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Drug overview for QNASL CHILDREN (beclomethasone dipropionate):
Generic name: BECLOMETHASONE DIPROPIONATE (BE-kloe-METH-a-sone)
Drug class: Nasal Steroids
Therapeutic class: Respiratory Therapy Agents
Beclomethasone dipropionate, a diester of beclomethasone, is a synthetic corticosteroid.
No enhanced Uses information available for this drug.
Generic name: BECLOMETHASONE DIPROPIONATE (BE-kloe-METH-a-sone)
Drug class: Nasal Steroids
Therapeutic class: Respiratory Therapy Agents
Beclomethasone dipropionate, a diester of beclomethasone, is a synthetic corticosteroid.
No enhanced Uses information available for this drug.
DRUG IMAGES
QNASL CHILDREN'S 40 MCG SPRAY
The following indications for QNASL CHILDREN (beclomethasone dipropionate) have been approved by the FDA:
Indications:
Allergic rhinitis
Professional Synonyms:
None.
Indications:
Allergic rhinitis
Professional Synonyms:
None.
The following dosing information is available for QNASL CHILDREN (beclomethasone dipropionate):
Dosage of beclomethasone dipropionate monohydrate is expressed in terms of anhydrous drug. A double-strength (84 mcg per metered spray) no longer is commercially available in the US. Each actuation of the spray pump delivers 100 mg of suspension containing 42 mcg of beclomethasone dipropionate.
Each 25-g bottle of beclomethasone dipropionate aqueous nasal spray provides 180 metered sprays. Patients should discard the bottle after 180 sprays have been used.
For the symptomatic treatment of seasonal or perennial allergic or nonallergic (vasomotor) rhinitis and for the management of nasal polyposis, the usual initial dosage of intranasal beclomethasone dipropionate as the aqueous suspension for adults and children 12 years of age or older is 42 or 84 mcg (1 or 2 sprays) in each nostril twice daily (168-336 mcg total daily dosage). The usual initial dosage of beclomethasone dipropionate spray pump for children 6-12 years of age is 42 mcg (1 spray) in each nostril twice daily (168 mcg total daily dosage). Patients not responding to 168 mcg daily or those with more severe symptoms may increase the dosage to 84 mcg (2 sprays) in each nostril (336 mcg total daily dosage).
Once adequate control is achieved, the dosage should be decreased to 84 mcg (1 spray in each nostril) twice daily.
In patients with seasonal or perennial rhinitis, symptomatic relief is usually evident within a few days of continuous therapy; however, up to 2 weeks may be required for optimum effectiveness in some patients. Although systemic effects are minimal at recommended dosages, therapy with intranasal beclomethasone dipropionate in patients with seasonal or perennial allergic or nonallergic rhinitis should not be continued beyond 3 weeks in the absence of substantial symptomatic improvement. The therapeutic effects of beclomethasone dipropionate on nasal polyps also are delayed, and several weeks or more of therapy may be necessary before effects can be fully assessed.
To ensure compliance and avoid patient-initiated escalation in dosage, patients should be advised prior to initiating therapy that onset of the beneficial effects of the drug will be delayed. There is no evidence that higher than recommended dosages or increased frequency of administration of intranasal beclomethasone dipropionate are beneficial; exceeding the usual recommended dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing's syndrome) and should be avoided. Maximum daily dosage of intranasal beclomethasone dipropionate should not exceed 2 sprays in each nostril twice daily (336 mcg daily).
Each 25-g bottle of beclomethasone dipropionate aqueous nasal spray provides 180 metered sprays. Patients should discard the bottle after 180 sprays have been used.
For the symptomatic treatment of seasonal or perennial allergic or nonallergic (vasomotor) rhinitis and for the management of nasal polyposis, the usual initial dosage of intranasal beclomethasone dipropionate as the aqueous suspension for adults and children 12 years of age or older is 42 or 84 mcg (1 or 2 sprays) in each nostril twice daily (168-336 mcg total daily dosage). The usual initial dosage of beclomethasone dipropionate spray pump for children 6-12 years of age is 42 mcg (1 spray) in each nostril twice daily (168 mcg total daily dosage). Patients not responding to 168 mcg daily or those with more severe symptoms may increase the dosage to 84 mcg (2 sprays) in each nostril (336 mcg total daily dosage).
