QVAR


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basiliximab

SimulectAeroBec (UK), Apo-Beclomethasone (CA), Asmabec (UK), Beclodisk (CA) (UK), Becloforte (CA) (UK), Beconase AQ Nasal Spray, Filair (UK), Hayfever Relief (UK), Nasobec (UK), Pollenase Nasal (UK), QVAR, Rivanase (CA)

Pharmacologic class: Monoclonal antibody

Therapeutic class: Immunosuppressant

Pregnancy risk category B

Pharmacologic class: Corticosteroid

Therapeutic class: Anti-inflammatory agent

Pregnancy risk category C

FDA Box Warning

• Give under supervision of physician experienced in immunosuppressive therapy and management of organ transplant recipients, in facility with adequate diagnostic and treatment resources.

Action

Blocks specific interleukin-2 (IL-2) receptor sites on activated T lymphocytes. Specific binding competitively inhibits IL-2-mediated activation and differentiation of lymphocytes responsible for cell-mediated immunity. Also impairs immunologic response to antigenic challenges.

Availability

Powder for injection: 10 mg, 20 mg in single-use vials

Indications and dosages

Prevention of acute organ rejection in kidney transplantation

Adults and children weighing 35 kg (77 lb) or more: 20 mg I.V. 2 hours before transplantation surgery, then 20 mg I.V. 4 days after surgery. Withhold second dose if complications, hyper-sensitivity reaction, or graft loss occurs.

Children weighing less than 35 kg (77 lb): 10 mg I.V. 2 hours before transplantation surgery, then 10 mg I.V. 4 days after surgery. Withhold second dose if complications, hypersensitivity reaction, or graft loss occurs.

Contraindications

• Hypersensitivity to drug
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• elderly patients
• females of childbearing age.

Administration

Give by central or peripheral I.V. route only.
• Reconstitute by adding 5 ml of sterile water for injection to vial for bolus injection, or dilute with normal saline solution or dextrose 5% in water to a volume of 50 ml and infuse over 20 to 30 minutes. Discard any remaining product after preparing each dose.
• Don't infuse other drugs simultaneously through same I.V. line.
• Know that drug should be used only as part of regimen that includes cyclosporine and corticosteroids.

Adverse reactions

CNS: headache, insomnia, paresthesia, dizziness, drowsiness, tremor, anxiety, confusion, coma, seizures

CV: palpitations, edema, chest pain, ECG abnormalities, hypotension, hypertension, prolonged QT interval

EENT: blurred vision, eye irritation, tinnitus, earache, epistaxis, nasopharyngitis, sinusitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia, oral blisters, oral candidiasis, GI hemorrhage

GU: urinary incontinence, intermenstrual bleeding, oliguria, renal failure

Hematologic: anemia, disseminated intravascular coagulation, hemorrhage, neutropenia, thrombocytopenia Metabolic: hypokalemia, hypomagnesemia, hyperglycemia, acidosis, hypoglycemia, hyperkalemia

Musculoskeletal: bone, back, neck, or limb pain

Respiratory: dyspnea, cough, hypoxia, tachypnea, hemoptysis, upper respiratory tract infection, pleural effusions

Skin: bruising, pruritus, dermatitis, skin lesions, diaphoresis, night sweats, erythema, hyperpigmentation, urticaria

Other: fever, lymphadenopathy, facial edema, bacterial infection, herpes simplex infection, injection site erythema, hypersensitivity reaction, sepsis

Interactions

Drug-drug.Immunosuppressants: additive immunosuppression

Drug-diagnostic tests.Calcium, glucose, potassium: increased or decreased levels

Hemoglobin, neutrophils, platelets: decreased values

Triglycerides: increased levels

White blood cells: decreased levels

Drug-herbs.Astragalus, echinacea, melatonin: interference with immunosuppressant action

Patient monitoring

Watch for signs and symptoms of hypersensitivity reaction. Keep emergency drugs at hand in case these occur.
• Monitor vital signs and observe patient frequently during I.V. infusion.
• Monitor laboratory values and drug blood level.

