Drug Interaction:
Corticosteroids Inhalational - Includes -
Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone Refer - Beclomethasone
Reports not available
Indication:
Seasonal or perennial rhinitis
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Flunisolide Allergic Rhinitis November 1993
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Flunisolide Respiratory Forest Labs 12-06-2007
Corticosteroids Inhalational -
Includes - Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone
Refer - Beclomethasone
Adverse Reaction:
Corticosteroids Inhalational -
Includes - Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone
Refer - Beclomethasone
Most common-
Mild nasopharyngeal irritatation, nasal irritation, ( budesonide 3% to 9% ), burning, stinging,,
dryness, headache
Other -
light headedness, nausea ( budesonide < 1% ) epistaxis ( budesonide 3% to 9% ),
bloody mucus, rebound congestion, bronchial asthma, occassional sneezing attacks
( more common in children)
rhinorrhea , anosmia or reduced sense of smell ( budesonide < 1 %)
loss of taste/bad in mouth ( budesonide < 1 %)
throat discomfort, ulceration of nasal mucosa , watery eyes, sore throat
Budesonide -pharyngitis, cough, increased ( 3% to 9% )
dry mouth, dyspepsia, (< 1 %)
nasal pain, facial edema, rash,pruritus, herpes simplex , alopecia, ( < 1% )
Contra-Indications:
Untreated localised infections involving the nasal mucosa, hypersensitivity to the drug
Warnings-
Systemic corticosteroids- combined admin. of alternate day systemic prednisolone with these products may increase the likelihood of HPA suppression. Therfore use with caution in patients already on alternate day prednisolone
During withdrawal from oral corticosteroids,some patients may experience symptoms
(joint or muscular pain, lassitude, depression ). Carefully monitor patients previously treated for prolonged corticosteroids and transferred to intranasal steroids to avoid adrenal insufficiency in response to stress.
Important in patients with asthma conditions or other conditions where too rapid a decrease in systemic corticosteroids may cause a severe excaberation of their symptoms
Hypersensitivity - rare casesf immediate and delayed hypersensitivity reactions including
angioedma and bronchospasm have occurred. Have epinephrine 1: 1000 immediately available
Pregnancy- use these agents during pregnancy only if the potential benefits outweigh the potential hazards to the fetus.
Lactation- Advice mothers taking pharmacologic doses not to nurse
Children- safety and efficacy in children < 6 years or < 12 yeras have not been established
Precautions-
Infections - when steroids are used in presence of infection, use proper anti-infective therapy
Wound healing- because of inhibitory effect of corticosteroids on wound healing , use nasal steroids with caution until healing has occurred.
Long term therapy- examine patients periodically over several months or longer for possible changes in nasal mucosa
Dosages/ Overdosage Etc:
Seasonal or perennial rhinitis
Dosage-
Starting dose is 2 sprays 50mcg in each nostril 2 times a day ( total dose 200mcg /day )
may increase to 2 sprays in each nostril 3 times a day ( total dose 300mcg/day )
Max. daily dose is 8 sprays in each nostril ( 400mcg/day )
Children- staring dose is 1 spray (25mcg ) in each nostril 3 times a day or
2 sprays ( 50mcg ) in each nostril 2 times a day ( total dose 150 to 200mcg/day)
Max. daily dose is 4 sprays in each nostril ( 200mcg/day )
Patient Information:
Corticosteroids Inhalational - Includes
Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone
Refer - Beclomethasone
1.Do not exceed the recommended dose
2. May cause irritation and drying of mucosa. Contact physician if symptoms do not improve , if the condition worsens, or if sneezing or nasal irritation occurs.
3. Clear nasal passage of secretion prior to use. If nasal passages are blocked , use a decongestant just before admin. to ensure adequate penetration of the spray.
4. Effects are not immediate. Benefits require reqular use and usually occurs within a few days
Pharmacology/ Pharmacokinetics:
Corticosteroids Inhalational - Includes
Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone
Refer - Beclomethasone
Interaction with Food:
Corticosteroids Inhalational - Includes
Beclomethasone,Budesonide , Dexamethasone, Flunisolide, Triamcinolone
Refer - Beclomethasone
Pregnancy and lactation:
Pregnancy-
use these agents during pregnancy only if the potential benefits outweigh the potential hazards to the fetus.
Lactation-
Advice mothers taking pharmacologic doses not to nurse
Children-
safety and efficacy in children < 6 years or < 12 yeras have not been established
Manufacturer Details