Rhinofluimucil spray nasal Uses,Dosage,Side Effects&Precautions

rhinofluimucil
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rhinofluimucil spray nasal Generic drug of the Therapeutic class: Otorhinolaryngology
active ingredients: Acetylcysteine , Tuaminoheptane , Benzalkonium chloride

Rhinofluimucil indication and Uses

rinofluimucil spray nasal Dosage

  • RESERVED FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OLD.
  • Adults and adolescents over 15 years: 2 sprays in each nostril, 3 to 4 times a day.
  • The maximum duration of treatment is 3 to 5 days.

Administration mode

  • Nasal sprays are done with the bottle upright, the head slightly bent forward, to avoid swallowing the product.

Contraindications

  • Benzalkonium hypersensitivity
  • Acetylcysteine ​​hypersensitivity
  • Hypersensitivity tuaminoheptane sulfate
  • Child
  • History of stroke
  • Risk of stroke
  • Severe hypertension
  • Poorly balanced high blood pressure
  • Severe coronary artery disease
  • Angle closure glaucoma
  • Urinary retention linked to urethroprostatic disorders
  • History of convulsion
  • Pregnancy
  • Feeding with milk

This medication is contraindicated in the following cases:

  • Hypersensitivity to the active substances or to any of the excipients listed in section composition.
  • Child under 15 years old.
  • Stroke of history or risk factors that increase the risk of stroke, because of the alpha sympathomimetic vasoconstrictor activity.
    • Severe arterial hypertension or not well balanced by the treatment.
    •   Severe coronary insufficiency.
  • Glaucoma Risk of angle closure.
  • Urinary retention risk related to urethroprostatic disorders.
    • History of seizures.
  •  In association with sympathomimetics with indirect action: vasoconstrictors intended to decongest the nose, whether they are administered orally or nasally [phenylephrine (alias neosynephrine), pseudoephedrine, ephedrine…] as well as methylphenidate, because of the risk of vasoconstricition 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 Rhinofluimucil

Pharmacotherapeutic group: SYMPATHOMIMETICS IN COMBINATION, EXCEPT CORTICOIDS , ATC code: R01AB08.

  • This drug contains alpha sympathomimetic, vasoconstrictor decongestant nasally, tuaminoheptane sulfate, antiseptic, benzalkonium chloride, and a mucolytic, N-acetylcysteine.

RHINOFLUIMUCIL Side Effects

Related to the presence of the vasoconstrictor = tuaminoheptane :

Cardiac disorders

  1. · Palpitations.
  2. · Tachycardia.
  3. · Myocardial infarction.

Visual disorders

  1. · Glaucoma crisis by closing the angle.

Gastrointestinal disorders

  1. · Dry mouth.
  2. · Nausea
  3. · Vomiting.

Nervous system disorders

  1. · 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.
  2. · Ischemic vascular accidents.
  3. · Headache.
  4. · Convulsions.

Psychiatric disorders

  1. · Anxiety.
  2. · Agitation.
  3. · Behavioral disorders.
  4. · Hallucinations.
  5. · 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.

Rhinofluimucil Interactions

Related to the presence of the vasoconstrictor = tuaminoheptane :

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.

RHINOFLUIMUCIL Warnings and Precautions

Special warnings

Due to the presence of tuaminoheptane :

  • Do not swallow.
  • Do not use for prolonged periods due to risk of rebound and iatrogenic rhinitis.
  • As soon as the packaging is opened, and even more so the first time a nasal preparation is used, microbial contamination is possible.
  • Repeated and / or prolonged instillations can lead to a significant systemic change in the active ingredients.
  • It is imperative to strictly adhere to the dosage, the duration of treatment of 3 to 5 days, the contraindications (see section Contraindications ).
  • Patients should be informed that the occurrence of high blood pressure, tachycardia, palpitations or cardiac arrhythmias, nausea, or any neurological signs (such as the onset or increase of headache) treatment.
  • Similarly, treatment monitoring should be strengthened in cases of high blood pressure, heart disease, hyperthyroidism, psychosis or diabetes.

This drug is not recommended because of the risk of vasoconstriction and / or hypertensive flares related to its sympathomimetic alpha activity, with the following drugs (see section Interactions with other medicinal products and other forms of interaction ):

  • · Non-selective MAOIs (iproniazide);
  • · Alkaloids of dopamine ergot (bromocriptine, cabergoline, lisuride or pergolide) or vasoconstrictors (dihydroergotamine, ergotamine, methylergometrine or methysergide).
  • Neurological disorders such as seizures, hallucinations, behavioral disturbances, agitation, and insomnia have been reported following administration of systemic vasoconstrictors, particularly during febrile episodes or during overdoses.

Therefore, it is appropriate in particular:

  • · Not to prescribe this treatment in combination with drugs likely to lower the epileptogenic threshold such as: terpene derivatives, clobutinol, atropine substances, local anesthetics … or in case of convulsive antecedents;
  • · In all cases, to respect the recommended dosage, and to inform the patient of the risks of overdose when combined with other drugs containing vasoconstrictors.
  • Due to the presence of benzalkonium chloride, this drug can cause edema of the nasal mucosa, especially in the case of long-term use, and respiratory discomfort.

Precautions for use

  • Athletes’ attention is drawn to the fact that this specialty containing tuaminoheptane can induce a positive reaction of the tests performed during anti-doping tests.

Drive and use machines

Not applicable.

RHINOFLUIMUCIL and PREGNANCY / BREAST FEEDING / FERTILITY

Pregnancy

  • There is no reliable data on teratogenesis in animals.
  • In clinical practice, the use of tuaminoheptane sulfate 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.
  • As a result and because of possible neonatal effects related to the potent vasoconstrictor properties of this molecule, the use of tuaminoheptane is not recommended during pregnancy.

Breastfeeding

  • The passage of tuaminoheptane into breast milk is not known.
  • Therefore, it is not recommended to administer tuaminoheptane during the breastfeeding period.

What is  Forms and Composition RHINOFLUIMUCIL?

FORMS 
  • Solution for nasal spray:   10 ml bottle (200 doses) + nebulizer.
COMPOSITION
 p bottle
Acetylcysteine ​​(INN) or N-acetylcysteine100 mg
Tuaminoheptane (DCI) sulfate50 mg
Benzalkonium chloride (DCI)1.25 mg
  • Excipients: hypromellose, disodium edetate, monosodium phosphate dihydrate, disodium phosphate dodecahydrate, dithiothreitol, 70% sorbitol, mint oil, 96% ethanol, sodium hydroxide, purified water.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

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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