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What is AZELASTINE HYDROCHLORIDE?
Azelastine Hydrochloride Nasal Spray, 0.1% (137 micrograms (mcg) per spray), 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 CHClNO∙HCl with the following chemical structure:
Azelastine Hydrochloride 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 heptahydrate, 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 does AZELASTINE HYDROCHLORIDE look like?
What are the available doses of AZELASTINE HYDROCHLORIDE?
Azelastine Hydrochloride Nasal Spray: 137 mcg of azelastine hydrochloride in each 0.137 mL spray. ()
What should I talk to my health care provider before I take AZELASTINE HYDROCHLORIDE?
Pregnancy: Based on animal data, may cause fetal harm ()
How should I use AZELASTINE HYDROCHLORIDE?
Azelastine Hydrochloride Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.
The recommended dosage of Azelastine Hydrochloride Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azelastine Hydrochloride Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.
What interacts with AZELASTINE HYDROCHLORIDE?
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What are the warnings of AZELASTINE HYDROCHLORIDE?
Sorry No Records found
What are the precautions of AZELASTINE HYDROCHLORIDE?
Sorry No Records found
What are the side effects of AZELASTINE HYDROCHLORIDE?
Sorry No records found
What should I look out for while using AZELASTINE HYDROCHLORIDE?
What might happen if I take too much AZELASTINE HYDROCHLORIDE?
There have been no reported overdosages with Azelastine Hydrochloride Nasal Spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of Azelastine Hydrochloride Nasal Spray contains 30 mg of azelastine hydrochloride. Clinical trials in adults with single doses of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse reactions. General supportive measures should be employed if overdosage occurs. There is no known antidote to Azelastine Hydrochloride Nasal Spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly, Azelastine Hydrochloride Nasal Spray should be kept out of the reach of children.
How should I store and handle AZELASTINE HYDROCHLORIDE?
Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze or shake. Do not use beyond the expiration date printed on the vial.Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze or shake. Do not use beyond the expiration date printed on the vial.Azelastine Hydrochloride Nasal Spray, 0.1% (137 mcg/spray) is supplied as a 30-mL package (NDC 51991-814-03) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming , each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date "EXP" printed on the medicine label and carton.
Chemical StructureNo Image found
Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H-receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine Hydrochloride Nasal Spray is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in studies. The major metabolite, desmethylazelastine, also possesses H-receptor antagonist activity.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
Antagonism has been demonstrated between clindamycin and erythromycin . Because of possible clinical significance, the two drugs should not be administered concurrently.
Use of Azelastine Hydrochloride Nasal Spray has been associated with somnolence .
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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