COMPOSITION
Each ml contains:
Oxymetazoline Hydrochloride IP 0.05% w/v
Benzalkonium Chloride BP 0.01% w/v (as preservative)
Water for Injections BP q.s.
DESCRIPTION
A clear, colorless to almost colorless solution.
PHARMACODYNAMIC
Oxymetazoline is a potent sympathomimetic agent which has at least ten times the potency of xylometazoline, a greater therapeutic index and greater duration of action. Acute toxicity studies in mice have indicated no unusual aspects of lethality.
Oxymetazoline relieves nasal congestion by vasoconstricting the respiratory microvasculature, in both resistance and capacitance blood vessels on the human nasal mucosa, leading to decreased nasal mucosal blood flow, edema, and airflow resistance.
ATC code: R01AA05
PHARMACOKINETICS
Tritiated oxymetazoline has been shown to be rapidly absorbed in dogs following intranasal administration. Approximately 30% are excreted in the urine within 72 hours and fecal excretion is about 10% within 120 hours. The drug is approximately 30% bound to human plasma proteins.
THERAPEUTIC INDICATION
For the relief of nasal congestion associated with disorders of the upper respiratory tract including infective and allergic rhinitis, sinusitis, nasopharyngitis and coryza.
DOSAGE AND ADMINISTRATION
Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
Overdose
No experience of overdose, but supportive measures would be the appropriate treatment.
INSTRUCTION FOR USE
For nasal use only. Shake well before use.
Remove the cap. Hold the container upright, place the tip of the container into each nostril. Hold the other nostril closed. Lightly squeeze the container twice as you breathe in through the nose at the same time. Repeat for the other nostril. Wipe the tip of the container with a clean, wet tissue and replace the cap immediately after the application.
This nasal solution/drops may be applied up to twice daily, or used at bedtime to give relief through the night.
CONTRAINDICATION
Use in patients with known hypersensitivity to sympathomimetics.
Use in patients receiving monoamine oxidase inhibitors or within fourteen days of stopping such treatment.
Use in acute coronary disease, cardiac asthma, thyrotoxicosis, hypertension, closed-angle glaucoma or urinary retention.
WARNING AND PRECAUTIONS
This product should be given with care to patients with prostatic enlargement, as it may increase difficulty in micturition.
Prolonged use may cause rebound congestion and drug induced rhinitis.
Use with caution in diabetic patients as this product may cause an increase in blood sugar.
The physician or pharmacist should reassure himself/herself that sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations).
This product should not be used for more than 5-7 consecutive days without medical advice.
Care should be taken not to exceed the stated dose.
This product should not be used by patients already taking medication without first consulting their physician.
May act as a cerebral stimulant giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform convulsions.
Interaction with other medicinal products and other forms of interaction
Concurrent use with halogenated anesthetic agents may provoke or worsen ventricular arrhythmias. The effects of this product may be altered by guanethidine, reserpine, methyldopa, phenothiazines and tricyclic anti-depressants.
PREGNANCY, LACTATION
NAZAL solution/drops should not be used in pregnancy unless considered essential by the physician.
SIDE EFFECTS
Side effects may include local stinging, irritation and dryness.
Prolonged use may cause rebound vasodilatation and chemical rhinitis.
PRESENTATION
NAZAL nasal solution/drops are supplied in Low density polyethylene (LDPE) white bottles with a white screw cap in pack size 10 ml.
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C.
Protect from light.
Keep this medicine out of the sight and reach of children.
Do not touch the container tip to any surface since this may contaminate the solution.
BBS/I/00