Ciclesonide Nasal

Ciclesonide is a man-made steroid that prevents the release of substances in the body that cause inflammation.

Ciclesonide nasal (for the nose) is used to treat nasal symptoms (congestion, sneezing, runny nose) caused by seasonal allergies in adults and children as young as 6 years old. Ciclesonide nasal is also used to treat nasal symptoms caused by year-round allergies in adults and children who are at least 12 years old.

Ciclesonide may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to ciclesonide.

To make sure ciclesonide nasal is safe for you, tell your doctor if you have:

• asthma, tuberculosis, or other lung problems;
• any type of infection caused by bacteria, virus, fungus, or parasites;
• glaucoma, cataracts, or herpes infection of the eyes;
• a sore inside your nose that has not yet healed;
• a recent nose injury or surgery; or
• if you have recently used any other steroid medicine (methylprednisolone, prednisone, beclomethasone, fluticasone, dexamethasone, and others).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ciclesonide nasal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zetonna™ in children 12 years of age and older with seasonal and perennial allergic rhinitis. However, safety and efficacy have not been established in children younger than 12 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Omnaris™ in children younger than 6 years of age with seasonal allergic rhinitis, and in children younger than 12 years of age with perennial allergic rhinitis. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ciclesonide nasal spray 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 nasal spray.

Pregnancy

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. When you are taking ciclesonide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ciclesonide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using ciclesonide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Nadroparin
• Pixantrone

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—Use with caution. May make these conditions worse.

• Chicken pox (includes recent exposure) or
• Herpes simplex infection of the eye or
• Infections (bacteria, fungus, virus, or parasite), active or untreated or
• Measles (includes recent exposure) or
• Tuberculosis, active or history of—Can reduce the body's ability to fight infections.

• Injury to the nose or
• Nose surgery, recent or
• Sores or ulcers in the nose, recent—May prevent proper healing of these conditions.

Hypersensitivity to ciclesonide or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Active or quiescent tuberculosis infections of the respiratory tract.

Intranasal Blow nose to clear nostrils. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. Avoid spraying directly onto the nasal septum or into eyes. Discard after the "discard by" date or after labeled number of doses has been used, even if bottle is not completely empty.

Omnaris: Shake bottle gently before using. Prime pump prior to first use (press 8 times until fine mist appears) or if spray has not been used in 4 consecutive days (press 1 time or until a fine mist appears). Nasal applicator may be removed and rinsed with warm water to clean.

Zetonna: Use nasal canister with supplied nasal actuator only. Prime pump prior to first use (press 3 times until fine mist appears) or if spray has not been used in 10 consecutive days (press 3 times or until a fine mist appears). If canister and actuator become separated, spray 1 test spray in air before using. Clean outside of nose piece with a clean, dry tissue or cloth weekly; do not wash or put in water.

>10%:

Respiratory: Epistaxis (≤11%)

1% to 10%:

Central nervous system: Headache (3% to 7%)

Gastrointestinal: Nausea (≥2%)

Genitourinary: Urinary tract infection (≥2%)

Infection: Influenza (≥2%)

Neuromuscular & skeletal: Back pain (≥2%), strain (≥2%)

Otic: Otalgia (2%)

Respiratory: Nasopharyngitis (2% to 7%), nasal discomfort (3% to 6%), pharyngolaryngeal pain (≥3%), bronchitis (≥2%), cough (≥2%; may be dose-responsive), nasal septum disorder (≥2%; may be dose-responsive), oropharyngeal pain (≥2%), sinusitis (≥2%), streptococcal pharyngitis (≥2%), viral upper respiratory tract infection (≥2%), upper respiratory infection (≤2%)

<1% (Limited to important or life-threatening): Angioedema (with angioedema of the lips, angioedema of the oropharynx, and angioedema of the tongue), dizziness, dysgeusia, dyspepsia, leukocytosis, nasal candidiasis, nasal congestion, nasal mucosa ulcer, pharyngeal candidiasis, rhinorrhea, throat irritation, xerostomia

Adverse events were observed in some animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Intranasal corticosteroids may be used in the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP, 2005; Wallace, 2008).

You should not use this medicine if you are allergic to ciclesonide.

To make sure ciclesonide nasal is safe for you, tell your doctor if you have:

• asthma, tuberculosis, or other lung problems;

• any type of infection caused by bacteria, virus, fungus, or parasites;

• glaucoma, cataracts, or herpes infection of the eyes;

• a sore inside your nose that has not yet healed;

• a recent nose injury or surgery; or

• if you have recently used any other steroid medicine (methylprednisolone, prednisone, beclomethasone, fluticasone, dexamethasone, and others).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ciclesonide nasal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

If you switched to ciclesonide from another steroid medicine, do not stop using the other steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.

Ciclesonide nasal is usually used once per day. The usual dose of Omnaris is 2 sprays in each nostril once daily. The usual dose of Zetonna is 1 spray in each nostril once daily. Carefully follow your doctor's dosing instructions.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Shake the Omnaris bottle well just before each use.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the spray in your other nostril.

• Do not blow your nose for at least a few minutes after using the nasal spray.

• Do not use the nasal spray more than once in a 24-hour period.

• If the spray gets in your eyes or mouth or on your skin, rinse with water.

It may take up 2 to 5 weeks before your symptoms improve. Call your doctor if your symptoms do not improve, or if they get worse.

If you use this medicine long-term, you may need frequent eye exams.

Store this medicine in an upright position at room temperature, away from moisture and heat. Do not allow the medicine to freeze. Keep the spray bottle clean and dry.

Keep the Zetonna canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

Throw away the Omnaris nasal spray after you have used 120 sprays or 4 months after removing the bottle from the foil pouch, even if there is still medicine left in the bottle.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.