Rhinofluimucil, spray 10 ml

Pharmacotherapeutic group:antagonist.
ATX code: R01AB08.

Pharmacological Properties

Pharmacodynamics

. The mucolytic and vasoconstrictor effect of Rinofluimucil® is a reflection of the pharmacological properties of its active ingredients.

Acetylcysteine has mucolytic activity due to free sulphhydryl group breaking disulphide bonds of mucus glycoproteins and having thinner effect on nasopharyngeal secretion.
Tuaminoheptane sulphate is a sympathomimetic amine having vasoconstrictor effect without systemic action when applied topically.
The two substances act synergistically to reduce intranasal resistance.

Pharmacokinetics

Absorption
After administration of the therapeutic dose (2 pressings of 50 µL) of Rinofluimucil®, the maximum plasma concentration of tuaminohepatan is reached between 0.25 h and 6.0 h.

Distribution
The mean Cmax value of tuaminoheptane after 2 50 µl pressings of Rinofluimucil® was 0.95 ng/ml, the mean Tmax value was 2 h.

Biotransformation
The metabolism of tuaminoheptane sulfate in human hepatocytes has been studied in vitro. No transformation occurred in human hepatocytes under in vitro conditions. The major metabolite of N-acetylcysteine is inorganic sulfate, which is excreted in the urine; other metabolites include taurine, cysteine, and N,N-diacetylcysteine. N-acetylcysteine is rapidly deacetylated to cysteine, which is incorporated into proteins. Excess cysteine enters the liver, where it is either metabolized for excretion or further modified.

Elimation
The average plasma half-life of tuaminoheptane after 2 50 µl pressings of Rinofluimucil® is 9.8 hours. Twelve hours after administration, tuaminoheptane was detected in all subjects (mean 0.42 ng/ml). Twenty-four hours after administration, the mean plasma concentration of tuaminoheptane was 0.30 ng/ml, but in most subjects the concentration was already below the limit of quantification (0.100 ng/ml).

Indications

Active ingredient

Composition

How to take, the dosage

The drug is injected into the nasal cavity in the form of a spray with a special nebulizer.

Adults: 2 doses of the spray (2 pressings of the valve) into each nasal passage 3 – 4 times a day.

Children over 6 years of age: 1 dose of the spray (1 pressure on the valve) in each nasal passage 3 to 4 times a day.

The duration of treatment should not exceed 7 days.

The recommended doses and course of treatment should not be exceeded without consulting a physician.

Interaction

Despite the low systemic absorption of tuaminoheptane, the following potential interactions should be considered when it is applied topically in the nasal cavity:

– Monoamine oxidase inhibitors (MAOIs), including reversible monoamine oxidase inhibitors (oMOIs): Increase risk of hypertensive crisis;

– Antihypertensive agents (including adrenergic neuron blockers or beta-blockers): may block the hypotensive effects of drugs;

– Cardiac glycosides: may increase the risk of cardiac arrhythmia;

– Ergot alkaloids: may increase the risk of ergotism;

– Parkinson’s disease drugs: May increase risk of cardiovascular toxicity;

– Oxytocin: may increase risk of hypertension;

Special Instructions

Synopsis

Contraindications

– Hypersensitivity to the active substance or any of the excipients.

– Cardiovascular disease, including hypertension.

– A history of cerebrovascular disease, including the presence of relevant risk factors (due to alpha-sympathomimetic activity).

– A history of seizures.

– Pheochromocytoma.

– Closed-angle glaucoma.

– Concurrent use of other sympathomimetic nasal agents, including other nasal congestion agents.

Patients who are currently receiving or have received monoamine oxidase inhibitors, including reversible monoamine oxidase inhibitors A (RIMA) for 2 weeks.

Pituitary glandectomy or surgery with dura mater exposure.

– Children under 6 years of age.

With caution:

– Occlusive vascular disease.

– Diabetes mellitus.

– Hyperthyroidism.

– Asthma.

– Prostate hypertrophy because it can make it difficult to urinate.

– Use of beta-blockers.

– Prolonged use may cause recurrence of symptoms of blockage and drug-induced rhinitis.

Side effects

System-organ class

Unwanted reaction

Disorders of the immune

Hypersensitivity

Mental disorders

Especially with prolonged and/or frequent use:

anxiety, hallucinations, delusions

Nervous system disorders

Especially with prolonged and/or frequent use: headache, anxiety, agitation,

insomnia, tremor

Cardiac disorders

Especially with prolonged and/or

frequent use: rapid

heartbeat, tachycardia, arrhythmia

Vascular disorders

Hypertension

Thoracic and mediastinal disorders

Especially with prolonged and/or frequent use: Dryness in the nose and throat, feeling

discomfort in the nose, nasal congestion

nasal congestion

Gastrointestinal tract disorders:

Nausea

Skin and subcutaneous tissue disorders

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Urticaria rash, rash

Relative and renal disorders

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urinary tract

Urinary retention

General disorders and reactions at the site of administration

Particularly with prolonged and/or

frequent use: irritation at the injection site, habituation

Overdose

In overdose in adult patients the following symptoms may be observed: arterial hypertension, photophobia, severe headache, tightness in the chest.

In overdose in children, hypothermia with a pronounced sedative effect may occur.

Treatment: symptomatic.

Pregnancy use