Therapeutic Equivalence
What determines equivalence?
The active ingredient or main ingredient.
Bioequivalent:
2 drugs that are equally effective & safe and are equally absorbed when taken into the body.
Therapeutic Interchange:
A physician prescribes esomeprazole 40 mg for his patient. Esomeprazole also treats acid reflux. These drugs aren't the same active ingredient, however, they are in the same class or "family" of drugs. They both are effective in the treatment of acid reflux and work using similar methods. It's possible that the pharmacist will interchange, or substitute, the pantoprazole for esomeprazole. Of course, these substitutions can only be made by the pharmacist and only with the prescribing physician's permission.
Preservative:
A substance added to the drug that are used to extend the life of the drug to prevent the growth of microorganisms, an inactive ingredient.
What is Therapeutic Equivalence?
According to FDA, when 2 drugs have the same clinical effect, but different manufacturers. Drugs must be safe and effective and they must be deemed as pharmaceutically equivalent. Dosage form and route must be the same.
Therapeutic equivalent drugs do not need to have the same:
Appearance, size or coloring. Scoring (groove in tablet), packaging or preservative
What are some factors that will help you better understand therapeutic equivalence, alternatives, and interchange?
Becoming more familiar with a drug's brand and generic names will help you identify therapeutic equivalents. Also, pay attention to the endings of generic drug names. They can help you determine which drugs are in the same drug class and may be interchangeable. But remember, only a pharmacist can make these recommendations to the physician or patient.
In order for drugs to be considered therapeutic equivalents, they must meet certain criteria:
Bioequivalent, safe & easily absorbed into the body, have the same identical amounts of the active ingredient, the substance is what it is designed to do. Must have same strengths, dosage form & route of administration. Must meet standards of quality and purity.
The best example of therapeutic equivalence is the:
Brand and Generic Names
Therapeutic Equivalence versus Pharmaceutical Alternatives:
Example as with Tylenol, different strengths, therefore not equivalent. Some have different routes. Same active ingredient though.
A generic name is the name given by the:
FDA and holds no ownership
Brand: Cipro
Generic: Ciprofloxacin
Brand: Motrin, Advil
Generic: Ibuprofen
Brand: Lopressor
Generic: Metoprolo Tartrate
Brand: Protonix
Generic: Pantoprazole
Brand: Tylenol
Generic: acetaminophen
Brand: Lipitor
Generic: atorvastatin
Therapeutic Equivalence can be checked via:
Looking at the Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as the Orange Book. FDA's official listing.
Are Advil and Tylenol therapeutic equivalent?
NO, one is an acetaminophen and Advil is ibuprofen. Same conditions, however different active ingredients.
Additional examples of therapeutic equivalents include:
Protonix 40 mg tablet and pantoprazole sodium 40 mg tablet (used in the treatment of acid reflux) Lopressor 25 mg tablet and metoprolol tartrate 25 mg tablet (used in the treatment of high blood pressure) Lipitor 10 mg tablet and atorvastatin 10 mg tablet (used in the treatment of high cholesterol) Cipro 10 mg/mL IV and ciprofloxacin 10 mg/mL IV (used in the treatment of bacterial infections)
