Re: Fixed dose combinations.

[Guest guest]

Dear All Netrum Members,

Fixed dose combinations (FDCs) are important for public health perspective and commonly used for malaria, tuberculosis , HIV/AIDs. FDCs have proved to be advantageous such as safe ad effective, increased efficiency, reduced incidence of adverse effects, low cost as compared to individual mediucations, improved patient complience and improved logistics.

On other hand if administered in unprofessional way FDCS have given problem of drug resistance in the case of antituberculosis and antimalarials. In some instances wrong understanding of FDCs have been proved to be fatal.

I have seen prescribing/consuming FDCs for simple headache without having understanding and usually think that FDCs are always better then single medication. FDCs prescription and usage must be striclty regulated in the country.

Kind regards and thanks

O.P.Singh

Consultant Health Research and Managment

194-B, 4 C Jamunapuri Colony,

Murlipura Scheme,

Jaipur 302013

Rajasthan India.

Ph: 91 9414752001 (m)

From: Mrunalini Kalikar <mrunalinikalikar@...>Subject: Fixed dose combinations.netrum Date: Monday, 21 February, 2011, 11:49 AM

Dear members,

I welcome you all for the discussion on the topic "Fixed dose combinations".

A fixed dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Rational fixed dose combination drug products may be advantageous and improve medication compliance of patients but irrational FDC's could be dangerous.

Regards,

Dr.Sonali pimpalhhute,

Dept.of Pharmacology,

GMC,Nagpur.

[Guest guest]

Dear group,

For FDC of Diclofenac + Serratiopeptidase, I want to mention that there is a definite rationality between these two ingredients. Both drugs have been known to reduce the inflammation by different mechanisms of actions. Individually, these drugs have been reported to reduce the pain and inflammation. Serratiopeptidase is actually an enzyme discovered in Japan. Both drugs when given concommitantly have not been reported to increase the incidence of peptic ulcer or any other side effect.

Lastly, the FDC of Diclofenac + Serratiopeptidase was approved by the office of DCG(I) after conducting a clinical trial. I was involved in the examination as well as entire approval process of aforesaid FDC.

For FDC of Nimesulide + Paracetamol - in next email

Regards

Rakesh Kumar Rishi

Pharmacologist

Central Drugs Laboratory,

Directorate General of Health Services,

Ministry of Health & Family Welfare, Govt. of India,

3, Kyd Street, Kolkata - 700 016

Phone: 09313323007 (Mobile)

From: mrunalinikalikar <mrunalinikalikar@...>Subject: Fixed dose combinations.netrum Date: Wednesday, 23 February, 2011, 6:29

Dear members,Fixed dose combinations in India.In India a variety of combinations of drugs are available which are not included in WHOs list of essential medicine and are irrational. Following are examples of some. Pediatric formulations of Nimesulide + Paracetamol can induce severe hypothermia in small children and lead to shock. FDCs of Diclofenac + Serratiopeptidase do not offer any particular advantage over the individual drugs despite vigorous claims that Serratiopeptidase promotes more rapid resolution of inflammation. On the other hand, the patient is exposed to greater risk of gastrointestinal [GI] irritation and serious bleeding from unsuspected peptic ulceration. FDCs of quinolones and nitroimidazoles (e.g. Norfloxacin + Metronidazole, Ciprofloxacin + Tinidazole, Ofloxacin + Ornidazole) have not been recommended in any standard books, but continue to be heavily prescribed drugs in GI infections, pelvic inflammatory

disease, dental infections, etc.. Such injudicious use of antibiotic FDCs can rapidly give rise to resistant strains of organisms, which is a matter of serious concern to the health care situation in our country. Regards,Dr.Sonali Pimpalkhute,Lecturer,Pharmacology.GMC,Nagpur.