Contraindications

If any of the following points apply, Otriven® must not be used:

An existing hypersensitivity reaction to xylometazoline or other components of Otriven®
An existing hypersensitivity reaction to the preservative benzalkonium chloride
Children under two years of age only after consultation with a pediatrician and
After surgical removal of the pineal gland (pituitary gland) as well as any other surgical procedures that expose the meninges.

Restricted areas of application

Otriven® may only be used for the following clinical pictures after consultation with the treating physician:

Severe cardiovascular diseases such as coronary heart disease, high blood pressure or angina pectoris
Simultaneous intake of MAO inhibitors
Simultaneous intake of drugs that increase blood pressure
Increased intraocular pressure as in narrow-angle glaucoma
Tumor of the adrenal gland (pheochromocytoma)
Enlarged prostate
Certain metabolic diseases like porphyria
Hyperthyroidism
Blood sugar disease (diabetes mellitus).

Application for children

Otriven® 0.05% may not be prescribed for infants and young children under two years of age. An Otriven® containing 0.025% xylometazoline hydrochloride has been specially formulated for this age group. Children from two to six years may use Otriven® 0.05%.

Long-term use and excessive daily doses should be avoided. Long-term use and higher doses should only be used under medical supervision. For school children and adults, Otriven® nose drops containing 0.1% xylometazoline hydrochloride are available. Again, the recommended daily dose should not be exceeded to avoid any adverse drug reactions. Otriven® Nose Drops have no effect on fitness to drive.

Use during pregnancy and lactation

Pregnancy: There is not sufficient evidence that Otriven® is a safe drug during pregnancy and therefore Otriven® should only be prescribed after a risk-benefit assessment with the treating physician.The recommended dose must not be exceeded in order to avoid possible consequential damage to the unborn child. An overdose can lead to a reduced supply of nutrients to the unborn child.
Breastfeeding: As there is insufficient evidence of safe use of Otriven® during breastfeeding, it should only be taken in consultation with the treating physician. The recommended daily dose should not be exceeded as Otriven® may reduce milk production.