OSONIDE
SUN PHARMA
Cicilesonide 80mcg/ 160mcg per metered dose inhaler,
Strength | Rate | Packing Style |
---|---|---|
80mcg | 254.52 | met. dose inhaler |
160mcg | 307.52 | met.dose inhaler |
List of Related Indications:
- Asthma
List Of Drugs:
- Ciclesonide - Intranasal - Respiratory Inhalant Products- (FDC-List) (Feb 2006)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pregnancy and lactation
Drug Interaction:
Potent inhibitors of CYP3A4 eg. ketoconazole, protease inhibitors
Indication:
Adverse Reaction:
Paradoxical bronchosapsm Hoarseness, bronchitis,
URTI Sore throat, flu syndrome,
Back pain, sinusitis Chest pain,
Potential systemic corticosteroid effects with dose during long term use
Decreased bone mineral density
Cataract Glaucoma
Sports events - restricted /banned
Contra-Indications:
Status asthmaticus, acute asthma
Special precautions
Active or quiescent pulmonary tuberculosis fungal or viral infetction Hepatic impairment
Elderly Transfer from systemic steroids Monitor pulmonary functions Withdraw slowly
Monitor height of children on prolonged therapy
Pregnancy Lactation
Dosages/ Overdosage Etc:
Indication-
Prophylaxis of persistent asthma
Dosage-
160mcg once daily preferably in the evening In severe cases - 320mcg twice daily
Reduce to minimum effective dose
Not recommended for children below 12 years
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling accompanying the product
1.Local Nasal Effects- Patients should be informed that treatment with OMNARIS Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with OMNARIS Nasal Spray. In addition, nasal corticosteroids are associated with nasal septal perforation and impaired wound healing. Avoid spraying OMNARIS Nasal Spray directly onto the nasal septum.
Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use OMNARIS Nasal Spray until healing has occurred.
Cataracts and Glaucoma- Patients should be informed that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform his/her health care provider if a change in vision is noted while using OMNARIS Nasal Spray
Immunosuppression- Patients who are on immunosuppressive doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and if exposed, to consult their physician without delay.
Patients should be informed of potential worsening of existing tuberculosis, fungal, 661 bacterial, viral or parasitic infections, or ocular herpes simplex.
Patients should use OMNARIS Nasal Spray at regular intervals since its effectiveness depends on its regular use. In clinical trials, the onset of effect was seen within 24 to 48 hours with further symptomatic improvement observed over 1 to 2 weeks in seasonal allergic rhinitis and 5 weeks in perennial allergic rhinitis.
Initial assessment of response should be made during this timeframe and periodically until the patients’ symptoms are stabilized. The patient should take the medication as directed and should not exceed the prescribed dosage
The patient should contact the physician if symptoms do not improve by a reasonable time or if the condition worsens.
Keep Spray Out of Eyes- Patients should be informed to avoid spraying OMNARIS Nasal Spray in their eyes.
Storage and Handling- It is important that the bottle is gently shaken prior to use to ensure that a consistent amount is dispensed per actuation. The bottle should be discarded after 120 actuations following initial priming or after 4 months after the bottle is removed from the foil pouch, whichever occurs first.
Manufactured for: 684 Sepracor Inc. 685 Marlborough, MA 01752 USA 686
Made in Germany 687 OMNARIS is a registered trademark of Nycomed GmbH and is used with permission. 688 For customer service, call 1-888-394-7377 689 To report adverse events, call 1-877-737-7226 690
For medical information, call 1-800-739-0565 691 692 901128R02 693 Month Year 694 695 F.1/USA/0609/6016300
Pregnancy and lactation:
Use contraindicated. Observe caution