PerioGard

chlorhexidine gluconate

Dosage Form: oral rinse
PerioGard®

(Chlorhexidine Gluconate

Oral Rinse, 0.12%)

PerioGard Description

PerioGard (Chlorhexidine Gluconate Oral Rinse, 0.12%) is an oral rinse containing 0.12% chlorhexidine gluconate [N,N" -bis (4-chlorophenyl)-3, 12-diimino-2, 4, 11, 13-tetraazatetradecanediimidamide di-D-gluconate] in a base containing water, 11.6% alcohol, glycerin, polysorbate 20, flavor, sodium saccharin and FD&C blue no. 1. PerioGard Oral Rinse is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid, with a molecular formula of C22H30Cl2N1O•2C6H12O7 and a molecular weight calculated to be 897.77.

Its chemical structure is:

PerioGard - Clinical Pharmacology

PerioGard Oral Rinse provides antimicrobial activity during oral rinsing. The clinical significance of 0.12% chlorhexidine gluconate oral rinse's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months' use. Use of chlorhexidine gluconate oral rinse in a six-month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

Pharmacokinetics

Pharmacokinetic studies with a 0.12% chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient is retained in the oral cavity following rinsing. This retained drug is slowly released into the oral fluids. Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0.206 µg/g in humans 30 minutes after they ingested a 300 mg dose of the drug. Detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered.

Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

Indications and Usage for PerioGard

PerioGard Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. PerioGard Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Contraindications

PerioGard Oral Rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Warnings

The effect of PerioGard Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse compared with control users. It is not known if chlorhexidine gluconate use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occurred. See CONTRAINDICATIONS.

Precautions

General

1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with PerioGard Oral Rinse should not be used as a major indicator of underlying periodontitis.


2. PerioGard Oral Rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in tooth staining. In clinical testing, 56% of the chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of the chlorhexidine gluconate users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from the use of PerioGard Oral Rinse does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis.
   

   Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from the PerioGard Oral Rinse treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.

   
   


3. Some patients may experience an alteration in taste perception while undergoing treatment with a chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via postmarketing surveillance.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagensis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PerioGard Oral Rinse is administered to nursing women. In parturition and lactation studies with rats, no evidence of impaired parturation or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30 mL (2 capfuls) of PerioGard Oral Rinse per day.

Pediatric Use

Clinical effectiveness and safety of PerioGard Oral Rinse have not been established in children under the age of 18.

Adverse Reactions

The most common side effects associated with chlorhexidine gluconate oral rinses are: (1) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation, and (3) an alteration in taste perception; see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%.

Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, uIcer, dry mouth, hypesthesia, glossal edema, and paresthesia.

Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinses.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadentitis) reported in patients using chlorhexidine gluconate oral rinse.

Overdosage

Ingestion of 1 or 2 ounces of PerioGard Oral Rinse by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of PerioGard Oral Rinse is ingested by a small child or if signs of alcohol intoxication develop.

PerioGard Dosage and Administration

PerioGard Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using PerioGard Oral Rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 1/2 fl. oz. ("15 mL" line on dosage cap) of undiluted PerioGard Oral Rinse. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using PerioGard Oral Rinse. PerioGard Oral Rinse is not intended for ingestion and should be expectorated after rinsing.

How is PerioGard Supplied

PerioGard Oral Rinse is supplied as a blue liquid in 16 fluid ounce amber plastic bottle with child-resistant dosage cap. Store above freezing (32°F).

Colgate Oral Pharmaceuticals, Inc., a subsidiary of Colgate-Palmolive Company

New York, NY 10022 U.S.A.

Questions/Comments: 1-800-962-2345

www.colgateprofessional.com

P10000593

Rev. 12/08

PRINCIPAL DISPLAY PANEL - 473 mL Label

Colgate®

NDC 0126-0271-16

PerioGard®

(Chlorhexidine Gluconote

Oral Rinse, 0.12%)

For questions or comments contact

your dentist or pharmacist.

KEEP OUT OF REACH OF CHILDREN

PLACE PHARMACY

LABEL HERE

Dispense in original container

or in amber glass.

