Biomist ND 0.05%
Xylometazoline Nasal Drops
Composition:
Xylometazoline Nasal Drops BP 0.05% w/v
Xylometazoline
Hydrochloride BP 0.05% w/v
In an Aqueous Isotonic Solution
Using Purified Water BP
Benzalkonium Chloride Solution BP 0.022% w/v
(As Preservative)
Excipients q.s.
Xylometazoline Nasal Drops BP 0.1% w/v
Xylometazoline
Hydrochloride BP 0.1% w/v
In an Aqueous Isotonic Solution
Using Purified Water BP
Benzalkonium Chloride Solution BP 0.022% w/v
(As Preservative)
Excipients q.s.
Chemical Name: 2-(4-tert-Butyl-2,6-dimethylbenzyl)-2-imidazoline hydrochloride
Category: Alpha-adrenoceptor agonist.
Description:
Xylometazoline Nasal Drop contains Xylometazoline hydrochloride. Xylometazoline hydrochloride is an alpha-adrenoceptor agonist which appears as white or almost white, crystalline powder; freely soluble in water, in ethanol (96%) & in methanol.
Pharmacology:
Pharmacodynamic
Xylometazoline is used for its vasoconstrictor properties, acting as a α2-agonist. It produces a rapid and prolonged vasoconstriction lasting for up to 8-12h. It is used as a topical agent on the nasal mucosa, to produce nasal decongestion. Prolonged use of xylometazoline on the nasal mucosa may produce rebound vasodilatation (drug-induced rhinitis). This may be due to inhibition of the release of norepinephrine from vasomotor adrenergic nerve endings through an action on the presynaptic α-receptors. Given topically in small doses, xylometazoline has no systemic effects in adults, although it is note worthy that the hypotensive effect of clonidine, which has a similar action, was first noted when the drug was under trail as a nasal decongestant.
Pharmacokinetic
Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.
Indications
Xylometazoline is used for the temporary relief of congestion or stuffiness in the nose caused by hay fever or other allergies, colds, or sinus trouble. Perennial and allergic rhinitis including hay fever, and other forms of allergies. This medication is also used for headache, tubal block and serous otitis media associated with nasal congestion.
OTHER USES: This drug may also be used to relieve “plugged ears” and to reduce swelling in the nose before certain surgeries or procedures.
Dosage and Administration:
For Xylometazoline Nasal Drops BP 0.05%w/v
Only for Children between 6 and 12 years for all indications
Xylometazoline Nasal Drops BP 0.05%w/v is contra-indicated in children under 6 years of age.
1 or 2 drops, in each nostril 1 or 2 times daily.
Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.
Not more than 2 doses should be given in any 24 hours.
Route of administration: Nasal use
Do not exceed the stated dose.
Keep out of the reach and sight of children to avoid self administration.
For Xylometazoline Nasal Drops BP 0.1%w/v
Only for Adults, Children over 12 years and the elderly
Not recommended for children below 12 years of age.
1 to 3 drops 2-3 times a day or as needed.
General Administration Instructions
To apply nasal drops, wash hands first. To avoid contamination, do not touch the dropper tip or let it touch the nose or any other surface. If needed, have another person place the drops in the nose.
Gently blow the nose before using this drug. Tilt the head back while sitting on a chair or lying down. Hold the dropper over the affected nostril and apply the directed number of drops. Keep the head tilted for a few minutes. Repeat these steps with the other nostril if needed. Do not swallow the medication if it drips into the throat.
Contraindications
Known hypersensitivity to Xylometazoline Nasal Drops.
Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
Special warning and Precaution
Patients are advised not to take decongestants for more than seven consecutive days. Xylometazoline, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.
Caution is recommended in patients with hypertension, cardiovascular and thyroid disease.
Pregnancy and Lactation:
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Xylometazoline Nasal Drops during pregnancy.
Label warning: If you are pregnant or taking any other medicines or are under a doctor’s care, consult him before using Xylometazoline Nasal Drops.
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Xylometazoline Nasal Drops should be used only on the advice of a doctor whilst breastfeeding
Children: Over dosage in children may produce profound sedation.
Xylometazoline Nasal Drops BP 0.05%w/v should not be used in children under 6 years of age.
The Xylometazoline Nasal Drops BP 0.1%w/v should not be used for infants or children under 12 years
Interactions
As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.
Effect to Drive and use the machine : None reported.
Adverse Reactions
The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.
Rarely, can cause rebound congestion. Intranasal use of xylometazoline may occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitation, tachycardia and arrhythmia.
Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Xylometazoline Nasal Drops to people with cardiovascular disease.
Overdosage
In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure, drowsiness, respiratory depression or irregularity. There is no specific treatment and appropriate supportive treatment should be initiated.
Packing :
Xylometazoline Nasal Drops BP 0.05% w/v: 10ml LDPE dropper bottle with Pink cap.
Xylometazoline Nasal Drops BP 0.1% w/v: 10ml LDPE dropper bottle with White cap.
Storage
Store in a dry place below 30°C. Protect from light.
Do not freeze.
Keep out of reach of children.