Instructions for use Nazivin nasal spray 0.05% bottle 10 ml
Composition
active ingredient: oxymetazoline;
1 ml of 0.025% solution contains 0.25 mg of oxymetazoline hydrochloride;
1 ml of 0.05% solution contains 0.5 mg of oxymetazoline hydrochloride;
Excipients: citric acid monohydrate; sodium citrate; glycerin (85%); purified water.
Dosage form
Nasal spray.
Main physicochemical properties: almost transparent, colorless to slightly yellowish solution.
Pharmacotherapeutic group
Anti-edematous and other drugs for topical use in diseases of the nasal cavity. Sympathomimetics.
ATX code R01A A05.
Pharmacological properties
Pharmacodynamics
Nazivin® Sensitive belongs to the group of local vasoconstrictors. Oxymetazoline has a sympathomimetic and vasoconstrictor effect, eliminating swelling of the nasal mucosa. Narrows the vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract, reduces nasal discharge. Restores nasal breathing. Elimination of swelling of the nasal mucosa contributes to the restoration of aeration of the paranasal sinuses and middle ear cavity, which prevents the development of bacterial complications.
Oxymetazoline has antiviral, anti-inflammatory, immunomodulatory and antioxidant effects. Thanks to this combined mechanism of action, clinical studies have proven a faster and more effective elimination of symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, malaise).
When applied topically to the nose in therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The half-life is about 35 hours after application. 2.1% of the drug is excreted by the kidneys, about 1.1% with feces.
Treatment with 0.05% oxymetazoline nasal spray significantly reduced the duration of the common cold compared with saline, from a mean of 6 days to 4 days (P < 0.001). A double-blind, parallel-group comparative study in 247 adult patients demonstrated a faster and more effective reduction in typical symptoms of acute rhinitis [nasal congestion, runny nose, sneezing, malaise (P < 0.05)] due to the combination of vasoconstrictor, antiviral, anti-inflammatory, and antioxidant effects of oxymetazoline.
Pharmacokinetics
The duration of action of the drug is up to 12 hours.
In the case of intranasal administration, the amount absorbed may sometimes be sufficient to initiate systemic effects, for example in the central nervous and cardiovascular systems.
Additional data from pharmacokinetic studies in humans are not available.
Preclinical safety data
Toxicity studies in dogs with repeated nasal administration of oxymetazoline did not reveal any safety risks for humans. The results of the in vitro bacterial mutagenicity test were negative. Data on the carcinogenicity of this medicinal product are currently unavailable. No teratogenic effects were observed in rats and rabbits. Doses higher than the therapeutic level were embryo-lethal or resulted in a decrease in fetal growth. In rats, inhibition of milk production was observed. There were no signs of impaired fertility.
Indication
Acute rhinitis.
Allergic rhinitis.
Attacks of non-infectious vasomotor rhinitis.
To restore drainage and nasal breathing in diseases of the paranasal sinuses of the nasal cavity, eustachitis associated with rhinitis.
To eliminate swelling before diagnostic manipulations in the nasal passages.
Contraindication
Hypersensitivity to oxymetazoline or any other component of the drug.
Atrophic rhinitis.
Do not use after transsphenoidal hypophysectomy or other surgical procedures involving exposure of the meninges.
Use of monoamine oxidase inhibitors (MAOIs) and the period of 2 weeks after discontinuation of treatment with MAO inhibitors, as well as the use of other drugs that contribute to an increase in blood pressure.
Increased intraocular pressure, especially in angle-closure glaucoma.
Severe forms of cardiovascular diseases (e.g. coronary heart disease) and arterial hypertension.
Pheochromocytoma.
Metabolic disorders (e.g. hyperthyroidism, diabetes mellitus).
Prostatic hyperplasia.
Porphyria.
Nazivin® Sensitive 0.025% is contraindicated for infants and children under 1 year of age, and Nazivin® Sensitive 0.05% is contraindicated for children under 6 years of age.
Interaction with other medicinal products and other types of interactions
Concomitant use of oxymetazoline with MAO inhibitors of the tranylcypromine type, tricyclic antidepressants and antihypertensives may increase blood pressure. Therefore, these drugs should not be used together.
Application features
Long-term use and overdose of the drug should be avoided. In particular, the effect of nasal decongestants may be weakened with long-term use and overdose (tachyphylaxis). This may require the use of the drug in higher doses or with more frequent administration, which may lead to the need for its continuous administration. In case of long-term use or overdose, treatment with this drug should be discontinued immediately.
The following phenomena may occur if rhinological drugs are used incorrectly:
reactive hyperemia of the nasal mucosa (ricochet effect);
chronic swelling of the nasal mucosa (rhinitis medicamentosa);
atrophy of the nasal mucosa.
Use for chronic rhinitis, as well as in higher doses than recommended, should only be done under the supervision of a physician.
Use during pregnancy or breastfeeding
Pregnancy.
