Medicinal Products

DETURGYLONE 0.0178% / 0.25%

Generic drug of the therapeutic class: Otorhinolaryngology
active ingredients: Prednisolone, Oxymetazoline
laboratory: Sanofi-Aventis France

Powder and solvent for nasal spray solution
Bottle of powder + spray bottle of 10 ml
All forms

Indication

Short-term local symptomatic treatment of congestive and inflammatory states during acute rhinitis in adults and adolescents over 15 years of age.

Dosage DETURGYLONE 0.0178% / 0.25% Powder and solvent for nasal spray solution Powder vial + 10 ml spray bottle

RESERVED FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OLD.

Adults and adolescents over 15 years old: 1 spray in each nostril, 3 times daily.

The maximum duration of treatment is 3 to 5 days.

Administration mode

Nasal sprays are done with the bottle in a vertical position, the head slightly bent forward, to avoid swallowing the product.

Against indications

This medicine is contraindicated in the following cases:

· Hypersensitivity to any of the constituents of the product.

· Child under 15 years old.

· History of stroke or risk factors that may lead to stroke, due to the sympathomimetic alpha activity of the vasoconstrictor.

· Hypertension severe or poorly balanced with treatment.

· Severe coronary insufficiency.

· Risk of glaucoma by closing the angle.

· Risk of urinary retention related to urethral-prostatic disorders.

· History of seizures

· Hemostasis disorder, including epistaxis.

Oro-oral-nasal and ophthalmic infection with herpes simplex virus.

· In combination with indirect-acting sympathomimetics: vasoconstrictors to decongest the nose, whether administered orally or nasally [phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine.] And methylphenidate, due to the risk of vasoconstriction and / or or hypertensive attacks (see section Interactions with other medicinal products and other forms of interaction ).

The combination of two decongestants is contraindicated, regardless of the route of administration (oral and / or nasal): such an association is useless and dangerous and corresponds to misuse.

Deturgylone side effects

Related to the presence of oxymetazoline

Cardiac disorders

· Palpitations.

· Tachycardia.

· Myocardial infarction.

Visual disorders

· Glaucoma crisis by closing the angle.

Gastrointestinal disorders

· Dry mouth.

· Nausea

· Vomiting.

Nervous system disorders

· Hemorrhagic stroke, exceptionally in patients who have used pseudoephedrine hydrochloride proprietary medicinal products; these cerebrovascular accidents have occurred during overdose or misuse in patients with vascular risk factors.

· Ischemic vascular accidents.

· Headache.

· Convulsions.

Psychiatric disorders

· Anxiety.

· Agitation.

· Behavioral disorders.

· Hallucinations.

· Insomnia.

A fever, an overdose, a drug combination likely to reduce the epileptogenic threshold or to promote an overdose, have often been found and seem to predispose to the occurrence of such effects (see sections Contraindications and Warnings and precautions for use ) .

Urinary disorders

· Dysuria (especially in cases of urethroprostatic disorders).

· Urinary retention (especially in cases of urethroprostatic disorders).

Skin disorders

· Sweats.

· Exanthema.

· Pruritus.

· Urticaria.

Vascular disorders

· Hypertension (hypertensive thrust).

Local Effects

· Sensation of nasal dryness. Exceptionally, local allergic manifestations.

Linked to the presence of prednisolone

Local Effects

· Possibility of epistaxis, irritation or burning sensation, dryness of the nasal mucosa, disturbances of taste and smell.

· In case of infections with nasal and pharyngeal Candida albicans during treatment, nasal corticosteroids should be discontinued and the appropriate treatment should be initiated.

Systemic effects

· The risk of systemic effects related to the nasal corticosteroid is not excluded (see section Warnings and precautions for use ). This risk is increased when concomitant administration of inhaled or systemic corticosteroid therapy.

· Growth retardation has been reported in children and adolescents on nasal corticosteroids.

· The risk of latent adrenocorticotropic insufficiency after prolonged administration should be considered in case of intercurrent infection, accident or surgery.

· Very rare frequency: cataract and glaucoma.

· Psychiatric disorders.

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