Biomist ND 0.1%

Composition:

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)

Category: Alpha-adrenoceptor agonist.

Description:

BIOMIST ND 0.05: Clear colorless to pale yellow solution filled in 10ml LDPE dropper bottle with Pink cap.

Pharmacology :

Xylometazoline is used for its vasoconstrictor properties, acting as a ?2-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 ?-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 Actions

Little information is available concerning the absorption, distribution, metabolism and elimination of xylometazoline in humans. Absorption into the nasal mucosal tissues is rapid.

However, because of the low dose required and the local application site, other systemic side effects are minimal. 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%(BIOMIST ND 0.05)

Only for Children between 6 and 12 years for all indications

Xylometazoline Nasal Drops BP 0.05% (BIOMIST ND 0.05) 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.

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

Narrow-angle glaucoma. Concurrent therapy with MAO inhibitors. Hypersensitivity to any component. Sensitivity to even small doses of adrenergic substances as manifested by sleeplessness, dizziness, light headedness, weakness, tremulousness, or cardiac arrhythmias. Do not use for irrigation or displacement following surgical procedures in which the dura mater may have been entered; e.g. sinus and transnasal operations.

Xylometazoline Nasal Drops is contraindicated in patients having known sensitivity to Xylometazoline Nasal Drops or any of the ingredients in Xylometazoline Nasal Drops.

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: Clinical data are inadequate to establish conditions for safe use in pregnancy and lactation.

Children: Over dosage in children may produce profound sedation.

Xylometazoline Nasal Drops BP 0.05% (BIOMIST ND 0.05) should not be used in children under 6 years of age.

Interactions

This product may alter the effects of some anti-hypertensives, such as beta-blockers, antiarrhythmics and of some anti-depressants – monoamine oxidase inhibitors, such as phenelzine, isocarboxazid, tranylcypromine and moclobemide, and others such as tricyclic and tetracyclic anti-depressants, ergotamine and methysergide.

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.

Consult doctor before using during pregnancy or if you are a nursing mother.

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

No cases of overdosage in adults have yet been reported. 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 :

BIOMIST ND 0.05: 10ml LDPE dropper bottle with Pink cap.

Storage

Store in a cool and dry place below 300C. Do not freeze.

Keep out of reach of children.

Shelf Life

Also Availabal as Biomist Nasal spray