Once adequate control is achieved, the dosage should be decreased to 84 mcg (1 spray in each nostril) twice daily.
In patients with seasonal or perennial rhinitis, symptomatic relief is usually evident within a few days of continuous therapy; however, up to 2 weeks may be required for optimum effectiveness in some patients. Although systemic effects are minimal at recommended dosages, therapy with intranasal beclomethasone dipropionate in patients with seasonal or perennial allergic or nonallergic rhinitis should not be continued beyond 3 weeks in the absence of substantial symptomatic improvement. The therapeutic effects of beclomethasone dipropionate on nasal polyps also are delayed, and several weeks or more of therapy may be necessary before effects can be fully assessed.
To ensure compliance and avoid patient-initiated escalation in dosage, patients should be advised prior to initiating therapy that onset of the beneficial effects of the drug will be delayed. There is no evidence that higher than recommended dosages or increased frequency of administration of intranasal beclomethasone dipropionate are beneficial; exceeding the usual recommended dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing's syndrome) and should be avoided. Maximum daily dosage of intranasal beclomethasone dipropionate should not exceed 2 sprays in each nostril twice daily (336 mcg daily).
Beclomethasone dipropionate is administered by nasal inhalation as the monohydrate using a spray pump. Nasal aerosol inhaler formulations of the drug no longer are commercially available in the US. Patients should be carefully instructed in the use of the nasal spray pump.
To obtain optimum results, patients should also be given a copy of the patient instructions provided by the manufacturers. An adult should carefully supervise a child in the administration of intranasal beclomethasone dipropionate. The manufacturer states that intranasal beclomethasone dipropionate should be used by nasal inhalation only.
Prior to administration of intranasal beclomethasone dipropionate, patients should clear their nasal passages; administration of a topical nasal vasoconstrictor may be required in patients with blocked nasal passages during the first 2-3 days of therapy to ensure adequate penetration of the drug. The aqueous suspension (pump spray) should be shaken well immediately prior to use. To actuate the spray pump for priming and for intranasal use, the bottle is held in one hand, with 2 fingers on the white collar of the pump unit and the thumb on the bottom of the bottle.
Before initial use of beclomethasone dipropionate nasal spray pump, patients should prime the pump by pressing downward and releasing the pump collar 6 times or until a fine mist is produced. If the nasal spray pump has not been used for 7 days, the pump should be reprimed until a fine mist appears. Caution should be exercised to avoid spraying beclomethasone dipropionate nasal spray into the eyes.
Prior to administration of beclomethasone dipropionate using the nasal spray pump, patients should clear their nasal passages by gently blowing their nose. Patients should insert the nasal spray tip into 1 nostril and tilt the head slightly forward while holding the bottle upright. The pump collar should then be firmly pressed downward to administer the drug into the nostril while holding the other nostril closed and gently inspiring through the nostril at the same time.
Patients should then breathe out through the mouth. This procedure then is repeated for the other nostril. To clean the nasal applicator, remove the dust cap and safety clip and press up gently on the white collar to free the nasal applicator.
The nasal applicator and dust cap should be washed with cold water and dried, then replaced on the nasal applicator. If the spray nozzle becomes clogged, remove the dust cap, unscrew the pump mechanism and soak the spray pump unit in warm water for a few minutes. The spray pump should be rinsed in cold water, dried, refitted to the bottle, and reprimed.
To obtain optimum results, patients should also be given a copy of the patient instructions provided by the manufacturers. An adult should carefully supervise a child in the administration of intranasal beclomethasone dipropionate. The manufacturer states that intranasal beclomethasone dipropionate should be used by nasal inhalation only.
Prior to administration of intranasal beclomethasone dipropionate, patients should clear their nasal passages; administration of a topical nasal vasoconstrictor may be required in patients with blocked nasal passages during the first 2-3 days of therapy to ensure adequate penetration of the drug. The aqueous suspension (pump spray) should be shaken well immediately prior to use. To actuate the spray pump for priming and for intranasal use, the bottle is held in one hand, with 2 fingers on the white collar of the pump unit and the thumb on the bottom of the bottle.
Before initial use of beclomethasone dipropionate nasal spray pump, patients should prime the pump by pressing downward and releasing the pump collar 6 times or until a fine mist is produced. If the nasal spray pump has not been used for 7 days, the pump should be reprimed until a fine mist appears. Caution should be exercised to avoid spraying beclomethasone dipropionate nasal spray into the eyes.
