How To Tell the Difference Between COVID-19, Allergies and Sinus Problems

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vasomotor rhinitis :: Article Creator

Azelastine Hcl

Azelastine HCl Prescription & Dosage Information - MPR Azelastine Hcl Generic Name & Formulations General Description Azelastine HCl 137mcg/spray; aqueous nasal spray; contains benzalkonium chloride. Pharmacological Class

Antihistamine.

How Supplied

Contact supplier

Mechanism of Action

Azelastine HCl, a phthalazinone derivative, exhibits histamine H1-receptor antagonist activity in isolated tissues, animal models, and humans.

Azelastine Hcl Indications Indications

Seasonal allergic rhinitis. Vasomotor rhinitis.

Azelastine Hcl Dosage and Administration Adult

≥12yrs: Seasonal allergic rhinitis: 1–2 sprays in each nostril twice daily. Vasomotor rhinitis: 2 sprays in each nostril twice daily.

Children

Seasonal allergic rhinitis: <5yrs: not established; 5–11yrs: 1 spray in each nostril twice daily. Vasomotor rhinitis: not established.

Azelastine Hcl Contraindications

Not Applicable

Azelastine Hcl Boxed Warnings

Not Applicable

Azelastine Hcl Warnings/Precautions Warnings/Precautions

Avoid eyes. Pregnancy. Nursing mothers: monitor infants.

Warnings/Precautions

Somnolence inActivities Requiring Mental Alertness

Alcohol and other CNS depressants

Pregnancy Considerations

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. 

    • Nursing Mother Considerations

    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. 

  • Monitor breastfed infants for signs of milk rejection.

  • Consider the developmental and health benefits of breastfeeding along with mother's clinical need for azelastine HCl nasal spray, 0.1% and any potential adverse effects on the breastfed infant or from the underlying maternal condition.

    • Clinical Considerations

    Pediatric Considerations

  • 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.

    • Azelastine Hcl Pharmacokinetics Elimination

  • Fecal (75%). 

  • Half-life: 22 hours.

    • Azelastine Hcl Interactions Interactions

    Potentiates CNS depression with alcohol, other CNS depressants. Caution with other antihistamines.

    Azelastine Hcl Adverse Reactions Adverse Reactions

    Bitter taste, headache, somnolence, dysesthesia, nasal burning, pharyngitis, dry mouth, paroxysmal sneezing, nausea, rhinitis, fatigue, dizziness, epistaxis, weight increase, myalgia. Children: also conjunctivitis, cough, asthma.

    Azelastine Hcl Clinical Trials Clinical Trials

    Seasonal Allergic Rhinitis – Two Sprays Per Nostril Twice Daily

  • Approval was based on data from 3 placebo-controlled clinical trials evaluating the efficacy and safety of azelastine HCl nasal spray 0.1% in 322 patients with seasonal allergic rhinitis, including 55 pediatric patients aged 12 to 16 years. Patients received 2 sprays per nostril twice a day of either azelastine HCl nasal spray or placebo for up to 4 weeks.

  • Efficacy was based on the 12-hour reflective Total Symptom Complex (TSC) and Major Symptom Complex (MSC).

  • Azelastine HCl nasal spray showed a greater decrease in the MSC compared with placebo. In dose-ranging trials, there was a statistically significant decrease in symptoms in the azelastine arm compared with placebo within 3 hours after initial dosing and persisted over the 12-hour dosing interval.

    • Seasonal Allergic Rhinitis – One Spray Per Nostril Twice Daily

  • Approval was based on data from 2 placebo-controlled clinical trials evaluating the efficacy and safety of azelastine HCl nasal spray 0.1% in 275 patient with seasonal allergic rhinitis. Patients received 1 spray per nostril twice a day of either azelastine HCl nasal spray or placebo for up to 2 weeks.

  • Efficacy was based on the 12-hour reflective Total Nasal Symptom Score (rTNSS). The primary efficacy endpoint was the change from baseline to Day 14 in rTNSS.

  • Azelastine HCl nasal spray achieved a greater mean change in rTNSS at Day 14 from baseline compared with placebo.

    • Vasomotor Rhinitis

  • Approval was based on data from 2 placebo-controlled clinical trials evaluating the efficacy and safety of azelastine HCl nasal spray 0.1% in 216 patients with vasomotor rhinitis. Patients received 2 sprays per nostril twice a day of azelastine HCl nasal spray or placebo for up to 4 weeks.

  • Azelastine HCl nasal spray 0.1% achieved a significantly greater decrease in symptom complex (rhinorrhea, post nasal drip, nasal congestion, sneezing) compared with placebo.

    • Azelastine Hcl Note Notes

    Formerly known under the brand name Astelin.

    Azelastine Hcl Patient Counseling

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    Learn about User Reviews and read IMPORTANT information about user generated content

    Conditions of Use and Important Information: This information is meant to supplement, not replace advice from your doctor or healthcare provider and is not meant to cover all possible uses, precautions, interactions or adverse effects. This information may not fit your specific health circumstances. Never delay or disregard seeking professional medical advice from your doctor or other qualified health care provider because of something you have read on WebMD. You should always speak with your doctor or health care professional before you start, stop, or change any prescribed part of your health care plan or treatment and to determine what course of therapy is right for you.

    This copyrighted material is provided by Natural Medicines Comprehensive Database Consumer Version. Information from this source is evidence-based and objective, and without commercial influence. For professional medical information on natural medicines, see Natural Medicines Comprehensive Database Professional Version.

    © Therapeutic Research Faculty 2018.





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