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Flovent for Dogs & Cats - HFA 220 mcg - [Asthma Treatment]

Flovent for Dogs & Cats - HFA 220 mcg - [Asthma Treatment]

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Recurring Saings in EprxAUTOSHIP & SAVE[Details]
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Description

Flovent HFA is used to treat asthma and helps to prevent symptoms of asthma. Flovent HFA contains a medicine called fluticasone propionate, which is a synthetic corticosteriod. Corticosteroids are nautral substances found in the body to help fight inflammation. Flovent helps reduce airway inflammation, an underlying cause of asthma symptoms.

Key Benefits

  • Treats chronic bronchitis in dogs and cats and chronic feline asthma and sinusitis
  • Flovent has no demonstrated side effects
  • Most effective when used with the AeroKat or AeroDawg Aerosol Chambers

Flovent HFA (fluticasone) is an inhaled aerosol steroid that is proven effective in humans, as well as cats and dogs suffering from chronic asthma or bronchitis. Your veterinarian can choose from three different strengths of Flovent for your pet. A built-in dose counter on the canister makes it easy to track the number of doses left. Using special feline and canine aerosol masks (sold separately) helps ensure that your pet receives the full dose of Flovent.

How It Works

Flovent helps reduce swelling and irritation in the airways of the lung so your dog or cat can breathe easier. The active ingredient in Flovent HFA (Fluticasone) is a corticosteroid that’s proven to reduce inflammation, a major cause of constricted, difficult breathing.

Indications

  • Maintenance treatment of asthma as prophylactic therapy in patients
  • Teatment of asthma in patients requiring oral corticosteroid therapy.
  • Not indicated for the relief of acute bronchospasm

Directions

View Floven HFA Drug Facts Sheet.

FLOVENT HFA should be administered by the orally inhaled route only in patients aged 4 years and older. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.

After asthma stability has been achieved, it is always desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The safety and efficacy of FLOVENT HFA when administered in excess of recommended dosages have not been established.

The recommended starting dosage and the highest recommended dosage of FLOVENT HFA, based on prior asthma therapy, are listed in Table 1.

Recommended Dosages of FLOVENT HFA Inhalation Aerosol

NOTE: In all patients, it is desirable to titrate to the lowest effective dosage once asthma stability is achieved.

Previous Therapy Recommended Starting Dosage Highest Recommended Dosage
Adult and adolescent patients (aged 12 yearsand older)
Bronchodilators alone 88 mcg twice daily 440 mcg twice daily
Inhaled corticosteroids 88-220 mcg twice dailya 440 mcg twice daily
Oral corticosteroidsb 440 mcg twice daily 880 mcg twice daily
Pediatric patients (aged 4-11 years)c 88 mcg twice daily 88 mcg twice daily

a Starting dosages above 88 mcg twice daily may be considered for patients with poorer asthma control or those who have previously required doses of inhaled corticosteroids that are in the higher range for the specific agent.

b For patients currently receiving chronic oral corticosteroid therapy, prednisone should be reduced no faster than 2.5 to 5 mg/day on a weekly basis beginning after at least 1 week of therapy with FLOVENT HFA. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency [see Warnings and Precautions (5.4)]. Once prednisone reduction is complete, the dosage of FLOVENT HFA should be reduced to the lowest effective dosage.

c Recommended pediatric dosage is 88 mcg twice daily regardless of prior therapy. A valved holding chamber and mask may be used to deliver FLOVENT HFA to young patients.

Prime FLOVENT HFA before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds and releasing 1 spray into the air away from the face.

Dosage forms and Strengths

Inhalation Aerosol. Dark orange plastic inhaler with a peach strapcap containing a pressurized metered-dose aerosol canister containing 120 metered inhalations and fitted with a counter. Each actuation delivers 44, 110, or 220 mcg of fluticasone propionate from the mouthpiece.

Cautions

Keep out of reach of children and pets. Store at room temperature. Shake product well before use.

Contraindications

  • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.
  • Hypersensitivity to any ingredient.

Warnings & Precautions

  • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
  • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to FLOVENT HFA.
  • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue FLOVENT HFA slowly.
  • Assess for decrease in bone mineral density initially and periodically thereafter.
  • Monitor growth of pediatric patients.
  • Close monitoring for glaucoma and cataracts is warranted.

Adverse Reactions

Most common adverse reactions (incidence greater than 3%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FAQ

FLOVENT HFA is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in people aged 4 years and older.

  • ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • FLOVENT HFA is not used to relieve sudden breathing problems.
  • It is not known if FLOVENT HFA is safe and effective in children younger than 4 years of age.

Do not use FLOVENT HFA:

  • to relieve sudden breathing problems
  • if you are allergic to fluticasone propionate or any of the ingredients in FLOVENT HFA. See "What are the ingredients in FLOVENT HFA?" below for a complete list of ingredients.

Tell your healthcare provider about all of your health conditions, including if you:

  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in FLOVENT HFA or any other medicines. See "What are the ingredients in FLOVENT HFA?" below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if FLOVENT HFA may harm your unborn baby.
  • are breastfeeding. It is not known if the medicine in FLOVENT HFA passes into your milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FLOVENT HFA and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you takeantifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Read the step-by-step instructions for using FLOVENT HFA at the end of this Patient Information.

  • Do not use FLOVENT HFA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use FLOVENT HFA with an adult's help, as instructed by the child's healthcare provider.
  • FLOVENT HFA comes in 3 different strengths. Your healthcare provider has prescribed the strength that is best for you.
  • Use FLOVENT HFA exactly as your healthcare provider tells you to use it. Do notuse FLOVENT HFA more often than prescribed.
  • It may take 1 to 2 weeks or longer after you start FLOVENT HFA for your asthma symptoms to get better. You must use FLOVENT HFA regularly.
  • Do not stop using FLOVENT HFA, even if you are feeling better, unless your healthcare provider tells you to.
  • Talk to your healthcare provider right away if you stop using FLOVENT HFA.
  • If you miss a dose of FLOVENT HFA, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT HFA does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

FLOVENT HFA can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT HFA to help reduce your chance of getting thrush.
  • weakened immune system and increased chance of getting infections (immunosuppression).
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as FLOVENT HFA). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
    • feeling tired
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of your face, mouth, and tongue
    • breathing problems
  • bone thinning or weakness (osteoporosis).
  • slowed growth in children. A child's growth should be checked often.
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using FLOVENT HFA.
  • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT HFA. Always have a rescue inhaler with you to treat sudden wheezing.

Common side effects of FLOVENT HFA include:

  • a cold or upper respiratory tract infection
  • throat irritation
  • headache
  • fever
  • diarrhea
  • ear infection

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with FLOVENT HFA. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  • Store FLOVENT HFA at room temperature between 68°F and 77°F (20°C and 25°C) with the mouthpiece down.
  • The contents of your FLOVENT HFA inhaler are under pressure. Do not puncture. Do not use or store near heat or open flame. Temperatures above 120°F may cause the canister to burst.
  • Do not throw into fire or an incinerator.
  • Safely throw away FLOVENT HFA in the trash when the counter reads 000.
  • Keep FLOVENT HFA and all medicines out of the reach of children.

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