Zetonna (ciclesonide)

Zetonna Nasal Aerosol may cause serious side effects, including:

• nose bleeds and nasal ulcers. Call your healthcare provider right away if you start to have more nose bleeds or nasal ulcers.
• hole in the cartilage in the nose (nasal septal perforation). Stop using Zetonna Nasal Aerosol and call your doctor right away if you have symptoms of a nasal perforation. Symptoms of nasal perforation may include:
  • crusting in the nose
  • nosebleeds
  • runny nose
  • whistling sound when you breathe
• thrush (Candida), a fungal infection in your nose, mouth, or throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
• slow wound healing. You should not use Zetonna Nasal Aerosol until your nose has healed, if you have a sore in your nose, if you have had surgery in your nose, or if your nose has been injured.
• eye problems such as glaucoma and cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use Zetonna Nasal Aerosol.
• immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that may weaken your body's ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use Zetonna Nasal Aerosol. Symptoms of an infection may include:
  • fever
  • pain
  • aches
  • chills
  • feeling tired
  • nausea
  • vomiting
• adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Call your healthcare provider right away if you experience the following symptoms of adrenal insufficiency:
  • tiredness
  • weakness
  • dizziness
  • nausea
  • vomiting
• slowed or delayed growth in children. A child's growth should be checked regularly while using Zetonna Nasal Aerosol.
• allergic reactions. Call your healthcare provider right away if you experience swelling of the lips, tongue, or throat.

The most common side effects with Zetonna Nasal Aerosol include:

• Nasal discomfort
• Headache
• Nose bleeds

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Zetonna Nasal Aerosol.

For more information, ask your doctor or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Administration Information

• Administer Zetonna by the intranasal route only.
• Prior to initial use, Zetonna must be primed by actuating three times.
• If Zetonna is not used for ten consecutive days, it must be primed by actuating three times.
• If Zetonna is dropped, the canister and actuator may become separated. If this happens, reassemble Zetonna and test spray once into the air before using. Illustrated patient's instructions for proper use accompany each package of Zetonna.

Allergic Rhinitis

• Adults and Adolescents (12 Years of Age and Older): The recommended dose of Zetonna is 1 actuation per nostril once daily (37 mcg per actuation).
• The maximum total daily dosage should not exceed 1 actuation in each nostril (74 mcg per day).

In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions.

In a drug interaction study, co-administration of orally inhaled ciclesonide and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged. Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of ciclesonide.

• There are no adequate and well-controlled trials in pregnant women. Zetonna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known if ciclesonide is excreted in human milk. However, other corticosteroids are excreted in human milk.
• Caution should be used when Zetonna is administered to nursing women.