Rhinovin 1 Mg/Ml Nasal Nebuliser 10 Ml

Rhinovin 1 Mg/Ml Nasal Nebuliser 10 Ml

Blocked Nose Relief Xylometazoline Hydrochloride

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ACTION AND MECHANISM

- [NASAL / PHARYNX DECONGESTANT], [ADRENERGIC AGONIST (ALPHA-2)]. Xylometazoline is an imidazole derivative of clonidine with alpha agonist activity. Its pharmacology is not perfectly established, but its topical vasoconstrictive effects appear to be due to binding to postsynaptic alpha-2 receptors, although certain alpha-1 effects cannot be ruled out. After its topical administration, it causes vasoconstriction of the capillaries of the mucosa, decreasing the blood content and the swelling of the mucosa, which produces a decongestant effect on the nasal passages.
The decongestant effects of xylometazoline are longer lasting than those of alpha-1 agonists, such as phenylephrine, although slower.

PHARMACOKINETICS

Nasal route:
- Absorption: The effects appear after 5-10 minutes, and last for a period of 5-6 hours, even reaching 10 hours.

INDICATIONS

- [NASAL CONGESTION]. Symptomatic treatment of nasal congestion associated with [RHINITIS], such as [SEASONAL ALLERGIC RHINITIS], [PERENNIAL ALLERGIC RHINITIS], or [VASOMOTOR RHINITIS], [COMMON COLD] and in [SINUSITIS].

POSOLOGY

DOSAGE:
- Adults, nasal: One nebulization or drop in each nostril, up to 3 times a day.
- Children, nasal:
* Children 12 years or older: A nebulization or drop in each nostril, up to 3 times a day.
* Children under 12 years of age: The safety and efficacy of this medicine have not been evaluated.
It is recommended to avoid treatments for more than 3 days in a row to avoid the appearance of rebound congestion, which is usually translated by the patient as an absence of effects, which entails a new administration, with the risk of overdose. The different doses should be separated by a period of 8-10 hours.

RULES FOR CORRECT ADMINISTRATION

- Nebulization: The container valve will be inserted into the nostrils, in a vertical position. Actuate the valve, simultaneously taking a deep breath to facilitate maximum drug penetration. Each press must be brief, that is, the time required to press fully and then release.
Once the medication has been administered, the end of the valve will be cleaned with hot water, then dried with a clean cloth.
- Drops: The patient must be placed in a lateral position, applying the drops in each nostril. It must remain in this position for the period necessary to prevent the solution from leaking out.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug.

PRECAUTIONS

- Patients in whom sympathetic stimulation could worsen their pathologies. Nasal administration of xylometazoline does not theoretically present a risk for these patients, although systemic absorption cannot be ruled out. Even in the case of such absorption, the effects on presynaptic alpha-2 receptors would theoretically predominate, with the consequent sympatholytic effects. However, it cannot be ruled out that this drug also has affinity for other adrenergic receptors, both alpha-1 and beta receptors, so most authors recommend taking extreme precautions in case of pathologies such as [DIABETES], [ GLAUCOMA], [CARDIOPATIA] ([CORONARY INSUFFICIENCY], [ISCHEMIC CARDIOPATIA]), [CARDIAC ARRHYTHMIA], [ARTERIAL HYPERTENSION], [HYPERTHYROIDISM], [FEOCROMOCYTOMA] or [PROSTATIC HYPERPLASIA].

- Rebound congestion. The administration of topical vasoconstrictors often leads to rebound congestion, which is usually accompanied by redosing by the patient. This can pose a risk of overdose, as well as an increase in congestion. It is recommended to gradually suspend the administration of xylometazoline in the event of rebound congestion, alternating the doses in each nostril, until definitive withdrawal.
WARNINGS ON EXCIPIENTS:

- Because it contains benzalkonium chloride, it can cause inflammation of the nasal mucosa, especially in long-term treatments. If persistent nasal congestion is suspected, a nasal product that does not contain this preservative should be used whenever possible.

