Oral budesonide is used to treat the following conditions with inflammation as a symptom:

• Eosinophilic esophagitis (EoE) in adults and children 11 years and older for up to 12 weeks (Eohilia [budesonide oral suspension 2 mg/10 mL])
• Active, mild to moderate Crohn’s disease (CD) that involves the ileum and/or ascending colon in adults and children 8 years and older who weigh at least 55 pounds (25 kg). Also used in adults for up to 3 months to maintain clinical remission in CD (Entocort EC, generic, and Ortikos [budesonide extended-release capsules 3 mg, 6 mg, 9 mg])
• Active, mild to moderate ulcerative colitis in adults, to help induce remission (Uceris and generic [budesonide extended-release tablets 9 mg])
• Primary immunoglobulin A nephropathy (IgAN) to reduce the loss of kidney function in those who are at risk for disease progression (Tarpeyo [budesonide delayed release capsules 4 mg])

Budesonide works by preventing the activation of inflammatory cells (such as mast cells, eosinophils, and neutrophils) and blocking inflammatory mediators such as histamine and cytokines, which are involved in allergic responses. Exactly how it works for EoE is not fully understood, but inflammation plays a key role in EoE development. It belongs to the drug class called corticosteroids.

Budesonide is a potent anti-inflammatory corticosteroid, 200 times stronger than cortisol and 15 times stronger than prednisolone. It has high glucocorticoid effects (strong effects on inflammation, immune system, wound healing, and intermediary metabolism) and weak mineralocorticoid effects (less effects on water, salt, and mineral metabolism).

Budesonide oral FDA approvals are as follows:

• Eohilia (budesonide oral suspension 2 mg/10 mL; February 9, 2024). No generic.
• Entocort EC (budesonide extended-release capsule 3 mg; October 2, 2001). Generic available.
• Ortikos (budesonide extended-release capsule 6 mg, 9 mg; June 13, 2019 [discontinued]).  
• Uceris (budesonide extended-release tablet 9 mg; January 14, 2013). Generic available.
• Tarpeyo (budesonide delayed-release capsule 4 mg; December 15, 2021). No generic. 

Budesonide side effects

The most common side effects of budesonide oral suspension (Eohilia) are:

• respiratory tract infection
• sore throat
• fungal infections of the mouth, throat, and esophagus (thrush)
• adrenal suppression
• headache
• acid-related damage to the lining of the esophagus (erosive esophagitis)
• infection of the stomach and intestine (gastroenteritis).

The most common side effects of budesonide extended-release capsules (Entocort EC, Ortikos, generic) are:

• headache
• infection in your air passages (respiratory infection)
• nausea
• back pain
• indigestion 
• dizziness
• stomach area (abdominal) pain
• gas
• vomiting
• tiredness
• pain.

The most common side effects of budesonide delayed-release capsules (Tarpeyo) are:

• swelling of the lower legs, ankles, and feet
• high blood pressure
• muscle spasms
• acne
• headache
• upper respiratory tract infection
• swelling of the face
• weight increase
• indigestion
• irritation or inflammation of the skin
• joint pain
•  increased white blood cell count

The most common side effects of budesonide extended release tablets (Uceris, generic) are:

• headache
• nausea
• decreased blood cortisol levels
• stomach-area pain
• tiredness
• stomach or intestinal gas
• bloating
• acne
• urinary tract infection
• joint pain
• constipation.

