Nazivin® sensitive

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAZIVIN® SENSITIVE (NASIVIN® SENSITIVE)

Composition:

Active substance:
oxymetazoline;

1 ml of 0.01% solution contains 0.1 mg of oxymetazoline hydrochloride;

Excipients:
citric acid monohydrate; sodium citrate; glycerol (85%); purified water.

Pharmaceutical form.
Nasal drops.

Main physicochemical properties:
almost clear solution, colorless to slightly yellowish.

Pharmacotherapeutic group.
Anti-edematous and other agents for local use in nasal cavity disorders. Sympathomimetics.

ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Nazivin® Sensitive belongs to the group of local vasoconstrictors. Oxymetazoline exerts a sympathomimetic and vasoconstrictive effect, reducing nasal mucosal edema. It constricts blood vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract, and decreases nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes re-aeration of the paranasal sinuses and the middle ear cavity, thus preventing the development of bacterial complications.

Oxymetazoline exerts antiviral, anti-inflammatory, immunomodulatory, and antioxidant effects. Due to this combined mechanism of action, clinical studies have demonstrated faster and more effective relief of symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, and general malaise).

When applied locally in therapeutic concentrations, it does not irritate the nasal mucosa and does not cause hyperemia.

Pharmacokinetics.

The elimination half-life is approximately 35 hours after administration. About 2.1% of the drug is excreted via the kidneys, and approximately 1.1% via feces.

The duration of action of the drug is up to 12 hours.

Following intranasal administration, the absorbed amount may sometimes be sufficient to initiate systemic effects, for example, in the central nervous and cardiovascular systems.

Additional pharmacokinetic data in humans are lacking.

Non-clinical safety data.

In toxicity studies in dogs, repeated nasal administration of oxymetazoline revealed no risks to human safety. Results of the in vitro bacterial mutagenicity test were negative. Data on carcinogenicity of this medicinal product are currently unavailable. No teratogenic effects were observed in rats and rabbits. Doses higher than the therapeutic level were embryolethal or caused fetal growth retardation. In rats, inhibition of maternal milk production was observed. There were no signs of impaired fertility.

Clinical characteristics.

Indications.

• Acute rhinitis.
• Allergic rhinitis.
• Attacks of non-infectious vasomotor rhinitis.
• To restore drainage and nasal breathing in diseases of the nasal accessory sinuses, eustachitis associated with rhinitis.
• To reduce swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

• Hypersensitivity to oxymetazoline or any other component of the drug.
• Atrophic rhinitis.
• Do not use after transsphenoidal hypophysectomy or other surgical interventions involving exposure of the meninges.
• Use of monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after discontinuation of MAO inhibitor therapy, as well as use of other drugs that may increase blood pressure.
• Increased intraocular pressure, especially in angle-closure glaucoma.
• Severe forms of cardiovascular diseases (e.g., ischemic heart disease) and arterial hypertension.
• Pheochromocytoma.
• Metabolic disorders (e.g., hyperthyroidism, diabetes mellitus).
• Prostate hyperplasia.
• Porphyria.

Interaction with other medicinal products and other types of interactions.

Concomitant use of oxymetazoline with MAO inhibitors of the tranylcypromine type, tricyclic antidepressants, and hypertensive agents may lead to increased blood pressure. Therefore, these drugs should not be used concomitantly.

Special precautions for use

Special caution is required when treating newborns and infants. In rare cases, serious adverse reactions (including apnea) have been reported in this age group after administration of the drug at therapeutic doses. Under no circumstances should the recommended dosage be exceeded.

Prolonged use and overdosing of the drug should be avoided. In particular, the effect of nasal decongestants may diminish with prolonged use or overdosing (tachyphylaxis). This may lead to administration of higher doses or more frequent applications, potentially resulting in the need for continuous use. If prolonged use or overdosing occurs, treatment with this drug should be discontinued immediately.

Improper use of nasal medications may lead to the following phenomena:

• Reactive hyperemia of the nasal mucosa
  (rebound effect);
• Chronic swelling of the nasal mucosa
  (medication-induced rhinitis);
• Atrophy of the nasal mucosa.

Use during chronic rhinitis or at higher than recommended doses should occur only under medical supervision.

Use during pregnancy or breastfeeding

Pregnancy

Data from a limited number of women exposed during the first trimester of pregnancy do not indicate adverse effects on the course of pregnancy or on the health of the fetus/newborn. Other relevant epidemiological data are currently unavailable. Animal studies have shown reproductive toxicity when doses exceeding the therapeutic dose were administered.

Nasivin® Sensitive, preservative-free nasal drops, should be used during pregnancy only after careful benefit-risk assessment and consultation with a physician.

During pregnancy, the recommended dosage should not be exceeded, as overdosing may impair fetal blood supply.

