Zetonna (ciclesonide) for Allergies: Side Effects & Warnings

Generic drug: ciclesonide

Brand name: Zetonna

What is Zetonna (ciclesonide), and how does it work?

Treatment Of Allergic Rhinitis

Zetonna (ciclesonide) Nasal Aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

What are the side effects of Zetonna?

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.

What is the dosage for Zetonna?

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).

What drugs interact with Zetonna?

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.

Is Zetonna safe to use while pregnant or breastfeeding?

• 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.