Glaxo Receives Approval For Flonase

31 October 1994

The US Food and Drug Administration has approved Glaxo's Flonase (fluticasone propionate) nasal spray for the treatment of seasonal and perenial allergic rhinitis. The company added that it should not be used for nonallergic rhinitis since there is no data to support its use.

The starting dose is two sprays in each nostril once-daily. Each spray delivers 50mcg of the drug. For maintenance treatment, said the company, the dose may be reduced to a total of 100mcg per day. Patients should use Flonase at regular intervals as directed, added Glaxo, since its effectiveness depends on its regular use.

The drug was effective and well tolerated at recommended doses in US studies involving more than 2,400 patients. Side effects included nasal burning, irritation, nosebleeds and headaches, which are "similar to those seen with other widely- used prescription nasal sprays," said the company.

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