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Drug overview for FLUNISOLIDE (flunisolide):
Generic name: FLUNISOLIDE (flew-NISS-oh-lide)
Drug class: Nasal Steroids
Therapeutic class: Respiratory Therapy Agents
Flunisolide is a synthetic fluorinated corticosteroid.
Flunisolide nasal solution is used for the symptomatic treatment of seasonal or perennial rhinitis when conventional therapy with antihistamines or decongestants is ineffective or produces intolerable adverse effects. In a comparative study in patients with seasonal allergic rhinitis, flunisolide nasal solution as Nasalide(R) or Nasarel(R) was more effective than either placebo vehicle, but there was no statistically significant difference in efficacy between the 2 flunisolide formulations; neither of these formulations currently is commercially available in the US. The US Food and Drug Administration (FDA) has determined that the generic (nonproprietary) formulation currently available in the US (Bausch & Lomb) is bioequivalent (and therefore therapeutically equivalent) to the previously available Nasalide(R) formulation.
Generic name: FLUNISOLIDE (flew-NISS-oh-lide)
Drug class: Nasal Steroids
Therapeutic class: Respiratory Therapy Agents
Flunisolide is a synthetic fluorinated corticosteroid.
Flunisolide nasal solution is used for the symptomatic treatment of seasonal or perennial rhinitis when conventional therapy with antihistamines or decongestants is ineffective or produces intolerable adverse effects. In a comparative study in patients with seasonal allergic rhinitis, flunisolide nasal solution as Nasalide(R) or Nasarel(R) was more effective than either placebo vehicle, but there was no statistically significant difference in efficacy between the 2 flunisolide formulations; neither of these formulations currently is commercially available in the US. The US Food and Drug Administration (FDA) has determined that the generic (nonproprietary) formulation currently available in the US (Bausch & Lomb) is bioequivalent (and therefore therapeutically equivalent) to the previously available Nasalide(R) formulation.
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The following indications for FLUNISOLIDE (flunisolide) have been approved by the FDA:
Indications:
Allergic rhinitis prevention
Allergic rhinitis
Chronic non-allergic rhinitis
Perennial allergic rhinitis
Professional Synonyms:
Allergic rhinitis prophylaxis
Atopic rhinitis
Chronic nonallergic rhinitis
Non-seasonal allergic rhinitis
Indications:
Allergic rhinitis prevention
Allergic rhinitis
Chronic non-allergic rhinitis
Perennial allergic rhinitis
Professional Synonyms:
Allergic rhinitis prophylaxis
Atopic rhinitis
Chronic nonallergic rhinitis
Non-seasonal allergic rhinitis
The following dosing information is available for FLUNISOLIDE (flunisolide):
After initial priming (5-6 sprays), the nasal inhaler delivers about 25 mcg of flunisolide per metered spray. The commercially available preparations deliver about 200 metered sprays. Dosage must be carefully adjusted according to individual requirements and response.
The therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate. This should be explained to the patient in advance to ensure compliance and continuation of the prescribed treatment regimen. Full therapeutic benefit usually requires regular use and usually is evident within a few days.
A longer period may be required in some patients. Response to the initial dosage generally should be assessed 4-7 days after starting therapy; about two-thirds of patients will experience some relief within this time period. Intranasal flunisolide should be discontinued in patients who do not experience clinically important benefit within 3 weeks of initiating therapy.
The therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate. This should be explained to the patient in advance to ensure compliance and continuation of the prescribed treatment regimen. Full therapeutic benefit usually requires regular use and usually is evident within a few days.
A longer period may be required in some patients. Response to the initial dosage generally should be assessed 4-7 days after starting therapy; about two-thirds of patients will experience some relief within this time period. Intranasal flunisolide should be discontinued in patients who do not experience clinically important benefit within 3 weeks of initiating therapy.
