Antiallergic Drugs

National Institute of Allergy and Respiratory Diseases

Drugs used for the temporary relief of the symptoms and allergy caused by allergic rhinitis, hay fever and allergy symptoms.

Cetirizine Hydrochloride 10 mg Tablets

Cetirizine Hydrochloride 10 mg film-coated tablets

Generic Name: Cetirizine Hydrochloride

Information For The User

Read all of this leaflet carefully before you start taking this medicine.

  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What Cetirizine is and what it is used for

Cetirizine belongs to a group of anti-allergy medicines. It helps you control your allergic reaction and its symptoms.

In adults and children aged 6 year and above, Cetirizine is indicated

  • for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
  • for the relief of chronic nettle rash (chronic idiopathic urticaria).

2. Before you use Cetirizine

Do not take Cetirizine

• if you are allergic (hypersensitive) to Cetirizine hydrochloride, to any of the other ingredients of Cetirizine tablets, to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines);

• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min).

Take special care with Cetirizine

If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor.

If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.

If you take Cetirizine over a long period of time it may lead to an increased risk of tooth decay due to mouth dryness. Oral hygiene is therefore very important.

If you plan having an allergy skin test made. The use of Cetirizine should be interrupted at least 3 days prior to skin tests.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Due to the profile of Cetirizine, no interactions with other drugs are expected.

Taking Cetirizine with food and drink

Food does not affect noticeably the absorption of Cetirizine.

No interactions susceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and Cetirizine used at the normal doses. However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.

Pregnancy and breast-feeding

There is limited experience of the use of Cetirizine in pregnant women. Cetirizine should therefore be used with caution during pregnancy. Tell your doctor if you are pregnant or think that you are pregnant.

Cetirizine passes into breast milk. Cetirizine should therefore be used with caution during breast-feeding. Tell your doctor if you are breast-feeding.

Driving and using machines

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine at the recommended dose.

If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose. You should closely observe your response to the drug. If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.

Important information about some of the ingredients of Cetirizine tablets

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

3. How to use Cetirizine

Always take Cetirizine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How and when should you take Cetirizine

These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine.

Please follow these instructions, otherwise Cetirizine may not be fully effective.

Tablets need to be swallowed with a glass of liquid.

Adults and adolescents over 12 years of age

10mg once daily as 1 tablet.

Children between 6 and 12 years of age

5mg twice daily as a half tablet twice daily.

Patients with moderate renal Impairment

Patients with moderate renal impairment are recommended to take 5mg once daily.

If you feel that the effect of Cetirizine is too weak or too strong, please consult your doctor.

Duration of treatment:

The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor.

If you take more Cetirizine than you should

If you think you have taken an overdose of Cetirizine, please inform your doctor.

Your doctor will then decide what measures, if any, should be taken.

After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, ailing, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.

If you forget to take Cetirizine

Do not take a double dose to make up for a forgotten dose. Continue with the normal prescribed dose.

If you stop taking Cetirizine

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Cetirizine: Possible side effects

Like all medicines, Cetirizine can cause side effects, although not everybody gets them.

Following side effects have been reported in post marketing experience.

Common side effects (more than 1 in 100 patients, but less than 1 In 10 patients):

- Dizziness - Headache
- Sleepiness - Fatigue
- Dry mouth - Nausea
- Diarrhoea - Pharyngitis
- Rhinitis (swelling and irritation inside the nose)

Uncommon side effects (more than 1 in 1,000 patients, but less than 1 in 100 patients):

- Agitation - Paraesthesia (feeling of pins and needles)
- Abdominal pain
- Rash - Pruritus (itching)
- Malaise (vague illness) - Asthenia (feeling of weakness)

Rare side effects (more than 1 In 10,000 patients, but less than 1 in 1,000 patients):

- Allergic reactions - Aggression
- Confusion - Depression
- Insomnia (difficulty in sleeping) - Hallucination
- Fits - Movement disorders
- Changes in liver function - Rapid heart beat
- Swelling - Hives
- Weight increased

Very rare side effects (less than 1 In 10,000 patients):

- Thromrjocytopenia (bleeding or bruising easily) - Life-threatening allergic reaction, including angioedema (which causes swelling of the face or throat)
- Fainting
- Tremor - Dysgeusia (altered taste in the mouth)
- Tic
- Difficulty focussing - Blurred vision
- Oculogyration (eyes having uncontrolled circular movements) - Fixed drug eruption
- Abnormal elimination of urine

Not known: (cannot be estimated from the available data):

- memory loss, memory impairment If you develop one of the side effects described above, please inform your doctor. At the first signs of a hypersensitivity reaction, stop taking Cetirizine. Your doctor will then assess the severity and decide on any further measures that may be necessary.

You should stop taking Cetirizine and see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty swallowing, hives and difficulty breathing.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Cetirizine tablets

Keep out of the reach and sight of children.

Do not use Cetirizine tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Cetirizine tablets: Further information

What Cetirizine tablets contains

- The active substance is Cetirizine hydrochloride. Each film-coated tablet contain 10 mg Cetirizine hydrochloride.

- The other ingredients are lactose monohydrate, crospovidone, pregelatinised starch (maize), magnesium stearate, hypromellose, titanium dioxide and macrogol (400).

What Cetirizine tablets look like and contents of the pack

White to off-white, film-coated, off-rectangular tablets, debossed with “X” on one side with ’20′ on the other side. Score line between ’2′ and ’0′. The tablet can be divided into equal halves.

PVC-PVDC Aluminium blisters:

1, 2, 7,10,14,15, 20, 21, 30, 50, 60, 90, 98 and 100 film-coated tablets

HDPE bottle:

250 film-coated tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

46/2, South street, Valletta, VLT11, Malta

Manufacturer

Milpharm Limited

Ares, Odyssey Business Park, West End Road,

South Ruislip HA4 6QD, United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

 

Austria: Cetirizin Aurobindo 10 mg Filmtabletten
Belgium: Cetirizine Aurobindo 10 mg filmomhulde tabletten
Bulgaria: Cetirizine Aurobindo 10 mg филмирани таблетки
Czech Republic: Cetirizine Aurobindo 10 mg potahované tablety
Denmark: Cetirizin “Aurobindo”
Finland: Cetirizin Aurobindo 10 mg kalvopäällysteinen tabletti
Germany: Cetirizin Aurobindo 10 mg Filmtabletten
Greece: Cetirizine Aurobindo 10 mg ετπκαλυμμένα με λετττό υμένιο δισκΐα
Hungary Cetirizine Aurobindo 10 mg filmtabletta
Ireland: Cetirizine Aurobindo 10 mg film-coated tablets
Italy: Cetirizina Aurobindo 10 mg, compresse rivestite con film
Lithuania: Cetirizin Aurobindo 10 mg plévele dengtos tabletas
Netherlands: Cetirizine diHCl Aurobindo 10 mg, filmomhulde tabletten
Norway: Cetirizin Aurobindo 10 mg filmdrasjerte tabletter
Poland: Cetirizine Aurobindo
Portugal: Cetirizina Aurobindo
Romania: Cetirizin Aurobindo 10 mg comprimate fílmate
Slovak Republic: Cetirizine Aurobindo 10 mg filmom obalené tablety
Slovenia: Cetirizine Aurobindo 10 mg filmsko oblozene tablete
Spain: Cetirizina Aurobindo 10 mg comprimidos recubiertos con película
Sweden: Cetirizine Aurobindo 10 mg filmdragerade tabletter
United Kingdom: Cetirizine hydrochloride 10 mg film-coated tablets

 

 

Clarityn Allergy Syrup [Loratadine] 1mg / ml

Clarityn Allergy Syrup 1mg / ml

Generic Name: Loratadine

This medicine is available without prescription, however you will still need to take Clarityn Allergy syrup carefully to get the best results from it.

