Ciclesonide

Ciclesonide is a prescription medication used to treat nasal symptoms from seasonal and year-round allergies. It is also used for the control and prevention of asthma in adults and children 12 years of age and older. Ciclesonide belongs to a group of drugs called synthetic corticosteroids, which reduce inflammation. Inflammation is a common factor in allergic and asthma symptoms.

This medication comes in the form of a nasal spray and is usually taken once a day.

This medication also comes in an aerosol inhalation form and is taken twice a day.

Common side effects of ciclesonide nasal spray include headache, nose bleeds, and stuffy nose.

Common side effects of ciclesonide inhalation include headache, swelling of nose and throat, and swelling of the sinuses.

Ciclesonide is a prescription medication used to treat nasal symptoms from seasonal and year-round allergies. It is also used for the control and prevention of asthma in adults and children 12 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ciclesonide may be found in some form under the following brand names:

• Alvesco

• Omnaris

• Zetonna

Common side effects with ciclesonide nasal spray include:

• headache
• nose bleeds
• stuffy nose
• ear pain
• sore throat
• dizziness

Common side effects with ciclesonide inhalation include:

• headache
• swelling of nose and throat 
• swelling of the sinuses 
• throat pain
• upper respiratory infection
• joint pain (arthralgia)
• nasal congestion
• pain in arms, legs, and back

See "Drug Precautions" section for other risks of using ciclesonide.

These are not all the possible side effects of ciclesonide. Tell your healthcare provider about any side effects that bother you or do not go away.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take ketoconazole (Nizoral).

Some serious side effects have occurred with ciclesonide nasal spray include:

• Nasal fungal infection.
• Slow healing of wounds. Do not use ciclesonide nasal spray until your nose has healed, if you have a sore in your nose, you have had surgery on your nose, or your nose has been injured.
• Eye problems, including glaucoma and cataracts. You should have regular eye exams. Tell your doctor if you notice a change in vision while using ciclesonide nasal spray.
• Immune system effects may increase your risk of infection. You should avoid being around people with Chicken Pox or Measles.
• Slow growth in children. A child taking ciclesonide should have his/her growth checked regularly.

• Increased wheezing (bronchospasm) can happen right away after using ciclesonide inhalation. Stop using ciclesonide inhalation and use an inhaled fast-acting bronchodilator (rescue inhaler) right away. Tell your healthcare provider right away so that a new medicine can be prescribed to control your asthma.

• Decreased bone mass (bone mineral density). People who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass which can affect bone strength. Talk to your healthcare provider about any concerns you may have about bone health.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ciclesonide there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving ciclesonide, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to ciclesonide, or any other medication
• have or have ever had:
  • tuberculosis
  • cataracts
  • glaucoma
  • untreated infection
  • herpes infection
• are pregnant or plan to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if ciclesonide is excreted in human breast milk or if it will harm your nursing baby. 

Use your nasal spray exactly as prescribed by your healthcare provider.

Seasonal allergy symptoms may improve over 1 to 2 weeks; year-round allergy symptoms may improve over 5 weeks. If your symptoms do not improve or get worse, call your healthcare provider.

Patient's Instructions for Use

Ciclesonide nasal spray is supplied in an amber glass bottle in a protective plastic sleeve and should be handled with care.

Preparing For Use

1. Remove ciclesonide nasal spray from its foil pouch. Count 4 months from today and write this new date on the sticker on the carton (the date that is 4 months after removing the bottle from the foil pouch). Peel off the sticker and place it in the space on your nasal spray bottle. It is important that you throw away the nasal spray bottle after this date.
2. Priming ciclesonide nasal spray. Before you use ciclesonide nasal spray for the first time, you will need to prime the bottle. Hold the bottle upright and shake the bottle gently. To prime ciclesonide nasal spray, fully press down on the finger rests of the applicator eight times. If you do not use the nasal spray for 4 days, you will need to shake the bottle gently, and prime the pump again by spraying one time, or until you see a fine mist.

