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Drug overview for QVAR REDIHALER (beclomethasone dipropionate):
Generic name: BECLOMETHASONE DIPROPIONATE (BE-kloe-METH-a-sone)
Drug class: Orally Inhaled Steroids
Therapeutic class: Respiratory Therapy Agents
Beclomethasone dipropionate is a synthetic corticosteroid.
No enhanced Uses information available for this drug.
Generic name: BECLOMETHASONE DIPROPIONATE (BE-kloe-METH-a-sone)
Drug class: Orally Inhaled Steroids
Therapeutic class: Respiratory Therapy Agents
Beclomethasone dipropionate is a synthetic corticosteroid.
No enhanced Uses information available for this drug.
DRUG IMAGES
QVAR REDIHALER 40 MCG
QVAR REDIHALER 80 MCG
The following indications for QVAR REDIHALER (beclomethasone dipropionate) have been approved by the FDA:
Indications:
Maintenance therapy for asthma
Professional Synonyms:
Therapy to achieve long-term asthma control
Indications:
Maintenance therapy for asthma
Professional Synonyms:
Therapy to achieve long-term asthma control
The following dosing information is available for QVAR REDIHALER (beclomethasone dipropionate):
The commercially available 7.3-g regular- or double-strength oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R)) delivers about 40 or 80 mcg of beclomethasone dipropionate per metered spray and provides 100 metered sprays. Dosage of orally inhaled beclomethasone dipropionate must be carefully adjusted according to individual requirements and response.
The recommended dosage of orally inhaled beclomethasone dipropionate administered via metered-dose aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R) is lower than that with inhalation aerosols containing CFC propellant (e.g., Beclovent(R), Vanceril(R), Vanceril(R) Double Strength; all no longer commercially available in the US), although a definitive comparative therapeutic ratio between non-CFC and CFC-containing beclomethasone preparations has not been demonstrated. The usual initial dosage of beclomethasone dipropionate oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R)) for adults and children 12 years of age or older in whom previous asthma therapy consisted of bronchodilators alone is 40 or 80 mcg twice daily. The usual initial dosage of the drug for adults and children 12 years of age or older in whom previous asthma therapy consisted of inhaled corticosteroids is 40-160 mcg twice daily.
In children 5-11 years of age in whom previous asthma therapy consisted of bronchodilators alone or inhaled corticosteroids, the usual initial dosage of the drug is 40 mcg twice daily. After a satisfactory response is obtained, dosage should be decreased gradually to the lowest dosage that maintains an adequate clinical response, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Cautions: Pediatric Precautions.) The manufacturer of QVAR(R) states that the safety and efficacy of dosages exceeding 320 mcg twice daily in adults and children 12 years of age or older or 80 mcg twice daily in children 5-11 years of age have not been established.
Patients who respond to beclomethasone dipropionate oral inhalation usually show improvement in pulmonary function within 1-4 weeks of continuous therapy.
The recommended dosage of orally inhaled beclomethasone dipropionate administered via metered-dose aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R) is lower than that with inhalation aerosols containing CFC propellant (e.g., Beclovent(R), Vanceril(R), Vanceril(R) Double Strength; all no longer commercially available in the US), although a definitive comparative therapeutic ratio between non-CFC and CFC-containing beclomethasone preparations has not been demonstrated. The usual initial dosage of beclomethasone dipropionate oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R)) for adults and children 12 years of age or older in whom previous asthma therapy consisted of bronchodilators alone is 40 or 80 mcg twice daily. The usual initial dosage of the drug for adults and children 12 years of age or older in whom previous asthma therapy consisted of inhaled corticosteroids is 40-160 mcg twice daily.
In children 5-11 years of age in whom previous asthma therapy consisted of bronchodilators alone or inhaled corticosteroids, the usual initial dosage of the drug is 40 mcg twice daily. After a satisfactory response is obtained, dosage should be decreased gradually to the lowest dosage that maintains an adequate clinical response, particularly in children, since inhaled corticosteroids have the potential to affect growth. (See Cautions: Pediatric Precautions.) The manufacturer of QVAR(R) states that the safety and efficacy of dosages exceeding 320 mcg twice daily in adults and children 12 years of age or older or 80 mcg twice daily in children 5-11 years of age have not been established.
Patients who respond to beclomethasone dipropionate oral inhalation usually show improvement in pulmonary function within 1-4 weeks of continuous therapy.
Beclomethasone dipropionate is administered by oral inhalation using an oral aerosol inhaler. Patients should be carefully instructed in the use of the oral inhaler. To obtain optimum results, patients should also be given a copy of the patient instructions provided by the manufacturer.
