Ryaltris

(Olopatadine Hydrochloride/Mometasone furoate)

The active ingredients in Ryaltris are olopatadine hydrochloride and mometasone furoate monohydrate. Olopatadine belongs to a class of medications known as antihistamines, while mometasone is classified as a corticosteroid. Each works a little bit differently to manage your allergy symptoms. Olopatadine blocks the release of histamine, a chemical commonly released during an allergic reaction. Mometasone, on the other hand, calms down your immune system and thus the body’s response to the allergen. Each of their mechanisms of action can effectively help relieve symptoms of seasonal allergies.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Ryaltris. However, the following is a synopsis of the general guidelines for the use of Ryaltris:

• Ryaltris should be used exactly as prescribed for ocular and nasal symptoms due to allergies.
• It is typically used as 2 sprays in each nostril twice daily. If using the spray for the first time, prime the spray by depressing the plunger until a fine mist is seen. Repeat if it has been more than 14 days since the last use.
• Ryaltris may make you feel sleepy or drowsy. Do not drive or operate heavy machinery until you know how Ryaltris affects you. Drinking alcohol or using other medications or substances that cause drowsiness while using Ryaltris should be avoided.
• If you miss a dose, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Ryaltris seen in clinical trials as compared to placebo include:

• An altered sense of taste that is often unpleasant
• Nose bleeds
• Nasal discomfort or irritation

Some individuals may experience serious side effects while using Ryaltris. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Any nose or throat problems, such as nosebleeds that do not stop, sores or ulcers in the nose, or symptoms of a nasal perforation or a hole in the nose, such as bleeding, crusting, runny nose, or a whistling sound when you breathe.
• Slow or poor healing of existing wounds, especially those in the nose.
• Signs of thrush or a fungal infection of the throat or mouth such as white patches at the back of the throat or in your nose and changes in your voice (especially hoarseness).
• Changes in vision
• Signs of a severe allergic reaction such as hives, rash, wheezing, difficulty breathing, or swelling of the face, mouth, and tongue.
• Symptoms of infection such as fever, chills, aches, pains, or unusual fatigue.
• Signs of adrenal insufficiency such as unusual fatigue or weakness, nausea, vomiting, or low blood pressure.
• Slowed growth in children.
• Excessive sleepiness or drowsiness.

These are not all of the possible side effects of Ryaltris. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Ryaltris, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether any of the following apply:

• Any nasal sores or injuries to the nose
• Nasal surgery
• Vision problems, including cataracts or glaucoma
• Tuberculosis
• General feelings of illness or symptoms of untreated infections, including eye infections such as those caused by the herpes virus
• Exposure to someone with chickenpox or measles
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Ryaltris if you have an allergy to olopatadine hydrochloride, mometasone furoate, or any of the other ingredients in Ryaltris.

Ryaltris begins to work against your allergy symptoms right after the first use, and you should see benefits within 15 minutes of use. However, it may take a few days of regular use to see the full effects of Ryaltris.

When Ryaltris is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• HIV medications such as ritonavir, atazanavir, indinavir, nelfinavir, and saquinavir
• Products containing cobicistat
• Ketoconazole
• Itraconazole
• Clarithromycin
• Telithromycin
• Nefazodone

Ryaltris nasal spray contains 665 mcg of olopatadine hydrochloride and 25 mcg of mometasone furoate in each spray. No other dosage forms are available.

Ryaltris should be stored at room temperature, in an upright position, away from light and moisture, and out of reach of children.

Ryaltris is manufactured by the pharmaceutical company Glenmark Specialty.

Currently, there is no generic available for the brand-name Ryaltris.

Consult your doctor or pharmacist before starting, stopping, or changing medications while using Ryaltris.

It is unknown if Ryaltris can harm the unborn child. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Ryaltris can pass into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.