Deltarinol Nasal Spray 0.5% + 0.125% Ephedrine Hydrochloride Bottle 15 ml

WARNINGS
Prolonged use of vasoconstrictors can alter the normal function of the mucous membrane of the nose and paranasal sinuses, also inducing addiction to the drug. Repeating applications for long periods can be harmful. Use with caution in patients with renal insufficiency and, due to the danger 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 interrupt the treatment and, if necessary, to institute a suitable therapy. However, in the absence of a complete therapeutic response, within a few days, consult your doctor; in any case, the treatment must not be continued for more than four days. In patients with cardiovascular diseases, especially in hypertensive patients, the use of nasal decongestants must in any case be subjected to the judgment of the doctor from time to time. Cardiovascular effects can be observed with the use of sympathetic mimetic drugs. There is some evidence from post-marketing data and published literature of rare cases of myocardial ischaemia in association with the use of beta agonists. Patients with pre-existing severe heart disease (e.g. ischemic heart disease, arrhythmia or severe heart failure) taking the drug should be advised to seek medical attention if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to the evaluation of symptoms such as dyspnoea and chest pain, as they can be of both respiratory and cardiac origin. Follow the recommended doses scrupulously. The product, if accidentally ingested or used for a long time in excessive doses, can cause toxic phenomena. It should be kept out of the reach of children as accidental ingestion can cause marked sedation. It must not be used orally. Avoid contact of liquid with eyes. Attention for those who carry out sporting activities: the product contains substances prohibited for doping. It is forbidden to take a different dose, for dosage schedule and route of administration, from those reported. Due to the presence of methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate as excipients, allergic reactions are possible, including delayed type. Ephedrine may be a substance prone to abuse.
PHARMACOTHERAPEUTIC CATEGORY
Rhinological preparations - decongestants.
STORAGE
Store at a temperature not exceeding 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients, heart disease and severe arterial hypertension, acute angle-closure glaucoma, hyperthyroidism, prostatic hypertrophy, pheochromocytoma, diabetes mellitus, pregnant or presumed pregnant or lactating women. The drug is contraindicated in children under the age of 12. Do not administer during or in the two weeks following antidepressant drug therapy.
NAME
DELTARINOL 5 MG / ML + 1.25 MG / ML NASAL SPRAY, SOLUTION
EXCIPIENTS
Methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium edetate, monobasic sodium phosphate, sodium phosphate, sodium hydroxide, purified water.
SIDE EFFECTS
The product can locally determine phenomena of sensitization and congestion of the rebound mucous membranes. 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, urination disturbances, circulatory changes in the extremities, arterial hypertension, reflex bradycardia and cardiac arrhythmias may also occur. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
The use of the product in women who are pregnant or presumed pregnant or breastfeeding and 'contraindicated.
INDICATIONS
Decongestant of the nasal mucosa.
INTERACTIONS
The active ingredients contained in the drug can negatively interact with antidepressant drugs. Consequently, the administration of the product during or in the two weeks following antidepressant drug therapy is contraindicated. Ephedrine can reduce the pharmacological efficacy of antihypertensive drugs; associated with clonidine, it can cause an increase in noradrenaline levels and a rise in blood pressure. If associated with NSAIDs, it can 'favor the onset of lesions of the gastric mucosa. Ephedrine can increase the metabolism of corticosteroids, reducing plasma levels. Asthma patients being treated with such drugs should therefore avoid taking ephedra products. Urinary excretion of ephedrine is pH dependent; acetazolamide, antacids, ammonium chloride and sodium bicarbonate are able to alkalize the urine, and consequently slow down the elimination of ephedrine. The simultaneous association of ephedrine with digoxin, phenylpropanolamine, cyclopropane and pseudoephedrine is associated with an increased risk of adverse cardiovascular events. Reserpine, causing norepinephrine depletion, may reduce the efficacy of ephedrine. Theophylline may cause a higher incidence of central gastrointestinal adverse effects, which occur following the administration of ephedrine. The combination of ephedrine and caffeine can potentiate the sympathomimetic effects of ephedrine.
DOSAGE
The medicine should be applied every 3-4 hours up to 4 times a day; only one 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 'give rise to serious systemic effects.
ACTIVE PRINCIPLES
100 ml of solution contain: ephedrine hydrochloride 0.500 g; naphazoline nitrate 0.125 g.