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Caution

This category gives you information on aspects of drug action and/or drug use that require special emphasis. Occasionally these warnings may relate to information provided in other categories. When included here, such entries warrant being repeated.

Precautions for Use by Infants and Children

Doses often MUST be changed for infants and children under 12 years of age, and some drugs and/or treatment situations call for special precautions. When administering any prescription or over-the-counter drug, it is best to ask your doctor or pharmacist about needed precautions.

Precautions for Use by Those Over 60 Years of Age

Our bodies change as we age, and people age at different rates and in different ways. Assessment of "age" must be based upon individual mental and physical condition, and never upon years alone. In general, changes that accompany aging may affect the actions of the body on the drug, as well as actions of the drug on the body. Appropriate precautions are outlined in this category.

Advisability of Use During Pregnancy: Pregnancy Category

Information about the safe use of a particular drug during pregnancy was one of the most forceful concerns that led to the formal petitioning of the Food and Drug Administration in 1975 to make sure that information was disclosed to the public. The FDA definitions of the five pregnancy categories are listed at the back of this book. The FDA does not make the initial category assignment; this is the responsibility of the manufacturer that markets the drug. The initial designation is then subject to review and modification by the FDA. The "Pregnancy Category" designations presented in each Profile were determined after thorough review of pertinent literature and consultation with appropriate authorities. They are offered at this time for initial guidance only. They are in no sense "official" and do not have the endorsement of either the manufacturer or the FDA.

Advisability of Use if Breast-Feeding

This section tells you about effects of the drug on milk production, if the drug goes into human milk, and the possible effects of the drug on the nursing infant. Prudent recommendations are given where appropriate. Also included are impacts of disease where appropriate.