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Detailed information
Description:
Otrivin Menthol Metered-Dose Nasal Spray 10 ml
Detailed Description:
Schedulding status S1 proprietary names (and dosage forms):
Otrivin® menthol metered-dose nasal spray.
Composition:
Otrivin metered-dose nasal spray contains 0.1% m/v of xylometazoline hydrochloride.
Preservative: benzalkonium chloride 0.01% m/v.
Pharmacological classification:
A 16.1 nasal decongestants.
Pharmacological action:
Otrivin menthol contains xylometazoline which belongs to the group of the arylalkyl imidazolines and acts on the ? - adrenergic receptors.
Otrivin menthol has a vasoconstrictor action, producing decongestion of the nasal and pharyngeal mucosa when applied locally.
Indications:
Decongestion of naso-pharyngeal mucosa in colds, sinusitis, rhinitis, hay-fever, otitis media and to facilitate rhinoscopy.
Identification:
Metered-dose nasal spray: opalescent to clear, colourless to white solution with an odour of menthol and eucalyptol.
Presentation:
Otrivin menthol metered-dose nasal spray:
Polyethylene bottle with spray pump and nosepiece containing 10 ml.
Marketed by Novartis Consumer Health SA a division of Novartis South Africa (Pty) Limited.
Date of publication of this package insert:
10 December 1998.
®Registered trade mark.
Otrivin is an effective decongestant which acts to clear a blocked nose within minutes and relieves excessive nasal secretions for several hours.
Useful for colds, sinusitis and otitis media.
10 ml.
Pack size:
10 ml
Quantity in pack:
1
Marketing description:
Otrivin®.
Xylometazoline HCI 1 mg/ml.
1 mg/ml.
Metered-dose nasal spray for adults.
Nasal decongestant.
Menthol.
Fast acting, long lasting.
Novartis.
Brand:
Otrivin
Package type:
Box
How to use
Usage instructions:
Dosage and directions for use:
Otrivin menthol metered-dose nasal spray is for nasal administration only, in adults and children over 12 years of age:
1 application of the metered-dose spray into each nostril; a total of 3 applications a day is usually sufficient.
Otrivin menthol should be used after blowing the nose.
Otrivin menthol metered-dose nasal spray:
Remove the protective cap. Before the first application, perform several pumping motions until an even spray appears in the air.
Insert the nozzle into the nostril and press once firmly on the spray head, and breathe in at the same time. Then withdraw the nozzle before releasing pressure. Repeat the operation in the other nostril.
Replace the protective cap after use.
The dosing spray ensures the Otrivin menthol solution is well distributed over the surface of the nasal mucosa. The standardised valve with which it is fitted permits accuracy of dosage and precludes the possibility of unintentional overdosage.
Storage instructions:
Store below 25 degrees C, protected from light and do not freeze.
Warnings:
Contra-indications:
Hypersensitivity to the ingredients.
Hyperthyroidism.
Patients with or predisposed to narrow angle glaucoma.
Diabetes mellitus.
Ischaemic heart disease, other heart disease including angina or hypertention.
Patients being treated with monoamine oxidase (MAO) - inhibitors or within 14 days after stopping treatment.
Otrivin menthol should not be employed in status post transsphenoidal hypophysectomy (or after transnasal or transoral surgical interventions in which the dura mater has been exposed).
Pregnancy and lactation: the use of Otrivin menthol during pregnancy is not advisable due to its potential systemic absorption. Safety in lactation has not been established.
Side-effects and special precautions:
The following side-effects have been encountered: rebound congestion after discontinuation or after prolonged use. A burning sensation in the nose and throat, local irritation, dryness of nasal mucosa, nausea, headache, lightheadedness, palpitations, anosmia and epistaxis, dizziness and insomnia.
Less frequently: transient visual disturbances or skin rash. Menthol may give rise to hypersensitivity reactions including contact dermatitis.
Special precautions:
Otrivin menthol should be used with caution in patients with hypertension and cardiovascular diseases.
Otrivin menthol should be used with caution in patients showing a strong reaction to sympathomimetic agents, as evidenced by signs of insomnia, dizziness etc.
Do not exceed the recommended dose, especially in children and in the elderly.
Otrivin menthol should not be employed continuously for periods exceeding two weeks: prolonged or excessive use may cause rebound congestion. Chronic use may lead to atrophic rhinitis.
Interactions:
Concurrent use of tricyclic or tetracyclic antidepressants may potentiate the systemic effects of xylometazoline.
Known symptoms of overdosage and particulars of its treatment:
Signs:
In instances of accidental poisoning in children, the clinical picture may be marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure and sometimes clouding of consciousness, sweating, drowsiness, coma, convulsions, circulatory collapse.
Treatment:
Symptomatic and supportive treatment under medical supervision is indicated.
Keep out of the reach of children.