ADVICE TO THE PATIENT

ADVICE TO THE PATIENT:
- The nose should be cleaned before each application.
- Correct nasal and applicator hygiene is advisable.
- It is recommended not to exceed the recommended daily doses or use for more than three days in a row to avoid rebound congestion.
- Treatment should be stopped and see a doctor if symptoms persist, worsen or if high fever, dizziness, insomnia or nervousness appear.
- It is common to have an itchy sensation or nasal discomfort after application, which disappears after several doses.

INTERACTIONS

Drug interactions have not been described with xylometazoline administered nasally, although this drug could be absorbed through the nasal mucosa or by ingestion of the product. There is some controversy about the effects of alpha-2 vasoconstrictors, since at the systemic level the affinity for presynaptic receptors would predominate, with sympatholytic effects. Despite this, and due to the possibility that this drug also acts on other adrenergic receptors, prudence advises to exercise extreme caution when administered together with drugs such as MAOI-type antidepressants or tricyclic antidepressants, with antihypertensives such as diuretics, beta-blockers, methyl-dopa or guanethidine, with thyroid hormones, with nerve stimulants, nitrates or with digoxin.

PREGNANCY

Animal studies have not been performed, although other sympathomimetic amines have resulted in teratogenic effects in some species. In a study carried out with 207 pregnant women who had been in contact with the drug during the first three months of gestation, it was found that it did not increase the risk of malformations. However, there are no adequate and well-controlled studies in humans, so it is unknown whether the nasal application of xylometazoline could lead to adverse effects, although possible systemic absorption should be taken into account. The use of this medicine is only accepted in the absence of safer therapeutic alternatives, and limiting its use to short periods of time.

LACTATION

It is unknown whether xylometazoline is excreted in human milk, and its possible effects on newborns. Taking into account that systemic absorption is possible, and since young children are especially sensitive to the adverse effects of sympathomimetic amines, it is recommended to stop breastfeeding or avoid the administration of this medicine.

CHILDREN

The safety and efficacy have not been evaluated in children under 12 years of age, so its use is not recommended. In children, the appearance of adverse reactions such as sedation is more common, which can become serious and require supportive treatment.

SENIORS

Elderly patients are more susceptible to adverse reactions after the use of sympathomimetics. They can also suffer from pathologies that could be worsened by the administration of sympathomimetics, as well as being treated with drugs with which this active principle could interact. It is recommended to closely monitor patients over 60 years of age, and to discontinue treatment at the slightest sign of significant adverse reactions. A dosage adjustment may be necessary.

ADVERSE REACTIONS

The adverse effects of this medicine are usually local and mild. However, a systemic absorption of this drug cannot be ruled out, with the appearance of systemic adverse effects, which may increase in intensity and severity at higher doses. The most frequent alterations are:
- Local effects: It is common the appearance of [SNEEZING], [NASAL IRRITATION], local itching and burning sensation, [NASAL DRYNESS] or [RINORRHEA]. Rebound [NASAL CONGESTION] is also common, especially with high doses or after prolonged periods of time. In case of drug abuse, [RHINITIS] may appear, the mucosa appearing edematous and with a reddish or pale gray color. These signs usually disappear after a week of stopping the drug.
- Systemic effects: The absorption of xylometazoline can lead to [DIZZINESS], [DROWSINESS], [NAUSEA], [VOMITING], [NERVOUS], [PALPITATIONS], [ARTERIAL HYPERTENSION], [BRADYCARDIA] reflex, [EXCESS OF SWEATING] or [PALE]. In children it may cause [Drowsiness].

OVERDOSE

Symptoms: There is not much experience on dosing with xylometazoline, since acute overdosage is not usually frequent due to the form of administration. In case of accidental ingestion of other drugs such as naphazoline, the appearance of nervous depression is common, with sedation, intense hypothermia, bradycardia and in severe situations, coma. This overdose is especially important in children. Headache, tremor, palpitations, nervousness or excessive sweating may also appear.
Treatment: Treatment should be symptomatic and supportive. In mild cases, oxygen will be administered. Plasma expanders will be used for shock, and in case of anticholinergic symptoms, intramuscular or intravenous physostigmine by slow infusion, at doses of 2 mg for adults or 0.5 mg for children. 

See leaflet Rhinovin 1 Mg / Ml Nasal Nebulizer 10 Ml

See Rhinovin Technical Data Sheet 1 Mg / Ml Nasal Nebulizer 10 Ml