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So you are a regular sufferer of headaches. To try and ease the pain you take medication which works so well you take it again as soon as the first signs of your next headache appea

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

r. Then you think to yourself that maybe taking more than the normal dose might be better for you. Then you find that the pills aren't working as well as they used to so what do you

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

do? Of course you take even more and before you realise it you are now in the cycle of headache-medication-headache that is known as a rebound headache.

First of all it is importan

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

to note that rebound headaches (also called medication overuse headaches) are not a sub-category of normal headaches but a syndrome. They are a result of self-medication by people

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ho suffer from frequent headaches (migraine etc.). They regularly use analgesics (any drug that is used to relieve pain) to try and get rid of the headache, this gives temporary rel

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ef so they take another pill and so on and so on.

The result is a headache that is caused by the very pain killers they take to get rid of it. By exceeding the safe limit the drugs

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

start to cause headaches. By taking the drug regularly a pattern is set up whereby essentially your brain, having got used to the pain relief, starts to crave more and more.

How

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

do I know I am having a rebound headache?

* You have daily or every other day headaches.

* The headaches are becoming more frequent.

* Your headache starts to get worse afte

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

only 3 hours following the medication.

* You find yourself relying on the medication more and more.

* Even though you are taking more medication you find that it isn't as effecti

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e.

* You are experiencing pain on both sides of the head that have a tightening feeling ("it feels like a tight belt around my head").

* You may find you start to suffer from mild

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

photophobia (sensitivity to light) or phonophobia (sensitivity to sound).

* You have tight and tender neck and shoulder muscles.

If you feel this is you then you need to completel

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

come off the medication. This however, is a slow and difficult process because you need to try and "re-educate" your body's craving, the first few weeks may even see you experienci

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

g a worsening of the symptoms (as your body goes through withdrawal). Having said that if you know which drug is the culprit then coming off it will give you a dramatic improvement

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ithin 4-8 weeks.

To start with try to ensure that you have at least two days that are drug-free between every day when you're taking the painkillers. If possible try to take no mor

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e than 10 doses a month, if you're taking much more than that, see a good doctor and look for other solutions like:

Stress Management

This is an important part of the treat

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ent of rebound headaches. The aim is to help the patient rid themselves of their knee-jerk reaction to head for the medicine cabinet at the first sign of their headache. Stress man

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

gement techniques such as relaxation, meditation, breathing techniques, visualisation and biofeedback have all proved useful.

My advice is to talk to others who have the same probl

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

m and see how they deal with it. Help groups and internet chat rooms will give you access to other people who will be willing to help. The important thing to get is that you are no

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

the only person suffering from this and as soon as you admit that something needs to be done you will be on the road to a medication-free life. You might even be one of the many wh

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

find that coming of the medication actually stops the headaches completely!

This content is provided by John Blachford. It may only be used in its entirety with all links included

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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