Serious side effects and warnings

Budesonide (oral) may cause the following serious side effects:

• Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of budesonide may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms:
  • acne
  • thicker body hair and facial hair
  • bruise easily
  • a fatty pad or hump between your shoulders (buffalo hump)
  • rounding of your face
  • pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms
  • ankle swelling.
• Adrenal suppression. Long-term use of budesonide can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms:
  • tiredness
  • nausea and vomiting
  • weakness
  • low blood pressure.
• Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including budesonide, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including budesonide, can also:
  • make current infections worse
  • increase the risk of infections spreading (disseminated)
  • increase the risk of making infections active again or making infections worse that have not been active (latent)
  • hide (mask) some signs of infection

These infections can be mild, but can also be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking budesonide. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking budesonide, including flu-like symptoms such as:

• • fever
  • cough
  • chills
  • pain
  • stomach area (abdominal) pain
  • feeling tired
  • aches 
  • nausea and vomiting
  • diarrhea.
• Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking budesonide. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking budesonide.
• Chicken pox and measles: People taking corticosteroid medicines, including budesonide, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
• Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking budesonide. Your healthcare provider will test you for HBV before you start taking budesonide.
• Amebiasis: Inactive (latent) amebiasis may become an active infection while taking budesonide. Your healthcare provider should check you for amebiasis before you start taking budesonide if you have spent time in the tropics or have unexplained symptoms.
• Fungal infections of the mouth (thrush), throat, and esophagus in patients using budesonide may occur. Symptoms of infection include
  • white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or
  • swallowing, loss of taste, and a feeling like cotton is in your mouth. Tell your healthcare provider if any of the above symptoms occur.
• Erosive esophagitis. Budesonide can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms such as:
  • heartburn
  • chest pain
  • trouble swallowing.
• Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking budesonide.
• Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking budesonide.
• Kaposi’s sarcoma: Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use budesonide if you are allergic to budesonide, Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC, or any of the excipients in oral budesonide products.

Before you take budesonide tell your healthcare provider if you have any other medical conditions including if you:

• have liver problems
• are planning to have surgery
• have chicken pox or measles, or have recently been near anyone with chicken pox or measles
• have certain kinds of infections that have not been treated, including fungal infections, bacterial infections, and viral infections
• parasitic infections, including threadworm (Strongyloides) infections
• herpes simplex infection of the eye (ocular herpes simplex)
• have or had tuberculosis
• have malaria of the brain (cerebral malaria)
• have an infection of the mouth, throat, or esophagus
• have diabetes or glaucoma, or have a family history of diabetes or glaucoma
• have cataracts
• have high blood pressure (hypertension)
• have low bone mineral density or osteoporosis
• have stomach ulcers
• have a weak immune system
• have unexplained diarrhea
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.

Pregnancy

Budesonide may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take budesonide when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with budesonide.

Breastfeeding

It is not known if budesonide passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take budesonide.

The Tarpeyo Prescribing information recommends routine monitoring of linear growth in infants with long-term use of budesonide in women who are breastfeeding.

How should I take budesonide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

How you take budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension

Eohilia stick packs

See the detailed Instructions for Use that comes with Eohilia for information about how to prepare and take Eohilia and how to properly store and throw away (dispose of) used Eohilia stick packs. Take Eohilia exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Eohilia to take.

• Eohilia is taken 2 times a day (1 time in the morning and 1 time in the evening).
• Shake the stick pack for at least 10 seconds before opening. After opening the top, squeeze the stick pack from bottom to top to dispense contents directly into the mouth.
• Repeat this 2 to 3 times until the stick pack is empty. Swallow all of the suspension and avoid eating or drinking anything for 30 minutes.
• After 30 minutes, rinse your mouth with water and spit out the contents without swallowing.

Do not mix Eohilia with food or liquid.

Do not eat or drink at the same time as taking Eohilia. Wait to eat or drink at least 30 minutes after taking Eohilia.

Your healthcare provider may change your dose if needed. Do not change your dose or stop taking Eohilia unless your healthcare provider tells you.

Budesonide extended-release capsules

Entocort EC extended-release capsules and generic

Take Entocort EC exactly as your healthcare provider tells you. Your healthcare provider will tell you how many Entocort EC capsules to take. Your healthcare provider may change your dose if needed.

