Ryaltris Nasal Spray Now Approved for Kids Ages 6-11 With Seasonal Allergies

The FDA has approved Ryaltris nasal spray for children ages 6 to 11 years who have seasonal allergies. Seasonal allergies can cause a stuffy nose, runny nose, nose itching, and sneezing. This medicine was already approved for adults and children ages 12 and older. Now, younger children with seasonal allergies can use this medicine too.

Ryaltris (olopatadine/mometasone) is a nasal spray that combines two different allergy medicines together: olopatadine and mometasone. Olopatadine is an antihistamine that helps block allergy symptoms. Mometasone is a steroid that reduces swelling and inflammation inside the nose.

Together, these two medicines help treat troublesome allergy symptoms. Seasonal allergies can affect a child’s sleep, schoolwork, and daily activities. Having both medicines in a single nasal spray helps simplify daily allergy care for children.

Why Was It Approved for Younger Children?

The FDA expanded the approval of Ryaltris based on a 14-day clinical study in 446 children ages 6 to 11 years with seasonal allergies. In the study, half of the children used Ryaltris nasal spray twice a day, while the other half used a placebo spray that contained no active medicine.

The main goal of the study was to see how well the spray relieved nasal allergy symptoms over two weeks. Children who used Ryaltris had a clear and meaningful improvement in their nasal symptoms compared to those who used the placebo spray. They had less nose stuffiness, less-runny noses, less itching, and less sneezing. They also reported better overall quality of life during the study.

The study also showed that Ryaltris was generally safe and well tolerated in younger children. Side effects were mostly mild or moderate and happened at similar rates with both the medicine and the placebo.

What Do Patients and Parents Need to Know?

Ryaltris is used only in the nose. For children ages 6 to 11 years, it is given as one spray in each nostril twice every day. Before using a bottle for the first time, you must prime it by spraying it six times into the air away from the face until a fine mist appears. If the spray has not been used for 14 days or more, prime it again with two sprays. Always shake the bottle well before each use.

The most common side effects include an unpleasant taste in the mouth, nosebleeds, nose discomfort, and headaches. Ryaltris can also cause sleepiness or drowsiness, so your child may need to avoid other medicines that make them sleepy. They should also avoid activities that require full mental alertness until they know how the spray affects them.

Parents should talk to their child’s health care provider before starting Ryaltris. Tell the health care provider if your child has had recent nose sores, recent nose surgery, recent exposure to measles or chickenpox, or has any active infections. Because this nasal spray contains a steroid, your health care provider will monitor your child’s growth regularly during treatment.

Tell your health care provider about all medicines your child takes. Certain antifungal medicines, antibiotics, or HIV drugs can interact with Ryaltris and increase the risk of side effects.