azelastine

Therapeutic Classification: allergy, cold and cough remedies, antihistamines

REMS

Temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to hay fever or other upper respiratory allergies.

Locally antagonizes the effects of histamine at H₁-receptor sites; does not bind to or inactivate histamine.

Therapeutic effects:

Decreased sneezing, nasal rhinitis, pruritus and postnasal drip.

Absorption: 40% absorbed after intranasal administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Most of absorbed azelastine is metabolized by the liver (converted to an active metabolite.

Half-Life: 22–25 hr.

(relief of symptoms)

ROUTE	ONSET	PEAK	DURATION
Intranasal	rapid	2–3 hr‡	12 hr

‡Plasma concentration.

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety not established in children 6 yr.

EENT: epistaxis, nasal burning, pharyngitis, sinusitis, sneezing

GI: bitter taste, dry mouth, nausea

Metab: ↑weight

MS: myalgia

Neuro: drowsiness, dizziness, dysesthesia, fatigue, headache

Drug-drug:

Additive CNS depression with CNS depressants, including alcohol, sedative/hypnotics, and opioid analgesics.
Concurrent use of cimetidine↑ blood levels.

Drug-Natural Products:

Concomitant use of kava, valerian, skullcap, chamomile, or hops can ↑ CNS depression.

(Adults and Children ≥12 yr): 2 sprays/nostril once daily or 1–2 sprays/nostril twice daily.
(Children 6–11 yr): 1 spray/nostril twice daily.

(Generic available)

Nasal spray: 205.5 mcg/spray (60–200 sprays/bottle) OTC
In combination with: fluticasone (Dymista); see Appendix [not included in this PDA edition].

Assess allergy symptoms (rhinitis, sneezing, conjunctivitis, hives) before and periodically during therapy.
Assess lung sounds and character of bronchial secretions. Maintain fluid intake of 1500–2000 mL/day to decrease viscosity of secretions.

Lab Test Considerations:

May cause false-negative allergy skin testing. Discontinue antihistamines at least 72 hr before testing.

Before initial use, remove the safety clip on the bottle and prime the delivery system with 6 sprays or until a fine mist appears. When ≥3 days have elapsed since last use, reprime the unit with 2 sprays or until a fine mist appears.

Instruct patient in the proper technique for administration of azelastine. Keep head tilted downward toward toes during instillation of intranasal spray to decrease bitter taste.
May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until effects of the medication are known.
Advise patient to avoid taking alcohol or other CNS depressants concurrently with this drug.
Advise patient that good oral hygiene, frequent rinsing of the mouth, and sugarless gum or candy may help relieve dry mouth. Patient should notify dentist if dry mouth persists >2 wk.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Instruct patient to contact health care professional if symptoms persist.

Decreased sneezing, nasal rhinitis, pruritus and postnasal drip.

NDC Code

0037- Meda Pharmaceuticals
- 0037-0241- Astelin
  - 0037-0241-30- 1 BOTTLE, SPRAY in 1 BOX (0037-0241-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

0037- Meda Pharmaceuticals
- 0037-0243- Astepro
  - 0037-0243-04- 1 BOTTLE, SPRAY in 1 BOX (0037-0243-04) > 22 SPRAY, METERED in 1 BOTTLE, SPRAY

0037- Meda Pharmaceuticals
- 0037-0243- Astepro
  - 0037-0243-30- 1 BOTTLE, SPRAY in 1 BOX (0037-0243-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

0054- West-Ward Pharmaceuticals Corp.
- 0054-0293- Azelastine Hydrochloride
  - 0054-0293-99- 1 BOTTLE in 1 CARTON (0054-0293-99) > 200 SPRAY, METERED in 1 BOTTLE

17478- Akorn, Inc.
- 17478-718- Azelastine Hydrochloride
  - 17478-718-10- 6 mL in 1 BOTTLE, DROPPER (17478-718-10)

42291- AvKARE, Inc
- 42291-153- AZELASTINE HYDROCHLORIDE
  - 42291-153-30- 1 BOTTLE, SPRAY in 1 CARTON (42291-153-30) > 30 mL in 1 BOTTLE, SPRAY

45802- Perrigo New York Inc
- 45802-026- azelastine hcl nasal
  - 45802-026-83- 1 BOTTLE in 1 CARTON (45802-026-83) > 200 SPRAY in 1 BOTTLE

47335- Sun Pharmaceutical Industries, Inc.
- 47335-779- Azelastine Hydrochloride
  - 47335-779-91- 1 BOTTLE, SPRAY in 1 BOX (47335-779-91) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