• Take Entocort EC 1 time each day in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

For patients unable to swallow a whole capsule, Entocort EC capsules can be opened and administered as follows:

1. Place 1 tablespoonful of applesauce into a clean container, such as an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2. Open the capsule. You may need to use more than 1 Entocort EC capsule for the dose prescribed by your healthcare provider.
3. Carefully empty all of the granules inside the capsule on the applesauce.
4. Stir the granules with the applesauce.
5. Swallow the applesauce and granules mixture within 30 minutes after preparing it. Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to help with complete swallowing of the granules. Do not chew or crush the granules.
6. Do not save the applesauce and granules for later use.

Ortikos extended-release capsules

Take Ortikos exactly as your healthcare provider tells you. Your healthcare provider will tell you how many capsules to take. Your healthcare provider may change your dose if needed.

• Take Ortikos 1 time each day, in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

Budesonide extended-release tablets

Uceris extended-release tablets and generic

Take Uceris extended-release tablets exactly as your healthcare provider tells you to take them.

• Take Uceris 1 time each day in the morning with or without food.
• Swallow the tablets whole with water. Do not chew, crush, or break the tablets before swallowing.

Budesonide delayed-release capsules

Tarpeyo delayed-release capsules

Take Tarpeyo exactly as your healthcare provider tells you. Your healthcare provider will decide how long you should take Tarpeyo. Do not stop taking Tarpeyo without first talking with your healthcare provider.

• Take Tarpeyo 1 time each day in the morning, at least 1 hour before a meal.
• Swallow Tarpeyo capsules whole. Do not open, chew, crush, or break Tarpeyo capsules before swallowing.

Dosing information

The dosage of budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension 2 mg/10 mL

Dosage for EOS (Eohilia): 2 mg twice daily for 12 weeks.

• 2mg is contained in one Eohilia stick pack.

Budesonide extended-release capsules

Dosage for the treatment of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 9 mg once daily for up to 8 weeks
• Repeat 8-week courses with recurring episodes of active disease
• Children 8 through 17 years (weight > 25 kg): 9 mg once daily for up to 8 weeks followed by 6 mg once daily for 2 weeks.

Dosage for the maintenance of clinical remission of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 6 mg once daily for up to 3 months.
• Taper to complete cessation after 3 months.
• Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
• When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating Ortikos.

Budesonide delayed-release tablets 

Dosage for ulcerative colitis (Uceris, generic)

• 9 mg once daily in the morning with or without food for up to 8 weeks.

Budesonide delayed-release capsules

Dosage for the treatment of IgAN in adults (Tarpeyo)

• 16 mg once daily
• Take in the morning at least 1 hour before food.
• The recommended duration of therapy is 9 months.
• When discontinuing, reduce the dosage to 8 mg once daily for the last 2 weeks.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

If you take budesonide for primary immunoglobulin A nephropathy, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I take too much budesonide?

If you take too much budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking budesonide?

Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.

Avoid receiving a “live” vaccine and being near people who are sick or have infections. The vaccine may not work as well while you are using budesonide. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Also call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using budesonide.

What other drugs will affect budesonide?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially if you use stomach acid reducers.

This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Eohilia: Store between 36°F to 77°F (2°C to 25°C). May be refrigerated. Do not freeze.

Entocort EC and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C).

Ortikos: Store at room temperature between 68° to 77°F (20° to 25°C). Keep in a tightly closed container.

Uceris and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Tarpeyo: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Keep all medicines out of the reach of children.

Ingredients

Eohilia ingredients

Active ingredient: budesonide

Inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Entocort EC ingredients

Active ingredient: budesonide

Inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres.

The capsule shell contains: gelatin, iron oxide, and titanium dioxide.

Ortikos ingredients

Active ingredient: budesonide

Inactive ingredients: acetyl tributyl citrate, corn starch, ethylcellulose aqueous dispersion, methacrylic acid and ethyl acrylate copolymer dispersion, polysorbate 80, simethicone emulsion, sucrose, talc, and triethyl citrate.

Capsule shell contains gelatin, iron oxide black (for 6 mg), iron oxide red, iron oxide yellow, sodium lauryl sulphate, and titanium dioxide.

The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.

