Olopatadine Intranasal-Mometasone Intranasal

Olopatadine Intranasal-Mometasone Intranasal is a prescription medication used to treat symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

• Olopatadine Intranasal-Mometasone Intranasal is available under the following different brand names: Ryaltris

Common side effects of Olopatadine Intranasal-Mometasone Intranasal include:

• changes in taste
• nosebleed
• nasal discomfort

Serious side effects of Olopatadine Intranasal-Mometasone Intranasal include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• severe dizziness
• nosebleeds
• nose sores
• runny nose
• crusting in the nose
• wheezing
• white patches or sores in the nose that won't heal
• vision problems
• signs of infection—fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising, or bleeding

Rare side effects of Olopatadine Intranasal-Mometasone Intranasal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intranasal spray

• (665 mcg/25 mcg)/spray

Seasonal allergic rhinitis

Adult dosage

• 2 sprays per nostril two times a day

Pediatric dosage

• Children younger than 12 years: Safety and efficacy not established
• Children 12 years and above: 2 sprays per nostril two times a day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Olopatadine Intranasal-Mometasone Intranasal has severe interactions with the following drug:
  • desmopressin
• Olopatadine Intranasal-Mometasone Intranasal has serious interactions with at least 220 other drugs
• Olopatadine Intranasal-Mometasone Intranasal has moderate interactions with the following drugs:
  • acrivastine
  • amisulpride
  • atazanavir
  • avapritinib
  • brimonidine
  • brivaracetam
  • ceritinib
  • clarithromycin
  • clobazam
  • cobicistat
• Olopatadine Intranasal-Mometasone Intranasal has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to any ingredients of nasal spray

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Olopatadine Intranasal-Mometasone Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Olopatadine Intranasal-Mometasone Intranasal?”

Cautions

• May cause somnolence; avoid operating heavy machinery or engaging in tasks that require mental alertness and coordination; caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination (e.g., operating machinery, driving a motor vehicle) after administration
• Avoid concurrent use with alcohol or other central nervous system depressants; additional reductions in alertness and additional impairment of CNS performance may occur
• Glaucoma and/or cataracts may develop; closely monitor patients with vision changes or a history of increased intraocular pressure, glaucoma, and/or cataracts
• Hypersensitivity reactions, including wheezing, have occurred after nasal administration of mometasone; discontinue therapy if such reactions occur
• Nasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients; routinely monitor the growth of pediatric patients; safety and efficacy not established in pediatric patients aged younger than 12 years; not indicated for use in this population
• Hypercorticism and adrenal suppression may occur when nasal corticosteroids are misused by taking higher-than-recommended dosages or in patients at risk for such effects
• Local nasal adverse reactions
  • Epistaxis, nasal ulceration, and nasal septal perforation were reported
  • Periodically monitor for signs of adverse effects on the nasal mucosa
  • Corticosteroids may impair wound healing; avoid use in patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma until resolved
  • Localized Candida infections of the nose and pharynx have occurred from mometasone intranasal; if infection occurs, discontinue therapy, and treat appropriately; examine periodically for evidence of Candida infection if use is over several months or longer
• Immunosuppression and risk of infections
  • Immunosuppressive drugs (e.g., corticosteroids) may increase susceptibility to infection
  • Chickenpox and measles may be more serious or even fatal in susceptible children or adults using corticosteroids
  • Risk of developing an infection based on therapy (i.e., dose, duration, route), underlying disease, and/or prior corticosteroid use is unknown
  • If exposed to chickenpox, prophylaxis with varicella zoster immune globulin may be indicated; if exposed to measles, prophylaxis with pooled IM immunoglobulin may be indicated; if chickenpox develops, consider treating it with antiviral agents
  • Use with caution in active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex
• Drug interaction overview
  • CNS depressants
    • Avoid coadministration
    • Alcohol and other CNS depressants may potentiate somnolence and CNS depression
  • Strong CYP3A4 inhibitors
    • Use with caution
    • Strong CYP3A4 inhibitors may inhibit the metabolism of, and increase mometasone furoate plasma concentration, and potentially increase the risk for adverse reactions

Pregnancy and Lactation

• Data are unavailable on use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • Data are unavailable on the presence of drugs in human milk, its effects on breastfed children, or milk production
  • Other corticosteroids are excreted in human milk
  • Olopatadine has been identified in the milk of nursing rats following oral administration; unknown whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk