What should a drug monograph include?
The information within these monographs is presented in a standardized format to provide the following information:
- Description/Classification.
- Mechanism of Action.
- Pharmacokinetics.
- Administration.
- Indications/Dosage.
- Interactions.
- Contraindications/Precautions.
- Adverse Reactions.
How do you find drug monographs?
Prescription and Non-prescription Monographs
- RxList. The Internet Drug Index – part of the WebMD network.
- Drugs.com. Data sources include the Physicians’ Desk Reference (PDR), Cerner Multum, Thomson Reuters Micromedex and Wolters Kluwer Health.
- Medscape Drugs & Diseases. Free registration required – from WebMD.
- RxFiles.
What is the monograph process?
An OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market …
What is a monograph product?
A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.
What are monographs used for?
A monograph is an academic text resulting from document research and used in education to provide information about the current status of a specific subject as far as knowledge about it is concerned.
What is the antibiotic monograph?
A drug monograph is a predetermined checklist covering active ingredients, doses, formulations and product labeling that the agency considers generally safe and effective for self use.
Is hand sanitizer an over-the-counter drug?
Hand Sanitizers and most form of antiseptic/antibacterial products are considered over-the-counter (OTC) drugs by the FDA.
What is Sulfameth used for?
This medication is a combination of two antibiotics: sulfamethoxazole and trimethoprim. It is used to treat a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections). It is also used to prevent and treat a certain type of pneumonia (pneumocystis-type).
What is a product monograph?
What are medications that start with Z?
Drugs beginning with the letter Z. Zaditen (ketotifen) Zaditor (ketotifen eye drops) zafirlukast ( Accolate ) Zamine (drospirenone – ethinyl estradiol (Yasmin)) Zanaflex (tizanidine) zanamivir inhalation (Relenza) Zantac (ranitidine)
What is an OTC monograph?
OTC Drug Monograph. OTC drugs are defined as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.”. OTC monographs define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in OTC final monograph, companies can manufacture and market that OTC product without FDA pre-approval.
What are the different types of medication?
Medication comes in three basic forms: solid, semi-solid, and liquid. Solids and semi-solids typically include medicines administered as tablets, capsules, pills, and chews. Liquid dosage forms, given orally, deliver medication to the body the fastest because they move so quickly through the system.
What is over counter medicine?
Over-the-counter drug. Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription from a healthcare professional, as opposed to prescription drugs, which may be sold only to consumers possessing a valid prescription.