16 fl oz (473 mL)

Rx ONLY

PerioGard  chlorhexidine gluconate  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0126-0271 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (Chlorhexidine) Chlorhexidine Gluconate 1.2 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE (Clear, light blue fluid with no precipates and/or contamination (suspended solids)) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0126-0271-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073695	03/02/2010

Labeler - Colgate-Palmolive Company (055002195)

Revised: 03/2010Colgate-Palmolive Company

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• Gingivitis
• Mucositis
• Periodontitis

Clarifoam EF

sulfur,sulfacetamide sodium

Dosage Form: aerosol, foam



Clarifoam EF


FOR EXTERNAL USE ONLY

Rx Only

Clarifoam EF Description

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]- acetamide, monosodium salt, monohydrate.

The structural formula is:

Each gram of CLARIFOAM® EF (sodium sulfacetamide 10% and sulfur 5%) Emollient Foam contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an aqueous based emollient foam vehicle containing cetyl alcohol NF, emulsifying wax NF, lactic acid USP, methylparaben NF, propylene glycol USP, propylparaben NF, steareth-10, water USP. Also contains: Propellant HFA-134A (1,1,1,2-tetrafluoroethane).

Clarifoam EF - Clinical Pharmacology

Sodium sulfacetamide exhibits antibacterial activity. The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.

It is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of keratolytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes thereby reducing the associated inflammation.

INDICATIONS

Clarifoam EF Emollient Foam is indicated in the topical control of acne vulgaris,acne rosacea and seborrheic dermatitis.

Contraindications

Clarifoam EF Emollient Foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Clarifoam EF Emollient Foam is not to be used by patients with kidney disease.

Warnings

Although rare, hypersensitivity reactions to products containing sodium sulfacetamide may occur, including Stevens-Johnson syndrome and exfoliative dermatitis. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC).

Precautions

General
The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy.

Information for Patients

Avoid contact with eyes, eyelids, lips, and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Category C. Animal reproduction studies have not been conducted with Clarifoam EF Emollient Foam. It is also not known whether Clarifoam EF Emollient Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Clarifoam EF Emollient Foam should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Clarifoam EF Emollient Foam. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Clarifoam EF Emollient Foam is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under the age of 12 have not been established.

Adverse Reactions

Although rare, sodium sulfacetamide may cause local irritation.

Clarifoam EF Dosage and Administration

Shake Vigorously, Tap Bottom of Can and Prime Before Initial Use. Shake Vigorously and Tap Before Each Use.

To Prime: After shaking, gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. Hold the can upright, direct away from patient, and firmly depress the actuator for 1 to 3 seconds or until foam begins to dispense. (If foam does not dispense within 3 seconds: re-shake can, gently tap bottom of can onto a solid surface at least 3 times, and depress the actuator again until foam begins to dispense.)

Before Each Use: Cleanse affected skin thoroughly and pat dry before each application. Shake vigorously and gently tap bottom of can onto palm of other hand or a solid surface at least 3 times.

During Use: Holding can upright, dispense Clarifoam EF Emollient Foam onto the fingertips.

WASH-OFF APPLICATION: Massage the dispensed foam into the affected area and

wait 10 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 3

times daily, or as directed by a physician.

LEAVE-ON APPLICATION: Massage the foam into the affected area 1 to 3 times

daily, or as directed by a physician.

Wipe off any excess foam from actuator after use.

How is Clarifoam EF Supplied

Clarifoam EF Emollient Foam is supplied in a 60g (NDC 16781-154-60) aluminum can.

Store between 59° and 86°F (15° and 30°C).

Protect from freezing.

Store upright.

