NEOSYNEPHRINE GTT 15ML2.5MG/ML

NEO–SYNEPHRINE 2.5 MG/ML NASAL GOCCE, DEVELOPMENT

active ingredients

A ml nasal solution contains: phenylphrine hydrochloride 2,5 mg. For excipients, see section 6.1

Excellent

sodium citrate; sodium chloride; 2–phenoxethanol; benzalconio chloride; citric acid anidro and purified water.

Therapeutic indications

Decongestant of nasal mucosa.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Heart disease and severe arterial hypertension. Gross hyperthyroidism. The drug is contraindicated in children under the age of 12. Do not administer during or in the two weeks following therapies with monoaminooxidase inhibitors.

Population

1–2 drops in each nostril. If necessary, repeat up to 3–4 times a day. Do not exceed the recommended doses. In the absence of complete therapeutic response within a few days, consult your doctor; in any case, the treatment should not be protracted for over 5 days. The drops must be instilled in each nostril with the head reclined in lateral and low position.

Conservation

The bottle should be kept well closed and sheltered from light as prolonged exposure to air, metals or intense light causes oxidation and a certain loss of power. Solutions with altered color, although harmless, should not be used, but should be eliminated. Store at a temperature not exceeding 25°C Use the product within 30 days from the first opening

Warnings

Sympathomimetic drugs must be used with caution in patients with hypertension, heart disease including arrhythmias, thyroid diseases, diabetes mellitus and prostate hypertrophy. In these cases, the use of nasal decongestants must be subjected to the doctor’s judgment. Bounce congestion is frequent with the use of nasal decongestants and can lead to excessive use of the product. It is therefore necessary to adhere carefully to the recommended doses. Protracted use of vasoconstrictors can alter the normal function of mucosa of the nose and paranasal breasts, can cause tachyphylaxis and therefore reduced effectiveness of the drug. Abuse of nasal vasoconstrictors can induce prolonged alterations of the mucosa which may result in atrophic medicament rhinitis. Children are more sensitive to the systemic effects of sympathomimetic vasoconstrictors.

Interactions

The dietary effects of phenylphrine can be enhanced by the contemporary use of antidepressant triceclic drugs.

Effects

Like other nasal decongestants, the use of Neo-Synephrine, especially if used for periods greater than 5 days, can induce transitional local irritation. Induced vasoconstriction can be followed by vasodilation or congestion of "rimbalzo". For treatments at high doses or extended beyond the recommended limit or in case of excessive absorption of active ingredient through inflamed mucosa, it is possible rarely the appearance of cardiovascular systemic effects (hypertension followed by rebound hypotension, sweats, bradycardia, pallor) and stimulation of the central nervous system (cephalea, insomnia, tremors, dizziness, restlessness).

Overdosing

The product, if accidentally ingested can determine toxic phenomena. In case of accidental overdose, arterial hypertension, tachycardia, photophobia, intense headache, thoracic oppression and, in children, hypothermia and severe depression of the Central Nervous System with strong sedation, requiring the adoption of adequate emergency measures.

Use carefully in the first months of pregnancy. The product should be used with caution during breastfeeding since it cannot be excluded that the drug is excreted in breast milk.

Source: Farmadati