How to use this book

Monograph Structure

Within each monograph the information is presented in sections as follows:

• GENERAL INFORMATION

  Includes, when necessary, notes on nomenclature, uses, and information about the results of observational studies, comparative studies, drug combination studies, placebo-controlled studies, and systematic reviews, in relation to reports of adverse drug reactions, and a general summary of the major adverse effects and adverse reactions.

• ORGANS AND SYSTEMS (for benefits, harms, and the benefit to harm balance)

  • Cardiovascular (includes heart and blood vessels)

  • Respiratory

  • Ear, nose, throat

  • Nervous system (includes central and peripheral nervous systems)

  • Neuromuscular function

  • Sensory systems (includes vision and the eyes, auditory and vestibular functions, olfaction, taste)

  • Psychological

  • Psychiatric

  • Endocrine (includes hypothalamus, pituitary, thyroid, parathyroid, adrenal, sex hormones)

  • Metabolism (includes diabetes mellitus and glucose, lipids, weight)

  • Nutrition (includes effects on amino acids, essential fatty acids, vitamins, micronutrients)

  • Electrolyte balance (includes sodium, potassium)

  • Mineral balance (includes calcium, phosphate)

  • Metal metabolism (includes copper, iron, magnesium, zinc)

  • Acid–base balance

  • Fluid balance

  • Hematologic (includes blood, spleen, and lymphatics)

  • Mouth

  • Teeth

  • Salivary glands

  • Gastrointestinal (includes esophagus, stomach, small bowel, large bowel)

  • Liver

  • Biliary tract

  • Pancreas

  • Urinary tract (includes kidneys, ureters, bladder, urethra)

  • Skin

  • Hair

  • Nails

  • Sweat glands

  • Connective tissue

  • Serosae (includes pleura, pericardium, peritoneum)

  • Musculoskeletal (includes muscles, bones, joints)

  • Sexual function

  • Reproductive system (includes ovaries, uterus, vagina)

  • Breasts

  • Immunologic (includes effects on the immune system and hypersensitivity reactions)

  • Autacoids (includes non-IgE-mediated anaphylactic, or so-called anaphylactoid, reactions, e.g. mediated by histamine or bradykinin)

  • Infection risk

  • Body temperature

  • Multiorgan damage or failure

  • Trauma

  • Death

• LONG-TERM EFFECTS

  • Quality of life

  • Drug abuse

  • Drug misuse

  • Drug tolerance and resistance (includes bacterial drug resistance)

  • Drug dependence

  • Drug withdrawal

  • Gene toxicity

  • Cytotoxicity

  • Mutagenicity

  • Tumorigenicity

  • Ecotoxicity

• SECOND-GENERATION EFFECTS

  • Fertility

  • Pregnancy (includes labor, cesarean section)

  • Teratogenicity

  • Epigenetic effects

  • Fetotoxicity

  • Lactation

  • Breast-feeding

• SUSCEPTIBILITY FACTORS (relates to features of the patient)

  • Genetic factors

  • Age

  • Sex

  • Altered physiology

  • Diseases (includes cardiac diseases, renal diseases, hepatic diseases, thyroid diseases)

  • Other susceptibility factors

• DRUG ADMINISTRATION

  • Drug formulations

  • Drug additives

  • Drug contamination (includes contamination with infective agents and adulteration with other drugs or heavy metals)

  • Drug dosage regimens (includes dose, timing, frequency, and duration of administration)

  • Drug administration route

  • Drug overdose

  • Accidental exposure

• DRUG INTERACTIONS

  • Drug–drug interactions

  • Drug–alcohol interactions

  • Drug–food interactions

  • Drug–device interactions

  • Drug–environment interactions

  • Drug–procedure interactions

  • Drug–radiation interactions

  • Drug–smoking interactions

• INTERFERENCE WITH DIAGNOSTIC TESTS

• DIAGNOSIS OF ADVERSE DRUG REACTIONS

• MANAGEMENT OF ADVERSE DRUG REACTIONS

• MONITORING THERAPY