Using the Spray

1. Blow your nose to clear your nostrils, if needed.
2. Shake the bottle gently and remove the dust cap.
3. Hold the bottle firmly with your index and middle finger on either side of the applicator (on finger rests) while supporting the base of the bottle with your thumb.
4. Insert applicator tip into one nostril, and close the other nostril with your finger.
5. Tilt your head forward slightly. Keep the bottle upright, and press the finger rests quickly and firmly to activate the pump. Breathe in (inhale) through your nose as you spray. Try not to get any spray in your eyes or directly on your nasal septum (the wall between the two nostrils).
6. Repeat steps 3-5 for the second spray in the same nostril and for each spray in the other nostril.

Each bottle of ciclesonide nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use a bottle of ciclesonide nasal spray after 120 sprays (not counting the priming sprays) have been used or after the “discard by date” you wrote on the sticker when you opened the foil pouch. You may still see some medicine in the bottle. Talk with your healthcare provider before your supply of ciclesonide nasal spray runs out to see if you should get a refill of your medicine.

Applicator Cleaning Instructions

Wipe the applicator tip with a clean tissue and replace the dust cap, after you use your nasal spray each day.

If the applicator is clogged or needs more thorough cleaning, use the following cleaning instructions (Do not try to unblock the tiny spray hole on the applicator with a pin or other sharp object. Do not twist or try to remove the white plastic pump attached to the medicine bottle.):

1. Remove the dust cap, hold the white plastic pump firmly with one hand and then carefully pull upwards to free the applicator.
2. Wash the dust cap and applicator with warm water.
3. Dry the applicator, and put it back on the bottle. The applicator will snap into place when properly positioned.
4. Prime the unit with one spray or until you see a fine mist.
5. Put the dust cap back on the applicator.

Use your ciclesonide inhalation exactly as prescribed by your healthcare provider.

Priming your ciclesonide inhalation for use

• Remove your ciclesonide inhalation from its package.
• Before you useciclesonide inhalation for the first time or if you have not used your medicine for 10 days in a row, you will need to prime your unit.
• Remove the plastic cap.
• Hold the actuator upright. Spray 3 times into the air away from the face, by pressing down fully onto the center of the dose indicator button.
• Make sure the canister is firmly placed in the mouthpiece each time you use your ciclesonide inhalation.
• You do not need to shake your ciclesonide inhalation unit before you use it.

Using your ciclesonide inhalation

1. Remove the cap from the mouthpiece.
2. Hold the actuator upright, between your thumb, forefinger, and middle finger with the mouthpiece pointing towards you.
3. Breathe out as fully as you comfortably can. Close your lips around the mouthpiece, keeping your tongue below it.
4. While breathing in deeply and slowly, press down on the center of the dose indicator with your finger. Press down fully on the canister until it stops moving in the actuator while delivering your dose.
   • When you have finished breathing in, hold your breath for about 10 seconds, or for as long as is comfortable.
   • Note: It is normal to hear a soft click from the indicator as it counts down during use.
5. Take your finger completely off the center of the dose indicator and remove the inhaler from your mouth. Breathe out gently.
6. Replace the cap to keep the mouthpiece clean.
7. Rinse your mouth with water and spit it out. Do not swallow.

Ciclesonide nasal spray:

• Use 1 time each day, 2 sprays in each nostril.
• Do not use more than a total of 2 sprays in each nostril each day.

Ciclesonide inhalation:

• Use inhaler twice daily, one or two inhalations at a time depending on the dose prescribed.

If you take too much ciclesonide call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If ciclesonide is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Ciclesonide nasal spray:

• Keep clean and dry at all times.
• Store between 59° F and 86° F.
• Do not freeze.
• Keep this medication and all medicines out of the reach of children.

Ciclesonide inhalation:

• Store at room temperature between 59°F to 86°F (15°C to 30°C)
• Do not puncture the inhalation aerosol canister
• Do not store the near heat or a flame. Temperatures above 120°F (49°C) may cause the canister to burst.
• Do not throw the canister into a fire or an incinerator.
• Safely throw away medicine that is out of date or no longer needed.
• Keep clean and dry at all times.
• Keep this medication and all medicines out of the reach of children.