Patient teaching

• Teach patient about purpose of therapy. Explain that drug decreases the risk of acute organ rejection.
• Tell patient he may be more susceptible to infection because of drug's immunosuppressant effect.
• Inform patient that he'll need lifelong immunosuppressant drug therapy.
• Advise women of childbearing age to use reliable contraception before, during, and for 2 months after therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.


beclomethasone dipropionate

AeroBec (UK), Apo-Beclomethasone (CA), Asmabec (UK), Beclodisk (CA) (UK), Becloforte (CA) (UK), Beconase AQ Nasal Spray, Filair (UK), Hayfever Relief (UK), Nasobec (UK), Pollenase Nasal (UK), QVAR, Rivanase (CA)


Pharmacologic class: Corticosteroid

Therapeutic class: Anti-inflammatory agent

Pregnancy risk category C

 

Action

Unclear. May decrease inflammation by stabilizing leukocytic lysosomal membrane, decreasing number and activity of inflammatory cells, inhibiting bronchoconstriction (leading to direct smooth muscle relaxation), and reducing airway hyperresponsiveness.

Availability

Inhalation aerosol: 40-mcg metered inhalation in 7.3-g canister; 80-mcg metered inhalation in 7.3-g canister

Inhalation capsules: 100 mcg, 200 mcg

Nasal spray: 0.042% (25-g bottle containing 180 metered inhalations)

Indications and dosages

Maintenance treatment of asthma as prophylaxis; asthma patients who require systemic steroids for whom adding an inhaled steroid may reduce or eliminate the need for systemic steroids

Adults and children ages 12 and older: When previous therapy was bronchodilator alone, 40 to 80 mcg by oral inhalation (QVAR) b.i.d.; maximum of 320 mcg b.i.d. When previous therapy was inhaled steroid, 40 to 160 mcg by oral inhalation (QVAR) b.i.d.; maximum of 320 mcg b.i.d.

Children ages 5 to 11: When previous therapy was bronchodilator alone, 40 mcg by oral inhalation (QVAR) b.i.d.; maximum of 80 mcg b.i.d. When previous therapy was inhaled steroid, 40 mcg by oral inhalation (QVAR) b.i.d.; maximum of 80 mcg b.i.d.

Seasonal or perennial rhinitis

Adults and children ages 12 and older: One or two inhalations (42 to 84 mcg Beconase AQ Nasal Spray) in each nostril b.i.d.

Children ages 6 to 12: One inhalation (42 mcg Beconase AQ Nasal Spray) in each nostril b.i.d.

Contraindications

• Hypersensitivity to drug
• Status asthmaticus

Precautions

Use cautiously in:
• active untreated infections, diabetes mellitus, glaucoma, underlying immunosuppression
• patients receiving concurrent systemic corticosteroids
• pregnant or breastfeeding patients
• children younger than age 6.

Administration

• Use spacer device to ensure proper delivery of dose and to help prevent candidiasis and hoarseness.
• After inhalation, tell patient to hold his breath for a few seconds before exhaling.
• For greater efficacy, wait 1 minute between inhalations.
• If patient is also receiving a bronchodilator, administer it at least 15 minutes before beclomethasone.
• Discontinue drug after 3 weeks if symptoms don't improve markedly.

Adverse reactions

CNS: headache

EENT: cataracts, nasal irritation or congestion, epistaxis, perforated nasal septum, nasopharyngeal or oropharyngeal fungal infections, hoarseness, throat irritation

GI: esophageal candidiasis

Metabolic: adrenal suppression Respiratory: cough, wheezing, bronchospasm

Skin: urticaria, angioedema

Other: anosmia, Churg-Strauss syndrome, hypersensitivity reactions

Interactions

None significant

Patient monitoring

• Assess patient's mouth daily for signs of fungal infection.
• Observe patient for proper inhaler use.