Breastfeeding

Data on the passage of oxymetazoline into breast milk are not available. The drug should be used during breastfeeding only after consultation with a physician and careful benefit-risk assessment. During breastfeeding, the recommended dosage should not be exceeded, as overdosing may reduce the amount of breast milk in women.

Ability to influence reaction speed when driving or operating machinery

When used at therapeutic doses, the drug does not affect reaction speed when driving or operating machinery. However, a general effect on the cardiovascular and nervous systems cannot be completely ruled out.

Method of Administration and Dosage

Nazivin® Sensitive, 0.01% nasal drops, is intended for instillation into the nose.

Children from birth to 4 weeks of age
Administer 1 drop of Nazivin® Sensitive into each nostril 2–3 times daily.

Children from 5 weeks of age to 1 year
1–2 drops of Nazivin® Sensitive into each nostril 2–3 times daily.

The medication should be administered into each nostril. The dosing bottle must be inverted and the dosing device pressed periodically. During instillation, the child’s head should be tilted backward. Hold the inverted dosing bottle in front of the nostril and administer the medication into each nostril.

The single dose of Nazivin® Sensitive should not be used more than 3 times daily or for longer than 7 consecutive days. Doses higher than those recommended should not be used.

Nazivin® Sensitive is recommended for use in infants and children up to 1 year of age. The appropriate dose for infants with low body weight or premature infants should be determined by a physician.

Use in chronic rhinitis, as well as at doses exceeding the recommended ones, should be performed only under medical supervision.

Repeated use of the medication is possible only after an interval of several days.

Children
The medication is indicated for children from birth up to 1 year of age.

Overdose

After prolonged use or overdose of nasal decongestants, their effect may diminish (tachyphylaxis). This may lead to increased dosing or more frequent administration, potentially resulting in dependence on the medication. If prolonged use or overdose occurs, treatment with this medication should be discontinued immediately.

Overdose may occur following nasal or accidental oral administration. The clinical picture of intoxication with imidazole derivatives may be unclear, as periods of stimulation may alternate with periods of depression of the central nervous, cardiovascular, and respiratory systems.

Stimulation of the central nervous system may manifest as anxiety, agitation, hallucinations, and seizures.

Depression of the central nervous system may manifest as decreased body temperature, lethargy, drowsiness, and potentially coma.

Other possible symptoms include: miosis, mydriasis, elevated temperature, sweating, pallor, cyanosis, tachycardia, bradycardia, cardiac arrhythmia, cardiac arrest, arterial hypertension, shock-like hypotension, nausea, vomiting, respiratory insufficiency, apnea, and psychiatric disturbances.

In particular, in children, overdose may predominantly cause effects on the central nervous system: seizures and development of coma, bradycardia, apnea, as well as arterial hypertension possibly progressing to arterial hypotension.

Intensive supportive therapy is indicated in cases of severe overdose. Immediate administration of activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of overdose with a large amount of the medication) is recommended, as oxymetazoline may be rapidly absorbed.

Vasopressor agents are contraindicated. Non-selective α-blockers may be used as an antidote. If necessary, measures to reduce body temperature, anticonvulsant therapy, and lung ventilation should be implemented.

Adverse Reactions

Undesirable effects are classified by frequency of occurrence as follows: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), and isolated cases.

From the nervous system.

Very rare: restlessness, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (especially in children).

From the cardiovascular system.

Rare: palpitations (awareness of heartbeat), tachycardia, arterial hypertension, chest pain.

Very rare: arrhythmias.

From the respiratory system.

Common: nasal discomfort (e.g., burning sensation) or dryness of the nasal mucosa, sneezing.

Uncommon: after the effect of Nazivin® Sensitive wears off – sensation of severe nasal congestion, epistaxis (nosebleed).

Very rare: apnea in infants and newborns.

From the musculoskeletal system.

Very rare: convulsions (especially in children).

From the immune system.

Uncommon: hypersensitivity reactions (angioneurotic edema, rash, pruritus).

General disorders and administration site reactions:

Very rare: increased fatigue (drowsiness), weakness.

Frequency not known: tachyphylaxis (with prolonged use or overdose).

Reporting of suspected adverse reactions after marketing authorization is very important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system.

Shelf life
3 years.

After first opening – no more than 12 months.

Storage conditions.
No special storage conditions required. Keep out of reach of children!

Packaging.
5 ml of solution in a bottle; 1 bottle per cardboard box.

Supply category.
Over-the-counter (without prescription).

Manufacturer.

1. P&G Health Austria GmbH & Co. OG
   (Batch release authorization)
2. Famar Health Care Services Madrid, S.A.U.
   (Full-cycle manufacturing)

Manufacturer's address and place of business.

1. Hosslgasse 20, 9800 Spittal an der Drau, Austria
2. Avda. Leganes, 62, Alcorcon, 28923 Madrid, Spain