Otrivine Child Nasal Drops
Xylometazoline Hydrochloride 0.05% w/v
For excipients see 6.1.
Nasal drops, solution
The product is a clear, colourless solution.
For the relief of nasal congestion associated with the common cold, perennial and allergic rhinitis (including hay fever), sinusitis.
Adults and elderly: Not applicable.
Otrivine Child Nasal Drops are contra-indicated in children under 6 years of age.
Children between 6 and 12 years (all indications):
1 or 2 drops, in each nostril 1 or 2 times daily.
Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
Not more than 2 doses should be given in any 24 hours.
Route of administration: Nasal use
Do not exceed the stated dose
Keep out of the reach and sight of children.
Known hypersensitivity to Otrivine or any of the excipients
Concomitant use of other sympathomimetic decongestants
Cardiovascular disease including hypertension
Closed angle glaucoma
Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)
Beta-blockers (see section 4.5)
Inflammation of the skin and/or mucosa of the nasal vestibule
Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater
Not to be used in children under the age of 6 years
Patients are advised not to take decongestants for more than five consecutive days. Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.
Do not exceed the stated dose
Do not take with any other cough and cold medicine.
Do not use continuously for more than five consecutive days. If symptoms persist consult your doctor
If your child is receiving medication or is under a doctor's care, consult him before giving Otrivine
Each Otrivine pack should be used by one person only to prevent any cross infection
For reasons of hygiene do not use this bottle for more than 28 days after first opening it
Some patients who have sensitive nasal passages may feel some local discomfort when applying nasal drops.
Other side effects such as palpitations, nausea and headache are very rare
Occasionally small children may show restlessness or sleep disturbance when Otrivine is used. If this occurs Otrivine should be stopped
Keep medicines out of reach and sight of children
Expectant mothers should consult their doctors before using Otrivine for themselves
As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine during pregnancy.
Label warning: Expectant mothers should consult their doctor before using Otrivine
Child Nasal Drops for themselves.
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.
The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.
Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Otrivine to people with cardiovascular disease. In isolated cases, systemic allergic reactions and transient visual disturbances.
Other cardiac dysrhythmias and hypertension
Hallucinations and paranoid delusions
Skin reactions including rash
Hypersensitivity reactions including that cross-sensitivity may occur with other sympathomimetics
Nausea and/or vomiting
Local effects irritation and dryness
Rebound congestion (rhinitis medicamentosa) especially with prolonged and/or heavy use
Tolerance with diminished effect especially with prolonged and/or heavy use
Cardiovascular effects (as with oral agents) particularly with prolonged and/or excessive use
CNS effects (as with oral agents) particularly with prolonged and/or excessive use
In rare instances 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.
Otrivine Child Nasal Drops is a sympathomimetic agent with marked alpha- adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. The effect of Otrivine Child Nasal Drops begins within a few minutes and lasts for up to 10 hours. Otrivine Child Nasal Drops is generally well tolerated and does not impair the function of ciliated epithelium.
In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the decongestant effect of Otrivin was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.
Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.
There are no findings in the preclinical testing which are of relevance to the prescriber.
Disodium phosphate dodecahydrate (Sodium phosphate)
Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)
Sorbitol 70% (non-crystallising)
Unopened: 36 months
After the container is opened for the first time: 28 days
Bottle: High density polyethylene
Pipette rod: Low density polythene
Pipette bulb: Halogenated butyl elastomer
The pipette forms an integral part of the cap.
Pack size: 10 ml
Keep all medicines out of the reach of children
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road