  • Ask your pharmacist if you need more information or advice.
  • You must contact a doctor if your symptoms worsen or do not improve.
  • If you develop serious side effects or you notice any not listed in this leaflet, please tell your doctor or pharmacist.

1. What Clarityn Allergy Syrup Is And What It Is Used For

Clarityn Allergy syrup belongs to a class of medicines known as antihistamines. Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body. The syrup relieves symptoms associated with allergic rhinitis (for example, hayfever) such as sneezing, runny or itchy nose and burning or itchy eyes. The syrup may also be used to help relieve symptoms of urticaria (itching and redness), which is often known as hives or nettle rash.

2. Before You Take Clarityn Allergy Syhup

Do not take Clarityn Allergy syrup

  • If you are allergic (hypersensitive) to loratadine or any of its other ingredients
  • If you are pregnant or breastfeeding

Take special care with Clarityn Allergy syrup

Before taking this syrup, tell your doctor or pharmacist if you have liver disease.

Taking other medicines

If you are taking any other medicines, including medicines taken without a prescription, please consult your pharmacist or doctor before use.

Laboratory tests:

If you are scheduled to have any skin tests for allergies, you should not take this syrup for two days before.

Taking Clarityn Allergy syrup with food and drink

The syrup can be taken with or without a meal. The syrup has not been shown to add to the effects of an alcoholic drink.

Driving and using machinery

At the recommended dose the syrup is not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machinery.

Important information about the ingredients of Clarityn Allergy syrup

This syrup contains sucrose. If you have an intolerance to some sugars, please speak to your pharmacist or doctor before taking this medicine.

3. How To Take Clarityn Allergy Syrup

Giving this medicine to children:

It is important to know how much your child weighs to make sure that you give the correct amount of medicine. For example, a 9 year old child weighs about 30kg (4st 71b). If in doubt weigh your child and then follow the instructions in the table. Do not give to children under 2 years.

Age How much to take How often to take
Adults and children over 12 years 2 x 5 ml spoonfuls Once daily
Children of 2 to 12 years who weigh more than 30kg (4st 7lb) 2 x 5 ml spoonfuls Once daily
Children of 2 to 12 years who weigh less than 30kg (4st7lb) 1x 5 ml spoonful Once daily
If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you follow their instructions.

If you take more syrup than you should

No serious problems are expected with accidental overdose. However, if you take more syrup than recommended contact your pharmacist or doctor.

If you forget to take your syrup

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking your syrup

If you have any further questions on the use of this product ask your pharmacist or doctor.

4. Clarityn Allergy Syrup: Possible Side Effects

Like all medicines Clarityn Allergy syrup can cause side effects, although not everybody gets them.

Patients have very rarely experienced hypersensitive reactions, such as difficulty in breathing, swelling of the face, neck, tongue or throat after use of this product. If you experience any of these side effects stop taking the syrup and contact your pharmacist or doctor at once.

The most commonly reported side effects in children aged 2 through 12 years include headache, nervousness and tiredness. The most commonly reported side effects in adults and adolescents include drowsiness, headache, increased appetite and difficulty sleeping.

Other side effects reported very rarely were dizziness, irregular or rapid heart beat, nausea (feeling sick), dry mouth, upset stomach, liver problems, hair loss, rash and tiredness. If you develop serious side effects or you notice any not listed in this leaflet, please tell your doctor or pharmacist.

5. How To Store Clarityn Allergy Syrup

Do not freeze. Store in original container.

6. Further Information

What Clarityn Allergy syrup contains

The active substance is loratadine 1 mg/ml

The other ingredients of the syrup are propylene glycol, glycerol (E422), sucrose, citric acid monohydrate, sodium benzoate (E211), artificial peach flavouring, purified water.

What Clarityn Allergy syrup looks like and contents of the pack

The pack contains 100ml of clear colourless to light yellow syrup.

Marketing Authorisation Holder and Manufacturer

MAH:

Merck Sharp & Dohme Limited

Hertford Road Hoddesdon

Hertfordshire, EN119BU UK

Manufacturer:

Schering-Plough Labo NV

Heist-op-den Berg

Belgium

 

Submission 1.1 Code 06U210035IN
Productname Clarityn Allergy Syrup
Concentration 1 mg/ml
Presentation 100 ml

 

 

 

Zetonna (Ciclesonide): Instructions for Use

Generic Drug Name: Ciclesonide

Zetonna Nasal Aerosol

«Ze toe’ nah»

Read these Instructions for Use for Zetonna Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

Note: For Use in the Nose Only.

• Do not spray Zetonna Nasal Aerosol in your eyes or directly onto your nasal septum (the wall between your 2 nostrils).

• Do not use your Zetonna Nasal Aerosol near heat or an open flame.

The Parts of Your Zetonna Nasal Aerosol

Zetonna Nasal Aerosol comes as a canister fitted into a nasal actuator with a dose indicator. Do not use the actuator with a canister of medicine from any other inhaler. Do not use the Zetonna Nasal Aerosol canister with an actuator from any other inhaler. (See Figure A)

Priming Your Zetonna Nasal Aerosol For Use

• Remove Zetonna Nasal Aerosol from its package.

• Before you use Zetonna Nasal Aerosol for the first time or if you have not used your medicine for 10 days in a row, you will need to prime your Zetonna Nasal Aerosol.

• Open the purple plastic dust cap by gently squeezing both sides and pulling the cap away from the nasal actuator. Hold the nasal actuator upright.

(See Figure B)

• Spray 3 times into the air away from the face, by pressing down fully on the top of the canister three times (See Figure C). Make sure the canister returns to its original position after each spray.

Using Your Zetonna Nasal Aerosol

Step 1.Open the purple plastic dust cap.

Step 2.Hold the nasal actuator upright, with the nose piece pointing upwards, between your thumb and forefinger (and middle finger) (See Figure D).

Step 3.Tilt your head back slightly and insert the end of the nose piece into 1 nostril, pointing it slightly toward the outside nostril wall away from the nasal septum (the wall between the 2 nostrils), while holding your other nostril closed with 1 finger (See Figure E). Do not get any spray in your eyes or directly on your nasal septum.

Step 4.Press down on the canister to release 1 spray and at the same time breathe in gently through the nostril. Hold your breath for a few seconds then breathe out slowly through your mouth.

Step 5.Remove the nose piece from your nostril. Make sure the canister has returned to its original position and repeat steps 2-4 for the second spray in your other nostril.

Step 6.Replace the protective purple dust cap on the nasal actuator.

Step 7.Avoid blowing your nose for the next 15 minutes.

Cleaning Your Nasal Actuator

The outside of the nose piece should be cleaned weekly, by wiping with a clean, dry tissue or cloth (see Figure F).

Do not wash or put any part of the Zetonna Nasal Aerosol canister or actuator in water.

How to Tell if Your Zetonna Nasal Aerosol Is Empty

• Each canister of Zetonna Nasal Aerosol contains enough medicine for you to spray medicine 60 times (or 30 times for sample size product). This does not count the first 3 priming sprays.