Prior to administration of beclomethasone dipropionate using the nasal spray pump, patients should clear their nasal passages by gently blowing their nose. Patients should insert the nasal spray tip into 1 nostril and tilt the head slightly forward while holding the bottle upright. The pump collar should then be firmly pressed downward to administer the drug into the nostril while holding the other nostril closed and gently inspiring through the nostril at the same time.
Patients should then breathe out through the mouth. This procedure then is repeated for the other nostril. To clean the nasal applicator, remove the dust cap and safety clip and press up gently on the white collar to free the nasal applicator.
The nasal applicator and dust cap should be washed with cold water and dried, then replaced on the nasal applicator. If the spray nozzle becomes clogged, remove the dust cap, unscrew the pump mechanism and soak the spray pump unit in warm water for a few minutes. The spray pump should be rinsed in cold water, dried, refitted to the bottle, and reprimed.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for QNASL CHILDREN (beclomethasone dipropionate):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Radioactive Iodide/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(2) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(3) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1) |
ADREVIEW, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123 |
| Sodium Iodide I 131/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(3) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(4) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2) |
HICON, SODIUM IODIDE I-131 |
There are 0 moderate interactions.
The following contraindication information is available for QNASL CHILDREN (beclomethasone dipropionate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 8 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Nasal septal perforation |
| Nasal septal ulcers |
| Nasal trauma |
| Ocular herpes simplex |
| Ocular hypertension |
| Open angle glaucoma |
| Operation on nose |
| Severe infection |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Adrenocortical insufficiency |
| Cataracts |
| Epistaxis |
| Inactive tuberculosis |
| Parasitic infection |
The following adverse reaction information is available for QNASL CHILDREN (beclomethasone dipropionate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 12 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Lesion of nasal mucosa |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Bronchospastic pulmonary disease Glaucoma Hypersensitivity drug reaction Immunosuppression Impaired wound healing Nasal septal perforation Ocular hypertension Pharyngeal candidiasis Wheezing |
There are 19 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Nasal passage irritation |
Crusted nasal mucosa Dizziness Dry nose Epistaxis Headache disorder Hoarseness Lethargy Nausea Rhinorrhea Sneezing Sore throat |
| Rare/Very Rare |
|---|
|
Cataracts Eye tearing Loss of taste Nasal candidiasis Parosmia Skin rash Urticaria |
The following precautions are available for QNASL CHILDREN (beclomethasone dipropionate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Intranasal beclomethasone dipropionate should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Since adrenal insufficiency may occur in neonates born to women who received corticosteroids during pregnancy, these neonates should be carefully monitored for signs and symptoms of this condition. Although there are no adequate and controlled studies to date in humans, subcutaneous beclomethasone dipropionate has been shown to be teratogenic and embryocidal in mice and rabbits receiving 0.1
mg/kg and 0.025 mg/kg daily, respectively, dosages that are about equal to the maximum recommended intranasal dosage in adults (on a mg/m2 basis). Teratogenic effects in these animals included fetal resorption, cleft palate, agnathia, microstomia, aglossia, delayed ossification, and agenesis of the thymus gland.
Teratogenic or embryocidal effects were not observed in rats following a combination of oral administration and inhalation of beclomethasone dipropionate at dosages of 10 and 0.1 mg/kg daily, respectively (about 240 times the maximum recommended adult intranasal dosage (on a mg/m2 basis)).
mg/kg and 0.025 mg/kg daily, respectively, dosages that are about equal to the maximum recommended intranasal dosage in adults (on a mg/m2 basis). Teratogenic effects in these animals included fetal resorption, cleft palate, agnathia, microstomia, aglossia, delayed ossification, and agenesis of the thymus gland.
Teratogenic or embryocidal effects were not observed in rats following a combination of oral administration and inhalation of beclomethasone dipropionate at dosages of 10 and 0.1 mg/kg daily, respectively (about 240 times the maximum recommended adult intranasal dosage (on a mg/m2 basis)).
Beclomethasone dipropionate should be used with caution in nursing women, since it is not known whether the drug is distributed into milk. Other corticosteroids are distributed into milk and may cause adverse effects such as growth suppression in nursing infants.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for QNASL CHILDREN (beclomethasone dipropionate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for QNASL CHILDREN (beclomethasone dipropionate)'s list of indications:
| Allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
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