1. Name Of The Medicinal Product
Non-Drowsy Sudafed Decongestant Nasal Spray
Sudafed Blocked Nose Spray
2. Qualitative And Quantitative Composition
Non-Drowsy Sudafed Decongestant Nasal Spray is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation.
For excipients see 6.1.
3. Pharmaceutical Form
Aqueous solution
4. Clinical Particulars
4.1 Therapeutic Indications
Non-Drowsy Sudafed Decongestant Nasal Spray is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies.
4.2 Posology And Method Of Administration
Adults and children 12 years and over:
Nasal. One spray to be expressed into each nostril 2-3 times daily, as necessary.
Maximum daily dose: 3 sprays.
Use for more than seven consecutive days is not recommended, [See Undesirable effects].
Children under 12 years:
Non-Drowsy Sudafed Decongestant Nasal Spray is not recommended for children under 12 years of age.
The Elderly
Experience has indicated that normal adult dosage is appropriate, [See Pharmacokinetics in the elderly].
Hepatic/renal dysfunction
Normal adult dosage is appropriate, [See Pharmacokinetic properties].
4.3 Contraindications
Non-Drowsy Sudafed Decongestant Nasal Spray is contraindicated in individuals with known hypersensitivity to the product or any of its constituents.
Non-Drowsy Sudafed Decongestant Nasal Spray is contraindicated in individuals who are taking or have taken, monoamine oxidase inhibitors within the preceding two weeks.
Non-Drowsy Sudafed Decongestant Nasal Spray is contraindicated in individuals with hypophysectomy or surgery exposing dura mater.
4.4 Special Warnings And Precautions For Use
There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, Non-Drowsy Sudafed Decongestant Nasal Spray should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Due to the low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is considered unlikely.
4.6 Pregnancy And Lactation
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential vasoconstrictor effect, it is advisable to take the precaution of not using Non-Drowsy Sudafed Decongestant Nasal Spray during pregnancy.
4.7 Effects On Ability To Drive And Use Machines
No special comment - unlikely to produce an effect.
4.8 Undesirable Effects
Xylometazoline nasal preparations are generally well tolerated following short-term use and local side effects are mild and infrequent. Localised burning, stinging, itching, soreness, dryness or irritation and sneezing may occur occasionally. Rarely, nausea and headache may occur.
Rebound congestion has been reported occasionally, particularly following longer-term use of xylometazoline.
4.9 Overdose
Symptoms and signs
Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits absorption. If systemic absorption does occur xylometazoline as an α2-adrenergic agonist could be expected to produce effects similar to those of clonidine with a short lived rise in blood pressure, followed by more prolonged hypotension and sedation.
Treatment
Treatment of overdose should be supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Xylometazoline is a sympathomimetic amine of the imidazoline class.
It act directly on α-adrenoreceptors but does not act on ß
5.2 Pharmacokinetic Properties
Absorption, Distribution, Metabolism and Elimination
Little information is available concerning the absorption, distribution, metabolism and elimination of xylometazoline in man. Absorption into the nasal mucosal tissues is rapid.
Pharmacokinetics in Renal/Hepatic Impairment
There have been no specific studies of Non-Drowsy Sudafed Decongestant Nasal Spray or xylometazoline in hepatic or renal impairment.
Pharmacokinetics in the Elderly
There have been no specific clinical studies of Non-Drowsy Sudafed Decongestant Nasal Spray or xylometazoline in the elderly.
5.3 Preclinical Safety Data
Mutagenicity
There is insufficient information available to determine whether xylometazoline has mutagenic potential.
Carcinogenicity
There is insufficient information available to determine whether xylometazoline has carcinogenic potential.
Teratogenicity
There is insufficient information available to determine whether xylometazoline has teratogenic potential.
Fertility
No studies have been conducted in animals to determine whether xylometazoline has the potential to impair fertility. There is no information on the effects of Non-Drowsy Sudafed Decongestant Nasal Spray on fertility.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Benzalkonium chloride solution
Disodium edetate
Sodium dihydrogen phosphate dihydrate
Sodium monohydrogen phosphate dihydrate
Sodium chloride
Sorbitol solution, 70% (Non crystalline)
Purified water
6.2 Incompatibilities
None known
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Amber glass bottle of either 10 ml or 15 ml nominal fill volume.
The bottle is sealed with an integral snap-on metered 0.14 ml pump consisting of a white plastic actuator and natural polyethylene pull-off overcap.
6.6 Special Precautions For Disposal And Other Handling
None applicable.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom.
8. Marketing Authorisation Number(S)
PL 15513/0074
9. Date Of First Authorisation/Renewal Of The Authorisation
21/04/99
10. Date Of Revision Of The Text
13 January 2010
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