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Gynecology

Sprintec to Mononessa

04/23/2008

Question:

After using Sprintec for several years, my pharmacy switched its vendor and gave me Mononessa this month. Though I know both are similar, are they really the same? For example, after using for 2 weeks, I am experiencing burning pain in one breast. Coincidence or slightly different formulation?

Answer:

Sprintec and Mononessa are both generic oral contraceptive pills which contain norgestimate and ethinyl estradiol.  They are the generic equivalent of Ortho Cyclen and Desogen.  As generics they contain the same active ingredients as the brand name products.  The Food and Drug Administration has specific requirements regarding the bioequivalence of generic drugs.  This means that a generic must be tested to prove that the body's absorption of the medication is similar to the brand name product.  However, the generic does not go through the same effectiveness trials as the brand name product. (Studies in which large numbers of individuals use the product and determine how well it works.)

 

Because generic drugs contain different inert or non-active components and because there is a small allowable difference in absorption between generics and brand name products, it is possible to experience slight differences when changing between generics or from brand name products to generics.  For oral contraceptives this might result in a change in breast tenderness, nausea, or bleeding pattern.  Such side effects are normally short-lived.  If breast symptoms or irregular bleeding persist, you should see a health care provider. 

The following link provides more information regarding generic drugs: 

http://www.fda.gov/drugs/resourcesforyou/consumers/questionsanswers/ucm100100.htm

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Response by:

Lisa M Keder, MD, MPH Lisa M Keder, MD, MPH
Clinical Associate Professor of Obstetrics & Gynecology
College of Medicine
The Ohio State University