What Are The Inactive Ingredients In Flonase?
Understanding Flonase Ingredients: Active and Inactive
Flonase is an over the counter nasal spray that is used for the long term control of symptoms associated with seasonal and perennial allergies. Unlike other allergy medications, such as Benadryl, that are used to control acute allergy symptoms on a short term basis, Flonase is intended for use over an extended period of time.
The drug was one of the first over the counter nasal sprays that became available without a prescription. Flonase is produced in formulas that are appropriate for both children and adults who experience regular allergy symptoms.
If you’re considering using Flonase to help control your allergy symptoms, you might be wondering “what are Flonase’s inactive ingredients?”
What is the difference between active and inactive ingredients?
All medications contain both active and inactive ingredients. The U.S. Food and Drug Administration (FDA) provides definitions for both types of ingredients in 21 Code of Federal Regulations (CFR) 210.3,Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs.
Active ingredients are defined in 21 CFR 210.3Part (b)(7) as any component of a drug product that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or animals.
In layman’s terms, the active ingredient in a drug is the component that provides relief from your symptoms and treats or cures a disease. For example, the active ingredient in a medication taken to relieve a hacking cough is the ingredient that actually stops you from coughing.
The other ingredients of the medication that do not provide a therapeutic effect are called inactive ingredients.
Inactive ingredients are defined by 21 CFR 210.3(b)(8) as any component of a drug product other than the active ingredient. In the average over the counter drug or prescription medication, approximately 75 percent of the drug consists of inactive ingredients, and according to the Harvard Medical School, the average medication contains approximately nine inactive ingredients.
These ingredients play a major role in determining how the finished medication looks, tastes, feels, and works in the body.
Inactive ingredients serve many purposes in medication, including:
- Binding the ingredients together to give the medicine a cohesive shape
- Preventing a medication from being dissolved
- Masking the bitter taste of some medications to make them easier to swallow
- Preserving the medication by preventing the growth of bacteria and fungi
- Helping the body to absorb the drug more easily by combining with an easily digestible substance like a fatty acid
What is the active ingredient in Flonase?
Flonase is produced in four different formulas: Flonase Allergy Relief, Flonase Sensimist Allergy Relief, Children’s Flonase Allergy Relief, and Children’s Flonase Sensimist Allergy Relief.
The adult and Children’s Flonase Allergy Relief formulas are traditional nasal sprays with a noticeable feeling of liquid spray, while the adult and Children’s Flonase Sensimist Allergy Relief products are marketed as providing a gentle mist that the user will barely feel.
Because the Flonase Allergy Relief spray is the formula with which most people are familiar, this article describes the active and inactive ingredients in that particular formula.
Flonase Allergy Relief contains 50 mcg of fluticasone propionate (glucocorticoid), the only active ingredient, in each spray.
Adults are directed to use two sprays in each nostril every day for the first week of use, then one to two sprays in each nostril once per day for the rest of the six month period.
Fluticasone propionate is an over the counter medication that is classified as a corticosteroid; specifically, fluticasone propionate is classified as a glucocorticoid. Drugs belonging to this class of medication help to reduce inflammation in the body, which can provide relief from certain symptoms.
Fluticasone propionate is commonly used to relieve symptoms associated with allergic and non-allergic nasal symptoms, including a stuffy or runny nose, itchy nasal passages, and sneezing. The drug can also help to relieve allergy symptoms that affect your eyes, such as itchy, water, or red eyes.
When your body is exposed to an allergen, such as a specific type of tree pollen, pet dander, dust mites, or mold, your immune system responds by creating an immune response. This immune response can cause the nasal passages and tissues to swell, causing you to experience symptoms commonly associated with an allergy attack.
What are Flonase’s inactive ingredients?
Flonase Allergy Relief contains the following inactive ingredients: benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, and sodium carboxymethylcellulose.
Benzalkonium chloride is a compound made from quaternary ammonium. While benzalkonium chloride was once used primarily in solutions for hard contact lens solutions, where it acted as an antimicrobial preservative, it is now commonly found in many type of solutions and liquid medications, where it acts as a preservative.
Dextrose is a type of sugar that is commonly derived from corn. Dextrose is included in many medications as an inactive ingredient because it acts as an effective binder. Binders are included in all types of medications in order to help the formula of the drug remain cohesive.
Microcrystalline cellulose is a type of cellulose that is included in many medications as an inactive ingredient. The ingredient helps to make medications easy to dissolve, allowing the body to absorb the active ingredient and spread it throughout the body, providing relief from symptoms.
Phenylethyl alcohol is a commonly used inactive ingredient that acts as both a preservative and a fragrance ingredient. Phenylethylalcohol is controversial as an ingredient in medication because this inactive ingredient has not been assessed for safety in humans, which means that we do not yet know how it might affect the human body. However, studies of the ingredient in animals have found that the ingredient can cause skin irritation at low doses and may cause brain, nervous system and reproductive effects at moderate doses.
Polysorbate 80 is a common solubilizing agent and excipient that can be used for a variety of purposes in medications. Typically, polysorbate 80 is included in medications to stabilize the active ingredient and formula, ensuring that the ingredient is properly absorbed.
Sodium carboxymethylcellulose is a common ingredient in a variety of pharmaceutical drugs, home products, food products, and personal care products. Used for its thickening and swelling properties, sodium carboxymethylcellulose is also commonly used in paper, water treatment, and mineral processing industries.
Are inactive ingredients associated with any risks?
Inactive ingredients are commonly found in every type of medication, but that doesn’t mean that they are completely safe. Although the FDA classifies inactive ingredients as “generally recognized as safe,” or GRAS, some people can experience adverse effects when using medications that contain certain ingredients.
Inactive ingredients play an important role in helping to improve the appearance, taste, color, absorption rate, and other qualities of different medications, but some people can be sensitive to their effects.
Although anyone can experience adverse effects associated with the use of medications containing inactive ingredients, people with allergies and food sensitivities are more likely to experience symptoms associated with a reaction to the ingredient.
Two of the most common risks associated with inactive ingredients in general include allergic reactions and digestive distress due to intolerances.
Allergic reactions can occur even when the medication is being used to treat allergy symptoms. A patient’s allergic reaction can vary in severity from mild to severe. Mild allergic reactions may take the form of skin irritation, as evidenced by redness, itchiness, hives, or the formation of a rash.
Most serious allergic reactions may take the form of a life threatening reaction called anaphylaxis, in which the face, lips, throat, and airways swell, causing difficulty breathing. Anaphylaxis can be potentially fatal.
Although allergic reactions are rare when considered in the context of the general population, at least 38 different inactive ingredients have been identified as potential allergens that are commonly included in medications.
Additionally, studies show that approximately 93 percent of medications included as part of one study contained at least one potential allergen.
Digestive distress associated with inactive ingredients is not life threatening, but it can be uncomfortable and embarrassing. People who are sensitive to certain inactive ingredients may experience digestive distress in the form of nausea, gas, bloating, diarrhea, or abdominal plan.
Although any ingredient can cause digestive distress, the types of inactive ingredients that most commonly trigger digestive distress are often classified as FODMAPs, an acronym that stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. FODMAP ingredients contain foods that are difficult for the body to digest.
Flonase Allergy Relief spray contains 50 mcg of fluticasone propionate (glucocorticoid) per spray as its active ingredient.
Flonase Allergy Relief contains the following inactive ingredients: benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, and sodium carboxymethylcellulose. Inactive ingredients are found in all types of prescription drugs and over the counter medications but can cause allergic reactions or digestive distress in some people.