CNS depressants

Alcohol,

cimetidine

Irritation of the inflammed nasal mucosa, can occur with manifestation like stinging, itching and sneezing, in isolated cases nose bleeding and headache may occur.

Improper administration may cause bitter taste and nausea

Hypersensitivity to any of the ingredients,

Special precautions-

Avoid eyes, activities requiring mental alertness

Elderly,

Pregnancy. Lactation

Date of Approval      1997

Indication-

Perennial and seasonal allergic rhinitis

Dosage-

Adults and children over 5 years- 1 spray per nostril twice daily

Children below 5 years -Not recommended

 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Patients should be instructed to use Dymista Nasal Spray only as prescribed. For the proper use of the nasal spray and to attain maximum improvement, the patient should read and follow carefully the accompanying FDA-Approved Patient Labeling. 

Somnolence-                                                                                                     Somnolence has been reported in some patients (6 of 853 patients) taking Dymista Nasal Spray.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Dymista Nasal Spray 

 Concurrent Use of Alcohol and other Central Nervous System Depressants- Concurrent use of Dymista Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

 Local Nasal Effects-                                                                                                  Nasal corticosteroids are associated with nasal septal perforation and impaired wound healing.

Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use Dymista 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 Dymista Nasal Spray 

Immunosuppression-                                                                                               Patients who are on immunosuppressant 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, bacterial, viral or parasitic infections, or ocular herpes simplex 

 Priming-                                                                                                                  Patients should be instructed to shake the bottle gently before each use and prime the pump before initial use and when Dymista Nasal Spray has not been used for 14 or more days 

 Keep Spray Out of Eyes-                                                                                       Patients should be instructed to avoid spraying Dymista Nasal Spray into their eyes.

 Keep Out of Children’s Reach-                                                                              Patients should be instructed to keep Dymista Nasal Spray out of the reach of children. If a child accidentally ingests Dymista Nasal Spray, seek medical help or call a poison control center immediately.

Potential Drug Interactions-                                                                                   Patients should be advised that coadministration of Dymista Nasal Spray and ritonavir is not recommended and to be cautious if Dymista Nasal Spray is coadministered with ketoconazole . U.S. Patents 8,163,723; 8,168,620

Manufactured by: Cipla Ltd. Goa, India Distributed by:

Pharmacology:

Azelastine has a potent and selective H-receptor antihistaminic effect.

Besides, it inhibits the triggering of pathological reactions provoked by leukotrienes, calcium ions, and PAF.

Pregnancy:

Avoid use of azelastine nasal spray during the first trimester of pregnancy