Saturday 7 April 2012

ciclesonide Nasal


sye-KLES-oh-nide


Commonly used brand name(s)

In the U.S.


  • Omnaris

Available Dosage Forms:


  • Spray

Therapeutic Class: Anti-Inflammatory


Pharmacologic Class: Adrenal Glucocorticoid


Uses For ciclesonide


Ciclesonide nasal spray is used to treat the nasal symptoms caused by hay fever and allergies, such as sneezing, a runny or stuffy nose, irritation, and discomfort. Ciclesonide belongs to the family of medicines called steroids .


ciclesonide is available only with your doctor's prescription .


Before Using ciclesonide


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ciclesonide, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to ciclesonide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of ciclesonide in children below 6 years of age with seasonal allergic rhinitis, and in children below 12 years of age with perennial (year-round) allergic rhinitis. Safety and efficacy have not been established in these age groups .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ciclesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving ciclesonide .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of ciclesonide. Make sure you tell your doctor if you have any other medical problems, especially:


  • Cataracts, history of or

  • Glaucoma, history of—May make these conditions worse .

  • Herpes simplex (virus) infection of the eye or

  • Infections, active or untreated (fungus, bacteria, virus, parasite) or

  • Tuberculosis, active or history of—May cover up the signs of these conditions .

  • Nose injury or sores (recent) or

  • Nose surgery (recent)—May prevent proper healing of these conditions .

Proper Use of ciclesonide


Use ciclesonide only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects .


ciclesonide comes with patient instructions. Read and follow these instructions carefully.


Before using ciclesonide, clear the nasal passages by gently blowing your nose. Gently shake the bottle before each use. The pump of the spray must be primed before you use it for the first time. Read the patient instructions and ask your doctor if you have questions on how to do this .


ciclesonide is for use only in the nose. Do not get it in your eyes, on the nasal septum (the wall between the two nostrils), or on your skin. If it does get on these areas, rinse it off right away .


In order for ciclesonide to help you, it must be used regularly as ordered by your doctor. ciclesonide usually begins to work in about two days, but up to two weeks may pass before you feel the full effects .


Dosing


The dose of ciclesonide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ciclesonide. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For nasal spray dosage form:
    • For perennial allergic rhinitis:
      • Adults and teenagers—2 sprays in each nostril once a day.

      • Children below 12 years of age—Use and dose must be determined by your doctor .


    • For seasonal allergic rhinitis:
      • Adults and teenagers—2 sprays in each nostril once a day.

      • Children 6 years of age and older—2 sprays in each nostril once a day.

      • Children below 6 years of age—Use and dose must be determined by your doctor .



Missed Dose


If you miss a dose of ciclesonide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using ciclesonide


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it .


ciclesonide may weaken your immune system. Avoid being around people who are sick or have infections such as chickenpox or measles. Tell your doctor right away if you think you have been exposed to chickenpox or measles .


ciclesonide may also increase your risk of having infections or sores in your nose or throat. Check with your doctor right away if you notice any signs of a nose, sinus, or throat infection .


ciclesonide may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think this is a problem .


ciclesonide may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you have any of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while taking ciclesonide .


Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .


If your symptoms do not improve within a few days or if they become worse, check with your doctor .


ciclesonide Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Bloody nose

  • fever

  • headache

  • muscle aches

  • nasal discomfort

  • sore throat

  • stuffy or runny nose

  • unusual tiredness or weakness

Rare
  • Acne, pimples

  • blindness

  • blistering, burning, crusting, dryness, or flaking of skin

  • bloody mucus or unexplained nosebleeds

  • blurred vision

  • change in vision

  • darkening of the skin

  • decreased vision

  • diarrhea

  • difficulty with breathing or troubled breathing

  • difficulty with swallowing

  • dizziness

  • eye pain

  • fainting

  • hives

  • itching, scaling, severe redness, soreness, or swelling of skin

  • loss of appetite

  • loss of consciousness

  • loss of vision

  • menstrual changes

  • mental depression

  • nausea

  • reddening of the skin, especially around the ears

  • skin rash

  • swelling of the eyes, eyelids, face, or inside of the nose

  • tearing

  • tightness in chest

  • vomiting

  • weight gain around the face, neck, and trunk

  • wheezing

  • white patches inside the nose or throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Ear pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


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



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More ciclesonide Nasal resources


  • Ciclesonide Nasal Use in Pregnancy & Breastfeeding
  • Ciclesonide Nasal Drug Interactions
  • Ciclesonide Nasal Support Group
  • 4 Reviews for Ciclesonide Nasal - Add your own review/rating


  • Omnaris Prescribing Information (FDA)

  • Omnaris Monograph (AHFS DI)

  • Omnaris Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • Omnaris Consumer Overview



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