An adult should carefully supervise a child in the administration of beclomethasone dipropionate for oral inhalation. The manufacturer states that beclomethasone dipropionate oral inhaler should be used by oral inhalation only. The manufacturer states that the regular- (40 mcg/metered dose) and double-strength inhalation aerosols with tetrafluoroethane (non-CFC) propellant (QVAR(R)) should be tested by spraying twice into the air before using the device for the first time or whenever the aerosol has not been used for more than 10 days.
Because the commercially available beclomethasone dipropionate oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R)) is formulated as a solution, it is not necessary to shake the inhaler prior to use. After exhaling as fully as is comfortable, the mouthpiece of the inhaler should be placed well into the mouth and the lips closed firmly around it, keeping the tongue below the mouthpiece. The patient should then inhale slowly and deeply through the mouth while pressing the metal canister down with the forefinger.
After holding the breath for as long as possible (about 5-10 seconds), the mouthpiece should be removed and the patient should exhale gently. If additional inhalations are required, the patient should repeat the procedure. Following each treatment, the patient should rinse the mouth thoroughly with water to remove drug deposited in the oropharyngeal area.
The patient instructions provided by the manufacturer should be referred to for further information regarding use of beclomethasone dipropionate for oral inhalation. Weekly cleansing of the mouthpiece of the beclomethasone dipropionate oral inhaler is recommended. The mouthpiece should be cleaned using a clean, dry tissue or cloth.
The patient should be instructed not to wash or place any part of the inhaler canister in water. According to the manufacturer of beclomethasone dipropionate inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R)), lung deposition does not differ when the drug is administered with or without a spacer device, and administration with a spacer device is not necessary. However, the manufacturer states that the QVAR(R) inhaler is compatible with the AeroChamber(R) spacer device, which may be used if preferred by the clinician or patient.
An adult should carefully supervise a child in the administration of beclomethasone dipropionate for oral inhalation. The manufacturer states that beclomethasone dipropionate oral inhaler should be used by oral inhalation only. The manufacturer states that the regular- (40 mcg/metered dose) and double-strength inhalation aerosols with tetrafluoroethane (non-CFC) propellant (QVAR(R)) should be tested by spraying twice into the air before using the device for the first time or whenever the aerosol has not been used for more than 10 days.
Because the commercially available beclomethasone dipropionate oral inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R)) is formulated as a solution, it is not necessary to shake the inhaler prior to use. After exhaling as fully as is comfortable, the mouthpiece of the inhaler should be placed well into the mouth and the lips closed firmly around it, keeping the tongue below the mouthpiece. The patient should then inhale slowly and deeply through the mouth while pressing the metal canister down with the forefinger.
After holding the breath for as long as possible (about 5-10 seconds), the mouthpiece should be removed and the patient should exhale gently. If additional inhalations are required, the patient should repeat the procedure. Following each treatment, the patient should rinse the mouth thoroughly with water to remove drug deposited in the oropharyngeal area.
The patient instructions provided by the manufacturer should be referred to for further information regarding use of beclomethasone dipropionate for oral inhalation. Weekly cleansing of the mouthpiece of the beclomethasone dipropionate oral inhaler is recommended. The mouthpiece should be cleaned using a clean, dry tissue or cloth.