Data on the effects of the drug in a limited number of women in the first trimester of pregnancy do not indicate the development of adverse reactions that would affect the course of pregnancy or the health of the fetus/newborn. Other epidemiological data are currently unavailable. Animal studies have shown reproductive dose-dependent toxicity when using doses exceeding therapeutic doses. The drug should be used with caution during pregnancy, only after consultation with a doctor and a careful assessment of the risk to the fetus and the benefit to the mother. During pregnancy, the recommended dosage should not be exceeded, as overdose may impair the blood supply to the fetus.
Breast-feeding.
Data on the penetration of oxymetazoline into breast milk are unknown. The drug should be used during breastfeeding only after consultation with a doctor and a careful assessment of the benefit-risk ratio. During breastfeeding, the recommended dosage should not be exceeded, as an overdose may reduce the amount of breast milk in a woman.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used in therapeutic doses, the drug does not affect the reaction rate when driving or using other mechanisms. However, a general effect on the cardiovascular and nervous systems cannot be ruled out.
Method of administration and doses
Nazivin® Sensitive, nasal spray, intended for use in the nose.
Children aged 1 to 6 years – 1 injection of Nazivin® Sensitive 0.025% into each nasal passage 2–3 times a day. A single dose should not be used more than 3 times a day and for longer than 7 days. Doses higher than recommended should not be used.
Adults and children over 6 years of age – 1 spray of Nazivin® Sensitive 0.05% into each nasal passage 2–3 times a day. A single dose should not be used more than 3 times a day and for longer than 7 consecutive days. Doses higher than recommended should not be used.
The spray mechanism is activated by pressing the dosing device. Before using the spray for the first time, remove the protective cap and periodically press the dosing device to ensure a stable spray. Hold the bottle under the nasal passage and spray once. After that, clean the dosing device and put on the protective cap.
Children
Nazivin® Sensitive 0.025% should be used in children aged 1 to 6 years, Nazivin® Sensitive 0.05% should be used in children aged 6 years and older.
Overdose
After prolonged use and overdose of nasal decongestants, their effect may decrease (tachyphylaxis). This may require the use of the drug in higher doses or with more frequent administration, which may lead to the need for its continuous administration. In case of prolonged use or overdose, treatment with this drug should be discontinued immediately.
Overdose may occur after nasal or accidental oral administration. The clinical picture of intoxication with imidazole derivatives may be ambiguous, since 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 spasms.
Central nervous system depression may manifest as decreased body temperature, lethargy, drowsiness, and possible coma.
The following symptoms may also occur: miosis, mydriasis, fever, sweating, pallor, cyanosis, rapid heartbeat, tachycardia, bradycardia, cardiac arrhythmia, cardiac arrest, arterial hypertension, shock-like hypotension, nausea, vomiting, respiratory failure and apnea, and mental disorders.
In particular, in children, overdose may cause mainly central nervous system effects: spasms and development of coma, bradycardia, apnea, as well as arterial hypertension with a possible transition to arterial hypotension.
The use of vasopressor drugs is contraindicated. Non-selective α-blockers can be used as an antidote. If necessary, measures can be taken to reduce body temperature, carry out anticonvulsant therapy and ventilation of the lungs.
Side effects
Adverse reactions are classified by frequency of occurrence into the following categories: very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%) and rare cases.
From the nervous system.
Very rare: restlessness, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (especially in children).
From the cardiovascular system.
Rare: palpitations (sensation of heartbeat), tachycardia, arterial hypertension, heart pain.
Very rare: arrhythmias.
On the part of the respiratory system.
Common: nasal discomfort (e.g. burning sensation) or dryness of the nasal mucosa, sneezing.
Uncommon: after the effect of using Nazivin® Sensitive wears off, there is a feeling of severe nasal congestion, nosebleeds.
Very rare: Apnoea in infants and newborns.
On the part of the musculoskeletal system.
Very rare: convulsions (especially in children).
From the immune system.
Uncommon: hypersensitivity reactions (angioedema, rash, itching).
General disorders and administration site reactions.
Very rare: increased fatigue (drowsiness), weakness.
Frequency unknown: tachyphylaxis (with prolonged use or overdose).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after a medicinal product has been authorised is very important. This allows the benefit/risk balance of the medicinal product to be continuously monitored. Healthcare professionals are asked to report suspected adverse reactions via the national reporting system.
Expiration date
3 years.
After first opening – no more than 12 months.
Storage conditions
Does not require any special storage conditions. Keep out of the reach of children!
Packaging
10 ml or 15 ml of the drug in a bottle; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
1. P&G Health Austria GmbH & Co. OG (Batch Release Authorization)
2. Sofarimex – Industria Quimica e Farmaceutica, SA (Full cycle production)
3. Famar Health Care Services Madrid, SAU (Full cycle production)
Address
1. Hosslgasse 20, 9800 Spittal an der Drau, Austria / Hosslgasse 20, 9800 Spittal an der Drau, Austria.
2. Av. das Industrias - Alto do Colaride, Cacém, 2735-213, Portugal.
3. Avda. Leganes, 62, Alcorcon, 28923 Madrid, Spain/Avda. Leganes, 62, Alcorcon, 28923 Madrid, Spain.
