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Pharm Chapter3

Adverse Reactions

Therapeutic Effect clinically desirable actions
Adverse Effect response to a drug that is not desired, it is potentially harmful, and occurs at usual therapeutic doses.
Toxic rxn amount of desired effect is excessive
Side Effect a dose-related rxn that is not part of the desired therapeutic outcome. Term often used interchangeably with "adverse rxn."
Idiosyncratic rxn a genetically related abnormal drug response; some may be due to an immonologic mechanism. Rxn is neither the drug's side effect or allergic rxn.
Drug allergy an immunologic response to a drug resulting in a rxn such as a rash or anaphylaxis.
Allergic rxns Are NOT predictable or dose-related.
Interference with natural defense mechanisms (ie adrenocorticosteroids)Long-term systemic administration of corticosteroids can result in decreased resistance to infection.
Bc perio disease involves infection and the immune response, these drugs could increase the effects of a pts poor oral hygiene Immunosuppresive
Five FDA Pregnancy Categories for Drugs A(least risky),B,C,D, and X(most risky)
Many Drugs in Dentistry are considered the safest (give examples) penicillin, erythromycin,acetaminophen (Tylenol), lidocaine
Dentistry Drugs contraindicated during pregnancy Tetracycline, nonsteroidal anti-inflammatory agents, benzodiazepines, and metronidazole
Drug Interactions Can occur when the effect of one drug is altered by another drug, and may result in undesirable effects.
Hypersensitivity (Allergic Rxn) occur when the immune system of an individual responds to the drug administered or applied.
Producing an allergic rxn Drug must act as an antigen and react with an antibody in a previously sensitized pt.
Type I Allergic Rxn Immediate Hypersensitivity rxns; IgE antibodies.Bronchioles-anaphylactic shock.Respiratory-rhinitis and asthma. Skin-urticaria and dermatitis.
Anaphylaxis -Type I Rxn characterized by hypotension,bronchospasm,laryngeal edema,and cardiac arrhythmias that can occur w/in a few min after drug administration.
Common dental drugs causing anaphylaxis penicillins, ester lacal anesthetics, and aspirin
Type II Allergic Rxn (cytotoxic/cytolytic) involve IgG and IgM antibodies.
Type III Allergic Rxn (immune complex) involve IgG
Type IV Allergic Rxn (delayed-hypersensitivity rxn) involve T-lymphocytes and macrophages. Often caused by Topical benzocaine,penicillin,poison ivy or oak, "cheap" jewelry.
Most common adverse rxn to penicillin: allergic rxn (rash)
Human Studies of Drugs involve how many phases? Four
Phase 1 :Human Studies determins biologic effects, metabolism, safe dosage range in humans, and toxic effects of a drug; primarily determines safety. Small and then increasing doses are administered to small healthy populations.
Phase 2 :Human Studies main purpose is to test effectiveness. Larger groups are given the drug and any adverse rxns are reported to FDA.
Phase 3:Human Studies Dosage is determined, safety and efficacy must be demonstrated. Clinical evals involving a large # of pts who have the condition for which the drug is indicated.
Phase 4:Human Studies Involves post-marketing surveillance; the toxicity of the drug that occurs in pts taking the drug after it is released is recorded.Drugs may be taken off market in this phase.
Created by: Hygiene103