Drugs List

Therapeutic Indications

Uses

Rhinitis - perennial
Seasonal allergic rhinitis - treatment

Contraindications

Children under 12 years

Precautions and Warnings

Uncontrolled nasal infection
Breastfeeding
Pregnancy
Pulmonary tuberculosis
Recent nasal surgery
Recent nasal trauma
Severe hepatic impairment

Caution in transfer from oral steroids in adrenal insufficiency
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
Monitor regularly the height of children receiving prolonged treatment
Prolonged or high dose may lead to adrenal suppression
Systemic side effects may occur
Maintain treatment at the lowest effective dose

Pregnancy and Lactation

Pregnancy

Use the combination of azelastine with fluticasone with caution in pregnancy.

There is little data from the use of azelastine with fluticasone in pregnant women. The manufacturer notes that this medication should only be considered if the benefit exceeds any possible risk to the foetus.

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 the combination of azelastine with fluticasone with caution in breastfeeding.

It is unknown whether nasally administered azelastine metabolites or fluticasone metabolites are excreted in human breast milk. The manufacturer notes that this medication should only be considered if the benefit to the mother exceeds any possible risk to the child.

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 in children
Anaphylactic reaction
Angioedema
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Cough
Cushing's syndrome
Cushingoid facies
Depression
Dizziness
Dry mouth
Dryness and irritation of throat
Dysgeusia
Epistaxis
Fatigue
Glaucoma
Growth retardation (children)
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Mucosal erosion
Nasal discomfort
Nasal dryness
Nasal irritation
Nasal itching
Nasal stinging (transient)
Nausea
Osteoporosis
Perforation of nasal septum
Pruritus
Psychological changes
Psychomotor hyperactivity
Rash
Sleep disturbances
Sneezing
Somnolence
Urticaria
Visual disturbances
Weakness

Presentation

Nasal spray containing azelastine with fluticasone.

Drugs List

Therapeutic Indications

Uses

Rhinitis - perennial
Seasonal allergic rhinitis - treatment

Dosage

Adults

Children

Contraindications

Children under 12 years

Precautions and Warnings

Uncontrolled nasal infection
Breastfeeding
Pregnancy
Pulmonary tuberculosis
Recent nasal surgery
Recent nasal trauma
Severe hepatic impairment

Caution in transfer from oral steroids in adrenal insufficiency
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
Monitor regularly the height of children receiving prolonged treatment
Prolonged or high dose may lead to adrenal suppression
Systemic side effects may occur
Maintain treatment at the lowest effective dose

Pregnancy and Lactation

Pregnancy

Use the combination of azelastine with fluticasone with caution in pregnancy.

There is little data from the use of azelastine with fluticasone in pregnant women. The manufacturer notes that this medication should only be considered if the benefit exceeds any possible risk to the foetus.

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 the combination of azelastine with fluticasone with caution in breastfeeding.

It is unknown whether nasally administered azelastine metabolites or fluticasone metabolites are excreted in human breast milk. The manufacturer notes that this medication should only be considered if the benefit to the mother exceeds any possible risk to the child.

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 in children
Anaphylactic reaction
Angioedema
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Cough
Cushing's syndrome
Cushingoid facies
Depression
Dizziness
Dry mouth
Dryness and irritation of throat
Dysgeusia
Epistaxis
Fatigue
Glaucoma
Growth retardation (children)
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Mucosal erosion
Nasal discomfort
Nasal dryness
Nasal irritation
Nasal itching
Nasal stinging (transient)
Nausea
Osteoporosis
Perforation of nasal septum
Pruritus
Psychological changes
Psychomotor hyperactivity
Rash
Sleep disturbances
Sneezing
Somnolence
Urticaria
Visual disturbances
Weakness

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: October 2017

Reference Sources

Summary of Product Characteristics: Dymista Nasal Spray. Meda Pharmaceuticals Ltd. Revised July 2017.