The FDA requires that all drugs have an information document for healthcare providers and consumers called a “package insert.” This document is a summary of the essential scientific information needed for the safe and effective use of the drug. You can ask your doctor for this information. Also, most package inserts are available on the internet. A package insert typically includes the following information:
• Chemical structure
• Information about how the body absorbs, distributes, metabolizes, and excretes the drug
• Results from some clinical trials
• What specific circumstances the drug is used for
• Dosing and administration schedules
• Side effects
• Contraindications
It is important to understand that once it has been determined that a drug is safe and it is approved by the FDA, physicians often use the drug for the treatment of medical conditions other than the specific condition that the FDA has approved it for.
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