Patient teaching

• Instruct patient to hold inhaled drug in airway for several seconds before exhaling and to wait 1 minute between inhalations.
• Advise patient to rinse mouth after using inhaler and to wash and dry inhaler thoroughly to help prevent fungal infections and sore throat.
• Encourage patient to document use of drug and his response in a diary.
• If patient is also using a bronchodilator, teach him to use it at least 15 minutes before beclomethasone.
• As appropriate, review all other significant and life-threatening adverse reactions.

beclomethasone

(be-kloe-meth-a-sone) ,

Qvar

(trade name)

Classification

Therapeutic: anti inflammatories steroidal
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

Maintenance treatment of asthma as prophylactic therapy. May decrease requirement for or eliminate use of systemic corticosteroids in patients with asthma.

Action

Potent, locally acting anti-inflammatory and immune modifier.

Therapeutic effects

Decreases frequency and severity of asthma attacks.
Improves asthma symptoms.

Pharmacokinetics

Absorption: 20%. Action is primarily local following inhalation.
Distribution: Crosses the placenta and enters breast milk in small amounts.
Metabolism and Excretion: Following inhalation, beclomethasone dipropionate is primarily converted to beclomethasone 17–monopropionate (active metabolite); primarily excreted in feces (<10% excreted in urine).
Half-life: 2.8 hr.

Time/action profile (improvement in symptoms)

ROUTEONSETPEAKDURATION
Inhalationwithin 24 hr1–4 wk*unknown
*Improvement in pulmonary function; decreased airway responsiveness may take longer

Contraindications/Precautions

Contraindicated in: Hypersensitivity (product contains alcohol); Acute attack of asthma/status asthmaticus.
Use Cautiously in: Active untreated infections; Diabetes or glaucoma; Underlying immunosuppression (due to disease or concurrent therapy); Systemic corticosteroid therapy (should not be abruptly discontinued when inhalable therapy is started; additional corticosteroids needed in stress or trauma); Obstetric / Lactation: Safety not established; Pediatric: Safety not established in children <5 yr; prolonged or high-dose therapy may lead to complications.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)

Ear, Eye, Nose, Throat

  • cataracts
  • dysphonia
  • oropharyngeal fungal infections
  • pharyngitis
  • rhinitis
  • sinusitis

Respiratory

  • bronchospasm
  • cough
  • wheezing

Endocrinologic

  • adrenal suppression (increased dose, long-term therapy only)
  • decreased growth (children)

Musculoskeletal

  • back pain

Interactions

Drug-Drug interaction

None known.

Route/Dosage

Inhalation (Adults and Children ≥12 yr) Previously on bronchodilators alone—40–80 mcg twice daily (not to exceed 320 mcg twice daily). Previously on inhaled corticosteroids—40–160 mcg twice daily (not to exceed 320 mcg twice daily).
Inhalation (Children 5–11 yr) Previously on bronchodilators alone—40 mcg twice daily (not to exceed 80 mcg twice daily).Previously on inhaled corticosteroids—40 mcg twice daily (not to exceed 80 mcg twice daily).

Availability

Inhalation aerosol: 40 mcg/metered inhalation in 7.3–g canister (delivers 100 metered inhlations), 80 mcg/metered inhlation in 7.3–g canister (delivers 100 metered inhalations)

Nursing implications

Nursing assessment

  • Monitor respiratory status and lung sounds. Pulmonary function tests may be assessed periodically during and for several months following a transfer from systemic to inhalation corticosteroids.
  • Assess patients changing from systemic corticosteroids to inhalation corticosteroids for signs of adrenal insufficiency (anorexia, nausea, weakness, fatigue, hypotension, hypoglycemia) during initial therapy and periods of stress. If these signs appear, notify physician or other health care professional immediately; condition may be life-threatening.
  • Monitor for withdrawal symptoms (joint or muscular pain, lassitude, depression) during withdrawal from oral corticosteroids.
  • Monitor growth rate in children receiving chronic therapy; use lowest possible dose.
  • Lab Test Considerations: Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic therapy. Children and patients using higher than recommended doses are at greatest risk for HPA suppression.
    • May cause increased serum and urine glucose concentrations if significant absorption occurs.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for infection (Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • After the desired clinical effect has been obtained, attempts should be made to decrease dose to lowest amount required to control symptoms. Gradually decrease dose every 2–4 wk as long as desired effect is maintained. If symptoms return, dose may briefly return to starting dose.
  • Inhalation: Allow at least 1 min between inhalations of aerosol medication.