• The actuator of your Zetonna Nasal Aerosol is fitted with a dose indicator which shows you how much medicine is left after each use. The dose indicator will display the number of sprays remaining in groups of 5 or 10 actuations.

• The display window will begin showing a green color. As you continue to use the medicine, the window will show a yellow color. A yellow color in the window means that you need to replace your medicine soon. When the medicine is almost empty, the window will show a red color.

• When the window shows red and you see the dose indicator read zero, “0″ (see Figure G), you should throw away the canister and nasal actuator.

• Do not throw your Zetonna Nasal Aerosol canister in the fire or an incinerator.

• Do not use your Zetonna Nasal Aerosol after zero is shown in the window of the dose indicator even though it may look like there is medicine left in the canister. You may not get the right amount of medicine.

• Talk with your healthcare provider before your supply of Zetonna Nasal Aerosol runs out to see if you should get a refill of your medicine.

What to Do if You Drop Your Zetonna Nasal Aerosol

• If you drop your Zetonna Nasal Aerosol, the canister may become separated from the actuator. If this happens, insert the canister into the actuator as shown in Figure H, test spray once into the air away from your face, then use as described above.

• If the Zetonna Nasal Aerosol is dropped, the dose counter may not work. It is recommended to keep track of the number of sprays taken from your Zetonna Nasal Aerosol based on your records.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for:

Sunovion Pharmaceuticals Inc.

Marlborough, MA 01752 USA

Made in the United Kingdom

 

Zetonna (Ciclesonide)

Generic Drug Name: Ciclesonide

Zetonna Nasal Aerosol

«Ze toe’ nah»

Note: For Use in the Nose Only.

• Do not spray Zetonna Nasal Aerosol in your eyes or directly onto your nasal septum (the wall between the 2 nostrils).

• Do not use your Zetonna Nasal Aerosol near heat or an open flame.

Read this Patient Information leaflet before you start using Zetonna Nasal Aerosol and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about Zetonna Nasal Aerosol, ask your healthcare provider or pharmacist.

What is Zetonna Nasal Aerosol?

Zetonna Nasal Aerosol is a prescription medicine that treats seasonal and year-round allergy symptoms in adults and children 12 years of age and older. Zetonna Nasal Aerosol contains ciclesonide, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body and reduce inflammation. When you spray Zetonna Nasal Aerosol into your nose, it may help reduce nasal symptoms of allergic rhinitis (inflammation of the lining of the nose) such as stuffy nose, runny nose, itching and sneezing. Zetonna Nasal Aerosol may also help you if you have red, itchy, and watery eyes.

It is not known if Zetonna Nasal Aerosol is safe and effective in children 11 years of age and younger.

Who should not use Zetonna Nasal Aerosol?

Do not use Zetonna Nasal Aerosol if you are allergic to ciclesonide or any of the ingredients in Zetonna Nasal Aerosol. See the end of this Patient Information leaflet for a complete list of ingredients in Zetonna Nasal Aerosol.

What should I tell my healthcare provider before using Zetonna Nasal Aerosol?

Before you use Zetonna Nasal Aerosol tell your healthcare provider if you:

• have had recent nose problems such as a hole in the cartilage of your nose, nasal ulcers, nasal surgery, or nasal injury.

• have or have had eye problems such as increased intraocular pressure, glaucoma, or cataracts.

• have any infections including tuberculosis or ocular herpes simplex.

• have not had or been vaccinated for chicken pox or measles.

• are pregnant or plan to become pregnant. It is not known if Zetonna Nasal Aerosol will harm your unborn baby. Talk to your healthcare provider about the best way to feed your baby if you are using Zetonna Nasal Aerosol.

• are breastfeeding or plan to breastfeed. It is not known if Zetonna Nasal Aerosol passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using Zetonna Nasal Aerosol.

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

Know the medicines you take. Keep a list of them to show your doctors and pharmacist when you get a new medicine.

How should I use Zetonna Nasal Aerosol?

• Read the Instructions for Use at the end of this leaflet for specific information about the right way to use Zetonna Nasal Aerosol.

• Use Zetonna Nasal Aerosol exactly as your healthcare provider tells you to use it. Do not take more of your medicine or take it more often than your healthcare provider tells you.

• Zetonna Nasal Aerosol is used 1 time each day, 1 spray in each nostril. Do not use more than a total of 1 spray in each nostril per day.

• Zetonna Nasal Aerosol may begin to work within 36 hours after you take your first dose. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.

• If your symptoms do not improve or get worse, call your healthcare provider.

What are the possible side effects of Zetonna Nasal Aerosol?

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.

How should I store Zetonna Nasal Aerosol?

• Store Zetonna Nasal Aerosol at room temperature between 59°F and 86°F (15°Cto30°C).

• Do not puncture the Zetonna Nasal Aerosol canister.

• Do not store the Zetonna Nasal Aerosol canister near heat or a flame. Temperatures above 120°F (49°C) may cause the canister to burst.

• Do not throw the Zetonna Nasal Aerosol canister into a fire or an incinerator.

• Safely throw away medicine that is out of date or no longer needed.

• Keep Zetonna Nasal Aerosol clean and dry at all times.

Keep Zetonna Nasal Aerosol and all medicines out of the reach of children.

General Information About the Safe and Effective Use of Zetonna Nasal Aerosol

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Zetonna Nasal Aerosol for a condition for which it was not prescribed. Do not give Zetonna Nasal Aerosol to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about Zetonna Nasal Aerosol. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Zetonna Nasal Aerosol that is written for health professionals. You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

For more information, go to www.Zetonna.com or call 1-888-394-7377.

What are the ingredients in Zetonna Nasal Aerosol?

Active ingredient: ciclesonide

Inactive ingredients: HFA propellant and ethanol

 

Pharmacoeconomic Considerations

The economic impact of allergic rhinitis is enormous. The direct costs have grown significantly over the past few years because of the increasing use of peripherally selective antihistamines and nasal steroids. The most recent detailed review estimated expenditures of $3.4 billion annually in the United States, with the majority of this cost attributed to prescription medications and outpatient visits. Of prescribed medications, 51% were peripherally selective antihistamines, 25% intranasal steroids, and 5% were older antihistamines. A total of 58% of patients received one or more agents. The mean prescription medication expenditure was $103 per patient for those on Medicaid, $155 with private insurance, and $69 for patients with no insurance. These figures do not include expenditures for non-prescription medications. With various brands and generic equivalents of nonprescription nonsedating products being heavily marketed to consumers, one would guess that usage of these agents would greatly increase. How this will affect the prescription market is unknown.

Direct-to-consumer advertising for prescription-only allergic rhinitis treatment options has also increased significantly. Indirect costs related to missed school or work days and loss of productivity may approach the amount for the direct costs.

The most cost-effective choice of treatment for allergic rhinitis is an individualized decision. Seasonal allergic rhinitis patients who see improvement and can tolerate nonprescription and/or generic anti-histamines will experience the least impact on out-of-pocket medical and drug expenses. If these are not effective, the economic picture becomes more complicated. Choices should follow the logical path based on symptoms, tolerance, and efficacy, as described earlier in this chapter.

Evaluation of therapeutic outcomes

With allergic rhinitis, the major outcomes issues include the effect of the disease on a patient’s life, the efficacy and tolerability of treatment, and patient satisfaction. Consideration must be given to how the condition is affecting the patient’s job or school performance, family and social interactions, and other aspects of quality of life. The drug therapy should prevent or minimize symptoms with minimal or no adverse effects. The patient should not have difficulty obtaining needed medication for financial or other reasons. Patients should be questioned about their satisfaction with the management of their allergic rhinitis. The management should result in minimal disruption to their lives.

