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RYALTRIS® dosing for seasonal allergic rhinitis relief 1

Discover a 2-in-1 combination therapy for your patients with SAR.

TWICE-DAILY DOSING: The recommended dosage of RYALTRIS® is 2 sprays in each nostril twice daily.1

Each bottle will deliver 240 metered sprays.1

Each spray delivers 665 mcg of olopatadine hydrochloride and 25 mcg of mometasone furoate.1

RYALTRIS® Nasal Spray

Administration

HOW TO ADMINISTER RYALTRIS® FOR THE TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS

Administer RYALTRIS® by the intranasal route only.

  • Patients should be instructed to shake the bottle well before each use and prime RYALTRIS® before initial use.
  • Prime by pushing down on the pump quickly and firmly 6 times, releasing the spray into the air, away from the eyes and face until a fine mist appears.
  • If you do not use RYALTRIS® for 14 or more days, you will need to shake the bottle well, and prime the pump with 2 sprays or until a fine mist appears.
  • Avoid spraying RYALTRIS® into the eyes or mouth.
  • For additional information, please see Instructions for Use.
Remove the dust cap

STEP 1

Remove the dust cap

Remove the purple plastic dust cap from the spray pump tip of the bottle.

Preparing the nasal spray bottle

STEP 2

Preparing the nasal spray bottle

Hold the nasal spray bottle firmly and upright with your index and middle fingers on either side of the applicator (on finger rests) while supporting the grooved base of the bottle with your thumb.

Before first use, push down on the pump quickly and firmly 6 times, releasing the spray into the air, away from the eyes and face until a fine mist appears.

If you do not use RYALTRIS® for 14 or more days, you will need to shake the bottle well, and prime the pump with 2 sprays or until a fine mist appears.

RYALTRIS® is now ready for use.

Using RYALTRIS

STEP 3

Using RYALTRIS®

Gently blow nose to clear your nostrils.

Using the nasal spray

STEP 4

Using the nasal spray

Shake the bottle well before each use (morning and evening).

Hold the bottle firmly with your index and middle fingers on either side of the applicator (on finger rests) while supporting the grooved base of the bottle with your thumb.

Hold 1 nostril closed with a finger

Hold 1 nostril closed with a finger. Insert the end of the spray pump tip into the other nostril, pointing it slightly toward the outside of the nose, away from the nasal septum (the wall between the 2 nostrils).

Tilt head forward slightly

Tilt your head forward slightly. Keep the bottle upright and press down once quickly and firmly on the finger rests to activate the pump. Breathe in (inhale) gently through your nose as you spray. Then breathe out through your mouth.

Try not to get any spray in your eyes or directly on your nasal septum (the wall between the 2 nostrils).

After you finish using the medicine, wipe the tip with a clean, dry tissue or cloth

Repeat all of step 4 and deliver a second spray in the same nostril.

Repeat all of step 4 with 2 sprays in the other nostril.

Do not blow your nose for at least 15 minutes after using RYALTRIS® to make sure that you receive all of the medicine.

Do not tip your head back right after using to keep the medicine from going into your throat.

After you finish using the medicine, wipe the tip with a clean, dry tissue or cloth.

Hold the spray pump unit and push the dust cap back on the spray pump tip of the bottle

STEP 5

Cleaning your bottle

Hold the spray pump unit and push the dust cap back on the spray pump tip of the bottle until you hear a click.

Each bottle of RYALTRIS® contains enough medicine for you to spray from the bottle 240 times after the first (initial) priming. You should keep track of the number of sprays used from each bottle of RYALTRIS®. Do not count any sprays used for initial priming of the bottle.

Do not pierce the spray nozzle tip

STEP 6

How to clear the RYALTRIS® spray pump unit if it becomes blocked

Do not try to unblock the spray pump unit by inserting a pin or other sharp object. This will damage the spray pump unit, and you may not get the correct dose of medicine.

If the spray pump unit becomes blocked, remove it by gently pulling upward. Remove the dust cap and place only the spray pump unit in warm water to soak.

Soak for 15 minutes

After soaking for 15 minutes, rinse the spray pump unit and dust cap with warm water, and allow them to dry completely.

Place the dust cap on the spray pump tip and put the spray pump unit back on the bottle

Place the dust cap on the spray pump tip and put the spray pump unit back on the bottle.

After following the steps to clear your blocked spray pump, see “Preparing the nasal spray bottle and priming” above and re-prime using 2 sprays. Replace the dust cap, and your RYALTRIS® is ready for use.

