Potent inhibitors of CYP3A4 eg. ketoconazole, protease inhibitors

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

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

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 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

Use contraindicated. Observe caution