Both the Medical Outcomes Study 36-Item Short Form Health Survey and the Rhinoconjunctivitis Quality of Life Questionnaire have been used to evaluate outcomes of treatment for seasonal and perennial allergic rhinitis. These tools go beyond measuring improvement in symptoms and include such items as sleep quality, nonallergic symptoms (e.g., fatigue, poor concentration, and others), emotions, and participation in a variety of activities. How well each of the current treatment modalities performs and how they compare in improving patient outcomes remain to be determined.

Clinicians caring for allergic rhinitis patients should develop a comprehensive pharmaceutical care plan that addresses several areas. Discuss and agree on therapeutic end points for allergic rhinitis, including the patient’s acceptable level of symptom relief, onset of symptom relief expectations, and seasonal starts and stops. Discuss adverse drug reaction self-monitoring and prevention based on treatment selection. Assess patient attitude toward adherence to and persistence with oral, ocular, intranasal, or immunologic therapies. Ensure proper matching of treatment to symptoms and intervene with the prescriber if necessary. Conduct seasonal or annual review with patient.

The therapeutic goal for all patients with allergic rhinitis is to minimize or prevent symptoms. Evaluation of success is accomplished primarily through the discussions with the patient, in whom both relief of symptoms and tolerance of drug therapy must be discussed.

Immunotherapy

The first report of the successful use of grass pollen extract injections to treat allergic rhinitis was published in 1911 by Noon. The therapy was first called desensitization; however, this did not seem appropriate because skin reactivity sometimes remained. The name was later changed to hyposensitization. While this term is still used today, immunotherapy is used more commonly and is less confusing.

Immunotherapy is the slow, gradual process of injecting increasing doses of antimmunoglobulin Ens responsible for eliciting allergic symptoms in a patient with the hope of inducing tolerance to the allergen when natural exposure occurs. Several mechanisms have been proposed to explain the beneficial effects of immunotherapy, including: induction of IgG antibodies, reduction in specific Immunoglobulin E (long-term), reduced recruitment of effector cells, altered T-cell cytokine balance (a shift from Th1 to Th2), T-cell anergy, and induction of regulatory T cells. Immunotherapy is expensive, has significant potential risks, and requires a major time commitment from the patient. For these reasons, it should be considered only in a select group of patients. Candidates for immunotherapy should have a strong history of severe symptoms unsuccessfully controlled by avoidance and pharmacotherapy, or stand to achieve more benefit in other significant ways, such as with asthma. Immunotherapy may postpone the onset of asthma or possibly even prevent it. Patients who have been unable to tolerate the adverse effects of properly managed drug therapy also should be considered. Patients must be committed to the necessary regular office visits required to complete this long course of therapy.

The effectiveness of immunotherapy for seasonal allergic rhinitis appears to be better than that seen with perennial rhinitis, in part because it is more difficult to determine which allergen is responsible for perennial symptoms, and it is more due to multiple sensitizations. Effectiveness has been shown in a number of clinical studies using a variety of pollen extracts, even in patients with severe disease resistant to pharmacotherapy. Specific immunotherapy for house dust mites has had good results in appropriately selected patients, while several studies have described marked improvement in patients with allergy to cats. Data indicate that in some patients 3 years of immunotherapy may be sufficient to give lasting benefit.

The selection of antimmunoglobulin Ens should be based on patient history and skin test results. Numerous regimens for administration of selected allergens have been suggested. In general, very dilute solutions are given initially one to two times per week. The concentration is increased until the maximum tolerated dose is achieved. This maintenance dose is continued every 2 to 6 weeks, depending on clinical response. In light of the present understanding of the immunologic results of immunotherapy, it should be given year-round rather than seasonally.

Adverse reactions can occur with immunotherapy and range from mild to life-threatening. Among the most common are mild local reactions, consisting of induration and swelling at the site of the injection. These may be immediate or delayed. Other more serious reactions (e.g., generalized urticaria, bronchospasm, laryngospasm, and vascular collapse) occur rarely; deaths can result from anaphylactic reactions. Severe reactions are treated with epinephrine. Antihistamines and systemic corticosteroids may also be used as adjunctive therapy, and in rare circumstances glucagon may be necessary.

Several patient types have been identified as poor candidates for immunotherapy, including: patients with any medical condition that would compromise the ability to tolerate an anaphylactic-type reaction, patients with impaired immune systems, and patients with a history of nonadherence to therapy.

New and alternative treatment options

Montelukast is the first leukotriene receptor antagonist that has received approved labeling for the treatment of seasonal allergic rhinitis. Leukotriene receptor antagonists inhibit the cysteinyl leukotriene receptor. The cysteinyl leukotrienes are among the inflammatory mediators released from mast cells. Montelukast is effective alone or in combination with an antihistamine. While this class represents a therapeutic alternative, studies published to date show them to be no more effective than peripherally selective antihistamines, and less effective than intranasal steroids.

TABLE. Dosage Regimens for Montelukast in Treatment of Allergic Rhinitis

Age Dosage
Adults and adolescents >15 years One 10-mg tablet daily
Children 6-14 years One 5-mg chewable tablet daily
Children 2-5 years One 4-mg chewable tablet or oral granule packet daily

The timing of drug administration can be individualized. If the patient has combined asthma and seasonal allergic rhinitis, the dose should be given in the evening.

The recent development of monoclonal antibodies directed against the binding site of Immunoglobulin E points to a potentially exciting new way to treat allergic respiratory diseases. Omalizumab, a recombinant humanized anti-Immunoglobulin E monoclonal antibody, is the first to show efficacy in allergic rhinitis. The actual mechanism of how this agent is thought to work is quite complex. Anti-Immunoglobulin E antibodies bind to the site on the Immunoglobulin E molecule that recognizes the Immunoglobulin E receptor, thereby preventing the Immunoglobulin E molecule from binding to mast cells or basophils. The half-life of Immunoglobulin E antibodies on the mast cell surface is about 6 weeks, and as the antibodies turn over they become available for binding to anti-Immunoglobulin E antibodies. Therefore, by giving repeated doses of omalizumab, the number of Immunoglobulin E antibodies on the mast cell surface can be significantly reduced over time. These new Immunoglobulin E molecules are not eliminated, but remain in circulation as small immune complexes. Immunoglobulin E receptor numbers on basophils and mast cells may be decreased as a result of downregulation. Because of the expensive nature of this therapy, omalizumab’s role has not been defined. Some promising results have been described when it is used in combination with immunotherapy.

Clinical controversy

Omalizumab may offer significant long-term benefits to allergic rhinitis patients, but it may prove to be too expensive to gain widespread acceptance.

As mentioned earlier in this chapter, microbial exposure in the early years of life could help prevent allergic disease by developing a non-atopic immune response. This concept was further studied by administering Lactobacillus rhamnosus prenatally to mothers who had at least one first-degree relative or partner with atopic disease (eczema, allergic rhinitis, or asthma) and postnatally for 6 months to their infants.

Clinical controversy

Recent evidence shows that probiotics might be useful in preventing the onset of allergic disease, but more research needs to be conducted before use of these products is recommended.

