AZELASTINE HYDROCHLORIDE- azelastine spray, metered

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)

Prieinama:

Amneal Pharmaceuticals LLC

INN (Tarptautinis Pavadinimas):

AZELASTINE HYDROCHLORIDE

Sudėtis:

AZELASTINE HYDROCHLORIDE 1 mg in 1 mL

Vartojimo būdas:

NASAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Azelastine hydrochloride (HCl) nasal spray, 0.1% 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. None. Risk Summary   Limited data from post-marketing experience over decades of use with azelastine HCl nasal spray, 0.1% in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. Oral administration of azelastine HCl to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.096 mg. However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine HCl caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 300 times the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight. Neither fetal nor maternal effects occurred in mice at approximately 15 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 3 mg/kg/day). In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine HCl caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 270 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). Azelastine HCl caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 610 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 20 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 2 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine HCl caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 530 times the MRHDID in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 5 times the MRHDID (on a mg/m2 basis at a maternal oral dose of 0.3 mg/kg/day). In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine HCl produced no adverse developmental effects on pups at maternal doses up to approximately 270 times the MRHDID (on mg/m2 basis at a maternal dose of 30 mg/kg/day). Risk Summary There are no data on the presence of azelastine HCl in human milk, the effects on the breastfed infant, or the effects on milk production. Breastfed infants should be monitored for signs of milk rejection during azelastine HCl use by lactating women (see Clinical Considerations) .The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelastine HCl nasal spray, 0.1% and any potential adverse effects on the breastfed infant from azelastine HCl nasal spray, 0.1% or from the underlying maternal condition. Clinical Considerations Monitoring for Adverse Reactions Breastfed infants of lactating women treated with azelastine HCl nasal spray, 0.1% should be monitored for possible signs of milk rejection related to the bitter taste of azelastine HCl. The safety and effectiveness of azelastine HCl nasal spray, 0.1% for the treatment of symptoms of seasonal allergic rhinitis have been established for patients 5 years and older [see Adverse Reactions (6.1) and Clinical Studies (14.1)] . The safety and effectiveness of azelastine HCl nasal spray, 0.1% for the treatment of vasomotor rhinitis have been established for patients 12 years and older [see Adverse Reactions (6.1) and Clinical Studies (14.2)] . The safety and effectiveness of azelastine HCl nasal spray, 0.1% in pediatric patients below the age of 5 years with seasonal allergic rhinitis and in pediatric patients below the age of 12 years with vasomotor rhinitis have not been established. Clinical trials of azelastine HCl nasal spray, 0.1% did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Azelastine Hydrochloride (ay” ze las’ teen hye” droe klor’ ide) Nasal Spray, 0.1% For the correct dose of medicine: - Keep your head tilted downward when spraying into your nostril. - Change nostrils each time you use the spray. - Breathe gently and do not tip your head back after using the spray. This will keep the medicine from running down into your throat. You may get a bitter taste in your mouth. Figure A identifies the parts of your azelastine HCl nasal spray, 0.1% pump Before you use azelastine HCl nasal spray, 0.1% for the first time, you will need to prime the bottle. Priming your azelastine HCl nasal spray, 0.1% Remove the dust cover over the tip of the pump and the white safety clip just under the “shoulders” of the pump (See Figure B) . Hold the bottle upright with 2 fingers on the shoulders of the spray pump unit and - put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action. Repeat this until you see a fine mist (See Figure C) . - To get a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. If you see a stream of liquid, the pump is not working correctly and you may have nasal discomfort. - This should happen in 4 sprays or less. Now your pump is primed and ready to use. - Do not use azelastine HCl nasal spray, 0.1% unless you see a fine mist after you do the priming sprays. If you do not see a fine mist, clean the tip of the spray nozzle. See the “Cleaning the Spray Tip of your azelastine HCl nasal spray, 0.1%” section below. Do not use azelastine HCl nasal spray, 0.1% unless you see a fine mist after you do the priming sprays. If you do not see a fine mist, clean the tip of the spray nozzle. See the “Cleaning the Spray Tip of your azelastine HCl nasal spray, 0.1%” section below. - If you do not use azelastine HCl nasal spray, 0.1% for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist. Using your azelastine HCl nasal spray, 0.1% If you do not use azelastine HCl nasal spray, 0.1% for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist. Using your azelastine HCl nasal spray, 0.1% Step 1. Blow your nose to clear your nostrils. Step 2. Keep your head tilted downward toward your toes. Step 3. Place the spray tip about ¼ inch to ½ inch into 1 nostril. Hold bottle upright and aim the spray tip toward the back of your nose (See Figure D) . Step 4. Close your other nostril with a finger. Press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (See Figure E) . Step 5. Repeat Step 3 and Step 4 in your other nostril. Step 6. If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 2 through 4 above for the second spray in each nostril. Step 7. Breathe in gently, and do not tilt your head back after using azelastine HCl nasal spray, 0.1%. This will help to keep the medicine from going into your throat. Step 8. When you finish using your azelastine HCl nasal spray, 0.1%, wipe the spray tip with a clean tissue or cloth. Put the safety clip and dust cover back on the bottle. Cleaning the Spray Tip of your azelastine HCl nasal spray, 0.1% - The spray tip opening is clogged, do not use a pin or pointed object to unclog the tip. Unscrew the spray pump unit from the bottle by turning it to the left (counter-clockwise) (See Figure F) . - Soak only the spray pump unit in warm water. Squirt the spray unit several times while holding it under water. Use the pumping action to clear the opening in the tip (See Figure G) . - Let the spray pump unit air dry. Make sure it is dry before you put it back onto the bottle. - Put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the right). - To keep the medicine from leaking out, use firm pressure when you put the pump back onto the bottle. - After cleaning, follow the instructions for priming. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 10-2018-02

