Data Sheet

Betnesol™ Aqueous Nasal Spray

Betamethasone Sodium Phosphate BP and Naphazoline Nitrate BP (20mcg of each per actuation) Aqueous Nasal Spray

Presentation

Betnesol Aqueous Nasal Spray consists of an aqueous solution of Betamethasone Sodium Phosphate BP 0.02%w/v, and Naphazoline Nitrate BP 0.02%w/v delivered by a metering atomising pump. Each 100mg spray delivered by the nasal applicator contains 20mcg Betamethasone Sodium Phosphate BP and 20mcg Naphazoline Nitrate BP.

Uses

Pharmacology

Betamethasone Sodium Phosphate BP is a glucocorticosteroid which has about eight to ten times the anti-inflammatory activity of prednisolone on a weight-for-weight basis.

Naphazoline Nitrate BP is a potent vasocontrictor with a rapid and prolonged action in reducing swelling and congestion when applied to mucous membranes.

Indications

Betnesol Aqueous Nasal Spray is recommended for use in the treatment of allergic, inflammatory, and congestive conditions of the nose. It is not intended for prolonged use.

Dosage and administration

Adults and children:

The recommended dosage is one or two sprays into each nostril. At least three hours should elapse between each dosage.

Prolonged use beyond 5 days may lead to rebound congestion.

Contraindications

There are no specific contraindications to the use of Betnesol Aqueous Nasal Spray.

Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Betnesol Aqueous Nasal Spray.

Precautions

Betnesol Aqueous Nasal Spray is not intended for prolonged use. If used continuously and for prolonged periods rebound congestion may occur. Special caution should be taken with use of the product in children.

Unnecessary administration of medicines during the first trimester of pregnancy is undesirable.

If recommended doses of Betnesol Aqueous Nasal Spray are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapies, systemic effects may occur, including reduction in growth velocity in children.

Side effects

No major side effects attributable to Betnesol Aqueous Nasal Spray have been reported. Transient irritation of the nasal mucosa may occur, and nausea and headache have been reported after use of Naphazoline Nitrate BP.

Interactions

Nil.

Overdosage

Overdosage or accidental administration by mouth of Naphazoline Nitrate preparations may cause depression of the central nervous system with marked reduction of body temperature and symptoms of bradycardia, sweating, drowsiness and coma, particularly in children; hypertension may be followed by rebound hypotension. Symptomatic treatment should be given, in addition to gastric lavage if necessary.

Pharmaceutical precautions

This product should be discarded three months after first using spray.

Shelf life

24 months.

Storage conditions

Betnesol Aqueous Nasal Spray should be protected from light and stored below 25°C.

Package quantities

Betnesol Aqueous Nasal Spray is supplied in an amber glass bottle fitted with a metering atomising pump and nasal applicator. Each bottle contains 15mL.

Medicines Classification

Prescription Only Medicine

Name and address

GlaxoSmithKline NZ Limited
Quay Tower
Cnr Albert & Customs Streets
Private Bag 106600
Downtown Auckland
NEW ZEALAND

Phone: (09) 367 2900
Facsimile: (09) 367 2506

Date of preparation

Date: 19 February 2003

Issue: 5

BETNESOL™ is a trademark of the GlaxoSmithKline group of companies.