Deltarinolo nasal spray - nasal mucosa decongestant - 15 ml vial

Product Description

Nasal mucosa decongestant.

Indications 

Deltarinolo Nasal Spray is a decongestant solution formulated to relieve nasal congestion and improve respiratory comfort. Thanks to the combination of active ingredients such as Ephedrine hydrochloride and Naphazoline nitrate, this spray is particularly effective in reducing swelling of the nasal mucosa. It is ideal for those who suffer from colds, sinusitis or allergies, offering fast and long-lasting relief.

Composition

Active ingredients

• Ephedrine hydrochloride 0.500 g
• Naphazoline nitrate 0.125 g

Excipients

• Methyl p-hydroxybenzoate
• Propyl p-hydroxybenzoate
• Sodium edetate
• Sodium phosphate monobasic
• Sodium phosphate
• Sodium hydroxide
• Purified water

How to use

The DELTARINOLO should be applied every 3-4 hours up to 4 times a day; a single spray is sufficient. Strictly adhere to the recommended doses. A higher dosage of the product, even if taken topically and for a short period of time, can cause serious systemic effects.

Warnings

Prolonged use of vasoconstrictors can alter the normal function of the nasal and paranasal sinus mucosa, also leading to drug addiction. Repeated applications for long periods can be harmful. Use with caution in patients with renal insufficiency and, due to the risk of urinary retention, in the elderly. The use, especially if prolonged, of topical products can give rise to sensitization phenomena; in this case, it is necessary to discontinue treatment and, if necessary, institute appropriate therapy. However, if a complete therapeutic response is not achieved within a few days, consult your doctor; in any case, treatment should not be continued for more than four days. In patients with cardiovascular disease, especially those with hypertension, the use of nasal decongestants should be carefully considered by a physician. Cardiovascular effects may be observed with the use of sympathomimetic drugs, such as DELTARINOL. There is some evidence from post-marketing data and published literature of rare cases of myocardial ischemia associated with the use of beta-agonists. Patients with pre-existing serious cardiac disease (e.g., ischemic heart disease, arrhythmia, or severe heart failure) taking DELTARINOL should be advised to consult a physician if they experience chest pain or other symptoms of worsening cardiac disease. Careful evaluation of symptoms such as dyspnea and chest pain should be performed, as they may be of respiratory or cardiac origin. Strictly adhere to the recommended dose. If accidentally ingested or if used for a long time at excessive doses, the product may cause toxicity. Keep out of reach of children as accidental ingestion may cause severe sedation. Do not use orally. Avoid contact of the liquid with eyes. Caution for athletes: the product contains substances prohibited for doping. Any dosage regimen or administration route other than those indicated is prohibited. Due to the presence of methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate as excipients, allergic reactions, including delayed reactions, are possible. Ephedrine may be a substance subject to abuse.

Interactions

The active ingredients contained in DELTARINOL may interact negatively with antidepressant drugs. Therefore, administration of the product during or within two weeks of antidepressant drug therapy is contraindicated. Ephedrine may reduce the pharmacological efficacy of antihypertensive drugs; when combined with clonidine, it may cause increased norepinephrine levels and an increase in blood pressure. When combined with NSAIDs, it may promote the onset of gastric mucosal lesions. Ephedrine may increase the metabolism of corticosteroids, reducing their plasma levels. Asthmatic patients treated with these drugs should therefore avoid taking ephedra-based products. Urinary excretion of ephedrine is pH-dependent; acetazolamide, antacids, ammonium chloride, and sodium bicarbonate can alkalinize the urine, consequently slowing the elimination of ephedrine. The simultaneous combination of ephedrine with digoxin, phenylpropanolamine, cyclopropane, and pseudoephedrine is associated with an increased risk of cardiovascular adverse events. Reserpine, by causing norepinephrine depletion, may reduce the efficacy of ephedrine. Theophylline may cause a higher incidence of central and gastrointestinal adverse effects, which occur following ephedrine administration. The combination of ephedrine and caffeine may enhance the sympathomimetic effects of ephedrine.

Overdose

In case of overdose or accidental ingestion, arterial hypertension, tachycardia, photophobia, severe headache, chest tightness, psychiatric reactions and, in children, hypothermia and severe central nervous system depression with marked sedation requiring the adoption of adequate emergency measures may occur.

Side effects

The product may cause local rebound sensitization and mucosal congestion. After topical use of naphazoline, systemic effects such as nausea, headache and dizziness have been reported. After administration of ephedrine, the most common adverse events reported are tachycardia, anxiety, restlessness and insomnia. Tremors, dry mouth, urinary disturbances, circulatory disturbances in the extremities, arterial hypertension, reflex bradycardia, and cardiac arrhythmias may also occur. A risk of haemorrhagic stroke has been reported in patients who have used ephedrine hydrochloride-based drugs, mainly in cases of misuse or overdose. Ischemic vascular accidents may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

The use of the product in women who are known or suspected to be pregnant or who are breastfeeding is contraindicated.

Format

15 ml spray