Derinox nasal spray Uses, Dosage, Side Effects, Precautions & Warnings

Derinox nasal spray
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Derinox nasal spray>>Generic drug of the therapeutic class: Otorhinolaryngology
active ingredients: Prednisolone Naphazoline

Important to know about Derinox ?

It is indicated as short-term local adjunctive treatment for congestive (stuffy nose) and acute inflammatory conditions in colds in adults and adolescents over 15 years of age.

Derinox indication and Uses

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

 Derinox Dosage

RESERVED FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OLD.

  • Adults and adolescents over 15 years old: 1 spray in each nostril, 3 to 6 times a day.
  • 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.

Contraindications

This medication is contraindicated in the following cases:

Hypersensitivity to any of the constituents of the product.

· Child under 15 years old.

  • History of cerebrovascular accident or of risk factors liable to favor the occurrence of cerebrovascular accident, due to the alpha sympathomimetic activity of the vasoconstrictor.
    • – Severe arterial hypertension or not well balanced by the treatment.
    • – Severe coronary insufficiency.
  • Risk of glaucoma by closing the angle.
  • Risk of urinary retention linked to urethro-prostatic disorders.
    • – History of seizures.
  • Haemostasis disorder, including epistaxis.
  • Oro-oral-nasal and ophthalmic infection by herpes simplex virus.
  • In combination with sympathomimetics with indirect action: vasoconstrictors intended to decongest the nose, whether administered orally or nasally [phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine, etc.] as well as methylphenidate, due to the risk of vasoconstriction and / or hypertensive surges (see section Interactions with other medicinal products and other forms of interactions ).

The combination of two decongestants is contraindicated, whatever the route of administration (oral and / or nasal): such a combination is unnecessary and dangerous and corresponds to misuse.

How it works Derinox

Pharmacotherapeutic group: DECONGESTANTS AND OTHER PREPARATIONS FOR TOPICAL USE, ATC code: R01AD52

This drug is a combination of a sympathomimetic alpha, vasoconstrictor decongestant and a glucocorticoid with anti-inflammatory activity on the nasal mucous membranes.

Derinox Side Effects

Linked to the presence of naphazoline

Cardiac disorders

  • Palpitations.
  • Tachycardia.
  • Myocardial infarction.

Visual disorders

  • Glaucoma crisis by closing the angle.

Gastrointestinal disorders

  • Oral dryness.
  • 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.
  • Restlessness.
  • 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.

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 of the nose, dryness of the nasal mucosa, disturbances of taste and smell.
  • In case of nasal and pharyngeal Candida albicans infections, nasal corticosteroids should be discontinued and the appropriate treatment initiated.

Systemic effects

  • The risk of systemic effects related to nasal corticosteroid is not excluded (see section 4.4).This risk is increased with concurrent administration of corticosteroids or inhaledlet alone systemically.
  • 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

Derinox Interactions

Related to the presence of naphazoline

Drug with same Active ingredient

Associations contraindicated

Indirect Sympathomimetics

[Phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine) and methylphenidate]

Risk of vasoconstriction and / or hypertensive relapses.

Associations advised against

Non-selective MAOIs (iproniazide)

Hypertensive crises (inhibition of the metabolism of pressurized amines). Due to the long action of MAOIs, this interaction is still possible 15 days after the cessation of the MAOI.

· Alkaloids of ergot dopaminergic rye (bromocriptine, cabergoline, lisuride, pergolide)

Risk of vasoconstriction and / or hypertensive relapses.

Alkaloids of the ergot of vasoconstrictor rye (dihydroergotamine, ergotamine, methylergometrine, methysergide)

Risk of vasoconstriction and / or hypertensive relapses.

Warnings and Precautions

Special warnings

  • Observe the instructions for use and the doses recommended in this leaflet.
  • Do not swallow.
  • As soon as the packaging is opened, and even more so the first time a nasal preparation is used, microbial contamination is possible. Do not keep a nasal preparation for too long, especially not to reuse it for another treatment.
  • DO NOT LEAVE THIS MEDICINE WITHIN THE SCOPE OR SIGHT OF CHILDREN.
  • It is imperative to strictly adhere to the dosage, the maximum duration of treatment of 3 to 5 days and contraindications.
  • During the treatment, in case of feeling of acceleration of the heart beat, palpitations, appearance or increase of headaches, appearance of nausea, behavioral disorders,
  • STOP THE TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY.

PREVENT YOUR DOCTOR , if you suffer:

  • high blood pressure,
  • cardiac disorders, hyperthyroidism (hyperfunctioning of the thyroid gland),
  • personality disorders,
  • of diabetes.

In case of superinfection (purulent bloating), fever or concomitant bronchopulmonary infection, tell your doctor.

PREVENT YOUR DOCTOR , if you take:

  • a drug based on non-selective MAOIs (iproniazide),
  • a treatment containing an alkaloid of ergot of rye:
    • dopaminergic, such as bromocriptine, cabergoline, lisuride or pergolide, (eg antiparkinsonian),
    • vasoconstrictor, such as dihydroergotamine, ergotamine, methylergometrine, methysergide), (for example an antimigraine agent).

In case of purulent nasal discharge, persistence of fever, lack of improvement after 3 to 5 days of treatment, CONSULT YOUR DOCTOR.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Drive and use machines

Not applicable.

PREGNANCY / BREAST FEEDING / FERTILITY

Pregnancy

  • There is no reliable data on teratogenesis in animals.In clinical practice, the use of naphazoline in a limited number of pregnancies has apparently not revealed any particular malformative or fetotoxic effect to date.
  • However, further studies are needed to assess the consequences of exposure during pregnancy.
  • Therefore, due to the long duration of action of this drug and possible neonatal effects related to the powerful vasoconstrictive properties of this molecule, the use of naphazoline is not recommended during pregnancy.

Breastfeeding

  • There are no data regarding the passage into naphazoline breast milk. Therefore, it is not recommended to give naphazoline during the breastfeeding period.

What should I do if I miss a dose?

  • Do not use a double dose to make up for the dose you forgot to use. Continue your treatment according to your prescription.

What happens if I overdose from Derinox ?

  • Immediately consult your doctor or pharmacist.
  • In any case, comply with your doctor’s prescription. Do not increase or decrease the dose without the advice of your doctor or pharmacist.

What is  Forms and Composition?

FORMS and PRESENTATIONS
  • Solution for nasal spray: 15 ml bottle of solution (on average 150 sprays) and dosing pump fitted with a dip tube and a nasal tip delivering 100 µl of solution.
COMPOSITION
 p pulv
Prednisolone (DCI)0,02 mg
Naphazoline (DCI) nitrate0,025 mg

Excipients: cetrimide, 96% ethanol, glycerol, sodium edetate, anhydrous sodium dihydrogen phosphate, sodium hydroxide, distilled water.

NOT’s

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general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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