Utabon 35 Mcg/Pulsation Nasal Nebulizer 15 Ml (oximetazoline)

Utabon 35 Mcg/Pulsation Nasal Nebulizer 15 Ml (oximetazoline)

ACTION AND MECHANISM

- [nasopharyngeal DISORDERS], [ADRENERGIC AGONIST (ALFA-2)]. Oxymetazoline is an imidazole derivative of clonidine with alpha agonist activity. Its pharmacology is not well established, but its topical vasoconstricting effects appear to be due to binding to postsynaptic alpha-2 receptors, although certain alpha-1 effects can not be ruled out. After its topical administration results in a vasoconstriction of the capillaries of the mucosa, decreasing the blood content and swelling of the mucosa, which produces a decongestant effect of the nasal passages. 
The decongestant effects of oxymetazoline are more durable than those of alpha-1 agonists, such as phenylephrine, although they are slower. 

PHARMACOKINETICS

Nasal route: 
Absorption: There have not been many pharmacokinetic studies with oxymetazoline. It has been shown that this drug could be absorbed after nasal administration. The decongestant effects appear after 5-10 minutes, being maximum after 6 hours. Its vasoconstricting activity can last up to 12 hours. 
- Elimination: The oxymetazoline is eliminated by urine, appearing 30% of the unchanged dose after 72 hours. It also has some fecal elimination (10%). Its elimination half-life is 5-8 hours. 

INDICATIONS

- [NASAL CONGESTION]. Symptomatic treatment of local and temporal nasal congestion.

POSOLOGY

- Adults and children from 6 years of age, nasal: 

A nebulization in each nostril every 10-12 hours, maximum two applications per day. 
- Children under 6 years: The safety and efficacy of this medicinal product has not been evaluated. 

RULES FOR CORRECT ADMINISTRATION

It is recommended to administer this medication in the morning and at night, avoiding treatments over 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. 
Before each administration, the nostrils need cleaning. 
The container valve will be inserted into the nostrils, upright. Operate the valve, simultaneously performing a deep inspiration to facilitate the maximum penetration of the medication. Each press should be brief, ie the time required to press fully and then release. 
Once the medication is administered, the end of the valve will be cleaned with hot water, then dried with a clean cloth. 
Nasal Spray: If this is the first use of this product or has not been used for a long time, it is necessary to charge the sprayer. To do this, keeping the container away from the body, press the sprayer down several times until a finely sprayed liquid comes out.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medicine.

PRECAUTIONS

- Patients in whom sympathetic stimulation could worsen their pathologies. Oxymetazoline administered nasally does not theoretically present a risk for these patients, although a systemic absorption can not be ruled out. Even in the case of such absorption, the effects on presynaptic alpha-2 receptors would theoretically predominate, with consequent sympatholytic effects. However, it can not be ruled out that this drug also has an affinity for other adrenergic receptors, both alpha-1 and beta-receptors, so most authors recommend extreme precautions in cases of pathologies such as [DIABETES], [ GLAUCOMA], [HEART DISEASE], [CHRONIC HEART DISEASE], [CARDIAC ARRHYTHMIA], [ARTERIAL HYPERTENSION], [HYPERTHROIDISM], [FEOCROMOCYTOMA] or [HYPERPLASIA PROSTATICA]. 
- Bounce congestion. The administration of topical vasoconstrictors often leads to rebound congestion, which is usually accompanied by a new dosage by the patient. This may pose a risk of overdose, as well as a potentiation of congestion. It is recommended to gradually stop the administration of oxymetazoline in case of rebound congestion, alternating the doses in each nostril, until a definitive suppression. 
WARNINGS ABOUT EXCIPIENTS:

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

PATIENT TIPS

ADVICE TO THE PATIENT: 
- The nose must be cleaned before each application. 
- It is advisable to have proper nasal and applicator hygiene. 
- It is recommended not to exceed recommended daily doses nor to use for more than three consecutive days to avoid rebound congestion. 
- Treatment should be discontinued and the doctor should be consulted if symptoms persist, worsen or if a fever, dizziness, insomnia or nervousness develops. 
- It is common the appearance of a itching sensation or nasal discomfort after the application, that disappears after several doses.