Pharmacologic Therapy

First-line therapeutic modalities for treating allergic rhinitis are directed at relief of symptoms. Antihistamines and decongestants (both oral and topical) generally are used first in treating allergic rhinitis with medications. Several options in these two categories are available without a prescription, but patients will need sound advice to make appropriate choices. Knowledge of pathophysiology and the inflammatory state has led to prophylactic therapy for more severe disease using agents such as cromolyn and topical steroids. However, in attempting to assess the evidence supporting any particular therapy, clinicians have difficulty interpreting the medical literature for a variety of reasons, including lack of uniformity in the research methodologies, inappropriate drug controls, and failure to identify types of rhinitis in study subjects (perennial versus seasonal and allergic versus nonallergic).

Antihistamines

Histamine (H1)-receptor antagonists are competitive antagonists to histamine. They bind to H1 receptors without activating them, preventing histamine binding and action. Newer antihistamines may also affect components of the inflammatory response such as histamine release, generation of adhesion molecules, and influx of inflammatory cells. While it was once thought that the older antihistamines had no anti-inflammatory action, some were shown to have these effects as early as the 1950s. Antihistamines are available in oral, ophthalmic, and intranasal dosage forms.

The oral antihistamines are the most commonly used and can be divided two major categories: nonselective (first-generation) and peripherally selective (second-generation). Nonselective agents are commonly referred to as sedating antihistamines, and peripherally selective agents are referred to as nonsedating antihistamines. These generalizing terms can be misleading. Individual agents should be judged on their specific characteristics because variation within these broad categories exists. Also, the nonsedating claim is only valid when the newer agents are used at recommended doses. This is of particular concern since some of these antihistamines are now available without a prescription. The mechanism for sedation is not well understood, but its central effect depends on the drugs’ ability to cross the blood-brain barrier. Most older antihistamines are lipid-soluble and cross this barrier easily. The peripherally selective agents have little or no central or autonomic nervous system effects.

TABLE. Relative Adverse-Effect Profiles of Antihistamines

Medication Relative

Sedative

Effect

Relative

Anticholinergic

Effect

Alkylamine class, nonselective
Brompheniramine maleate Low Moderate
Chlorpheniramine maleate Low Moderate
Dexchlorpheniramine maleate Low Moderate
Ethanolamine class, nonselective
Carbinoxamine maleate High High
Clemastine fumarate Moderate High
Diphenhydramine hydrochloride High High
Ethylenediamine class, nonselective
Pyrilamine maleate Low Low to none
Tripelennamine hydrochloride Moderate Low to none
Phenothiazine class, nonselective
Promethazine hydrochloride High High
Piperidine class, nonselective
Cyproheptadine hydrochloride Low Moderate
Phenindamine tartrate Low to none Moderate
Phthalazinone class, peripherally selective
Azelastine (nasal only) Low to none Low to none
Piperazine class, peripherally selective
Cetirizine Low to moderate Low to none
Piperidine class, peripherally selective
Desloratadine Low to none Low to none
Fexofenadine Low to none Low to none
Loratadine Low to none Low to none

Antihistamines are more effective in preventing the actions of histamines than in reversing these actions once they have taken place. Reversal of symptoms is, at least in part, caused by the anticholinergic properties of these drugs. This activity is responsible for the drying effect of antihistamines, which reduces the problem of nasal, salivary, and lacrimal gland hypersecretion. Antihistamines antagonize increased capillary permeability, wheal-and-flare formation, and itching.

In general, the antihistamines are well absorbed, have large volumes of distribution, and are metabolized by the liver. Serum half-lives vary considerably between patients. Also, the therapeutic effects of these agents are more prolonged than might be predicted by their half-lives.

Drowsiness is usually the chief complaint of patients who take antihistamines. It can interfere with a patient’s ability to drive a car or operate machinery and may interfere with the patient’s ability to function adequately at the workplace. Remember that these problems can also be a reflection of the disease itself. For this reason, many recommend the use of peripherally selective agents as first-line treatment for any patients at high risk for the development of adverse events. This includes patients with renal or hepatic impairment, those with small weights (for whom adult doses may provide larger-than-recommended doses on a milligram per kilogram basis), patients with pre-existing central nervous system or cardiac disorders, patients who require higher doses, and patients who have shown tendencies to overuse nonprescription or prescription medications.

The sedative effects of antihistamines can be useful in patients who suffer from sleeplessness caused by the symptoms of allergic rhinitis. In these patients, a bedtime dose may prove beneficial. However, they may cause residual daytime sedation, decreased alertness, and performance impairment.

The logic of preferentially using the newer agents is not clear cut. A recent meta-analysis of performance-impairment trials did not show a clear and consistent distinction between diphenhydramine and the peripherally selective agents. Another study showed that tolerance to sedation secondary to diphenhydramine developed by day 4 of treatment, becoming indistinguishable from placebo, but sedation must be distinguished from impairment, as the two are not equivalent.

Anticholinergic (drying) effects contribute to the agents’ therapeutic efficacy, but they also cause most adverse effects. Dry mouth, difficulty in voiding urine, constipation, and potential cardiovascular effects may be troublesome. Keep in mind that the differences may be small. Patients with a predisposition to urinary retention (e.g., elderly men and those on concurrent anticholinergic therapy) should use antihistamines with caution. Caution also should be used in patients with increased intraocular pressure, hyperthyroidism, and cardiovascular disease.

Other adverse effects of oral antihistamines include loss of appetite (and paradoxically, weight gain with increased appetite), nausea, vomiting, and epigastric distress.

Antihistamines are only fully effective when taken approximately 1 to 2 hours before anticipated exposure to the offending allergen. If tolerance develops to the therapeutic effect, a change to an agent in a different chemical class may be effective.

Patients should be counseled about the proper use of antihistamines. Adverse effects, especially drowsiness, should be emphasized. Patients should be warned against taking other central nervous system depressants, including the use of alcohol. Patients should be told not to take a double dose when a dose is missed. Taking the antihistamine with meals or at least a full glass of water will help prevent gastrointestinal adverse effects such as nausea, vomiting, and epigastric distress. Patients should check with their health care professional and read labels before taking nonprescription medications. Many cold products and sleep aids contain antihistamines. Patients should be instructed not to use more than one antihistamine at a time.

TABLE. Oral Dosages of Commonly Used Oral Antihistamines and Decongestants

Medication

 

 

Availability

 

 

Dosage and Interval
Adults Children
Nonselective (First-generation) antihistamines
Chlorpheniramine maleate, plain OTC 4 mg every 6 h 6-12 y: 2 mg every 6 h
Chlorpheniramine maleate, sustained-release OTC 8-12 mg daily at bedtime or 8-12 mg every 8 h 2-5 y: 1 mg every 6 h 6-12 y: 8 mg at bedtime <6 y: Not recommended
Clemastine fumarate OTC 1.34 mg every 8 h 6-12 y: 0.67 mg every 12 h
Diphenhydramine hydrochloride

 

OTC 25-50 mg every 8 h 5 mg/kg per day divided every 8 h (up to 25 mg per dose)

 

Peripherally selective (second-generation) antihistamines

 

Loratadine OTC 10 mg once daily 6-12 y: 10 mg once daily
Fexofenadine RX 60 mg twice daily or 180 mg once daily 2-5 y: 5 mg once daily 6-11 y: 30 mg twice daily
Cetirizine RX 5-10 mg once daily >6 y: 5 mg once daily Infants 6-11 moc
Oral decongestants

Pseudoephedrine, plain

OTC 60 mg every 4-6 h 6-12 y: 30 mg every 4-6 h 2-5 y: 1 5 mg every 4-6 h
Pseudoephedrine, sustained-release OTC 120 mg every 12 h Not recommended

Dosage adjustment may be needed in renal/hepatic dysfunction. Refer to manufacturers’ prescribing information,

Available in liquid form,  0.25 m/kg orally demonstrated to be safe.