Uceris ingredients

Active Ingredient: budesonide

Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

Tarpeyo ingredients

Active ingredient: budesonide

Inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid.

The capsules contain: hypromellose and titanium oxide (E171).

The printing ink on the capsules contains: shellac, propylene glycol and black iron oxide (E172).

The enteric coating on the capsules contains: methacrylic acid and methacrylate copolymer, talc and dibutyl sebacate.

Who makes budesonide?

Budesonide is made by various manufacturers.

Budesonide oral suspension (2 mg/10 mL, Eohilia) is made by Takeda Pharmaceuticals America, Inc., in Lexington, MA.

Budesonide extended-release oral capsules (3 mg, Entocort EC brand) are made by Perrigo. They acquired the rights to this medication from AstraZeneca in 2015. Perrigo is headquartered in Dublin, Ireland, with U.S. operations based in Michigan, USA.

• A generic Entocort 3mg delayed-release oral capsule 3 mg is available manufactured by Aurobindo Pharma USA, Zydus Pharma, Amneal Pharma, Dr Reddys Labs SA, and Rising.

Budesonide extended-release oral capsules (6 mg, 9 mg, Ortikos brand) were made by Sun Pharmaceutical Industries Ltd., in Gujarat, India.

Budesonide extended-release oral tablets (9 mg, Uceris brand) are made by Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals). Salix Pharmaceuticals is the specific division or subsidiary of Bausch Health Companies that markets and distributes Uceris tablets.

• A generic Uceris extended-release oral tablet 9 mg is made by Actavis Labs FL Inc., and Mylan.

Budesonide delayed release capsules (4mg, Tarpeyo) are made by Calliditas Therapeutics AB, with headquarters in Stockholm, Sweden.

Introduction

Corticosteroid secreted by the adrenal cortex; topical anti-inflammatory agent.

Uses for Hydrocortisone (Topical)

Corticosteroid-responsive Dermatoses

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Nonprescription preparations used for temporary relief of minor skin irritations, itching, and rash caused by eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, or jewelry.

Nonprescription preparations used for temporary relief of itchy anal and/or genital areas.

Nonprescription preparations used for temporary relief of itching and minor scalp irritation caused by scalp dermatitis.

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)

Response may vary from one topical corticosteroid preparation to another.

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.

Infected Dermatoses

Topical treatment of infected dermatoses in combination with topical anti-infectives (e.g., neomycin, polymyxin B) or antifungals.

If a topical corticosteroid is used in combination with a topical anti-infective, weigh benefits against risks.

Oral Lesions

Hydrocortisone acetate paste used as an adjunct for temporary symptomatic relief of oral inflammatory or ulcerative lesions resulting from trauma.

Ulcerative Colitis and Anorectal Disorders

Used rectally as a retention enema for adjunctive treatment of mild or moderate acute ulcerative colitis limited to the rectosigmoid or left colon.

Used rectally as a retention enema for mild acute ulcerative colitis of the transverse or descending colon.

Retention enema usually is effective in mild or moderate acute rectosigmoid ulcerative colitis when response to sulfasalazine (generally considered the maintenance drug of choice) is inadequate or when sulfasalazine cannot be given.

Systemic corticosteroids and/or corticosteroid enemas are more effective than sulfasalazine in acute ulcerative colitis attacks, but if surgery is required, it should not be delayed in favor of corticosteroid therapy.

Hydrocortisone acetate rectal suppositories or suspension (foam), may be effective as adjunctive treatment of rectal ulcerative colitis.

Hydrocortisone acetate rectal suppositories also are used in the treatment of other anorectal inflammatory conditions (e.g., inflamed hemorrhoids, postirradiation or factitial proctitis, cryptitis, pruritus ani).

Fixed-combination preparations of a corticosteroid and local anesthetic may be useful for symptomatic relief of anorectal conditions (e.g., hemorrhoids), but combinations with antihistamines, astringents, keratolytics, and/or vasoconstrictors are of questionable efficacy.

