RYALTRIS (olopatadine hcl/mometasone furoate)

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
Epistaxis
Inactive tuberculosis
Nasal septal ulcers
Parasitic infection

There are 23 severe adverse reactions.

More Frequent	Less Frequent
Viral infection	Asthma Bronchitis Chest pain Dysmenorrhea Earache Nasal septal perforation Nasal septal ulcers Sinusitis Upper respiratory infection

Rare/Very Rare
Anaphylaxis Angioedema Cataracts Dysgeusia Glaucoma Impaired wound healing Increased creatine kinase level Lesion of nasal mucosa Migration of implant Nasal candidiasis Nasal septal perforation Oral candidiasis Parosmia

There are 33 less severe adverse reactions.

More Frequent	Less Frequent
Conjunctivitis Cough Dysgeusia Epistaxis Headache disorder Otitis Pharyngitis Upper respiratory infection	Asthma Bronchitis Chest pain Dysmenorrhea Earache Nasal septal perforation Nasal septal ulcers Sinusitis Upper respiratory infection

Rare/Very Rare
Depression Dizziness Drowsy Fatigue Flu-like symptoms Influenza Loss of sense of smell Nasal pain Nasal passage irritation Parosmia Pharyngitis Sore throat Vomiting Xerostomia

Reproduction studies in rats and rabbits receiving oral olopatadine dosages of 600 or 400 mg/kg daily, respectively (i.e., 93,750 or 62,500 times the maximum recommended human ocular dosage, respectively, based on a drop size of 40 mcL, and approximately 1000 or 1400 times the maximum recommended human dose, respectively, for adults on a mg/m2 basis), have not revealed evidence of teratogenicity. However, a decrease in the number of live fetuses was observed in rabbits and rats receiving oral olopatadine dosages of 25 and 60 mg/kg (approximately 88 and 100 times the maximum recommended human dose, respectively, for adults on a mg/m2 basis) or higher. In rats receiving an oral olopatadine dose of 60 mg/kg (approximately 100 times the maximum recommended human dose for adults on a mg/m2 basis), viability and body weights of pups were reduced on day 4 postpartum; however, no effect on viability was observed at a dose of 20 mg/kg (approximately 35 times the maximum recommended human dose for adults on a mg/m2 basis).

There are no adequate and well-controlled studies to date using olopatadine in pregnant women, and the drug should be used during pregnancy only if the potential benefits justify the possible risks to the embryo or fetus. Category C. (See Users Guide.) Administration of corticosteroids during pregnancy may result in hypoadrenalism in the infant.

Drug/Drug Class	Severity	Precaution Description	Pregnancy Category Description
Mometasone	2	Acog guidelines rec inhaled corticosteroids for asthma treatment in pregnancy	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.
Olopatadine	2	Insufficient human data available on developmental toxicity risk.	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.

Olopatadine is distributed into milk in rats following oral administration. It is not known whether topical ophthalmic administration of olopatadine could result in sufficient systemic absorption to produce detectable quantities in milk; therefore, olopatadine ophthalmic solutions should be used with caution in nursing women. Olopatadine nasal spray should be used in nursing women only if the potential benefits to the woman outweigh the potential risks to the infant.

Not known whether mometasone furoate is distributed in milk. Caution is advised if the drug is administered in nursing women.

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
Mometasone	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)	Unlikely clinically significant amount excreted with top/nasal administration
Olopatadine	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)	Insufficient human data available

No substantial differences in safety and efficacy relative to younger adults.