Controlled-release product available: 240 mg once daily (60-mg immediate-release with 180-mg controlled-release).

Many patients respond to and tolerate the older agents quite well. Because many of the older agents are available generically, they are much less expensive. Patient cost for many of the older nonprescription agents is less than $5 for a 30-day supply, compared with more than $20 for some of the nonprescription selective agents, and more than $70 dollars for the selective prescription-only products. While cost is a concern, patient safety should be the first consideration. Interestingly, in a 2003 survey, the most frequently recommended nonprescription antihistamine to adults by pharmacists was diphenhydramine. This may change with the heavy promotion of competing brands of nonprescription loratadine. Loratadine in combination with pseudoephedrine did show up in the survey as the top pharmacists’ pick in the “adult multisymptom allergy” category in that 2003 survey.

For seasonal allergic rhinitis, an intranasal antihistamine, azelastine, is available. Azelastine has been used successfully in patients who did not respond to loratadine. Using the nasal route offers an alternative to switching to another oral antihistamine. Patient satisfaction has been varied because while the product produces rapid symptom relief, patients complain of drying effects, headache, and diminished effectiveness over time. Patients should be warned of the medication’s potential to produce drowsiness, as its systemic availability is approximately 40%.

Allergic conjunctivitis, often associated with allergic rhinitis, can be treated with an ophthalmic antihistamine such as levocabastine. Since systemic antihistamines usually are also effective for allergic conjunctivitis, levocabastine is a logical addition to nasal steroids when ocular symptoms occur, and is an acceptable approach in patients whose only symptoms involve the eyes.

Clinical Controversy

While many clinicians strongly prefer a peripherally selective agent as the first antihistamine choice, economic considerations still result in the first-line choice of the less expensive and more sedating products by some prescription plans and clinicians.

Decongestants

Topical and systemic decongestants are sympathomimetic agents that act on adrenergic receptors in the nasal mucosa, producing vasoconstriction. Decongestants shrink swollen mucosa and improve ventilation. When nasal congestion is part of the clinical picture, decongestants work well in combination with antihistamines.

Topical Decongestants. Topical decongestants are applied directly to swollen nasal mucosa via drops or sprays. The use of these agents results in little or no systemic absorption.

TABLE. Duration of Action of Topical Decongestants

Medication Duration (h)
Short-acting
Phenylephrine hydrochloride Up to 4
Intermediate-acting
Naphazoline hydrochloride 4-6
Tetrahydrozoline hydrochloride  
Long-acting
Oxymetazoline hydrochloride Up to 12
Xylometazoline hydrochloride  

Because these agents are extremely effective and are available to patients without a prescription, they are widely used. However, prolonged use of these agents (for more than 3 to 5 days) can result in a condition known as rhinitis medicamentosa, or rebound vasodilation, with associated congestion. Patients who develop this condition use more spray more often with less response. While the methods used to treat this “addiction” have not been studied formally, several are used commonly. Abrupt cessation works, but it is difficult because of rebound congestion that may leave the patient congested for several days or weeks. Sleeping may become difficult. Nasal steroids have been used successfully, but they take several days to work. Weaning the patient off topical decongestants can be accomplished by decreasing the dosing frequency or the concentration over several weeks. Combining the weaning process with nasal steroids may prove useful.

Other adverse effects of topical decongestants include burning, stinging, sneezing, and dryness of the nasal mucosa.

Patients should be counseled on the use of topical decongestants to prevent rhinitis medicamentosa. Patients should be instructed to use as small a dose as possible as infrequently as possible and only when absolutely necessary (e.g., at bedtime to aid in falling asleep). Duration of therapy always should be limited to 3 to 5 days.

Systemic Decongestants. Oral decongestants are not as effective on an immediate basis as the topical agents, but their effects sometimes last longer and they cause less local irritation.

Also, rhinitis medicamentosa is not a problem with older agents. The most commonly used agent is pseudoephedrine. An oral form of phenylephrine is available by prescription only.

Concerns of safety have greatly limited the systemic decongestant options. Pseudoephedrine continues to be the most frequently used and the safest choice. Doses of 180 mg have been shown to produce no measurable change in blood pressure or heart rate. In higher doses (210 to 240 mg), pseudoephedrine has raised both blood pressure and heart rate. Pseudoephedrine can cause mild central nervous system stimulation, even at therapeutic doses. Stroke, related to oral decongestant use including pseudoephedrine, can occur in patients with hypertension and/or vasospasm. Although stroke complications seem to be associated with higher-than-recommended doses, there is also a stroke risk when these agents are taken properly. Severe hypertensive reactions can occur when pseudoephedrine is given concomitantly with monoamine oxidase inhibitors. Hypertensive patients should, unless absolutely necessary, avoid systemic decongestants.

Combination Products

Numerous products combine an antihistamine with a decongestant. The combination is rational because of the different mechanisms of action. Both nonselective and peripherally selective antihistamines are available in such combinations. As mentioned previously, patients should read labels to avoid therapeutic duplication.

Nasal Steroids

Nasal steroids are an excellent choice for treating perennial rhinitis, and can be useful in seasonal rhinitis, especially if dosed in advance of symptoms.

TABLE. Dosage of Nasal Steroids

Medication Dosage and Interval
Beclomethasone

dipropionate

>12 y: 1 inhalation (42 meg) per nostril

2-4 times a day (maximum, 336 meg/day) 6-12 y: 1 inhalation per nostril 3 times per day

Beclomethasone dipropionate, mo no hydrate >12y:1-2 inhalations once daily 6-12 y: 1 inhalation per nostril (42 meg) twice daily to start
Budesonide >6 y: 2 sprays (64 meg) per nostril in am and pm or 4 sprays per nostril in am (maximum, 256 meg)
Flunisolide Adults: 2 sprays (50 meg) per nostril twice daily (maximum, 400 meg)

Children: 1 spray per nostril 3 times a day

Fluticasone Adults: 2 sprays (100 meg) per nostril once daily; after a few days decrease to 1 spray per nostril

Children >4 y and adolescents: 1 spray per nostril once daily (maximum, 200 meg/day)

Mometasone furoate >12 y: 2 sprays (100 meg) per nostril once daily
Triamcinolone acetonide >12 y: 2 sprays (110 meg) per nostril once daily (maximum, 440 meg/day)

Nasal steroids appear to be effective with minimal adverse effects. Some believe that nasal steroids should be recommended as initial therapy over antihistamines because of their high level of efficacy when used properly and along with avoidance of allergens. Multiple mechanisms are involved with the effects of nasal steroids on the nasal mucosa: reducing inflammation by reducing mediator release, suppressing neutrophil chemotaxis, reducing intracellular edema, causing mild vasoconstriction, and inhibiting mast cell-mediated late-phase reactions.

Topical steroids produce only minor adverse effects, most commonly sneezing, stinging, headache, and epistaxis. Despite concerns about safety of systemic steroids, nasal steroids have been found to have no significant association with hypothalamic-pituitary axis suppression, cataract formation, glaucoma, or bone mineral density changes in the doses used for allergic rhinitis. Growth suppression remains a question with some evidence showing that nasal steroids with higher bioavailability (e.g., beclomethasone) may have a greater growth suppression effect than less bioavailable agents. These findings require more study. Most likely, all currently available nasal steroids are safe in the majority of patients and their clinical benefits outweigh any small growth suppressive effect. Other concerns include local infections with Candida albicans, which have occurred rarely.