Hydrocortisone (Topical) Dosage and Administration

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.
• Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.
• Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin). Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.
• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercial preparations with another vehicle may decrease effectiveness.
• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol). (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.

Apply creams, lotions, ointments, solutions, and aerosol foams topically to the skin or scalp.

Apply paste topically inside the oral cavity.

Apply rectal creams and ointments externally to the anal area; some commercially available creams also may be applied externally to the anogenital areas.

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.

Apply cream, lotion, ointment, or solution sparingly in a thin film and rub gently into affected area.

For scalp dermatoses, part the hair and apply small amount of lotion or solution directly to the affected area; rub gently into scalp. Maintain usual hair care, but do not wash out lotion immediately after application. Alternatively, for scalp dermatoses, apply aerosol to dry scalp after shampooing.

To dispense foam, shake container well (for 5–10 seconds) immediately prior to use. Hold container upright and press down on container cap until foam appears. Apply a small amount to affected area.

For use in the mouth, press a small amount of paste to the lesion without rubbing until a thin film develops.

After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.

Administration with Occlusive Dressing

Occlusive dressings may be used for severe or resistant dermatoses (e.g., psoriasis). (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream, lotion, or ointment; rub gently into the lesion; and apply another thin film. Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape. For added moisture in dry lesions, apply cream, ointment, or lotion and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.

Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed. Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion. (See Occlusive Dressings under Cautions.)

Rectal Administration

Administer rectally as a retention enema, suppository, or aerosol foam.

Administer retention enema, suppository, or foam carefully according to manufacturer’s instructions.

Dosage

Available as hydrocortisone (dosage expressed in terms of the base) and as hydrocortisone acetate, buteprate, butyrate, and valerate (dosage expressed in terms of the salt).

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy.

Corticosteroid-responsive Dermatoses

Topical

Nonprescription hydrocortisone preparations should not be used in children <2 years of age unless directed and supervised by a clinician.

Children ≥2 years of age: Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.

Adults

Corticosteroid-responsive Dermatoses

Topical

Apply appropriate cream, lotion, ointment, or solution sparingly 1–4 times daily.

Apply aerosol foam to affected area 2–4 times daily.

Nonprescription preparations should not be used for self-medication for >7 days.

If the condition worsens or symptoms persist, discontinue and consult a clinician.

Oral Lesions

Topical

Apply a small amount of paste to the lesion 2 or 3 times daily after meals and at bedtime.

If substantial regeneration or repair of oral tissues does not occur after 7 days, further investigate etiology of the lesions.

Ulcerative Colitis and Anorectal Disorders

Rectal (as Retention Enema)

Adjunctive treatment of ulcerative colitis: 100 mg nightly. Some clinicians recommend 100 mg twice daily followed by 100 mg nightly when improvement occurs.

Usually given for 21 days or until clinical and proctologic remissions are achieved.

Lay on left side during and for 30 minutes after administration to distribute drug throughout the left colon. Retain for ≥1 hour, preferably all night.

Symptoms may improve in 3–5 days, followed by proctologic improvement. Discontinue if clinical or proctologic improvement does not occur within 2–3 weeks.

Protologic remission may require 2–3 months of therapy.

Following treatment for >21 days, gradually withdraw use; give every other night for 2–3 weeks, then discontinue.

Rectal (as Foam)

Ulcerative proctitis of the distal rectum: 90 mg (1 applicatorful of a 10% aerosol foam suspension) 1 or 2 times daily for 2–3 weeks. Then, if necessary, every other day until clinical and proctologic improvement.

Symptoms may improve within 5–7 days.

Rectal (as Suppository)

Adjunctive treatment of ulcerative colitis of the rectum and other inflammatory conditions of the anorectum: 25 mg in the morning and at night for 2 weeks.

Severe proctitis: 25 mg 3 times daily or 50 mg twice daily.

Adjunctive treatment of postirradiation or factitial proctitis: 25 mg in the morning and at night for 6–8 weeks (or less if an adequate response is attained).

