DYMISTA (azelastine hcl/fluticasone propionate)

There are 0 contraindications.

There are 8 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Nasal septal perforation
Nasal septal ulcers
Nasal trauma
Ocular herpes simplex
Ocular hypertension
Open angle glaucoma
Operation on nose
Severe infection

There are 6 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Adrenocortical insufficiency
Cataracts
Drowsy
Epistaxis
Inactive tuberculosis
Parasitic infection

There are 27 severe adverse reactions.

More Frequent	Less Frequent
None.	Bronchitis Cough Lesion of nasal mucosa Urticaria

Rare/Very Rare
Adrenocortical insufficiency Anaphylaxis Angioedema Atrial fibrillation Blurred vision Bronchospastic pulmonary disease Cataracts Contact dermatitis Glaucoma Hematuria Hypercortisolism Immunosuppression Impaired wound healing Nasal candidiasis Nasal septal perforation Ocular pain Pharyngeal candidiasis Pruritus of skin Skin rash Stomatitis Tachycardia Urinary retention Visual changes

There are 67 less severe adverse reactions.

More Frequent	Less Frequent
Drowsy Dry nose Dysesthesia Dysgeusia Epistaxis Headache disorder Nasal passage irritation Pharyngitis	Acute abdominal pain Conjunctivitis Cough Crusted nasal mucosa Dizziness Dysgeusia Epistaxis Erythema of nasal mucosa Fatigue Fever Myalgia Nasal congestion Nasal pain Nasal passage irritation Nausea Pain in oropharynx Pharyngitis Rhinitis Rhinorrhea Sinusitis Sneezing Sore throat Weight gain Xerostomia

Rare/Very Rare

Acute cognitive impairment Aphthous stomatitis Chest pain Constipation Contact dermatitis Depression Diarrhea Dry eye Dyspnea Eczema Eye tearing Facial edema Flu-like symptoms Flushing Folliculitis Furunculosis Gastroenteritis Glossitis Hyperkinesis Hypertension Hypoesthesia Increased appetite Lacerations Lesion of nasal mucosa Loss of sense of smell Nervousness Palpitations Paresthesia Parosmia Pruritus of skin Sleep disorder Symptoms of anxiety Toothache Voice change Vomiting

Fluticasone propionate nasal spray should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Since adrenal insufficiency may occur in neonates born to women who received corticosteroids during pregnancy, these neonates should be monitored carefully for manifestations of this condition. Although there are no adequate and well-controlled studies to date using fluticasone propionate in pregnant women, fluticasone propionate has been shown to be teratogenic and embryotoxic in mice or rats when administered subcutaneously at daily dosages of 45 or 100 mcg/kg, respectively (approximately equivalent to 4 times the maximum recommended daily intranasal dosage in adults based on surface area).

Observed fetal toxicity was characteristic of potent glucocorticoid compounds and included embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. Fetal weight reduction and cleft palate were observed in offspring of rabbits given fluticasone propionate 4 mcg/kg subcutaneously (less than the maximum recommended daily intranasal dosage in adults). Following oral administration of up to 300 mcg/kg (approximately 25 times the maximum recommended daily intranasal dosage in adults on a mcg/m2 basis) daily of fluticasone propionate in rabbits, the drug was not detected in plasma, and no maternal effects nor increased incidence of external, visceral, or skeletal fetal defects was detected.

The low bioavailability and small distribution of fluticasone propionate across the placenta may account for the lack of teratogenicity; in rats and rabbits receiving oral fluticasone propionate dosages of 100 mcg/kg (590 mcg/m2) or 300 mcg/kg (3.6 mg/m2), respectively, less than 0.008% of the dose crossed the placenta. Long-term experience with the use of oral glucocorticoids suggests that rodents are more prone to teratogenic effects of glucocorticoids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous glucocorticoid dose and many will not need glucocorticoid treatment during pregnancy.

Fluticasone propionate should be used with caution in nursing women, since it is not known whether the drug is distributed into milk in humans. Subcutaneous administration of tritiated fluticasone propionate to lactating rats (10 mcg/kg, less than the maximum recommended daily intranasal dosage in adults on a mcg/m2 basis) resulted in measurable radioactivity in both plasma and milk. Other corticosteroids are distributed into milk and in systemic amounts may cause adverse effects, such as growth suppression, in nursing infants.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Azelastine	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Occasional use not expected to cause adverse effects
Fluticasone (inhal, Nasal)	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Insuff human data avail; significant exposure to a nursing infant is unlikely

No enhanced Geriatric Use information available for this drug.