Azelastine and Fluticasone

Name: Azelastine and Fluticasone

What are some other side effects of Azelastine and Fluticasone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Nosebleed.
  • Nose irritation.
  • Change in taste.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Nasal:

Ticalast: Azelastine hydrochloride 0.1% [137 mcg/spray] and fluticasone propionate 0.037% [50 mcg/spray] (23 g) & sterile saline wash (117 mL) [contains benzalkonium chloride; 120 metered sprays]

Suspension, Nasal:

Dymista: Azelastine hydrochloride 0.1% [137 mcg/spray] and fluticasone propionate 0.037% [50 mcg/spray] (23 g) [contains benzalkonium chloride; 120 metered sprays]

Use Labeled Indications

Seasonal allergic rhinitis: Relief of symptoms of seasonal allergic rhinitis in patients ≥6 years of age

Dosing Pediatric

Seasonal allergic rhinitis: Children ≥6 years and Adolescents: Refer to adult dosing.

Administration

For intranasal administration only. Prime pump (press 6 times until fine spray appears) prior to first use. If ≥14 days have elapsed since last use, then reprime pump with 1 spray or until a fine mist appears. Shake bottle gently before using. Blow nose to clear nostrils. Keep head tilted downward when spraying. Insert applicator tip 1/4 to 1/2 inch into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. After each use, wipe the spray tip with a clean tissue or cloth and replace cap. Clean spray pump unit and dust cap at least 1 time each week in warm water and allow to completely dry before placing back on bottle. Avoid spraying directly into nasal septum, eyes or mouth. Discard after 120 medicated sprays have been used, even if bottle is not completely empty. The 10 mL bottle [Canadian product] should be discarded after 28 medicated sprays have been used.

Adverse Reactions

Reactions/percentages reported with combination product; also see individual agents.

1% to 10%:

Central nervous system: Headache (2%)

Gastrointestinal: Dysgeusia (4%)

Respiratory: Epistaxis (4%; frequency and severity may be increased in children)

<1% (Limited to important or life-threatening): Abnormality in thinking, anosmia, anxiety, application site irritation, atrial fibrillation, blurred vision, bronchospasm, burning sensation, cataract, chest pain, confusion, conjunctivitis, diarrhea, dizziness, drowsiness, drug tolerance, dry nose, dry throat, dyspnea, erythema, generalized ache, glaucoma, hoarseness, hypersensitivity reaction, hypertension, increased heart rate, increased intraocular pressure, insomnia (initial), muscle spasm, nasal obstruction, nasal septum perforation, nasal sores, nervousness, palpitations, paresthesia, restlessness, sedation, skin rash, sore throat, swelling of eye, therapeutic response unexpected, urinary retention, vertigo, visual disturbance, weight loss, xerophthalmia

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache or change in taste. Have patient report immediately to prescriber signs of infection, severe dizziness, passing out, severe nausea, severe vomiting, severe loss of strength and energy, severe nose irritation, rhinitis, wheezing, vision changes, eye pain, severe eye irritation, severe nosebleed, fatigue, or thrush (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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