For internal hemorrhoid symptoms and adjunctive treatment of other anorectal inflammatory conditions: 10 mg in the morning and at night for 2–6 days.

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses

Self-medication

Topical

Maximum 7 days.

Adults

Corticosteroid-responsive Dermatoses

Self-medication

Topical

Maximum 7 days.

Cautions for Hydrocortisone (Topical)

Contraindications

• Known hypersensitivity to hydrocortisone or any ingredient in the formulation.
• Rectal corticosteroid therapy in patients with intestinal obstruction, abscess, impending perforation, peritonitis, extensive fistulas, and fresh intestinal anastomoses or sinus tracts.

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.

General Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression.

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.

HPA-axis function recovery generally is prompt and complete following drug discontinuance.

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.

Systemic Effects

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Adverse systemic effects may occur when corticosteroids are used on large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.

Infants and children may be more susceptible to adverse systemic effects.

Local Effects

Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue; these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.

If irritation occurs, discontinue drug and initiate appropriate therapy.

Skin Infection

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy. If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation. In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.

Do not use occlusive dressings in patients with primary skin infection.

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin); however, most clinicians believe topical corticosteroids may be used with caution if the infection is treated.

Severe Ulcerative Colorectal Disease

Use rectally with caution in severe ulcerative disease and only after adequate proctologic examination; risk of intestinal perforation.

Occlusive Dressings

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly. (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy. (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.

Do not use occlusive dressings in patients with primary skin infection.

Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.

Use plastic occlusive material with care to avoid the risk of suffocation.

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether topical hydrocortisone is distributed into milk. Caution advised if topical hydrocortisone is used.

Pediatric Use

Nonprescription hydrocortisone preparations should not be used in children <2 years of age unless directed and supervised by a clinician.

Tight-fitting diapers or plastic pants should not be used on a child being treated in the diaper area, since such garments may constitute occlusive dressings.

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio, especially when topical corticosteroids are applied to >20% of body surface area. The risk of adrenal suppression appears to increase with decreasing age. (See Systemic Effects under Cautions.)

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.

Children also are at greater risk of glucocorticoid insufficiency during and/or after withdrawal of treatment.

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.

Striae has been reported in children treated inappropriately with topical corticosteroids.

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.

Common Adverse Effects

Burning, stinging, itching, irritation, dry skin, erythema, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.

Drug Interactions

Specific Drugs and Laboratory Tests

Hydrocortisone (Topical) Pharmacokinetics

Absorption

Bioavailability

Percutaneous penetration of corticosteroids following topical application to the skin varies among individuals and may be increased by occlusive dressings, high corticosteroid concentrations, and certain vehicles.

Only minimal amounts of topical corticosteroid reach the dermis and subsequently the systemic circulation after application to most normal skin areas; more absorption occurs from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole.

Absorption is markedly increased by loss of the skin’s keratin layer and by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema).

Occlusive dressings used with hydrocortisone for 96 hours substantially enhance percutaneous penetration; occlusive dressings used for up to 24 hours do not appear to alter penetration.

In healthy individuals, up to 30–90% of hydrocortisone administered rectally as a retention enema may be absorbed. Greater amounts of hydrocortisone may be absorbed if the intestinal mucosa is inflamed.

Distribution

Extent

Not known whether topical hydrocortisone is distributed into milk.

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in the bile.

Stability

Storage

Topical

Creams, Lotions, Ointments, Solutions, Aerosol Foams

Room temperature; consult product information for specific recommendations.

Rectal

Creams, Suspensions for Retention Enemas, Aerosol Foams, Suppositories

Room temperature; consult product information for specific recommendations.

Actions

• Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding.
• Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.
• Anti-inflammatory effects may occur through induction of phospholipase A₂ inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids. Decreased arachidionic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).
• Decreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown.

