Sedative-hypnotics are a class of drugs that work on the central nervous system (CNS) to produce a calming or drowsy effect and are often prescribed for insomnia, anxiety, and seizure disorders. They can be classified into three main categories: benzodiazepines, barbiturates, and Z-drugs (non-benzodiazepine hypnotics). Here's a brief overview of these classes, along with some examples of individual agents and…
1 · Introduction Pharmacovigilance (PV) is the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem” (WHO). In an era of precision medicine, globalised supply chains and accelerated approvals, PV has become indispensable for safeguarding patients throughout the therapeutic life-cycle—from first-in-human dosing to decades of post-marketing exposure. Not merely a regulatory…
Oral contraceptives (OCs) are hormone-containing medications taken to prevent pregnancy and for management of various gynecologic conditions. They are among the most widely used medicines globally, and have undergone major changes in formulation, pharmacokinetics, and safety since their introduction. Types of Oral Contraceptives TypeActive IngredientsExamplesClinical FeaturesCombined Oral Contraceptives (COCs)Estrogen (usually ethinylestradiol) + progestin (various generations)EE+levonorgestrel, EE+drospirenoneMost common; cycle control, wide…
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Main Takeaway: Over-the-counter (OTC) drugs are non-prescription medications available directly to consumers for self-treatment of common ailments. With over 800 active ingredients comprising more than 100,000 products, OTC medications provide safe and effective treatment when used as directed, though they require careful attention to labeling and proper usage to avoid potential risks. 1. Definition and Regulation Over-the-counter drugs are medicines sold directly to consumers without requiring a prescription from a healthcare professional. Unlike prescription drugs that require medical supervision, OTC medications have been deemed safe and effective for public use when consumers can: In the United States, OTC drugs are regulated by the Food and Drug Administration (FDA) through two primary pathways: OTC Monograph System The majority of OTC products are marketed under the monograph system, established in the 1970s. Monographs serve as "recipe books" that specify: New Drug Application (NDA) Process Some OTC products that don't fit within existing monographs require individual FDA approval through the traditional NDA pathway. 2. Major OTC Drug Categories OTC medications are organized into numerous therapeutic categories: CategoryExamplesCommon Active IngredientsPain ReliefTylenol, Advil, MotrinAcetaminophen, Ibuprofen, NaproxenCold & CoughRobitussin, SudafedDextromethorphan, GuaifenesinAllergiesClaritin, Zyrtec, BenadrylLoratadine, Cetirizine, DiphenhydramineDigestive HealthPepto-Bismol, Tums, PrilosecBismuth subsalicylate, Calcium carbonate, OmeprazoleSkin CareHydrocortisone creamsHydrocortisone, Benzoyl peroxide Pain Relief Medications OTC pain relievers fall into two main categories: Acetaminophen (Tylenol) NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) 3. Safety Considerations and Drug Facts Labeling All OTC products must display a standardized "Drug Facts" label that includes: Key Safety Questions for Consumers Before using any OTC medication, consumers should consider: 4. Current Usage Patterns and Concerns Growing Prevalence OTC medication usage has dramatically increased: Common Misuse Patterns Research identifies several concerning trends: High-Risk Behaviors Particular concern exists regarding misuse of certain OTC drugs for recreational purposes: 5. Regulatory Updates and Future Directions CARES Act Reforms (2020) The Coronavirus Aid, Relief, and Economic Security Act modernized OTC drug regulation by replacing the slow rulemaking process with a more efficient administrative order system. OTC Monograph Drug User Fee Program (OMUFA) This FDA program expedites review processes while maintaining safety standards by imposing user fees on manufacturers, allowing FDA to allocate additional resources for timely assessments. 6. International Variations Regulatory approaches vary globally. For example: Over-the-counter medications represent a vital component of modern healthcare, providing accessible treatment for common ailments while requiring informed consumer decision-making and proper regulatory oversight to ensure public safety.
This summary covers the major classes, mechanisms, indications, and clinical guidance for drug management of glaucoma, as established in standard pharmacology texts and clinical guidelines.Drugs used for the treatment of…
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