The patient should be instructed not to wash or place any part of the inhaler canister in water. According to the manufacturer of beclomethasone dipropionate inhalation aerosol with tetrafluoroethane (non-CFC) propellant (QVAR(R)), lung deposition does not differ when the drug is administered with or without a spacer device, and administration with a spacer device is not necessary. However, the manufacturer states that the QVAR(R) inhaler is compatible with the AeroChamber(R) spacer device, which may be used if preferred by the clinician or patient.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| QVAR REDIHALER 40 MCG | Maintenance | Adults inhale 2 puffs (80 mcg) by inhalation route 2 times per day |
| QVAR REDIHALER 80 MCG | Maintenance | Adults inhale 2 puffs (160 mcg) by inhalation route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for QVAR REDIHALER (beclomethasone dipropionate):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Desmopressin/Glucocorticoids SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Glucocorticoids increase the risk of hyponatremia.(1-4) CLINICAL EFFECTS: Concurrent use of glucocorticoids may increase the risk of hyponatremia with desmopressin.(1-4) PREDISPOSING FACTORS: Predisposing factors for hyponatremia include: polydipsia, renal impairment (eGFR < 50 ml/min/1.73m2), illnesses that can cause fluid/electrolyte imbalances, age >=65, medications that cause water retention and/or increase the risk of hyponatremia (carbamazepine, chlorpromazine, lamotrigine, loop diuretics, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants). PATIENT MANAGEMENT: The concurrent use of systemic or inhaled glucocorticoids with desmopressin is contraindicated.(1-4) Desmopressin may be initiated 3 days or 5 half-lives after glucocorticoid discontinuation, whichever is longer. If concurrent use is deemed medically necessary, make sure serum sodium levels are normal before beginning therapy and consider using the desmopressin nasal 0.83 mcg dose. Consider measuring serum sodium levels more frequently than the recommended intervals of: within 7 days of concurrent therapy initiation, one month after concurrent therapy initiation and periodically during treatment. Counsel patients to report symptoms of hyponatremia, which may include: headache, nausea/vomiting, feeling restless, fatigue, drowsiness, dizziness, muscle cramps, changes in mental state (confusion, decreased awareness/alertness), seizures, coma, and trouble breathing. Counsel patients to limit the amount of fluids they drink in the evening and night-time and to stop taking desmopressin if they develop a stomach/intestinal virus with nausea/vomiting or any nose problems (blockage, stuffy/runny nose, drainage).(1) DISCUSSION: In clinical trials of desmopressin for the treatment of nocturia, 4 of 5 patients who developed severe hyponatremia (serum sodium <= 125 mmol/L) were taking systemic or inhaled glucocorticoids. Three of these patients were also taking NSAIDs and one was receiving a thiazide diuretic.(2) Drugs associated with hyponatremia may increase the risk, including loop diuretics, carbamazepine, chlorpromazine, glucocorticoids, lamotrigine, NSAIDs, opioids, SSRIs, thiazide diuretics, and/or tricyclic antidepressants.(1,3-4) |
DDAVP, DESMOPRESSIN ACETATE, NOCDURNA |
There are 3 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 |
| Cosyntropin/Agents Affecting Plasma Cortisol Levels SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Agents affecting plasma cortisol levels may impact the accuracy of the cosyntropin diagnostic test.(1) CLINICAL EFFECTS: Concurrent use of agents affecting plasma cortisol levels may impact the accuracy of the cosyntropin diagnostic test.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of cosyntropin states accuracy of diagnosis using the cosyntropin diagnostic test may be complicated by concomitant medications affecting plasma cortisol levels.(1) Agents affecting plasma cortisol levels and recommendation to stop prior to cosyntropin diagnostic test include: - Glucocorticoids: May elevate plasma cortisol levels. Stop these drugs on the day of testing. Long-acting glucocorticoids may need to be stopped for a longer period before testing. - Spironolactone: May elevate plasma cortisol levels. Stop spironolactone on the day of testing. - Estrogen: May elevate plasma total cortisol levels. Discontinue estrogen containing drugs 4 to 6 weeks prior to testing to allow cortisol binding globulin levels to return to levels within the reference range. Alternatively, concomitant measurement of cortisol binding globulin at the time of testing can be done; if cortisol binding globulin levels are elevated, plasma total cortisol levels are considered inaccurate.(1) DISCUSSION: Concurrent use of agents affecting plasma cortisol levels may impact the accuracy of the cosyntropin diagnostic test.(1) |
CORTROSYN, COSYNTROPIN |
| 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 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Quinolones/Corticosteroids SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Quinolone-induced arthropathy is a class effect of the quinolones.(1) Exactly how corticosteroid use increases the risk of tendon rupture is unknown. CLINICAL EFFECTS: Concurrent use of quinolones and corticosteroids may increase the risk of tendonitis and/or tendon rupture. This affect is most common in the Achilles tendon, but has been reported in the rotator cuff (shoulder), hand, biceps, thumb, and other tendons.(2-9) PREDISPOSING FACTORS: Risk factors for tendinitis and tendon rupture include age greater than 60; a history of kidney, heart, or lung transplantation, strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. PATIENT MANAGEMENT: Quinolone use should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should be instructed to rest and refrain from exercise until the diagnosis of tendonitis tendon rupture has been excluded.