INTERACTIONS

No drug interactions have been reported with oxymetazoline administered nasally, although this drug may have an absorption 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 predominates, appearing sympatholytic effects. However, due to the possibility that this drug also acts on other adrenergic receptors, prudence advises extreme caution when administered together with drugs such as MAOI antidepressants or tricyclic antidepressants, with antihypertensives such as diuretics, beta-blockers, methyl-dopa or guanethidine, with thyroid hormones, with nerve stimulants, nitrates or digoxin. 

PREGNANCY

FDA Category C. No animal studies have been performed, although other sympathomimetic amines have given rise to teratogenic effects in some species. There are no adequate and well-controlled studies in humans, so it is not known whether the nasal application of oxymetazoline could lead to adverse effects, although the possible systemic absorption should be taken into account. The use of this medicine is only accepted in case of absence of safer therapeutic alternatives, and limiting its use to short periods of time. 

LACTATION

It is not known whether oxymetazoline is excreted in breast milk and its possible effects on newborns. Given that systemic absorption is possible, and since young children are especially sensitive to the adverse effects of sympathomimetic amines, it is recommended to discontinue breast-feeding or to avoid the administration of this drug. 

CHILDREN

Safety and efficacy have not been evaluated in children under 6 years of age, and therefore its use is not recommended. In children, it is more common the appearance of adverse reactions of the type of sedation, which can become severe and need supportive treatment. 

ELDERLY

Elderly patients are more susceptible to adverse reactions following the use of sympathomimetics. In addition they may suffer pathologies that could be worsened by the administration of sympathomimetics, as well as being in treatment with drugs with which this active principle could interact. Patients over 60 years of age are closely monitored and treatment discontinued at the least indication of significant adverse reactions.A dose adjustment may be necessary.

EFFECTS ON DRIVING

Oxymetazoline may lead to sedation, substantially affecting the ability to drive and / or operate machinery. Patients should avoid handling dangerous machinery, including automobiles, until they are reasonably certain that the drug treatment does not adversely affect them.

ADVERSE REACTIONS

The side effects of this medication are usually local and mild. However, a systemic absorption of this drug can not 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: The appearance of [STORM], [NASAL IRRITATION], local itching and burning sensation, [NASAL SEQUITY] or [RINORRHEA] is common. Bouncing is also common, especially at high doses or after prolonged periods of time. In case of drug abuse, [RINITIS] may appear and the edematous mucosa appearing with a reddish or pale gray color. These signs usually go away after a week of drug discontinuation. 
- Systemic effects: Absorption of oxymetazoline may result in [MAREO], [VERTIGO], [NAUSEAS], [VOMITOS], [NERVOOSISM], [PALPITATIONS], [BLOOD HYPERTENSION], [BRADICARDIA] reflects, [EXCESS SWEATING] or [PALIDEZ]. In children it can cause [SOMNOLENCE].

OVERDOSE

Symptoms: There is not much experience in dosing with oxymetazoline, since acute administration of overdose is not frequent due to the form of administration. In case of accidental ingestion of other drugs such as nafazolin, the onset of nervous depression, with sedation, intense hypothermia, bradycardia and in severe situations, coma is common. This overdose is especially important in children. Headache, tremor, palpitations, nervousness, or excessive sweating may also occur. The LD50 is 10 mg in children 2 years, and about 100 mg in adults. 
Treatment: Following ingestion, it is recommended to remove the drug by gastric lavage and active carbon administration every 4-6 hours. In the early stages, emetics and saline laxatives can be given. However, these measures do not seem to be very effective, since sedation appears quickly. 
Treatment should be symptomatic and supportive. In case of convulsions diazepam will be administered. The administration of vasopressors should be avoided if the patient presents with hypotension. Monitoring of cardiac function and vital signs is recommended.

Prospectus Utabon 35 Mcg/Pulsation Nasal Nebulizer 15 Ml

Utabon 35 Mcg/pulsaton Nasal Nebulizer 15 Ml