Produkto santrauka:

Azelastine HCl nasal spray 0.1%, 137 mcg, is supplied as a 30-mL package (NDC 65162-676-84) 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 or clear plastic dust cover. The net content of the bottle is 30 mL (net weight 30 g of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine HCl, USP. After priming [see Dosage and Administration (2.3)] , each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine HCl, USP. 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 HCl nasal spray, 0.1% should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage: Store upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

AZELASTINE HYDROCHLORIDE- AZELASTINE SPRAY, METERED
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZELASTINE
HYDROCHLORIDE NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
AZELASTINE HYDROCHLORIDE NASAL SPRAY.
AZELASTINE HYDROCHLORIDE NASAL SPRAY, FOR INTRANASAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Azelastine HCl nasal spray, 0.1% is an H -receptor antagonist
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. (1)
DOSAGE AND ADMINISTRATION
For intranasal use only. (2.3)
Seasonal allergic rhinitis:
Pediatric patients 5 to 11 years of age: 1 spray per nostril twice
daily. (2.1)
Adults and adolescents 12 years of age and older: 1 or 2 sprays per
nostril twice daily. (2.1)
Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and
adolescents 12 years of age and older.
(2.2)
Prime azelastine HCl nasal spray, 0.1% before initial use and when it
has not been used for 3 or more
days. (2.3)
DOSAGE FORMS AND STRENGTHS
Azelastine HCl nasal spray, 0.1%: 137 mcg of azelastine HCl, USP in
each 0.137 mL spray. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Somnolence: Avoid engaging in hazardous occupations requiring complete
mental alertness such as
driving or operating machinery when taking azelastine HCl nasal spray,
0.1%. (5.1)
Alcohol and other central nervous system (CNS) depressants: Avoid
concurrent use with azelastine HCl
nasal spray, 0.1% because further decreased alertness and impairment
of CNS performance may
occur. (5.1)
ADVERSE REACTIONS
The most common adverse reactions (≥2% incidence) are: bitter taste,
headache, somnolence,
dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis,
sinusitis, paroxysmal sneezing, nausea, dry
mouth, fatigue, dizziness, and weight increas