Adrenergic agonist
An agonist is a drug that binds to a receptor site on a cell and causes a response by the cell. An agonist often mimics the action of a naturally occurring substance and an adrenergic agonist mimics the action of adrenaline. While an agonist produces an action, an antagonist generally occupies a cellular receptor and prevents access to the receptor by the agonist. Although the antagonist may have no effect of its own, it often produces a response opposite to the agonist by preventing the agonist from stimulating the receptor. For example, the adrenergic agonist, adrenaline stimulates the heart to beat faster and an adrenergic antagonist would generally slow the heart rate by blocking the effect of adrenaline.
Anticholinergic
A term that describes the action of certain medications that inhibit the effects of the parasympathetic neurotransmitter, acetylcholine. Among other actions, acetylcholine is responsible in part for the contraction or narrowing of the airways and can make breathing more difficult during respiratory distress. Selected anticholinergic or cholinergic antagonists would facilitate breathing.
ATP
Adenosine-triphosphate or ATP is a rapidly available form of stored energy used by virtually all living cells to carry out daily functions. The body restores the supply of used ATP as needed from ingested or stored fuels, primarily carbohydrates and fats. ATP is a critically important compound in the supply of energy within cells in the body.
Enantiomer
An enantiomer is one of a pair of molecules that are identical in composition except their structures are mirror images and cannot be superimposed. Enantiomers were first identified for the ability of some individual enantiomers to bend light in opposite directions from their mirror images. These enatiomers are said to be optically active.
Inotropic
Used scientifically, inotropic describes agents that alter the quality of the developed force or vigor of muscle contractions. An inotrophic agent will generally stimulate the heart to contract faster and with more strength.
Racemic Mixture
An equimolecular mixture of a pair of enantiomers. Such mixtures do not exhibit optical activity.
Sterioisomers
Isomers are molecules that possess identical constitution, but which differ in the arrangement of their atoms in space.
Sympathomimetics
A term used to describe the activity of certain medications that mimic the actions of adrenaline or noradrenaline mediated through adrenergic receptors. These activities might include among others actions to accelerate the heart rate, constrict blood vessels, dilate airways, increase available energy and raise blood pressure.
MEDICAL TERMS
Anaphylaxis
Anaphylaxis is an acute allergic reaction that is sudden, severe, and involves the whole body. Common causes include insect bites, vaccines, food and drug allergies. Sometimes there is no identifiable cause. Uncorrected anaphylaxis can cause extremely low blood pressure, heart arrhythmias, shock and cardiac arrest because the allergic response releases histamine and toxic chemicals that dilate blood vessels and constrict the airways. These toxic mediators reduce the delivery of oxygen and fuel to the tissues by lowering blood pressure too far and making breathing difficult by constricting the airways (lungs) too far. Furthermore the dilated blood vessels leak fluids into the tissues and lung air sacks (alveoli) and cause tissue swelling and pulmonary edema. Anaphylaxis occurs infrequently; however, it is life threatening.
Angina Pectoris
A specific type of chest pain caused by inadequate blood flow through the blood vessels (coronaries) that supply oxygen and fuel to the heart muscle (myocardium).
Asthma
A disease in which inflammation of the airways (lungs) causes airflow into and out of the lungs to be restricted. Asthma attacks can last minutes or days and become dangerous if the airflow becomes severely restricted. It is characterized by periodic attacks of wheezing, shortness of breath, chest tightness, coughing, and increased production of mucus.
Arrhythmias
This term refers to a group of abnormal heart rhythms including bradycardia (slow heart rate), tachycardia (fast heart rate), and dysrythmias (general irregular heart rates). Causes include malfunction of the sinus node (the “natural” heart pacemaker); medications such as beta-adrenergic agonists, sympathomimetics, anticholinergics, calcium blockers, and digitalis; and disorders that cause scarring, degeneration, or damage to the conduction system. Arrhythmias are termed lethal if they cause a severe decrease in the pumping function of the heart as when the pumping function is severely decreased for more than a few seconds, blood circulation is essentially stopped (cardiac arrest) and organ damage (brain damage) may occur within a few minutes leading to death.
