Fixed dose combination
Encyclopedia
A combination drug or fixed-dose combination (FDC) is a formulation of two or more active ingredient
s combined in a single dosage form
, available in certain fixed doses. Fixed-dose combination drug products may improve medication compliance
by reducing the pill burden of patients, as well as any usual advantages of combination therapy
.
Typically, fixed-dose combination drug products are developed to target a single disease (such as with antiretroviral FDCs used against AIDS
). However, FDCs may also target multiple diseases, such as Caduet
or EXFORGE. Caduet contains atorvastatin
to treat hypercholesterolemia
and amlodipine
to treat hypertension
.
Since FDCs are reviewed by the Food and Drug Administration
, the active ingredients used in the FDC are unlikely to exhibit adverse drug interaction
s with each other. However, FDCs may interact with other drugs that a patient is taking.
While FDCs may reduce pill burden, there are some disadvantages. If a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient. In addition, if an adverse drug reaction
occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. However, this problem may be avoided by starting the medications individually and monitoring for reactions, and then switching to an FDC when no problems have been observed.
as a way to extend the marketability of a drug product. Since FDCs may be protected by patent
s, a company may obtain exclusive rights to sell the FDC, even though the individual active ingredients may be off-patent.
Active ingredient
An active ingredient is the substance of a pharmaceutical drug or a pharmaceutical ingredient and bulk active in medicine; in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient...
s combined in a single dosage form
Dosage form
-Introduction:Dosage forms are a mixture of active drug components and nondrug components. Depending on the method of administration they come in several types. These are liquid dosage form, solid dosage form and semisolid dosage forms. A Liquid dosage form is the liquid form of a dose of a...
, available in certain fixed doses. Fixed-dose combination drug products may improve medication compliance
Compliance (medicine)
In medicine, compliance describes the degree to which a patient correctly follows medical advice...
by reducing the pill burden of patients, as well as any usual advantages of combination therapy
Combination therapy
Combination therapy or polytherapy is the use of more than one medication or other therapy. In contrast, monotherapy is any therapy which is taken by itself....
.
Typically, fixed-dose combination drug products are developed to target a single disease (such as with antiretroviral FDCs used against AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
). However, FDCs may also target multiple diseases, such as Caduet
Caduet
The drug combination atorvastatin/amlodipine is a medication approved by the Food and Drug Administration for the treatment of high cholesterol and high blood pressure. It is a fixed dose combination drug containing the calcium channel blocker amlodipine and the statin atorvastatin...
or EXFORGE. Caduet contains atorvastatin
Atorvastatin
Atorvastatin , sold by Pfizer under the trade name Lipitor, is a member of the drug class known as statins, used for lowering blood cholesterol. It also stabilizes plaque and prevents strokes through anti-inflammatory and other mechanisms...
to treat hypercholesterolemia
Hypercholesterolemia
Hypercholesterolemia is the presence of high levels of cholesterol in the blood. It is not a disease but a metabolic derangement that can be caused by many diseases, notably cardiovascular disease...
and amlodipine
Amlodipine
Amlodipine is a long-acting calcium channel blocker used as an anti-hypertensive and in the treatment of angina...
to treat hypertension
Hypertension
Hypertension or high blood pressure is a cardiac chronic medical condition in which the systemic arterial blood pressure is elevated. What that means is that the heart is having to work harder than it should to pump the blood around the body. Blood pressure involves two measurements, systolic and...
.
Since FDCs are reviewed by the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
, the active ingredients used in the FDC are unlikely to exhibit adverse drug interaction
Drug interaction
A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. Typically, interaction between drugs come to mind...
s with each other. However, FDCs may interact with other drugs that a patient is taking.
While FDCs may reduce pill burden, there are some disadvantages. If a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient. In addition, if an adverse drug reaction
Adverse drug reaction
An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...
occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. However, this problem may be avoided by starting the medications individually and monitoring for reactions, and then switching to an FDC when no problems have been observed.
Profit motive
Fixed-dose combination drug products may be developed by a pharmaceutical companyPharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
as a way to extend the marketability of a drug product. Since FDCs may be protected by patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
s, a company may obtain exclusive rights to sell the FDC, even though the individual active ingredients may be off-patent.