Qvar

• TEVA Pharmaceuticals USA Inc.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Drugs in the same class as Qvar are secreted in human milk. Because of the potential for serious harm in nursing infants from QVAR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Use Qvar exactly as prescribed.

Qvar comes in an aerosol inhaler form and typically is taken twice a day. It may take up to 2 weeks for Qvar to reach its full effectiveness.

Patients should be instructed on the proper use of their inhaler. Ask your doctor and/or pharmacist on the proper use of Qvar inhaler.

Make sure to rinse your mouth after using Qvar. 

If you miss a dose by several hours, skip the missed dose and take your next dose at the regular time. Do not take two doses of Qvar at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your physician recommends may be based on the following:

• The condition being treated
• Other medical conditions you have
• Other medications you are taking
• Previous treatment
• How you respond to this medication
• Your age

Adults and Adolescents: The recommended dose range of Qvar is 40 to 320 mcg taken twice daily, and will depend on previous treatments.

Children 5 to 11 years: The recommended dose range of Qvar is 40 to 80 mcg taken twice daily, and will depend on previous treatments.

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 this medicine.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medication;

• 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; or

• signs of low adrenal gland hormones--worsening tiredness, lack of energy, weakness, feeling light-headed, nausea, vomiting.

Common side effects may include:

• headache;

• sore throat; or

• irritation in your nose or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with beclomethasone inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

• It is used to treat asthma.
• Do not use Qvar (beclomethasone (oral inhalation)) to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Redness or white patches in mouth or throat.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped Qvar (beclomethasone (oral inhalation)).
• Change in eyesight.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using this medicine, use a rescue inhaler and get medical help right away.

QVAR is a pressurized, metered-dose aerosol with a dose counter intended for oral inhalation containing beclomethasone dipropionate in the following 2 strengths:

QVAR 40 mcg is supplied in an aluminum canister with a beige plastic actuator with a dose counter and a gray dust cap. Each actuation delivers 50 mcg of beclomethasone dipropionate from the valve and 40 mcg from the actuator. QVAR 40 mcg is available as a 120-inhalation/8.7 g canister.

QVAR 80 mcg is supplied in an aluminum canister with a dark mauve plastic actuator with a dose counter and a gray dust cap. Each actuation delivers 100 mcg of beclomethasone dipropionate from the valve and 80 mcg from the actuator. QVAR 80 mcg is available as a 120-inhalation/8.7 g canister.

Click here to enter Warnings and Precautions

Local Effects

Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving QVAR. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with QVAR therapy, but at times therapy with QVAR may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised.

Deterioration of Asthma and Acute Episodes

QVAR is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta-2 agonist, not QVAR, should be used to relieve acute symptoms such as shortness of breath. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with QVAR. During such episodes, patients may require therapy with oral corticosteroids.

Transferring Patients from Systemic Corticosteroid Therapy

Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infections (particularly gastroenteritis) or other conditions with severe electrolyte loss. Although QVAR may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid that is necessary for coping with these emergencies.

During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physician for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack.

Patients requiring oral or other systemic corticosteroids should be weaned slowly from oral or other systemic corticosteroid use after transferring to QVAR. Lung function (FEV1 or PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral or other systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to QVAR may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions.

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function.

Immunosuppression

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. It is not known how the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection. Nor is the contribution of the underlying disease and/or prior corticosteroid treatment known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.

Paradoxical Bronchospasm

Inhaled corticosteroids may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs following dosing with QVAR, it should be treated immediately with an inhaled, short-acting bronchodilator. Treatment with QVAR should be discontinued and alternate therapy instituted.

Immediate Hypersensitivity Reactions

Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of QVAR. Discontinue QVAR if such reactions occur [see Contraindications (4.2)]

Hypercorticism and Adrenal Suppression

QVAR will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since beclomethasone dipropionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of QVAR in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with QVAR should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when beclomethasone dipropionate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of QVAR should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

Effects on Growth

Orally inhaled corticosteroids, including QVAR, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving QVAR routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including QVAR, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care.

Eye Disorders

Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the use of long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts while using QVAR.

How Supplied

QVAR is supplied in 2 strengths:

QVAR 40 mcg is supplied in a box of one 8.7 g canister containing 120 actuations with a beige plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 59310-202-12.

QVAR 80 mcg is supplied in a box of one 8.7 g canister containing 120 actuations with a dark mauve plastic actuator with a dose counter and gray dust cap, and Patient Information and Instructions for Use; box of one; 120 Actuations – NDC 59310-204-12.

The correct amount of medication in each inhalation cannot be assured after 120 actuations from the 8.7 g canister even though the canister is not completely empty. Patients should be informed to discard the QVAR inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

Storage and Handling

Store at 25ºC (77ºF).

Excursions between 15º and 30ºC (59º and 86ºF) are permitted (see USP Controlled Room Temperature). For optimal results, the canister should be at room temperature when used. QVAR Inhalation Aerosol canister should only be used with the QVAR Inhalation Aerosol actuator and the actuator should not be used with any other inhalation drug product.

Store QVAR Inhalation Aerosol when not being used, so that the product rests on the concave end of the canister with plastic actuator on top.

CONTENTS UNDER PRESSURE

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49ºC (120ºF) may cause bursting. Never throw container into fire or incinerator.

Keep out of reach of children.

QVAR®40mcg Inhalation Aerosol, 120 Metered Inhalations Carton Text

NDC 59310-202-12

With Dose

Counter

QVAR®40mcg

(beclomethasone

dipropionate HFA, 40mcg

INHALATION AEROSOL

For Oral Inhalation with

QVAR® Actuator Only

Discard inhaler when dose counter reaches 0 or

after the expiration date on the product, whichever

comes first.

120

Metered

Inhalations

TEVA Respiratory

8.7g Net Contents

Applies to beclomethasone: inhalation aerosol liquid, inhalation aerosol powder, inhalation capsule, inhalation spray

Along with its needed effects, beclomethasone (the active ingredient contained in Qvar) 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 while taking beclomethasone:

• 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

• 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 or vomiting
• painful or difficult urination
• skin rash
• sore mouth or tongue
• tearing
• thoughts of killing oneself
• unusual tiredness or weakness
• white patches in the mouth or on the tongue

Some side effects of beclomethasone 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:

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