Fixed dose combinations

[Guest guest]

Dear members,

Advantages of FDC's

1. Simpler dosage schedule improves compliance and therefore improves

treatment outcomes.

2. Less expensive than single ingredient drugs

3. Allows for synergistic combinations (i.e., trimethoprim/sulfamethoxazole

combination allows each drug to selectively interfere with successive steps in

bacterial folate metabolism.)

4. Side effect of one component is counteracted by the other. ,e.g. thiazide

and spironolactone

5. The therapeutic effect of two components being same may add up while the

side effect being different may not,e.g. atenolol +amlodipine as

antihypertensive.

Before prescribing a combination ,the physician must consider whether any of the

ingredient is unnecessary; if it is ,the combination should not be prescribed.

Regards,

Dr. Sonali Pimpalkhute

Lecturer, Pharmacology

GMC, Nagpur

[Guest guest]

Dear members,

It is interesting to note that a lot of discussion is going on FDCs. I want to bring to the notice that recently DCG(I) office has made guidelines for submission of proposals for FDCs for the purpose of market authorization in the country. These guidelines are quite exhaustive and can be accessed at www.cdsco.nic.in.

The menace of irrational FDCs floating in the country is largely due to fragmented drug regulatory setup. The irrational FDCs are indiscriminately permitted by State Licensing Authorities without permission from the Office of DCG(I). This is an illegal practice. However, despite several efforts done by DCG(I) office for last many years (even approaching State Health Secreatry Level) could not curb this practice. Only way out was to form an independant autonomous "Central Drug Authority" which has also been turned down by the Parliamentary Standing Committee on Health and Family Welfare.

Rest 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 combinationsnetrum Date: Tuesday, 22 February, 2011, 7:46

Dear members,Advantages of FDC's1. Simpler dosage schedule improves compliance and therefore improves treatment outcomes.2. Less expensive than single ingredient drugs3. Allows for synergistic combinations (i.e., trimethoprim/sulfamethoxazole combination allows each drug to selectively interfere with successive steps in bacterial folate metabolism.)4. Side effect of one component is counteracted by the other. ,e.g. thiazide and spironolactone5. The therapeutic effect of two components being same may add up while the side effect being different may not,e.g. atenolol +amlodipine as antihypertensive.Before prescribing a combination ,the physician must consider whether any of the ingredient is unnecessary; if it is ,the combination should not be prescribed.Regards,Dr. Sonali PimpalkhuteLecturer, PharmacologyGMC, Nagpur