Reference

  1. RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.
 

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

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CONTRAINDICATIONS

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

CONTRAINDICATIONS

Patients with known hypersensitivity to any ingredients of RYALTRIS, including mometasone furoate. (4)

WARNINGS AND PRECAUTIONS

  • Epistaxis, nasal ulcerations, nasal septal perforations, impaired wound healing, and Candida albicans infection: Monitor patients periodically for signs of adverse reactions on the nasal mucosa. (5.1)
  • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery when taking RYALTRIS. (5.2)
  • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with RYALTRIS because additional reductions in alertness and additional impairment of CNS performance may occur. (5.2)
  • Glaucoma and cataracts: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. (5.3)
  • Hypersensitivity Reactions: Hypersensitivity reactions can occur with RYALTRIS. Hypersensitivity reactions including wheezing, have occurred after the nasal administration of mometasone furoate. Discontinue RYALTRIS if such reactions occur. (5.4)
  • Immunosuppression and Risk of Infections: Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients: Use caution in patients with the above because of the potential for worsening of these infections. (5.5)
  • Hypercorticism and adrenal suppression with misuse or use of higher-than-recommended dosages or at the regular dosage in susceptible patients at risk for such effects. (5.6)
  • Potential reduction in growth velocity in children: Routinely monitor the growth in pediatric patients receiving RYALTRIS. (5.7, 8.4)

ADVERSE REACTIONS

The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, and nasal discomfort. (6.1)

INDICATIONS

RYALTRIS is a combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

For more information, please see the Full Prescribing Information.

To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364.

Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

RYALTRIS and the RYALTRIS logo are registered trademarks of Glenmark Specialty SA.

Distributed by: Hikma Specialty USA Inc. Columbus, OH 43228

Reference
  1. RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

Read More...

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

IMPORTANT SAFETY INFORMATION

  • Do not take RYALTRIS if you are allergic to olopatadine hydrochloride, mometasone furoate monohydrate or any of the ingredients in RYALTRIS. Ask your healthcare provider if you are not sure.
  • RYALTRIS can cause sleepiness or drowsiness. Do not drive, operate machinery or do anything that requires alertness until you know how RYALTRIS affects you.
  • Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using RYALTRIS.

RYALTRIS may cause serious side effects, including the following:

  • Sleepiness or drowsiness.
  • Nose and throat problems. Symptoms of nose and throat problems may include: nosebleeds, sores (ulcers) in the nose, hole in the cartilage between your nose (nasal septal perforation). Symptoms of nasal septal perforation may include: crusting in the nose, nosebleeds, runny nose and/or a whistling sound when you breathe.
  • Slow wound healing. You should not use RYALTRIS until your nose has healed if you have a sore in your nose, if you have had surgery on your nose or if your nose has been injured.
  • Fungal infection in your nose and throat (thrush, or Candida). Tell your healthcare provider if you have any redness or white-colored patches in your nose or mouth.
  • Eye problems, including glaucoma or cataracts. You should have regular eye exams when using RYALTRIS.
  • Allergic reactions. Call your healthcare provider or get emergency medical care if you have any of the following signs of a serious allergic reaction: wheezing, rash, hives, swelling of your face, mouth, and tongue and breathing problems.
  • Immune system problems that may increase the risk of infection. Taking medicines that weaken your immune system makes you more likely to get infections. These infections may include tuberculosis (TB), ocular herpes simplex infections, and infections caused by fungi, bacteria, viruses, and parasites. Avoid contact with people who have contagious diseases, such as chickenpox or measles, while using RYALTRIS. If you come in contact with someone who has chickenpox or measles, call your healthcare provider right away. Symptoms of infection may include: fever, aches or pains, chills and tiredness.
  • Adrenal insufficiency. Adrenal insufficiency happens when your adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include: tiredness, weakness, nausea, vomiting and low blood pressure.
  • Slowed growth in children. A child’s growth should be checked regularly while using RYALTRIS.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

  • The most common side effects of RYALTRIS include unpleasant taste, nosebleeds and nasal discomfort.
  • Tell your healthcare provider if you have side effects that bother you or do not go away.
  • These are not all of the possible side effects of RYALTRIS. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. RYALTRIS and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

  • Certain medicines for HIV, cobicistat-containing products, certain antifungals, certain antibiotics and/or certain antidepressants. Ask your healthcare provider or pharmacist for a list of your medicines if you are not sure.

Before you use RYALTRIS, tell your healthcare provider about all of your medical conditions, including if you:

  • Have had recent nasal sores, nasal surgery or nasal injury.
  • Have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eyes).
  • Have tuberculosis or any untreated fungal, bacterial or viral infections or eye infections caused by herpes.
  • Have been near someone who has chickenpox or measles.
  • Are not feeling well or have any other symptoms that you do not understand.
  • Are pregnant or plan to become pregnant. It is not known if RYALTRIS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • Are breastfeeding or plan to breastfeed. It is not known if RYALTRIS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using RYALTRIS.

INDICATIONS

RYALTRIS is a prescription nasal spray that contains 2 medicines, olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid. RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

For more information, please see Full Prescribing Information.

To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364.

Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

RYALTRIS and the RYALTRIS logo are registered trademarks of Glenmark Specialty SA.

Distributed by: Hikma Specialty USA Inc. Columbus, OH 43228

Reference

  1. RYALTRIS® Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.