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Astepro

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Astepro

Astepro

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Activities Requiring Mental Alertness

In clinical trials, the occurrence of somnolence has been reported in some patients taking ASTEPRO Nasal Spray [see ADVERSE REACTIONS)]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray. Concurrent use of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see DRUG INTERACTIONS].

Patient Counseling Information

[See FDA-Approved Patient Labeling]

Patients should be instructed to use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray only as prescribed. For the proper use of the nasal spray and to attain maximum improvement, the patient should read and follow carefully the accompanying FDA-Approved Patient Labeling.

Activities Requiring Mental Alertness

Somnolence has been reported in some patients taking ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray [see WARNINGS AND PRECAUTIONS].

Concurrent Use of Alcohol and other Central Nervous System Depressants Concurrent use of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see WARNINGS AND PRECAUTIONS].

Common Adverse Reactions

Patients should be informed that the treatment with ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray may lead to adverse reactions, which include bitter taste, nasal discomfort, epistaxis, headache, fatigue, somnolence, and sneezing [see ADVERSE REACTIONS].

Priming

Patients should be instructed to prime the pump before initial use and when ASTEPRO Nasal Spray has not been used for 3 or more days [see DOSAGE AND ADMINISTRATION].

Keep Spray Out of Eyes

Patients should be instructed to avoid spraying ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray into their eyes.

Keep Out of Children's Reach

Patients should be instructed to keep ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray out of the reach of children. If a child accidentally ingests ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray, seek medical help or call a poison control center immediately.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In 2-year carcinogenicity studies in rats and mice, azelastine hydrochloride did not show evidence of carcinogenicity at oral doses up to 30 mg/kg and 25 mg/kg, respectively. These doses were approximately 150 and 60 times the maximum recommended human daily intranasal dose [MRHDID] on a mg/m² basis.

Azelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.

Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses up to 30 mg/kg (approximately 150 times the MRHDID in adults on a mg/m² basis). At 68.6 mg/kg (approximately 340 times the MRHDID on a mg/m² basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, pre-implantation loss was not increased.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled clinical trials in pregnant women. Azelastine hydrochloride has been shown to cause developmental toxicity in mice, rats, and rabbits. ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Teratogenic Effects

In mice, azelastine hydrochloride caused embryo-fetal death, malformations (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at an oral dose approximately 170 times the maximum recommended human daily intranasal dose (MRHDID) in adults on a mg/m² basis. This dose also caused maternal toxicity as evidenced by decreased body weight. Neither fetal nor maternal effects occurred at a dose that was approximately 7 times the MRHDID.

In rats, azelastine hydrochloride caused malformations (oligo-and brachydactylia), delayed ossification and skeletal variations, in the absence of maternal toxicity, at an oral dose approximately 150 times the MRHDID in adults on a mg/m² basis. At a dose approximately 340 times the MRHDID, azelastine hydrochloride also caused embryo-fetal death and decreased fetal weight; however, this dose caused severe maternal toxicity. Neither fetal nor maternal effects occurred at a dose approximately 15 times the MRHDID.

In rabbits, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight at oral doses approximately 300 times the MRHDID in adults on a mg/m² basis; however, these doses also resulted in severe maternal toxicity. Neither fetal nor maternal effects occurred at a dose approximately 3 times the MRHDID.

Nursing Mothers

It is not known whether azelastine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray in pediatric patients below the age of 12 years have not been established.

Geriatric Use

Clinical trials of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray did not include sufficient numbers of patients 65 years of age and older 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.

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

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