Xylometazoline

Registered South African indications:

• Relief of nasal congestion accompanying hay fever, allergic rhinitis, colds, sinusitis and otitis media
• Facilitation of rhinoscopy

Registered South African contraindications

Nasal spray 1mg/ml

• Hypersensitivity to the active ingredient or any of its excipients
• Prolonged use of vasoconstrictor medicines is not indicated in cases of chronic rhinitis
• Not to be used with antihypertensive medicines of the adrenergic neuron blocking type or monoamine oxidase inhibitors (MAOIs) or within 10 days of their discontinuation
• Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater
• Children aged less than 12 years

Nasal spray 0.5mg/ml, Nasal drop 0.5mg/ml and 1mg/ml

• Hypersensitivity to the active ingredient or any of its excipients
• Contraindicated in the following conditions
  • Hyperthyroidism
  • Narrow angle glaucoma
  • Ischaemic heart disease
  • Rhinitis sicca or atrophic rhinitis
  • Patients being treated with monoamine oxidase (MAO)-inhibitors or 10 days after stopping treatment
• Should not be employed in status post transsphenoidal hypophysectomy (or after transnasal or transoral surgical interventions in which the dura mater has been exposed)
• Children aged less than 2 years old (0.5mg/ml nas & nod)
• Children aged less than 12 years (1mg/ml nas & nod)

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Hypertension
• Cardiovascular disease
• Hyperthyroidism (1mg/ml nas)
• Narrow angle glaucoma (1mg/ml nas)
• Diabetes mellitus
• Patients showing a strong reaction to sympathomimetic medicines, as evidenced by signs of insomnia, dizziness, etc

Duration of use

• Xylometazoline is intended for short-term use only. Prolonged use may lead to reactive hyperaemia, with increased nasal congestion and obstruction
• Patients should be instructed to discontinue use and consult a physician if symptoms persist or worsen, or if new symptoms occur

Excipient cautions

• Xylometazoline contains benzalkonium chloride which may cause oedema of the nasal mucosa with long-term use

Effects on ability to drive and use machines

• Xylometazoline can cause side effects such as drowsiness. Caution is advised before driving a vehicle or operating machinery until the effects of xylometazoline are known

Forms avail. in SA and covered in this monograph: dro, nas

South African registered indications and dosages

Relief of nasal congestion accompanying hay fever, allergic rhinitis, colds, sinusitis and otitis media
Facilitation of rhinoscopy

• Nasal (dro): 1mg/ml sol. Instil 2-3 drops per nostril, 3 times a day; Total of 3 applications a day is usually sufficient
• Nasal (nas): 1mg/ml sol. 1 spray per nostril, 2-3 times a day, as required; Max: 3 applications/24hrs

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Do not use for more than 7 days. Do not exceed recommended dosage

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Should be used after blowing the nose

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Method of administration: Nasal spray

1. Remove plastic cap from nozzle
2. On first use, press the plunger downwards, and release until a single spray is delivered
3. Hold the bottle upright and place nozzle into one nostril. Depress the plunger and at the same time breathe in through your nose. Release the plunger and remove nozzle from the nostril. Repeat this procedure for the other nostril
4. To keep clean, wipe the nozzle and replace the plastic cap after use

Paed. forms avail. in SA and covered in this monograph: dro, nas

South African registered indications and dosages

Relief of nasal congestion accompanying hay fever, allergic rhinitis, colds, sinusitis and otitis media
Facilitation of rhinoscopy

Younger than 2 years

• Contraindicated

Between 2-12 years

• Nasal (nas): 0.5mg/ml sol. 1 spray per nostril, 1-2 times a day, as required; Max: 2 applications/24hrs
• Nasal (dro): 0.5mg/ml sol. Instil 1-2 drops per nostril, 1-2 times a day; Max: 2 applications/24hrs

Older than 12 years

• See adult dosages

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Do not use for more than 7 days. Do not exceed recommended dosage

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Should be used after blowing the nose

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The 0.1mg/ml is contraindicated in children under 12 years of age

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Method of administration: Nasal spray

1. Remove plastic cap from nozzle
2. On first use, press the plunger downwards, and release until a single spray is delivered
3. Hold the bottle upright and place nozzle into one nostril. Depress the plunger and at the same time breathe in through your nose. Release the plunger and remove nozzle from the nostril. Repeat this procedure for the other nostril
4. To keep clean, wipe the nozzle and replace the plastic cap after use

Pregnancy

South African recommendations

• Caution; not recommended
• Safety of in pregnancy has not been established

Pregnancy

South African recommendations

• Caution
• No evidence of any adverse effect on the breastfed infant. However, it is unknown whether xylometazoline or its metabolites are excreted in human milk, therefore it should only be used on the advice of a doctor while breastfeeding

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no dose adjustment recommended
  Recommended dose should not be exceeded, especially in the elderly

Immune System Disorders

Frequency unknown

• Hypersensitivity

Psychiatric Disorders

Frequency unknown

• Insomnia
• Somnolence

Nervous System Disorders

Less frequent

• Burning sensation mucosal

Frequency unknown

• Headache

Eye Disorders

Frequency unknown

• Transient visual disturbance

Cardiac Disorders

Frequency unknown

• Palpitations
• Systemic cardiovascular effects

Respiratory, Thoracic and Mediastinal Disorders

Less frequent

• Nasal dryness
• Local irritation

Frequency unknown

• Sneezing
• Epistaxis

Gastrointestinal Disorders

Frequency unknown

• Nausea

General Disorders and Administration Site Conditions

Less frequent

• Rebound effect

• Monoamine oxidase inhibitors
• Tricyclic antidepressants
• Tetracyclic antidepressants
• Antihypertensive medicines of the adrenergic neuron blocking type

None routine

Xylometazoline is a sympathomimetic amine of the imidazoline class with a marked alpha-adrenergic activity. Xylometazoline has a vasoconstrictive effect which produces decongestion of mucous membranes when administered locally thereby improving nasal breathing and discharge of secretion. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long lasting relief.

Nasal spray (per spray) 0.5mg

• Otrivin Paed (GSK) originator

Nasal spray (per spray) 1mg

• Nazovin Adult Metered-Dose Spray (Actor)
• Otrivin Menthol (Novartis) originator
• Otrivin Adult (GSK) originator
• Sinutab (Johnson & Johnson) originator

Nasal drops (per ml) 0.5mg

• Nazovin Paediatric Nasal Drops (Actor)
• Otrivin Paed (GSK) originator

Nasal drops (per ml) 1mg

• Otrivin Adult (GSK) originator

COMBINATION PREPARATIONS

Ipratropium/ Xylometazoline

Nasal spray (per ml) 0.6mg/0.5mg

• Otrivin Plus (GSK) originator