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Astepro

What is the purpose of the nose?

The purpose of the nose is to warm, clean, and humidify the air you breathe as well as help you to smell and taste. A normal person will produce about two quarts of fluid each day (mucus), which aids in keeping the respiratory tract clean and moist. Tiny microscopic hairs (cilia) line the surfaces of the nasal cavity, helping to brush away particles. Eventually the mucus blanket is moved to the back of the throat where it is unconsciously swallowed. This entire process is closely regulated by several body systems.

Structurally, the nose is separated into two passageways (left and right nostrils) by a structure called the septum. Protruding into each breathing passage are bony projections, called turbinates, which help to increase the surface area of the inside of the nose. There are three turbinates on each side of the nose (inferior or lower turbinates, middle turbinates, superior or upper turbinates). The sin...

Astepro

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ASTEPRO
(azelastine hydrochloride) Nasal Spray 0.1%

ASTEPRO
(azelastine hydrochloride) Nasal Spray 0.15%

DRUG DESCRIPTION

ASTEPRO (azelastine hydrochloride) Nasal Spray 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) Nasal Spray 0.15%, 205.5 micrograms (mcg), is 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 C22H24ClN3O·HCl with the following chemical structure:

ASTEPRO (azelastine hydrochloride) Structural Formula Illustration

ASTEPRO Nasal Spray 0.1% contains 0.1% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4).

After priming [see DOSAGE AND ADMINISTRATION], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.

ASTEPRO Nasal Spray 0.15% contains 0.15% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4).

After priming [see DOSAGE AND ADMINISTRATION], each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine hydrochloride (equivalent to 187.6 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 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 Astepro »

What are the precautions when taking azelastine hydrochloride nasal spray (Astepro)?

Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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 disease, inability to sit upright or stand for 30 minutes, low level of calcium in the blood (hypocalcemia), disorders of the esophagus (such as esophageal stricture or achalasia), difficult or painful swallowing, stomach/intestinal disorders (such as ulcers).

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene,...

Read All Potential Precautions of Astepro »

Last reviewed on RxList: 3/10/2011
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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