Advice to Patients

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes. (See Topical Administration under Dosage and Administration.)
• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.
• Importance of informing parents of children receiving the drug that if hydrocortisone is applied in the diaper area, tight-fitting diapers or plastic pants should not be used since they may act as an occlusive dressing.
• Importance of reporting any local adverse reactions, especially those occurring under occlusive dressings, to a clinician.
• Potential for hydrocortisone acetate suppositories to stain fabric; take appropriate precautionary measures.
• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs; other corticosteroid-containing preparations should not be used without first consulting with clinician.
• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.
• Importance of informing patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Uses for Qvar

Beclomethasone is used to help control the symptoms of asthma and improve breathing. It is used when a patient’s asthma has not been controlled sufficiently on other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

Beclomethasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine is available only with your doctor’s prescription.

Before using Qvar

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled QVAR® inhaler in children 5 years of age and older and inhaled QVAR® Redihaler in children 4 years of age and older. Safety and efficacy have not been established in children younger than 5 years of age for QVAR® inhaler and in children younger than 4 years of age for QVAR® Redihaler.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled beclomethasone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving inhaled beclomethasone.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aspirin
• Bemiparin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.

• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, fungus, or parasite) or
• Measles or
• Tuberculosis, active or history of—Inhaled beclomethasone can reduce the body’s ability to fight off these infections.

• Immobilization for long periods of time or
• Osteoporosis, family history of—Beclomethasone may make your bones weaker and increase the chance of a broken bone after a minor fall or injury.

Proper use of Qvar

Inhaled beclomethasone is used to prevent asthma attacks. It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Inhaled beclomethasone is used with a special inhaler that comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the QVAR® inhaler or QVAR® Redihaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the QVAR® inhaler:

• Do not use the inhaler for this medicine with any other medicine. Do not remove the canister from the actuator.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• Before you use an inhaler for the first time, prime it by pointing it away from your face and spraying into the air 2 times. If the inhaler has not been used for 10 days or longer, prime it again.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
• While pressing down firmly and fully on the metal canister, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Take the inhaler out of your mouth. Hold your breath for about 10 seconds, then breathe out slowly.
• If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the next puff.
• Wipe the mouthpiece dry with a cloth or tissue. Do not wash it with water. Put the cap back on right away.
• Gargle and rinse your mouth with water after each dose.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the count is 0. You may not receive the right amount of medicine.

To use the QVAR® Redihaler:

• Take the inhaler out of the carton before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• This medicine does not require priming. Do not shake the inhaler. Do not use it with a spacer or volume holding chamber.
• Always use the inhaler in an upright position with the mouthpiece facing downwards.
• Do not open the white cap of the inhaler or leave it open unless you are ready to use it. Close the cap before each use or if it has been left open for more than 2 minutes.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• Close the white cap to prepare for the next inhalation.
• If your doctor has told you to take more than 1 inhalation per dose, make sure the cap is closed and repeat the previous steps.
• Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed. Do not wash or put any part of the inhaler in water.
• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0 after opening the carton.

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (aerosol):
  • QVAR® inhaler:
    • For preventing an asthma attack:
      • For patients who have received bronchodilators alone:
        • Adults and children 12 years of age and older—At first, one puff two times a day. Each puff contains 40 or 80 micrograms (mcg) of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
        • Children 5 to 11 years of age—At first, one puff two times a day. Each puff contains 40 mcg of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
        • Children younger than 5 years of age—Use and dose must be determined by your doctor.
      • For patients who have received inhaled corticosteroids:
        • Adults and children 12 years of age and older—At first, one to two puffs two times a day. Each puff contains 40 or 80 micrograms (mcg) of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
        • Children 5 to 11 years of age—At first, one puff two times a day. Each puff contains 40 mcg of beclomethasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
        • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • QVAR® Redihaler:
    • For preventing an asthma attack:
      • For patients who have not received inhaled corticosteroids:
        • Adults and children 12 years of age and older—At first, 40 to 80 micrograms (mcg) beclomethasone 2 times a day. The doses should be at least 12 hours apart. Your doctor may increase your dose as needed. However, the dose is usually not more than 320 mcg two times a day.
        • Children 4 to 11 years of age—At first, 40 mcg of beclomethasone 2 times a day. The doses should be at least 12 hours apart. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mcg two times a day.
        • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of QVAR® Redihaler, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Qvar

If you will be using this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

• Your or your child’s symptoms do not improve after using this medicine for 2 weeks or if they become worse.
• You or your child have a big decrease in your peak flow when measured as directed by your doctor.

