Drugs List

Therapeutic Indications

Uses

Perennial allergic rhinitis - prevention and treatment
Seasonal allergic rhinitis - prophylaxis and treatment
Treatment of nasal polyps

Contraindications

Children under 3 years
Uncontrolled nasal infection
Recent nasal surgery
Recent nasal trauma

Precautions and Warnings

Children aged 3 to 18 years
Transfer from other steroid therapy
Uncontrolled systemic infection
Breastfeeding
Pregnancy
Tuberculosis of respiratory tract

Corticosteroid cover required in adrenal insufficiency
May mask symptoms or signs of infections
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Concomitant treatment may be necessary for allergy eye symptoms
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
Unilateral polyps unusual/irregular/ulcerating/bleeding to be investigated
Corticosteroids may cause growth retardation in children under 18 years
During transfer from oral steroids allergic conditions may be unmasked
Systemic effects possible with any inhaled corticosteroid
Discontinue if localised infection occurs
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Advise patient to seek medical advice if treatment is ineffective
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use mometasone with caution in pregnancy.

The manufacturer notes that mometasone furoate should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the mother or foetus.

Briggs (2015) notes that it is not known if mometasone crosses the animal or human placenta. The molecular weight (about 513) is low enough for passage but the very low systemic bioavailability suggests that little, if any, drug will reach the embryo of foetus. No reports describing the use of mometasone in human pregnancy have been located. The animal data suggests risk but the observed developmental toxicity is similar to that observed after systemic exposure to other corticosteroids. The animal reproduction studies were not conducted with the nasal spray formulation of mometasone.

Infants born to mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use mometasone with caution in breastfeeding.

The manufacturer notes that mometasone furoate should not be used during breastfeeding unless the potential benefit to the mother justifies the potential risk to the mother or infant.

Briggs (2015) notes that no reports describing the use of mometasone during human lactation have been located. Other corticosteroids are excreted into breast milk in low concentrations. The molecular weight (about 513) suggests that the drug, if it reached the plasma, would be excreted into breast milk. However, the very low systemic concentrations obtained after use of the nasal spray formulation suggest that any excretion into milk will be clinically insignificant.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Adrenal suppression
Aggression
Anaphylactic reaction
Angioedema
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Cushing's syndrome
Cushingoid facies
Depression
Dyspnoea
Epistaxis
Glaucoma
Growth retardation (children)
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Nasal burning
Nasal irritation
Nasal ulceration
Perforation of nasal septum
Pharyngitis
Psychological changes
Psychomotor hyperactivity
Sleep disturbances
Smelling disturbances
Systemic effects
Taste disturbances
Throat irritation
Upper respiratory tract infection

Presentation

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

Drugs List

Therapeutic Indications

Uses

Perennial allergic rhinitis - prevention and treatment
Seasonal allergic rhinitis - prophylaxis and treatment
Treatment of nasal polyps

Dosage

Adults

Children

Contraindications

Children under 3 years
Uncontrolled nasal infection
Recent nasal surgery
Recent nasal trauma

Precautions and Warnings

Children aged 3 to 18 years
Transfer from other steroid therapy
Uncontrolled systemic infection
Breastfeeding
Pregnancy
Tuberculosis of respiratory tract

Corticosteroid cover required in adrenal insufficiency
May mask symptoms or signs of infections
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Concomitant treatment may be necessary for allergy eye symptoms
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
Unilateral polyps unusual/irregular/ulcerating/bleeding to be investigated
Corticosteroids may cause growth retardation in children under 18 years
During transfer from oral steroids allergic conditions may be unmasked
Systemic effects possible with any inhaled corticosteroid
Discontinue if localised infection occurs
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Advise patient to seek medical advice if treatment is ineffective
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use mometasone with caution in pregnancy.

The manufacturer notes that mometasone furoate should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the mother or foetus.

Briggs (2015) notes that it is not known if mometasone crosses the animal or human placenta. The molecular weight (about 513) is low enough for passage but the very low systemic bioavailability suggests that little, if any, drug will reach the embryo of foetus. No reports describing the use of mometasone in human pregnancy have been located. The animal data suggests risk but the observed developmental toxicity is similar to that observed after systemic exposure to other corticosteroids. The animal reproduction studies were not conducted with the nasal spray formulation of mometasone.

Infants born to mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use mometasone with caution in breastfeeding.

The manufacturer notes that mometasone furoate should not be used during breastfeeding unless the potential benefit to the mother justifies the potential risk to the mother or infant.

Briggs (2015) notes that no reports describing the use of mometasone during human lactation have been located. Other corticosteroids are excreted into breast milk in low concentrations. The molecular weight (about 513) suggests that the drug, if it reached the plasma, would be excreted into breast milk. However, the very low systemic concentrations obtained after use of the nasal spray formulation suggest that any excretion into milk will be clinically insignificant.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Adrenal suppression
Aggression
Anaphylactic reaction
Angioedema
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Cushing's syndrome
Cushingoid facies
Depression
Dyspnoea
Epistaxis
Glaucoma
Growth retardation (children)
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Nasal burning
Nasal irritation
Nasal ulceration
Perforation of nasal septum
Pharyngitis
Psychological changes
Psychomotor hyperactivity
Sleep disturbances
Smelling disturbances
Systemic effects
Taste disturbances
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: September 2018

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Nasonex 50micrograms/actuation Nasal Spray. Merck Sharp & Dohme Limited. Revised December 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 5 September 2018