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Pharm Chapter3
Adverse Reactions
Question | Answer |
---|---|
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. |