Biomist NS 0.05%

Composition:

Xylometazoline Nasal Spray 0.05%w/v

Each Spray Delivers:

Xylometazoline Hydrochloride BP 35 mcg.

 

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 Spray 0.1 %w/v

Each Spray Delivers:

Xylometazoline Hydrochloride BP 140 mcg.

 

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.

 

Indication:

• Xylometazoline is used for the temporary relief of congestion or stuffiness in the nose caused by hay fever, 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.

 

Contraindication:

• Narrow-angle glaucoma.
• Concurrent therapy with MAO inhibitors.
• Hypersensitivity to any component. Do not use for irrigation
• Sensitivity to even small doses of adrenergic substances as manifested by sleeplessness, dizziness, light headedness, weakness, tremulousness, or cardiac arrhythmias.

 

Special Warnings and Precautions of Use:

• Patients are advised not to take decongestants for more than seven consecutive days.
• Caution is recommended in patients with hypertension, cardiovascular and thyroid disease.

 

Drug Interactions:

• Antihypertensives, 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.
• It is advisable to take the precaution of not using xylometazoline nasal drops during pregnancy.

 

Pregnancy & Lactation:

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

 

Effect to drive a machine

• No reports available on effect to drive and use of the machine.

 

Dosage and administration:

For Xylometazoline Nasal Spray 0.05%w/v Only for Children between 6 and 12 years for all indications

Xylometazoline Nasal Spray 0.05%w/v is contra-indicated in children under 6 years of age.

1 or 2 sprays, 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: Intranasal

Do not exceed the stated dose. Keep out of the reach and sight of children to avoid self-administration

 

For Xylometazoline Nasal Spray 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 2 sprays 2-3 times a day or as needed.

 

General Administration Instructions

To apply nasal spray, wash hands first. To avoid contamination, do not touch the dropper

tip or let it touch the nose or any other surface.

Gently blow the nose before using this drug. Bend your head forward slightly and insert the nozzle into one of your nostrils. Try to hold the nasal spray upright. Press the pump firmly and spray the number of times as indicated. Remove the nasal spray from your nose and breathe in deeply through your nostril to help keep the medicine in your nose. Repeat these steps with the other nostril if needed. Do not swallow the medication if it drips into the throat.

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.

 

Side effects:

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.

 

Shelf Life: 36 months

 

Storage: Store in a dry place below 30^o C. Protect from light. Do not freeze. Keep out of reach of children.

 

Excipients:

Benzalkonium Chloride Solution BP, Anhydrous Disodium Hydrogen Phosphate BP, Disodium Edetate BP, Sodium Dihydrogen Phosphate Dihydrate BP, Sodium Chloride BP, Purified Water BP

 

Presentation:

Xylometazoline Nasal Spray 0.05%w/v:

15ml plastic bottle crimped with a nasal spray pumps of 0.07ml delivery & fitted with an actuator and a cap

Xylometazoline Nasal Spray 0.1 %w/v:

15ml plastic bottle crimped with a nasal spray pumps of 0.140ml delivery & fitted with an actuator and a cap