(2-9) DISCUSSION: Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving ciprofloxacin,(2) gatifloxacin,(3) levofloxacin,(4) lomefloxacin,(5) moxifloxacin,(6) nalidixic acid,(7) norfloxacin,(8) and ofloxacin.(9) A retrospective review of the IMS Health database examined quinolone use use from July 1, 1992 to June 30, 1998. The adjusted relative risk of tendon disorder with concurrent quinolone use was 1.9. Relative risk increased to 3.2 in patients aged 60 or older compared to 0.9 in patients aged less than 60. In patients aged 60 or older who used corticosteroids and quinolones concurrently, relative risk increased to 6.2.(10) In contrast, another retrospective review examined patients from a health insurance claims database and found no apparent effect from concurrent quinolone and corticosteroid use.(11) In a review of the follow-up to 42 spontaneously reported case of quinolone-associated tendon disorders in the Netherlands between January, 1988 and January, 1998, risk factors for tendon disorders included age older than 60, oral corticosteroid use, and existing joint problems.(12) In a review of the Swiss Drug Monitoring system, four of seven cases of levofloxacin-associated tendon problems also involved concurrent oral or inhaled corticosteroids.(13) In a review of the Medline database from 1966-2001, 98 case reports of tendinopathy associated with quinolones were located. Thirty-two (32.7%) of the patients had received systemic or inhaled corticosteroids before and during quinolone therapy. Of the 40 patients who suffered a tendon rupture, 21 (52.5%) were receiving corticosteroids.(14) Other authors have reported cases of tendon disorders in patients receiving concurrent corticosteroids and ciprofloxacin,(15) levofloxacin, (16-20) and ofloxacin.(21) |
AVELOX IV, BAXDELA, CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CIPROFLOXACIN-D5W, GATIFLOXACIN SESQUIHYDRATE, LEVOFLOXACIN, LEVOFLOXACIN HEMIHYDRATE, LEVOFLOXACIN-D5W, MOXIFLOXACIN, MOXIFLOXACIN HCL, NALIDIXIC ACID, OFLOXACIN |
The following contraindication information is available for QVAR REDIHALER (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 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Active tuberculosis |
| Inactive tuberculosis |
| Measles contact |
| Ocular herpes simplex |
| Ocular hypertension |
| Parasitic infection |
| Varicella contact |
There are 4 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 |
| Glaucoma |
| Osteoporosis |
The following adverse reaction information is available for QVAR REDIHALER (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 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Adrenocortical insufficiency Angioedema Central serous chorioretinopathy Glaucoma Hypersensitivity drug reaction Immunosuppression Osteopenia Paradoxical bronchospasm Suicidal ideation Urticaria |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Headache disorder Oropharyngeal candidiasis Pain in oropharynx Pharyngitis Upper respiratory infection Xerostomia |
Cough Dysgeusia Dysmenorrhea Nausea Pain Sinusitis Voice change |
| Rare/Very Rare |
|---|
|
Aggressive behavior Blurred vision Cataracts Depression Ocular hypertension Skin rash Sleep disorder |
The following precautions are available for QVAR REDIHALER (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 |
Orally inhaled beclomethasone dipropionate should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Although there are no adequate and controlled studies to date in humans, 20 asthmatic patients who became pregnant and were receiving oral inhalation of beclomethasone dipropionate at usual dosages delivered healthy children. Other women with severe asthma who received orally inhaled beclomethasone dipropionate during pregnancy to reduce systemic corticosteroid dosage requirements also delivered healthy children; however, a cardiac malformation was reported in an infant whose mother had complications and was receiving other drugs.
Several of these pregnancies resulted in premature deliveries and low birthweight infants, but evidence of neonatal adrenal insufficiency was not observed. Infants born to women who received substantial doses of corticosteroids during pregnancy should be carefully monitored for manifestations of hypoadrenalism. Subcutaneous beclomethasone dipropionate has been shown to be teratogenic and embryocidal in mice and rabbits at dosages about one-half the maximum recommended daily inhalation dose 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 following oral inhalation of beclomethasone dipropionate at 190 times the maximum recommended daily human dosage on a mg/m2 basis or following oral administration at 1000 times the usual human dosage in rats.
Several of these pregnancies resulted in premature deliveries and low birthweight infants, but evidence of neonatal adrenal insufficiency was not observed. Infants born to women who received substantial doses of corticosteroids during pregnancy should be carefully monitored for manifestations of hypoadrenalism. Subcutaneous beclomethasone dipropionate has been shown to be teratogenic and embryocidal in mice and rabbits at dosages about one-half the maximum recommended daily inhalation dose 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 following oral inhalation of beclomethasone dipropionate at 190 times the maximum recommended daily human dosage on a mg/m2 basis or following oral administration at 1000 times the usual human dosage in rats.
Since corticosteroids are distributed into milk and potentially may cause serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for QVAR REDIHALER (beclomethasone dipropionate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for QVAR REDIHALER (beclomethasone dipropionate)'s list of indications:
| Maintenance therapy for asthma | |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
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