Non-Drowsy Sudafed Decongestant Nasal Spray

Sudafed Blocked Nose Spray

Sudafed Mucus Relief 0.1% Nasal Spray

This product 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.

Aqueous solution

This product 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.

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:

This product 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].

This product is contraindicated in individuals with known hypersensitivity to the product or any of its constituents.

This product is contraindicated in individuals who are taking or have taken, monoamine oxidase inhibitors within the preceding two weeks.

This product is contraindicated in individuals with hypophysectomy or surgery exposing dura mater.

There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus.

Due to the low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is considered unlikely.

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 this product during pregnancy.

No special comment - unlikely to produce an effect.

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.

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.

Xylometazoline is a sympathomimetic amine of the imidazoline class.

It act directly on α-adrenoreceptors but does not act on ß-receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of action is within minutes, the decongestant effect being prolonged and lasting for up to 10 hours.

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 this product or xylometazoline in hepatic or renal impairment.

Pharmacokinetics in the Elderly

There have been no specific clinical studies of this product or xylometazoline in the elderly.

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 this product on fertility.

Benzalkonium chloride solution

Disodium edetate

Sodium dihydrogen phosphate dihydrate

Sodium monohydrogen phosphate dihydrate

Sodium chloride

Sorbitol solution, 70% (Non crystalline)

Purified water

None known

3 years.

Do not store above 25°C.

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.

None applicable.

McNeil Products Limited

FoundationPark

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom.

PL 15513/0074

21/04/99

5 May 2011