INDICES> Metamizole in your country?

["Vladimir S. Shoukhov" <shoukhov@cityline.ru>]

Dear colleagues,

Several month ago we together with Dr. Jonathan Harper made an attempt to
understand the problem with analgesics and anesthesia in Russia.
Unfortunately our survey was devoted not only to metamizole, but taking into
account possible topicality of this issue, we've devoted a much portion of
our attention to this drug.
Please find below some facts and comparisons regarding metamizole place in
Russia analgesia.
Hope this can be useful for some of you.
For those who can read in Russian (for Natalie especially!) I will be
pleased to
e-mail (on request) a *.pdf copy of our article (Metamizole and metamizole
combinations: safety issues) that was published at the end of 1999.

Prof. Vladimir S. Shoukhov, M.D., D.Sci (Med)
+7 (095) 930 4105
shoukhov@yahoo.com
___________________________________

...
Non-narcotic analgesics represent approximately 30% of the Russian
pharmaceutical market (fluctuations from 28% in 2000 to 32% in 1999) and
form the largest therapeutic group by sales volume. Analgesics as a
percentage of the total pharmaceutical market volume appear to be high in
Russia compared to Western countries.

It can be stated that most popular non-narcotic analgesic drugs (or better
to say "drugs for pain"!) utilised in Russia are:

* combination preparations containing either Metamizole (Dipyrone),
Acetylsalicylic acid or Paracetamol as the core ingredient. Combination
ingredients commonly include one or more of the following: Caffeine,
Propifenazone, Phenobarbitone, Papaverine or Vitamin C;

* NSAIDs. Although the main indication of NSAIDs is for anti-inflammatory
therapy they have a limited but recognised usage in the treatment of pain
syndromes related to other pathological morbidity. In Russia, the
traditional NSAIDs, Diclofenac and Indomethacin, are arguably used in a
wider pain treatment role than for internationally accepted indications.

In addition to drugs that are internationally recognised as analgesics,
medicines which can be classified as "para-analgesics" (not
co-analgesics!!!) are widely utilised in Russia. Many of these drugs have
been available in Russia for many years, and to a large extent are very
specific to this region of the World, however under the current conditions
of severe psychosocial stress the utilization of such drugs has increased.
Many of the drugs that fit into this category are not present in the
pharmaceutical markets of Western countries. This 'para analgesics' can be
broadly split into two classes:

  a) Spasmolytics - drugs possessing visceral relaxing effects. This class
of drugs include single component or
  combination spasmolytic drugs such as papaverine or the papaverine
analogue drotaverine (single component drotaverine according to IMS -
pharmaceutical sales database - is the largest selling drug in Russia by
value). Combination analgesic/spasmolytic drugs are widely utilised in
Russia and tend to be taken for stress related conditions.

  b) Domestically produced OTC herbal multicomponent medications
possessing a sedative effect due to organic components (typically
Valerian) frequently with the addition of synthetic components
(particularly phenobarbitone).


Non-narcotic analgesic analogues registered in Russia (1998-2000)
        MONOCOMPONENT
            Metamizole - 7
            Aspirin (includes Aspirin + Vitamin C)  - 28
            Paracetamol (includes Paracetamol + Vitamin C) - 34
        POLYCOMPONENT
            Metamizole combination - 11
            Aspirin + caffeine  - 1
            Paracetamol + caffeine - 3
            Paracetamol + codeine - 2
            Paracetamol + phenylephrine - 1
            Aspirin + paracetamol + caffeine - 10
            Others combinations - 39

Metamizole (Dipyrone) and its various combinations are the most widely
utilised analgesics in Russia. From a public health viewpoint, this should
raise some serious concerns based on the controversy that surrounds this
drug and actions taken by many countries to restrict its usage.
Of particular interest and concern is the dominance in Russia of the
combination Metamizole class of preparations (which include a wide variety
of added components). It can be safely assumed that the side effect and
adverse drug reaction profile of combination Metamizole preparations is
likely to be higher than for monocomponent Metamizole.

MAIN COMBINATION Metamizole PRODUCTS AVAILABLE IN RUSSIA: BRAND NAMES
AND INGREDIENTS
        PENTALGIN (Metamizole sodium 300mg, Paracetamol 300mg, Caffeine
50mg, Codeine phosphate 8mg, Phenobarbitone 10mg)
        BARALGIN (Metamizole sodium 500mg, Carbmethoxy benzaphenone HCl
5mg, Diphenyl piperidyl acetamide brommethylate 100mg)
        TEMPALGIN (Metamizole sodium 500mg, Tempidone 200mg)
        SPAZGAN (Metamizole sodium 500mg, Pitofenone 5mg, Phenpiverinic
bromide 20mg)
        MAXIGAN (Metamizole sodium 500mg, Pitofenone 5mg, Phenpiverinic
bromide 20mg)
        BENALGIN (Metamizole sodium 500mg, Caffeine 50mg, Thiamine 40mg)
        BELLALGIN (Metamizole sodium 250mg, benzocaine 250mg, extract
Belladonna 15mg, Sodium hydrocarbonate 300mg)
        REMIDON (Metamizole sodium 200mg, Paracetamol 200mg, Caffeine
50mg)
        TRIGAN (Metamizole sodium 500mg, Piperidine ethoxil
carbomethoxybenzaphenone HCl 5mg, diphenylpiperidinoethyl acetamide
0.1mg)
        PYRENAL (Metamizole sodium 250mg, Aminophenazone 250mg)
        ANAPIRIN (Metamizole sodium 200mg, Aminophenazone 250mg,
Caffeine sodium benzoate 100mg)

The only known victory on metamizole in Russia occured in 2000
(26.10.2000) when with the special written decision (protocol #12) from
the Pharmaceutical Committee of Russia Federation (MoH division)
metamizole (analgin) officially wasn't recommended for OTC (without
prescription)  pharmacy sales to customers under 18th years old(!!!!).

....


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