Using too much of this medicine or using it for a long time may cause problems with your adrenal gland. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Follow your doctor’s directions carefully if you are switching from an oral corticosteroid to this medicine.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine. Use a short acting inhaler right away to treat your symptoms.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.

This medicine may cause children to grow more slowly than usual. Talk to your child’s doctor if you have any concerns.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of Qvar

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain
• congestion
• cough
• difficulty with breathing
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• trouble swallowing
• voice changes

Incidence not known

• Attack, assault, or force
• blindness
• blurred vision
• changes in behavior
• chills
• darkening of the skin
• decreased vision
• diarrhea
• dizziness
• eye pain
• fainting
• headache
• loss of appetite
• lower back or side pain
• mental depression
• nausea
• painful or difficult urination
• skin rash
• sore mouth or tongue
• tearing
• thoughts of killing oneself
• unusual tiredness or weakness
• vomiting
• white patches in the mouth or on the tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Cramps
• heavy bleeding
• pain
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• tightness of the chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects.

Commonly used brand name(s)

In the U.S.

• Beclovent
• Qvar
• Qvar Redihaler

Available Dosage Forms:

• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

What is Qvar Redihaler?

Beclomethasone is an inhaled steroid that is used to prevent asthma attacks in adults and children at least 4 years old.

Qvar Redihaler will not treat an asthma attack that has already begun.

Qvar Redihaler may also be used for purposes not listed in this medication guide.

Qvar Redihaler side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Beclomethasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using Qvar Redihaler.

Qvar Redihaler may cause serious side effects. Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• worsening asthma symptoms;
• white patches or sores inside your mouth or on your lips;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• signs of infection–fever, chills, body aches, vomiting;
• signs of low adrenal gland hormones–worsening tiredness, lack of energy, weakness, feeling light-headed, nausea, vomiting; or
• increased adrenal gland hormones–hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes.

Common side effects of Qvar Redihaler may include:

• a yeast infection in the mouth;
• sinus pain, irritation in your nose; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Before taking this medicine

You should not use beclomethasone if you are allergic to it.

Tell your doctor if you have ever had:

• any type of bacterial, fungal, or viral infection;
• tuberculosis;
• herpes infection of the eyes;
• osteoporosis, or low bone mineral density;
• a weak immune system; or
• cataracts, glaucoma, or increased pressure inside your eyes.

Tell your doctor if you are pregnant or breastfeeding.

How should I use Qvar Redihaler?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Qvar Redihaler is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read and carefully follow any instructions for using Qvar Redihaler, priming the inhaler device, and cleaning the device. Ask your doctor or pharmacist if you do not understand these instructions.

Do not allow a young child to use this medicine without help from an adult.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor’s instructions about tapering your dose.

To reduce the chance of developing a yeast infection in your mouth, rinse with water (but do not swallow) after using Qvar Redihaler.

It may take up to 4 weeks or longer before your symptoms improve. Keep using the medicine and call your doctor if your symptoms do not begin to improve after 2 weeks.

You should not stop using Qvar Redihaler suddenly. Stopping suddenly may make your condition worse.

Use all asthma medications as directed. Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your dose or stop using a medicine without your doctor’s advice. Tell your doctor if any of your medicines seem to stop working.

Store at room temperature away from moisture and heat. Keep the cover on your inhaler when not in use. Keep away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Throw away the inhaler device when the inhalations counter shows “0” or the expiration date on the label has passed. Get your prescription refilled before you run out of medicine completely.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Qvar Redihaler?

Rinse with water if Qvar Redihaler gets in your eyes.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medication.