has suggested , the first step would be to find out what excipients were used to make this brand of amlodipine.

some binding and bulking agents (and some preservatives) have been known to cause allergies

[Linnear]

There's also a mesilate just to confuse the issue!

[Foston1]

I now have the SmPC from Pharma. It would seem that Maleate is the name of the drug that I am trying to match.

An extract from the SmPC reads:

'One Amlodipine KRKA 5 mg or 10 mg tablet contains amlodipine maleate equivalent to either 5 mg or 10 mg amlodipine per tablet.

For the excipients: see 6.1. “List of excipients”.
6.1
Microcrystalline cellulose (E460)
Pregelatinised corn starch
Sodium starch glycollate “Type A”
Anhydrous colloidal silicon (E551)
Magnesium stearate (E470b)'

Can any one help me understand how I might find a formulation made as above?

[Zoggite]

The only way I can think of right now is a rather low-tech way: Go to the dispensary and scrutinize all the leaflets inside the various makes of generic amlo. maleate tabs on the shelf...?