47335- Sun Pharmaceutical Industries, Inc.
- 47335-938- Azelastine Hydrochloride
  - 47335-938-90- 1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) > 6 mL in 1 BOTTLE, PLASTIC

50090- A-S Medication Solutions
- 50090-2330- Azelastine Hydrochloride
  - 50090-2330-0- 1 BOTTLE, SPRAY in 1 CARTON (50090-2330-0) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

50090- A-S Medication Solutions
- 50090-2538- Azelastine Hydrochloride
  - 50090-2538-0- 1 BOTTLE, SPRAY in 1 BOX (50090-2538-0) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

50090- A-S Medication Solutions
- 50090-3833- Azelastine Hydrochloride
  - 50090-3833-0- 1 BOTTLE, SPRAY in 1 CARTON (50090-3833-0) > 30 mL in 1 BOTTLE, SPRAY

50383- Hi-Tech Pharmacal Co., Inc.
- 50383-738- Azelastine Hydrochloride
  - 50383-738-30- 1 BOTTLE in 1 CARTON (50383-738-30) > 30 mL in 1 BOTTLE

50383- Hi-Tech Pharmacal Co., Inc.
- 50383-942- Azelastine Hydrochloride
  - 50383-942-30- 1 BOTTLE, PUMP in 1 CARTON (50383-942-30) > 30 mL in 1 BOTTLE, PUMP

51525- Wallace Pharmaceuticals Inc.
- 51525-0234- Azelastine Hydrochloride
  - 51525-0234-3- 1 BOTTLE in 1 CARTON (51525-0234-3) > 200 SPRAY, METERED in 1 BOTTLE

51525- Wallace Pharmaceuticals Inc.
- 51525-0294- Azelastine Hydrochloride
  - 51525-0294-3- 1 BOTTLE, SPRAY in 1 BOX (51525-0294-3) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

51991- Breckenridge Pharmaceutical, Inc.
- 51991-814- AZELASTINE HYDROCHLORIDE
  - 51991-814-03- 1 BOTTLE, SPRAY in 1 CARTON (51991-814-03) > 30 mL in 1 BOTTLE, SPRAY

60505- Apotex Corp.
- 60505-0578- AZELASTINE HYDROCHLORIDE
  - 60505-0578-4- 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) > 6 mL in 1 BOTTLE, PLASTIC

60505- Apotex Corp.
- 60505-0833- Azelastine Hydrochloride
  - 60505-0833-5- 1 BOTTLE, SPRAY in 1 CARTON (60505-0833-5) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

60505- Apotex Corp.
- 60505-0848- Azelastine Hydrochloride
  - 60505-0848-5- 1 BOTTLE, SPRAY in 1 CARTON (60505-0848-5) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

61314- Sandoz Inc
- 61314-308- Azelastine Hydrochloride
  - 61314-308-02- 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) > 6 mL in 1 BOTTLE, PLASTIC

65162- Amneal Pharmaceuticals LLC
- 65162-676- Azelastine Hydrochloride
  - 65162-676-84- 1 BOTTLE, SPRAY in 1 CARTON (65162-676-84) > 30 mL in 1 BOTTLE, SPRAY

65162- Amneal Pharmaceuticals LLC
- 65162-706- Azelastine Hydrochloride
  - 65162-706-84- 200 CARTON in 1 BOTTLE (65162-706-84) > 1 SPRAY, METERED in 1 CARTON

67877- Ascend Laboratories, LLC
- 67877-477- Azelastine
  - 67877-477-50- 1 SPRAY, METERED in 1 BOTTLE (67877-477-50)

68071- NuCare Pharmaceuticals,Inc.
- 68071-4359- Azelastine Hydrochloride
  - 68071-4359-6- 6 mL in 1 BOTTLE (68071-4359-6)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-415- AZELASTINE HYDROCHLORIDE
  - 68382-415-06- 1 BOTTLE in 1 CARTON (68382-415-06) > 200 SPRAY, METERED in 1 BOTTLE

70069- Somerset Therapeutics, LLC
- 70069-091- Azelastine Hydrochloride
  - 70069-091-01- 1 BOTTLE in 1 CARTON (70069-091-01) > 6 mL in 1 BOTTLE

70771- Cadila Healthcare Limited
- 70771-1313- AZELASTINE HYDROCHLORIDE
  - 70771-1313-2- 1 BOTTLE in 1 CARTON (70771-1313-2) > 200 SPRAY, METERED in 1 BOTTLE

76519- H.J. Harkins Company, Inc.
- 76519-1222- AZELASTINE HYDROCHLORIDE
  - 76519-1222-0- 30 mL in 1 BOTTLE, SPRAY (76519-1222-0)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

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