Cardiac Arrest
Cessation of the heart beat. If not reestablished within a few minutes, death occurs.
Cardiac Necrosis
It is caused by ischemia (lack of oxygen to the heart tissues) with resulting damage to the muscles and can cause death.
COPD
COPD or Chronic Obstructive Pulmonary Disease includes chronic bronchitis, emphysema, and asthma and represents any prolonged or persistent condition of respiratory (breathing) dysfunction resulting in oxygenation or carbon dioxide elimination at a rate that is not sufficient to meet demands of the body; it may become severe enough to cause respiratory failure.
Hypertension
A disorder characterized by high blood pressure. Essential hypertension has no identifiable cause and comprises over 95% of all hypertension.
Hypotension
A disorder characterized by low blood pressure. Orthostatic hypotension is low blood pressure caused by assuming an erect position from a supine or reclining position.
Intractable Seizure
A sudden attack which is not easily cured or relieved.
Paradoxyl Bronchospam
The constriction of air caused by spasmodic contraction of bronchial muscles.
Palpitation
An abnormal (rapid) beating of the heart. This can be due to exertion, strong emotion, or disease.
Rebound Nasal Congestion
As a result of continuous usage of topical nasal congestant medication, a return to a congested state rapidly after usage of the medication.
GOVERNMENT REGULATORY TERMS
Clinical Trials
There are four types of clinical trial prescribed by the FDA. The trials are conducted in sequence and each type of trial must be successfully completed prior to initiation of the subsequent type of clinical trial. The first three types of trial are required in order to obtain an NDA which is required in order to sell a prescription pharmaceutical product in the U.S. All clinical trials are conducted under FDA Approved Protocols:
Phase I: This type of trial is conducted on a very limited number of healthy volunteers. Its principal objective is to obtain in indication of the drugs safety in humans. Efficacy is not assessed.
Phase II: This is a very rigorous early evaluation of both drug safety and efficacy in sick patients. A Phase II trial is normally conducted with a few hundred patients carefully monitored by physicians in facilities that have been approved by the FDA for the conduct of Phase II evaluations. Dose ranging studies are a critical part of this program.
Phase III: Several thousand sick people are normally enrolled in a Phase III Program, the drug is evaluated for both safety and efficacy and biostatistical data are extracted from the study at a P ratio in the +(-). 002 range, studies are conducted at several centers, and successful conclusions result in an NDA.
Phase IV: Occasionally, the FDA requires additional monitoring of a drug after its approval for sale under a Phase IV Program or, alternatively, a pharmaceutical company may elect to evaluate a new use of a drug under this Phase.
Current Good Laboratory Practice Guidelines are issued by the FDA . Companies selling products to the American public must evaluate products they manufacture in laboratories and under methodologies described in these guidelines.
The FDA issues current Good Manufacturing Practice Guidelines. Companies selling products to the American public must conform to procedures and in facilities qualifying under these guidelines. Non-conformance can result in product withdrawal from the marketplace.
U. S. Food and Drug Administration
The FDA grants an Investigational New Drug for potential pharmaceutical products that qualify based upon Pre-Clinical Data submitted to the FDA for its approval. An IND is required prior to testing any potential drug in humans.
NDA
An NDA (New Drug Approval) is granted by the FDA for products that qualify for safety and efficacy during Clinical Testing in humans. An NDA is required to sell a prescription pharmaceutical product in the U.S.
Pre-Clinical Testing is conducted under requirements prescribed by the FDA and includes both in-vitro (testing that is not conducted in animals) and in-vivo (testing in various species of animals) testing. These evaluations comprise the IND submissions to the FDA.
Protocols (procedures for the conduct of clinical trials) are submitted to the FDA for its approval prior to initiation of testing in humans and no deviation from an approved protocol is permitted.