Patient/Family Teaching

  • Advise patient to take medication exactly as directed. If a dose is missed, take as soon as remembered unless almost time for next dose. Advise patient not to discontinue medication without consulting health care professional; gradual decrease is required.
  • Advise patients using inhalation corticosteroids and bronchodilator to use bronchodilator first and to allow 5 min to elapse before administering the corticosteroid, unless otherwise directed by health care professional.
  • Advise patient that inhalation corticosteroids should not be used to treat an acute asthma attack but should be continued even if other inhalation agents are used.
  • Patients using inhalation corticosteroids to control asthma may require systemic corticosteroids for acute attacks. Advise patient to use regular peak flow monitoring to determine respiratory status.
  • Caution patient to avoid smoking, known allergens, and other respiratory irritants.
  • Advise patient to notify physician if sore throat or mouth occurs.
  • Instruct patient whose systemic corticosteroids have recently been reduced or withdrawn to carry a warning card indicating the need for supplemental systemic corticosteroids in the event of stress or severe asthma attack unresponsive to bronchodilators.
  • Metered-Dose Inhaler: Instruct patient in the proper use of the metered-dose inhaler. Canister must be primed prior to first use. Do this by releasing 2 actuations into air away from face. Canister will remain primed for 10 days. If not used for more than 10 days, reprime with 2 actuations. Shake inhaler well. Exhale completely and then close lips firmly around mouthpiece. While breathing in deeply and slowly, press down on canister. Hold breath for as long as possible to ensure deep instillation of medication. Remover inhaler from mouth and breathe out gently. Allow 1–2 min between inhalations. Rinse mouth with water or mouthwash after each use to minimize fungal infections, dry mouth, and hoarseness. Clean only the mouthpiece weekly with clean dry tissue or cloth. Do not place in water (see ).

Evaluation/Desired Outcomes

  • Management of the symptoms of chronic asthma.
  • Improvement in asthma symptoms.

QVAR®

Pulmonology An inhaled corticosteroid–beclomethasone dipropionate–administered by a metered dose inhaler to control asthma. See Asthma.
References in periodicals archive ?
Moreover, the odds of asthma control were significantly worse with large-particle beclomethasone than with QVAR.
Martin has served on the advisory board and speakers bureau for Teva Pharmaceutical Industries, which markets QVAR.
Real-Life Results', Qvar Easi-Breathe for Teva UK Limited, by Woolley Pau Gyro
Healthcare Professional, International Campaign 'Small Particles', Qvar for Teva EU Limited, by Woolley Pau Gyro
QVAR does not replace quick-relief inhalers for sudden symptoms.
Among these are Teva, which has two successful branded asthma inhalers, Proair (salbutamol) and Qvar (beclomethasone dipropionate); and Orion, with its Easyhaler DPI.
Based on results from the Phase I study that evaluated the pharmacokinetics, safety and tolerability of BDP HFA, the systemic exposure following administration of the treatment (up to 320 mcg/day) was approximately 27 percent of orally inhaled BDP HFA, which is marketed by Teva as the asthma treatment QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol.
There are treatments available with extra-fine particle size, such as QVAR, which allows asthma control to be delivered deep in the lung, due to more effective penetration throughout the large and small airways.
Graceway, Vyloma, Zyclara, Aldara, QVAR and Nidagel are registered or pending trademarks of Graceway Pharmaceuticals, LLC.
With the additional QVAR donation, we can now ensure that patients have full asthma control and the ability to manage the underlying cause of the disease--inflammation," said Mark Salyer, General Manager of Teva's Respiratory Division.
QVAR, indicated for the long-term treatment of asthma in adults and children as young as five years old, offers comparable efficacy at half the dose.
Food and Drug Administration (FDA) seeking approval for use of QVAR (beclomethasone diproprionate HFA) (BDP) inhalation aerosol in children age 5-11.