The therapeutic benefits of topical steroids are not immediate. Patients need to understand this to ensure cooperation and continuation of therapy. Some patients notice improvement in a few days, but peak responses may not be observed for 2 to 3 weeks. Once a response is achieved the dosage may be reduced. Blocked nasal passages should be cleared with a decongestant before administration to ensure adequate penetration of the spray. Patients should be advised to avoid sneezing or blowing their noses for at least 10 minutes after administration. Topical steroids should not be used in patients with nasal septum ulcers or recent nasal surgery or trauma.

One additional benefit of nasal steroids in treating allergic rhinitis in individuals with asthma and upper airway conditions is that they may confer some protection against exacerbations of asthma, leading to fewer emergency room visits. The overall relative risk for an emergency visit among asthma patients who received intranasal steroids was O.7. No effect was seen in patients receiving antihistamines.

Other Inhalant Medications

Cromolyn sodium and ipratropium bromide offer two additional approaches for treating allergic rhinitis. Cromolyn sodium is a mast cell stabilizer. Increased interest in this product has resulted from it becoming available without a prescription. Ipratropium bromide is an anticholinergic agent useful in perennial allergic rhinitis.

Cromolyn sodium nasal spray is used for the symptomatic prevention and treatment of allergic rhinitis. It curtails antimmunoglobulin En-triggered mast cell degranulation and release of the mediators of allergic reactions, including histamine. Cromolyn sodium has no direct antihistaminic, anticholinergic, or anti-inflammatory properties. Similarly to topical steroids, the most common adverse effects — sneezing and nasal stinging — result from local irritation. The dose in adults and children at least 2 years of age is one spray in each nostril three to four times per day at regular intervals every 4 to 6 hours. Cromolyn sodium must cover the entire nasal lining; therefore patients should be instructed to clear nasal passages before administration. Inhaling through the nose during administration aids in this process. Dosing must be repeated at 6-hour intervals to maintain the effect.

For seasonal rhinitis, treatment with cromolyn sodium should be initiated just before the usual start of the offending allergen’s season and continued throughout the season. In perennial rhinitis, the effects may not be seen for 2 to 4 weeks; therefore antihistamines or decongestants may be needed during this initial phase of therapy. As cromolyn sodium begins to work, the need for these medications should decrease.

Ipratropium nasal spray is an anticholinergic agent that exhibits antisecretory properties when applied locally. It provides symptomatic relief of rhinorrhea associated with allergic and other forms of chronic rhinitis. The 0.03% solution is given as two sprays (42 meg) two to three times daily. The optimal dose should be determined based on the specific patient’s symptoms and response. Adverse effects are mild, with the most common being headache, nosebleeds, and nasal dryness.

Treatment: Allergic Rhinitis

Desired outcome

The therapeutic goal for patients with allergic rhinitis is to minimize or prevent symptoms. This goal should be accomplished with no or minimal adverse medication effects and reasonable medication expenses. The patient should be able to maintain a normal lifestyle, including participating in outdoor activities, yard work, and playing with pets as desired.

General approach to treatment

Once the causative allergens and the specific symptoms are identified, management consists of three possible approaches: (1) allergen avoidance, (2) pharmacotherapy for prevention or treatment of symptoms, and (3) specific immunotherapy. The pharmacotherapy for symptoms approach includes several options that are based on patient-specific information.

Avoidance

Avoidance of offending allergens is the most direct method of preventing allergic rhinitis, but it is often the most difficult to accomplish, especially for perennial allergens. Mold growth can be reduced by maintaining household humidity below 50% and removing obvious growth with bleach or disinfectant. Patients sensitive to animals will benefit most by removing pets from the home; however, most animal lovers are reluctant to comply with this approach. Cats may be more of a problem than dogs. Cat allergen is so prevalent and persistent in the air that in one survey 25% of cat-free houses contained detectable cat allergen. Washing cats weekly may reduce allergens but studies have been inconclusive. Some dogs display more profuse antimmunoglobulin Ens than do others; clinically, a sensitized person may tolerate one animal better than another. Efforts to eliminate dust mites should be rigorous, particularly in the bedroom. Exposure to dust mites can be reduced by encasing mattresses and pillows with impermeable covers and washing bed linens in hot water. Washable area rugs are preferable to wall-to-wall carpeting. Acaricide treatment of carpets has been shown to denature the dust mite allergen, but must be done repeatedly, resulting in inconvenience and expense. Atopic infants who are exposed to high levels of dust mites are at increased risk for developing asthma. Environmental control of these allergens may be helpful in forestalling further rhinitis and preventing later asthma.

Older central air-filtration systems for houses were expensive and minimally effective. High-efficiency particulate air (HEPA) filters have minimal effect on the dust mite allergens because these allergens are heavy and heavily charged electrically and are not typically floating in the air in the first place. These filters are effective in removing lightweight airborne particulates, including pollens, mold spores, and cat allergen, thus reducing allergic respiratory symptoms.

Patients with seasonal allergic rhinitis should keep windows closed and minimize time spent outdoors during pollen seasons. Immediate hair washing and change of clothes are recommended upon returning indoors. Use of fans that direct outside air into the house should be avoided. Filter masks can be worn while gardening or mowing the lawn. The few clinical trials on the effectiveness of avoidance measures have been inconclusive. These measures are intended to be a part of a comprehensive treatment strategy that will likely include pharmacotherapy and in selected cases, immunotherapy

TABLE. Pharmacotherapeutic Options For Allergic Rhinitis

Medication Class Symptoms Controlled Comments
Antihistamines
Systemic Sneezing, rhinorrhea, conjunctivitis

itching,

For seasonal allergic rhinitis, begin treatment before allergen exposure. Nonsedating agents should be tried first. If ineffective or too expensive for the patient, the older agents may be used. For perennial allergic rhinitis, use an intranasal steroid as an alternative to or in combination with systemic antihistamines.
Ophthalmic Conjunctivitis Logical addition to nasal steroids if ocular symptoms are present.
Intranasal Sneezing, rhinorrhea,

nasal pruritus

Option for seasonal allergic rhinitis. Warn patients of potential drowsiness.
Decongestants
Systemic Nasal congestion Only needed when nasal congestion is present.
Topical Nasal congestion Only needed when nasal congestion is present. Do not exceed 3-5 days.
Intranasal corticosteroids Sneezing, rhinorrhea, nasal congestion

itching,

For seasonal allergic rhinitis, an option when congestion is present. Must begin therapy before allergen exposure. Excellent choice for perennial rhinitis.
Mast cell stabilizers See comments Prevents symptoms; therefore, for seasonal allergic rhinitis, use before offending allergen’s season starts. For perennial rhinitis, improvement may not be seen for up to 1 month.
Intranasal anticholinergics Rhinorrhea Reserve for use when above therapies fail or cannot be tolerated.

FIGURE. Treatment algorithm for allergic rhinitis.