Manufactured For:

Onset Therapeutics

Cumberland, RI 02864

www.onsettx.com

888-713-8154

PATENT PENDING
P/N 2603-pf Rev. 4

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Outer Package - 5g

NDC 16781-154-06

Rx Only


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)

For topical control of acne vulgaris, acne rosacea, and senhorrheic dermatitis

See prescribing information enclosed


LEAVE-ON

OR

WASH-OFF

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Inner Label - 5g

NDC 16781-154-06

Rx Only

Professional Sample

Not for Sale

Net Weight 5g


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)


LEAVE-ON
OR

WASH-OFF


Sample will not dispense entire contents.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Outer Package  - 60g

NDC 16781-154-60

Rx Only


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)

For topical control of acne vulgaris, acne rosacea, and senhorrheic dermatitis


LEAVE-ON

OR

WASH-OFF


Net Weight 60g

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Inner Label - 60g

NDC 16781-154-60

Rx Only


Clarifoam®™ EF Emollient Foam

Sodium Sulfactetamide (10%), Sulfur (5%)


Net Weight 60g

Clarifoam EF  sulfur,sulfacetamide sodium  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16781-154 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (SULFUR) SULFUR 5 g  in 100 g SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 10 g  in 100 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   CETYL ALCOHOL   LACTIC ACID   METHYLPARABEN   PROPYLPARABEN   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 16781-154-06 5 g In 1 CAN None 2 16781-154-11 10 g In 1 CAN None 3 16781-154-60 60 g In 1 CAN None 4 16781-154-96 100 g In 1 CAN None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/01/2007

Labeler - Onset Dermatologics LLC (793223707)

Registrant - Onset Dermatologics LLC (964275155)

Establishment
Name	Address	ID/FEI	Operations
Onset Dermatologics LLC		793223707	Manufacture

Revised: 06/2011Onset Dermatologics LLC

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AeroBid

Generic Name: flunisolide inhalation (flew NISS oh lide)

Brand Names: AeroBid, AeroBid-M

What is AeroBid (flunisolide inhalation)?

Flunisolide is a steroid. It prevents the release of substances in the body that cause inflammation.

Flunisolide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Flunisolide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about AeroBid (flunisolide inhalation)?

Do not use flunisolide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

What should I discuss with my healthcare provider before using AeroBid (flunisolide inhalation)?

Before using this medication, tell your doctor if you have been sick or had an infection of any kind (especially tuberculosis). You may not be able to use flunisolide inhalation until you are well.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether flunisolide passes into breast milk or if it could harm a nursing baby. Do not use flunisolide inhalation without telling your doctor if you are breast-feeding a baby.

Flunisolide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child younger than 5 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

How should I use AeroBid (flunisolide inhalation)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Flunisolide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use flunisolide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using flunisolide inhalation. Do not swallow.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

It is important to use flunisolide inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Contact your doctor if your asthma symptoms do not improve after using flunisolide inhalation for 4 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to flunisolide inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. Store flunisolide inhalation at room temperature away from moisture and heat. Keep the medicine canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of flunisolide inhalation is not expected to produce life-threatening symptoms.

What should I avoid while using AeroBid (flunisolide inhalation)?

Steroid medication can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. Avoid being near people who are sick or have infections. Contact your doctor if you have been exposed to someone with measles or chicken pox.

AeroBid (flunisolide inhalation) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  weakness, tired feeling, nausea, loss of appetite, weight loss;

  
  


• 
  

  fast or pounding heartbeats, pain or fluttering in your chest;

  
  


• 
  

  wheezing or breathing problems after using this medication;

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);

  
  


• 
  

  worsening asthma symptoms.

  
  

Less serious side effects may include:

• 
  

  nausea, diarrhea, upset stomach;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  dryness in your mouth, nose, or throat;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  stuffy nose, sinus pain, sore throat, cough; or

  
  


• 
  

  hoarseness or deepened voice.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect AeroBid (flunisolide inhalation)?

There may be other drugs that can interact with flunisolide inhalation. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More AeroBid resources

• AeroBid Side Effects (in more detail)
• AeroBid Use in Pregnancy & Breastfeeding
• AeroBid Drug Interactions
• AeroBid Support Group
• 1 Review for AeroBid - Add your own review/rating

• AeroBid Monograph (AHFS DI)


• Flunisolide Prescribing Information (FDA)


• Flunisolide Professional Patient Advice (Wolters Kluwer)


• Aerobid Aerosol Inhaler MedFacts Consumer Leaflet (Wolters Kluwer)


• Aerobid Prescribing Information (FDA)

Compare AeroBid with other medications

• Asthma

Where can I get more information?

• Your pharmacist can provide more information about flunisolide inhalation.

See also: AeroBid side effects (in more detail)