Astelin

DRUG DESCRIPTION

Astelin® (azelastine hydrochloride) Nasal Spray, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24CIN3O•HCl with the following chemical structure:

Astelin®  (azelastine hydrochloride)  Structural Formula Illustration

Astelin® Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ±0.3. It also contains benzalkonium chloride (125 mcg/mL), edetate disodium, hypromellose, citric acid, dibasic sodium phosphate, sodium chloride, and purified water. After priming, each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.

What are the possible side effects of azelastine nasal (Astelin, Astepro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using azelastine and call your doctor at once if you have any of these serious side effects:

  • bronchospasm (shortness of breath, tightness in chest, wheezing); or
  • fast or uneven heartbeats.

Less serious side effects may include:

  • a bitter taste in your mouth;
  • headache;
  • drowsiness or...

Read All Potential Side Effects and See Pictures of Astelin »

What are the precautions when taking azelastine hydrochloride (Astelin)?

Before using azelastine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this...

Read All Potential Precautions of Astelin »


Astelin Consumer (continued)

SIDE EFFECTS: A bitter taste in the mouth, drowsiness, a burning feeling inside the nose, sneezing fits, nausea, weight gain, muscle aches, and red eyes may occur. Strange feelings on the skin (e.g., pins and needles, crawling sensation) may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

The bitter taste can be reduced by sniffing gently through your nose after each spray, rather than breathing in through your nose so deeply that the medication goes to the back of your throat and gets into your mouth.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using azelastine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Astelin Patient Information Including Side Effects

Brand Names: Astelin, Astepro

Generic Name: azelastine nasal (Pronunciation: a ZEL uh steen)

  • What is azelastine nasal (Astelin)?
  • What are the possible side effects of azelastine nasal (Astelin)?
  • What is the most important information I should know about azelastine nasal (Astelin)?
  • What should I discuss with my healthcare provider before using azelastine nasal (Astelin)?
  • How should I use azelastine nasal (Astelin)?
  • What happens if I miss a dose (Astelin)?
  • What happens if I overdose (Astelin)?
  • What should I avoid while taking azelastine nasal (Astelin)?
  • What other drugs will affect azelastine nasal (Astelin)?
  • Where can I get more information?

What is azelastine nasal (Astelin)?

Azelastine is an antihistamine. It blocks the effects of the chemical histamine in your body.

Azelastine prevents sneezing, itching, runny nose, and other nasal symptoms of allergies.

Azelastine nasal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of azelastine nasal (Astelin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using azelastine and call your doctor at once if you have any of these serious side effects:

  • bronchospasm (shortness of breath, tightness in chest, wheezing); or
  • fast or uneven heartbeats.

Less serious side effects may include:

  • a bitter taste in your mouth;
  • headache;
  • drowsiness or dizziness;
  • dry mouth, sore throat;
  • burning in your nose;
  • weight gain;
  • nausea;
  • nosebleed;
  • cough, sneezing, runny nose, cold symptoms; or
  • eye redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about azelastine nasal (Astelin)?

Azelastine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase drowsiness and dizziness caused by azelastine.

Before using azelastine nasal, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by azelastine nasal.

Talk with your doctor if your allergy symptoms do not improve or if they get worse.

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  • Astelin
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