Ipratropium Nasal

Use ipratropium only as directed by your doctor . 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.

ipratropium comes with patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

ipratropium is only used in the nose. Do not get it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.

Some patients using ipratropium may feel better right away. For others, it may take 1 or 2 weeks before the medicine helps. Keep using the medicine on a regular schedule as your doctor ordered.

To use the nasal spray:

• Remove the clear plastic dust cap and the green safety clip from the nasal spray pump. The safety clip prevents the accidental discharge of the spray when you are not using it.
• When you use the spray pump for the first time, you must prime the bottle. Pump the bottle 7 times or until a fine spray comes out.
• Gently blow your nose before using the spray. Insert the tip of the bottle into your nostril.
• Close the opposite nostril with a finger and lean your head slightly forward.
• Spray into your nostril and sniff deeply through your nose. Then breathe out through your mouth.
• Take the spray pump out of your nostril. Lean your head backward for a few seconds.
• If a second dose is needed in the same nostril, lean the head slightly forward and repeat the same steps.
• Spray the opposite nostril using the same steps.
• Replace the clear plastic dust cap and the green safety clip.
• If the spray pump gets clogged, hold the tip of the bottle under warm running water for about 1 minute. Dry the pump and prime it again.
• If you do not use the bottle for more than 24 hours, prime it again by releasing two sprays.
• If you do not use the bottle for more than 7 days, clean the spray tip and prime it again by releasing seven sprays.
• Keep track of the number of sprays you use. Throw the bottle away after you use 345 sprays (0.03% nasal spray) even if some liquid remains in the bottle.
• You should not take extra doses of the nasal spray without checking first with your doctor.

Dosing

The dose of ipratropium 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 ipratropium. 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 the 0.03% nasal spray:
  • For runny nose caused by allergic and nonallergic perennial rhinitis:
    • Adults, teenagers, and children 6 years of age and older—2 sprays in each nostril two or three times a day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For the 0.06% nasal spray:
  • For runny nose associated with the common cold:
    • Adults, teenagers, and children 5 years of age and older—2 sprays in each nostril three or four times a day. Do not use the medicine for more than 4 days.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of ipratropium, 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

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

If you or your child feel that your symptoms do not improve within a few weeks or if they become worse, check with your doctor.

ipratropium may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using ipratropium and call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using ipratropium.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain or discomfort, 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).

ipratropium may cause dizziness or trouble in seeing clearly. Make sure you know how you react to ipratropium before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to see well.

If you have dryness of the nose or have unexplained nosebleeds, call your doctor right away.

Ipratropium nasal spray may cause dryness of the mouth or throat. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Blurred vision
• burning, dry, or itching eyes
• discharge or excessive tearing
• itching, redness, tearing, or other sign of eye irritation not present before use of ipratropium or becoming worse during use
• nasal dryness
• nosebleeds
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

• Pain or cramping in the abdomen or stomach
• painful or difficult urination

• Difficulty with swallowing
• dizziness
• fast heartbeat
• hives or welts
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash
• tightness in the chest

• Nasal dryness
• nosebleeds

• Blurred vision
• dizziness
• eye redness or pain
• fast, slow, or irregular heartbeat
• pain or cramping in the abdomen or stomach
• painful or difficult urination
• ringing or buzzing in the ears
• sore 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:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• dry mouth or throat
• increased nasal congestion or runny nose
• nasal itching, burning, or irritation
• nausea

• Dry mouth or throat
• increased nasal congestion

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nose irritation.
• Nosebleed.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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Protein Binding

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Adverse events have not been observed in animal reproduction studies.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe nasal irritation, severe nosebleeds, or vision changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Avoid getting this medicine in your eyes.

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Applies to ipratropium nasal: nasal spray

Along with its needed effects, ipratropium nasal 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 while taking ipratropium nasal:

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Blurred vision
• burning, dry, or itching eyes
• discharge or excessive tearing
• itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use
• nasal dryness
• nosebleeds
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

• Pain or cramping in the abdomen or stomach
• painful or difficult urination

• Difficulty with swallowing
• dizziness
• fast heartbeat
• hives or welts
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash
• tightness in the chest

• Nasal dryness
• nosebleeds

• Blurred vision
• dizziness
• eye redness or pain
• fast, slow, or irregular heartbeat
• pain or cramping in the abdomen or stomach
• painful or difficult urination
• ringing or buzzing in the ears
• sore throat

Some side effects of ipratropium nasal 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:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• dry mouth or throat
• increased nasal congestion or runny nose
• nasal itching, burning, or irritation
• nausea

• Dry mouth or throat
• increased nasal congestion

Applies to ipratropium nasal: nasal spray

General

Ipratropium has been generally well-tolerated, and void of systemic effects when administered intranasally.[Ref]

Local

Local side effects have included blood-tinged mucus (17%), nasal dryness (10%), epistaxis (7%), and nasal irritation (2%).[Ref]

Nervous system

Nervous system side effects have included headache is reported in approximately 9% of the patients treated with the nasal spray. Dizziness has occurred infrequently.[Ref]

Hypersensitivity

Hypersensitivity side effects have included reports of allergic-type reactions including skin rash, angioedema of the throat, tongue, lips,and face, generalized urticaria, laryngospasm, and anaphylactic reactions.[Ref]

Ocular

Ocular side effects have included blurred vision and conjunctivitis after the medication came in contact with the eyes.[Ref]

Genitourinary

Genitourinary side effects have not been usually observed with the low doses given by nasal spray. Urinary retention has been reported occasionally in patients receiving larger doses by nebulizer. Caution may be warranted when using ipratropium in men with prostatic hypertrophy.[Ref]

Respiratory

Respiratory side effects have included pharyngitis and upper respiratory tract infection has been reported in 8% and 9% of patients, respectively.[Ref]

Cardiovascular

Cardiovascular side effects have included rare reports of tachycardia and palpitations.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.[Ref]

Dermatologic

Dermatologic side effects have included rare reports of skin rash.[Ref]

Some side effects of ipratropium nasal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.