Flunisolide is administered by nasal inhalation using a special nasal inhaler. Patients should be carefully instructed in the use of the nasal 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 flunisolide nasal solution. The manufacturer states that flunisolide nasal solution should not be administered by oral inhalation, since the safety of polyethylene glycol in the vehicle of the nasal solution has not been established for this route of administration. Prior to administration of flunisolide nasal solution, patients should clear their nasal passages; administration of a topical nasal decongestant about 5-15 minutes before flunisolide administration may be required in patients with blocked nasal passages during the first 2-3 days of therapy to ensure adequate penetration of the drug and to prevent loss of the drug from the nasal passages via excess secretions.
Prior to initial use, the nasal inhaler must be assembled and primed. After assembly is complete, the patient should tilt his head slightly forward, insert the spray tip into one nostril, and point the tip toward the inflamed nasal turbinates and away from the nasal septum. For maximum therapeutic effect and to ensure adequate penetration of the drug, the patient should pump the drug into one nostril while holding the other nostril closed and should concurrently inspire through the nose; this procedure is then repeated for the other nostril.
The manufacturer recommends cleansing the nasal adapter and/or pump in warm water if the holes in the device become clogged. If the nasal inhaler is disassembled for any reason (including the cleansing procedure) or not used for 5 days or longer, it must be primed again prior to use. Opened containers of flunisolide nasal solution should be discarded after 3 months.
An adult should carefully supervise a child in the administration of flunisolide nasal solution. The manufacturer states that flunisolide nasal solution should not be administered by oral inhalation, since the safety of polyethylene glycol in the vehicle of the nasal solution has not been established for this route of administration. Prior to administration of flunisolide nasal solution, patients should clear their nasal passages; administration of a topical nasal decongestant about 5-15 minutes before flunisolide administration may be required in patients with blocked nasal passages during the first 2-3 days of therapy to ensure adequate penetration of the drug and to prevent loss of the drug from the nasal passages via excess secretions.
Prior to initial use, the nasal inhaler must be assembled and primed. After assembly is complete, the patient should tilt his head slightly forward, insert the spray tip into one nostril, and point the tip toward the inflamed nasal turbinates and away from the nasal septum. For maximum therapeutic effect and to ensure adequate penetration of the drug, the patient should pump the drug into one nostril while holding the other nostril closed and should concurrently inspire through the nose; this procedure is then repeated for the other nostril.
The manufacturer recommends cleansing the nasal adapter and/or pump in warm water if the holes in the device become clogged. If the nasal inhaler is disassembled for any reason (including the cleansing procedure) or not used for 5 days or longer, it must be primed again prior to use. Opened containers of flunisolide nasal solution should be discarded after 3 months.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FLUNISOLIDE 0.025% SPRAY | Maintenance | Adults spray 2 sprays in each nostril by intranasal route 2 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FLUNISOLIDE 0.025% SPRAY | Maintenance | Adults spray 2 sprays in each nostril by intranasal route 2 times per day |
The following drug interaction information is available for FLUNISOLIDE (flunisolide):
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, VOLUMEX |
| 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 FLUNISOLIDE (flunisolide):
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 FLUNISOLIDE (flunisolide):
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 20 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abdominal pain with cramps Cough Crusted nasal mucosa Dizziness Dysgeusia Epistaxis Headache disorder Hoarseness Lesion of nasal mucosa Lethargy Nausea Parosmia Rhinorrhea Sore throat Vomiting |
| Rare/Very Rare |
|---|
|
Growth failure Nasal candidiasis Nasal septal perforation Ocular hypertension Pharyngeal candidiasis |
There are 3 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dry nose Nasal passage irritation |
Sneezing |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for FLUNISOLIDE (flunisolide):
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 |
Flunisolide nasal solution 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, flunisolide has been shown to be teratogenic and fetotoxic in rabbits and rats at oral dosages of 40 and 200 mcg/kg per day, respectively. Teratogenic effects in these animals included cleft palate and reduced ossification, which are similar to observations noted with other corticosteroids.
Flunisolide 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 FLUNISOLIDE (flunisolide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FLUNISOLIDE (flunisolide)'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 |
| Allergic rhinitis prevention | |
| 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 |
| Chronic non-allergic rhinitis | |
| J31.0 | Chronic rhinitis |
| Perennial allergic rhinitis | |
| J31.0 | Chronic rhinitis |
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