INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo VENTNAZE AQUEOUS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

VENTNAZE AQUEOUS

COMPOSITION:
Each metered spray contains
Beclomethasone Dipropionate 100 micrograms.
Preservative: Benzalkonium Chloride 0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 21.5.1 Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
Beclomethasone dipropionate is a synthetic corticosteroid which exerts a topical anti-inflammatory effect on the nasal mucosa.

INDICATIONS:
Prophylaxis and treatment of perennial and seasonal allergic rhinitis and hayfever.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.
Bleeding tendencies or recurrent nasal bleeding, quiescent or active tuberculosis. Pregnancy and lactation. Children under the age of six years.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 6 years of age:
The usual maintenance dose is 400 micrograms daily, taken as 2 sprays (200 micrograms) once daily or 1 spray (100 micrograms) twice daily into each nostril. The dosage depends on age and severity of symptoms. Maximum dosage: 400 micrograms daily.
Children aged 6 - 12 years must initially receive the lower dosage of 1 spray twice daily. This dosage must only be increased if no response is obtained on the lower dosage.
Before using Ventnaze Aqueous read the following instructions and follow them carefully:
1. Blow the nose. Shake the nasal spray container well and remove the protective cap from the spray nozzle.
2. Hold the nasal spray container as shown in the picture. Press down towards the thumb when spraying.
3. Place the nozzle into one nostril. Close the other nostril tightly with the finger. Breathe in while spraying, then breathe out slowly through the nose.
4. Cleaning the nozzle:
  Remove the protective cap and gently detach the nozzle from the container. Rinse the nozzle and cap in warm water, dry well and reassemble.
Important:
For full therapeutic effect regular use is essential as maximum relief may not be obtained with the first few doses. Do not exceed the dosage prescribed by the doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nasal irritation, sneezing, haemorrhagic nasal discharge, nasopharyngeal candidiasis and increased susceptibility to intra- and paranasal infections.
Systemic administration of corticosteroids causes atrophy of the adrenal glands and suppression of the hypothalamic- pituitary-adrenal axis. Thus, care must be taken when transferring patients from systemic steroid treatment to Ventnaze Aqueous as abrupt withdrawal of the exogenous corticosteroids can produce a hypoadrenal state. Patients receiving systemic corticosteroid treatment should continue with the treatment for a week after starting with Ventnaze. Thereafter, the dose of systemic treatment should be gradually reduced.
Ventnaze Aqueous should be used with caution, if at all, in patients with untreated fungal, bacterial, systemic viral infections or ocular herpes simplex. Patients using Ventnaze over several months or longer should be examined periodically due to possible changes in the nasal mucosa. If localised fungal infection of the nose and pharynx is present it may require appropriate treatment or discontinuance of therapy with Ventnaze Aqueous .
Ventnaze Aqueous should be discontinued with persistent nasal irritation.
Beclomethasone dipropionate is absorbed into the circulation. Although systemic effects have been minimal with recommended doses, this potential increases with excessive doses. Use of excessive doses of Ventnaze Aqueous may suppress hypothalamic-pituitary adrenocortical function.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of excessive use of Ventnaze Aqueous leading to adrenal suppression, treatment must be discontinued and the patient protected from stress situations. Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
A white opaque suspension.
Once shaken, the spray appears as a fine mist when sprayed through the nasal applicator.

PRESENTATION:
Ventnaze Aqueous is supplied in a white plastic bottle fitted with a metering atomising pump and nasal applicator. Before using the nasal spray, the bottle cap is unscrewed and the spray pump is fitted to the bottle. Each bottle contains 200 metered sprays.

STORAGE INSTRUCTIONS:
Store at room temperature below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
29/21.5.1/0021

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton        2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 August 1994

308421        031003

        Harry's Printers-K00000 J03

New addition to this site: April 2005
Source: Pharmaceutical Industry

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