Treatment algorithm for allergic rhinitis

Treatment algorithm for allergic rhinitis

TABLE. Environmental Controls to Prevent Allergic Rhinitis

Pollens
•  Keep windows and doors closed during pollen season
• Avoid fans that draw in outside air
•  Use air conditioning
•  If possible, eliminate outside activities during times of high pollen counts
•  Shower, shampoo, and change clothes following outdoor activity
•  Use a vented dryer rather than an outside clothesline
Molds
•  Use similar controls as above
• Avoid walking through uncut fields, working with compost or dry soil, and raking leaves
• Clean indoor moldy surfaces
•  Fix all water leaks in home
•  Reduce indoor humidity to <50% if possible
House dust mites
•  Encase mattress, pillow, and box springs in an allergen-impermeable cover
• Wash bedding in hot water weekly
•  Remove stuffed toys from bedroom
•  Minimize carpet use and upholstered furniture
•  Reduce indoor humidity to <50% if possible
Animal allergens (if removal of pet is not acceptable)
•  Keep pet out of patient’s bedroom
•  Isolate pet from carpet and upholstered furniture
• Wash pet weekly
Cockroaches
•  Keep food and garbage in tightly closed containers
• Take out garbage regularly
• Clean up dirty dishes promptly
•  Use roach traps
Other recommendations
•  Do not allow smoking around the patient, in the patient’s house, or in the family car
•  Minimize the use of wood-burning stoves and fireplaces

Complications of Allergic Rhinitis

Not only is allergic rhinitis aggravating, it also frequently leads to further complications, particularly if the patient does not receive adequate treatment. Symptoms of untreated rhinitis may lead to inability to sleep, chronic malaise, fatigue, and poor work or school efficiency. Patients often are plagued by loss of smell or taste, with sinusitis or polyps underlying many cases of allergy-related hyposmia. Postnasal drip with cough, hoarseness, and even vocal polyps also can be bothersome.

The role of allergic rhinitis in the development of acute otitis media or chronic middle ear effusion remains controversial. Children with allergic rhinitis appear to be at greater risk of these conditions because of nasal obstruction, insufflation of nasal secretions into the middle ear via eustachian tube obstruction, and negative middle ear pressure. Hearing problems in children related to middle ear effusion may lead to delayed development of language in young children or school problems in older children.

Structural facial and dental problems can result from chronic allergic rhinitis. The chronic edema and venous stasis may contribute to the development of a high-arched, V-shaped palate. Mouth breathing caused by nasal obstruction can be responsible for dental malocclusion and orthodontic problems. Constant upward rubbing of the nose (allergic salute) can cause a lasting transverse crease across the lower nose; nasal congestion leads to venous pooling and dark circles under the eyes known as allergic shiners.

Allergic rhinitis is clearly a risk factor for asthma. As many as 78% of asthma patients have nasal symptoms, while about 38% of allergic rhinitis patients have asthma. Asthma is more common in those with perennial than seasonal allergic rhinitis, and it is less likely to be “outgrown” when associated with allergic rhinitis.

Recurrent and chronic sinusitis are relatively common complications of allergic rhinitis. The structure of the mucus blanket breaks down, with a severe decrease of water production by serous glands, leaving hair cells trapped in the larger mucus layer. This greatly reduces the clearance of trapped bacteria. This offers ideal breeding grounds and greatly increased growing time for the bacteria. Nasal polyps are less common but nonetheless bothersome; they require specific therapy but may improve with management of the underlying allergic state. Epistaxis also can be a problem; it is related to mucosal hyperemia and inflammation.

Clinical Presentation of Allergic Rhinitis

Symptoms and diagnosis

The patient with allergic rhinitis typically complains of clear rhinorrhea, paroxysms of sneezing, nasal congestion, postnasal drip, and pruritic eyes, ears, nose, or palate. Symptoms of allergic conjunctivitis are associated more frequently with seasonal than perennial allergic rhinitis, since a majority of the perennial allergens, such as dust mites and molds, are indoors, where air velocity is too low for substantial deposition of allergenic particles on the conjunctivae. However, with heavy exposure from animal or mold allergens, allergic conjunctivitis can be pronounced.

Symptoms secondary to the late-phase reaction, predominantly nasal congestion, begin 3 to 5 hours after antimmunoglobulin En exposure and peak at 12 to 24 hours. Subsequent symptoms, both allergic and irritant, are elicited more easily because of the priming effect. For instance, a ragweed-sensitive patient, when exposed to ragweed pollen out of season, responds with modest symptoms and may be very tolerant of irritants such as air pollution or tobacco smoke. During the ragweed season, however, when the nasal mucosa is already inflamed, exposure to small doses of pollen or to irritants to which the patient is usually tolerant elicits a response clinically indistinguishable from his allergy.

Allergic rhinitis is differentiated from other causes of rhinitis by a thorough history, physical examination, and certain diagnostic tests. The medical history consists of a careful description of symptoms, environmental factors and exposures, results of previous therapy, use of other medications, previous nasal injuries, previous nasal or sinus surgery, family history, and the presence of other medical problems. Identification of specific causative allergens may be difficult. For example, a reaction induced by mowing the lawn may not be caused by grass pollens, but by the disturbance of various weeds, molds, or other plants in the lawn. With perennial allergic rhinitis, the cause-effect and temporal relationships are less clear, making the diagnosis more difficult, especially with such covert allergens as house dust mites and molds.

Physical examination may reveal allergic shiners, a transverse nasal crease caused by repeated rubbing of the nose, and adenoidal breathing. Pale, bluish, edematous nasal turbinates coated with thin, clear secretions are characteristic of apurely allergic reaction. Tearing, conjunctival injection and edema, and periorbital swelling may be present. Physical findings are generally less clear-cut in adults.

Nasal scrapings will provide a representative sample of cells infiltrating the nasal mucosa and can be helpful in supporting the diagnosis. Microscopic examination of the nasal smear from an allergic individual typically will show numerous eosinophils. The blood eosinophil count may be elevated in allergic rhinitis, but it is nonspecific and has limited usefulness.

Allergy testing can help determine whether a patient’s rhinitis is caused by an allergic response to allergens. Immediate-type hyper-sensitivity skin tests are commonly used for the diagnosis of allergic rhinitis. These skin tests can be performed by the percutaneous route, where the diluted allergen is pricked or scratched into the skin surface, or by the intradermal route, where a small volume (0.01 to 0.05 mL) of diluted allergen is injected between the layers of skin. Percutaneous tests are more commonly performed and are safer and more generally accepted, with intradermal tests reserved for patients requiring confirmation.

In percutaneous testing, a positive control (histamine) and a negative control are essential for correct interpretation. After 15 minutes of the application of the allergen, the site is examined for a positive reaction (defined as a wheal and flare reaction). Because correct testing is done with extremely minute doses, undetectable by nonsensitized individuals, this reaction is evidence of the presence of mast cell-bound Immunoglobulin E specific to the allergen tested. Common allergens are available as standardized allergenic extracts.

Antihistamines and a few other medications interfere with the wheal and flare reaction. First-generation antihistamines should be stopped 3 days before testing, while second-generation, nonsedating antihistamines should be stopped for 10 days. Medications with anti-histamine properties (e.g., sympathomimetic agents, phenothiazines, and tricyclic antidepressants) and H2-receptor antagonists (e.g., cimetidine, ranitidine, and famotidine) should be discontinued before skin testing. The radioallergosorbent test (RAST) was the first commonly used method for detecting Immunoglobulin E antibodies in the blood that are specific for a given allergen. Several other quantitative assays that include a reference curve calculated against standardized Immunoglobulin E are available. These tests are highly specific but less sensitive than percutaneous tests.