Otrivin

OTRIVIN^®
0.1 %, 0.05%

Composition
Otrivin^® 0.1 % contains 1 mg/ml of xilomethazoline hydrochloride
Otrivin^® 0.05% contains 0.5 mg/ml of xilomethazoline hydrochloride

Pharmaceutical forms 
Nasal Drops 0.1 % F5
Nasal Drops 0.05 % F5

Clinical particulars 
Therapeutic indications
For the relief of nasal congestion due to colds, hay fever or other allergic rhinitis, sinusitis. To aid drainage of secretions in affections of the paranasal sinuses. As an adjuvant in otitis media, to decongest the nasopharyngeal mucosa. To facilitate rhinoscopy.

Posology and method of administration
Otrivin^® 0.05% Nasal Drops : For infants and children up to 6 years of age (with adult supervision).
1 or 2 drops of the solution into each nostril once or twice daily (every 8 to 10 hours) are generally sufficient; do not exceed a total of 3 applications daily into each nostril.
Otrivin^® 0.1 % Nasal drops : For adults and children over 6 years of age.
3 to 4 times daily: 2 or 3 drops of the solution into each nostril

Contraindications 
Hypersensitivity to any ingredients
As for other vasoconstrictor, do not use in patients with transphenoidal hypophysectomy or surgery exposing the durameter.

Special warnings and special precautions for use
Otrivin^®, like other sympathomimetic agents, should be used with cautions in patients showing a strong reaction to adrenergic substances, as manifested by sign of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.

Like other topical
vasoconstrictors, Otrivin^® should not be used for more than ten consecutive days: prolonged or excessive use may cause rebound congestion
Do not exceed the recommended dose, especially in children and in the elderly

Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus.

Interactions with other medicinal products and other forms of interaction
As for all sympathomimetics, a reinforcement of the systemic effects of xilomethazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.

Pregnancy and lactation
In view of its potential systemic vasoconstrictor effect, as precaution, do not use Otrivin^® during pregnancy.
There is no evidence of any adverse effects on the breast-fed infant. However, it is not known if xilomethazoline is excreted in breast milk, therefore caution should be exercised and Otrivin^® should be used only by prescription while breast-feeding.

Effects on ability to drive and use machines
None

Undesirable effects
The following side effects may occasionally be observed: local burning sensation, dryness or irritation of nasal mucosa, nausea, headache. In isolated cases, systemic allergic reactions, transient visual disturbances and irregular or fast heartbeat have been reported.

Overdose
In rare instance 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 and sometimes consciousness clouding.

There is no specific treatment. Appropriate supportive measures should be initiated.

Pharmacological properties 
Pharmacodynamic properties 
Pharmacoterapeutic group
R0lA A07 : decongestants for topical use, sympathomimetics, plain.
Mechanism of action and pharmacodynamic effects
Xylomethazoline is a sympathomimetic agent acting on -adrenergic receptors in the nasal mucosa. Administered in the nose, it constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighboring regions of the pharynx. The decongests nasal passages and enables patients suffering from blocked nose to breathe more easily through the nose. The effect of Otrivin^® begins within a few minutes and lasts for up to 1 0 hours.
Otrivin^® is well tolerated, even by patients with a sensitive mucosa, and does not impair the mucociliary function. The moisturizing formula contains soothing ingredients that help prevent dryness and irritation of the nasal mucosa.

Pharmacokinetic properties
Plasma concentrations of xylomethazoline in man after local nasal application of the product are below the limit of detection.

Preclinical safety data 
Xylomethazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylomethazoline was given subcutaneously in mice and rats.

Pharmaceutical particulars 
List of excipient
Otrivin^® moisturizing formula F.5: benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate, disodium phosphate, sodium chloride, sorbitol, methylhydroxypropylcellulose and purified water.

Incompatibilities 
Not applicable

Special precautions for storage
Do not store above 30°C, protect from heat.
The product may be used up to the date "EXP" shown on the package
Medicines should be kept out of reach and sight of children

Nature and contents of container
High density polyethylene bottle with a low density polyethylene pipette with elastomer bulb and cap. Content: 10 ml.

Instruction for handling 

1. Clear the nose
2. Tilt the head back as far as is comfortable or, if lying on a bed, hang the head over the side
3. Apply the drops into each nostril and keep the head tilted back for a short time to allow the drops to spread throughout the nose.
4. Replace cap right after use

PACKAGE QUANTITIES AND REGISTRATION NUMBER
Otrivin^® Nasal Drops 0.1 % : Bottle of 10 ml, Reg. No: DTL0030410747Bl
Otrivin^®  Nasal Drops 0.05 % : Bottle of 10 ml, Reg. No: DTL0030410747Al

P No 1

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Manufactured by
PT Novartis Indonesia, Citeureup, Bogor Indonesia

Under license of
Novartis Consumer Health SA Nyon, Switzerland

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