Drugs List

Therapeutic Indications

Uses

Rhinitis - allergic
Rhinitis - perennial

Contraindications

Children under 12 years
Uncontrolled nasal infection
Nasal septum perforation
Recent nasal surgery
Recent nasal trauma

Precautions and Warnings

Uncontrolled systemic infection
Breastfeeding
Ocular herpes simplex infection
Pregnancy
Tuberculosis of respiratory tract

Re-evaluate therapy in active or quiescent pulmonary tuberculosis
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Advise ability to drive/operate machinery may be affected by side effects
Contains benzalkonium chloride
Advise patient to avoid spraying this preparation into or near the eyes
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Inspect nasal mucosa regularly in patients on long term treatment
Monitor regularly the height of children receiving prolonged treatment
Prolonged or high dose may lead to adrenal suppression
Corticosteroids may cause growth retardation in children under 18 years
Systemic side effects may occur
Do not withdraw this drug suddenly
Discontinue if hypersensitivity reactions occur
Maintain treatment at the lowest effective dose
Advise patient to avoid alcohol during treatment
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Use regularly to maintain freedom from symptoms

Systemic effects of intranasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Possible systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataracts and glaucoma and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.

Patients should be examined periodically when being treated for several months or longer for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Olopatadine may cause somnolence in some patients when absorbed systemically. Concurrent use of the nasal suspension with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and impairment of CNS performance may occur.

Concomitant use of olopatadine with other antihistaminic drugs administered via nasal, ocular or oral route may increase the risk of antihistimine adverse effects.

Pregnancy and Lactation

Pregnancy

Use mometasone furoate and olopatadine with caution during pregnancy.

The manufacturer advises caution if mometasone furoate and olopatadine nasal suspension is used during pregnancy. The manufacturer recommends that the nasal suspension is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Some studies in animals have shown reproductive toxicity following administration of mometasone furoate and also olopatadine. At the time of writing, there is limited data available on the use of mometasone or olopatadine in human pregnancy. Risks are unknown. The manufacturer recommends that infants born to mothers who took corticosteroids during pregnancy should be monitored for hypoadrenalism.

Lactation

Use mometasone furoate and olopatadine hydrochloride with caution during breastfeeding.

The manufacturer notes that mometasone furoate and olopatadine nasal suspension should not be used during breastfeeding unless the potential benefit to the mother justifies the potential risk to the mother or infant. Animal studies have shown excretion of mometasone furoate into milk. It is unknown whether mometasone furoate and/or its metabolites are excreted in human breast milk.

Side Effects

Abdominal pain
Adrenal suppression
Aggression
Anaphylactic reaction
Angioedema
Anxiety
Bacterial vaginosis
Blurred vision
Bronchospasm
Cataracts
Constipation
Cushing's syndrome
Cushingoid facies
Depression
Dizziness
Dry eyes
Dry mouth
Dysgeusia
Dyspnoea
Ear pain
Epistaxis
Fatigue
Glaucoma
Growth retardation (children)
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Insomnia
Laceration
Lethargy
Migraine
Nasal discomfort
Nasal dryness
Nasal irritation
Nasal mucosa reactions
Nausea
Ocular discomfort
Oropharyngeal pain
Perforation of nasal septum
Pharyngitis
Psychomotor hyperactivity
Sleep disturbances
Sneezing
Somnolence
Sore tongue
Throat irritation
Upper respiratory tract infection

Presentation

Nasal spray suspension containing mometasone furoate (as the monohydrate) and olopatadine hydrochloride.

Drugs List

Therapeutic Indications

Uses

Rhinitis - allergic
Rhinitis - perennial

Dosage

Adults

Children

Contraindications

Children under 12 years
Uncontrolled nasal infection
Nasal septum perforation
Recent nasal surgery
Recent nasal trauma

Precautions and Warnings

Uncontrolled systemic infection
Breastfeeding
Ocular herpes simplex infection
Pregnancy
Tuberculosis of respiratory tract

Re-evaluate therapy in active or quiescent pulmonary tuberculosis
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Advise ability to drive/operate machinery may be affected by side effects
Contains benzalkonium chloride
Advise patient to avoid spraying this preparation into or near the eyes
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Inspect nasal mucosa regularly in patients on long term treatment
Monitor regularly the height of children receiving prolonged treatment
Prolonged or high dose may lead to adrenal suppression
Corticosteroids may cause growth retardation in children under 18 years
Systemic side effects may occur
Do not withdraw this drug suddenly
Discontinue if hypersensitivity reactions occur
Maintain treatment at the lowest effective dose
Advise patient to avoid alcohol during treatment
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Use regularly to maintain freedom from symptoms

Systemic effects of intranasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Possible systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataracts and glaucoma and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.

Patients should be examined periodically when being treated for several months or longer for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Olopatadine may cause somnolence in some patients when absorbed systemically. Concurrent use of the nasal suspension with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and impairment of CNS performance may occur.

Concomitant use of olopatadine with other antihistaminic drugs administered via nasal, ocular or oral route may increase the risk of antihistimine adverse effects.

Pregnancy and Lactation

Pregnancy

Use mometasone furoate and olopatadine with caution during pregnancy.

The manufacturer advises caution if mometasone furoate and olopatadine nasal suspension is used during pregnancy. The manufacturer recommends that the nasal suspension is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Some studies in animals have shown reproductive toxicity following administration of mometasone furoate and also olopatadine. At the time of writing, there is limited data available on the use of mometasone or olopatadine in human pregnancy. Risks are unknown. The manufacturer recommends that infants born to mothers who took corticosteroids during pregnancy should be monitored for hypoadrenalism.

Lactation

Use mometasone furoate and olopatadine hydrochloride with caution during breastfeeding.

The manufacturer notes that mometasone furoate and olopatadine nasal suspension should not be used during breastfeeding unless the potential benefit to the mother justifies the potential risk to the mother or infant. Animal studies have shown excretion of mometasone furoate into milk. It is unknown whether mometasone furoate and/or its metabolites are excreted in human breast milk.

Side Effects

Abdominal pain
Adrenal suppression
Aggression
Anaphylactic reaction
Angioedema
Anxiety
Bacterial vaginosis
Blurred vision
Bronchospasm
Cataracts
Constipation
Cushing's syndrome
Cushingoid facies
Depression
Dizziness
Dry eyes
Dry mouth
Dysgeusia
Dyspnoea
Ear pain
Epistaxis
Fatigue
Glaucoma
Growth retardation (children)
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Insomnia
Laceration
Lethargy
Migraine
Nasal discomfort
Nasal dryness
Nasal irritation
Nasal mucosa reactions
Nausea
Ocular discomfort
Oropharyngeal pain
Perforation of nasal septum
Pharyngitis
Psychomotor hyperactivity
Sleep disturbances
Sneezing
Somnolence
Sore tongue
Throat irritation
Upper respiratory tract infection

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: December 2021

Reference Sources

Summary of Product Characteristics: Ryaltris 25microgram/actuation and 600micrograms/actuation Nasal Spray, Suspension. Glenmark Pharmaceuticals Europe Limited. Revised May 2021.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 December 2021