Oxyphrine 22.5 µg/dose (0.05%) 15ml metered nasal spray
pharmachologic effect
Adrenomimetic agent for local use. Has a vasoconstrictor effect. When administered intranasally, swelling of the mucous membrane of the upper respiratory tract decreases. When instilled into the conjunctival sac, it reduces swelling of the conjunctiva.
Composition and release form Oxyphrine 22.5 µg/dose (0.05%) 15 ml dosed nasal spray
Spray - 1 dose:
- Active substance: oxymetazoline hydrochloride 22.5 mcg.
- Excipients: anhydrous citric acid - 25.065 mcg, sodium citrate dihydrate - 172.035 mcg, anhydrous glycerol - 952.425 mcg, liquid water - 43.828 mg.
280 doses (15 ml) - plastic bottles (1) with a dosing nozzle - cardboard packs.
Description of the dosage form
Nasal spray dosed in the form of a transparent or almost transparent liquid from almost colorless to light yellow.
Directions for use and doses
Apply topically.
Pharmacodynamics
Oxymetazoline belongs to the group of alpha-agonists for topical use. Has a vasoconstrictor effect. When administered intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract and nasal discharge.
Restores nasal breathing.
Elimination of swelling of the nasal mucosa helps restore aeration of the paranasal sinuses and middle ear cavity, which reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis media). When used locally intranasally in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa.
Oxymetazoline begins to act quickly, within a few minutes.
The duration of action of the drug is up to 12 hours.
Pharmacokinetics
The effect appears 15 minutes after application and lasts for 6-8 hours.
Indications for use Oxyphrine 22.5 µg/dose (0.05%) 15 ml dosed nasal spray
Difficulty in nasal breathing due to colds, inflammation of the sinuses, eustachitis, hay fever, allergic rhinitis, congestion and swelling of the conjunctiva.
Contraindications
Inflammation of the mucous membrane of the nasal passages without secretion, chronic heart failure, hyperthyroidism, diabetes mellitus, pregnancy, children under 6 years of age (for eye drops), increased sensitivity to oxymetazoline, atrophic rhinitis, lactation, arrhythmias, severe atherosclerosis, arterial hypertension, chronic renal failure , angle-closure glaucoma.
Use of Oxyphrine 22.5 mcg/dose (0.05%) 15 ml dosed nasal spray during pregnancy and breastfeeding
Oxymetazoline is contraindicated for use during pregnancy and lactation (breastfeeding).
Use in children
Contraindicated in children under 6 years of age (for eye drops).
special instructions
The recommended dosage can be used for no more than 3 days without consulting a doctor. Avoid contact of the drug intended for intranasal administration with the eyes.
Impact on the ability to drive vehicles and operate machinery
The drug affects vision and may reduce reaction speed.
Overdose
Symptoms: anxiety, restlessness, hallucinations, convulsions, decreased body temperature, lethargy, drowsiness, coma, constriction or dilation of pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure , nausea, vomiting, respiratory depression, respiratory arrest.
Treatment: gastric lavage, taking activated carbon (in case of accidental ingestion of the drug); symptomatic.
Side effects Oxyphrine 22.5 µg/dose (0.05%) 15 ml dosed nasal spray
From the respiratory system: possible transient dryness and burning of the mucous membrane of the nasal passages, dry mouth and throat, sneezing; with long-term use, reactive hyperemia of the mucous membrane and atrophy of the mucous membrane may occur.
From the cardiovascular system: palpitations; rarely - arterial hypertension.
From the side of the central nervous system: increased excitability, dizziness, headache, sleep disturbances; with long-term use - tachyphylaxis.
From the digestive system: nausea.
On the part of the organ of vision: with conjunctival administration, mydriasis, accommodation paresis, irritation of the conjunctiva and surrounding tissues, and eyelid retraction are possible.
Drug interactions
With the simultaneous administration of MAO inhibitors and tricyclic antidepressants, an increase in blood pressure is possible.
Oxymetazoline slows down the absorption of local anesthetic drugs and prolongs their effect.
Co-administration of other vasoconstrictor drugs increases the risk of side effects.
Oxyphrine spray naz doses 0.05% (11.25 mcg/dose) 15 ml x1
Brand name: Oxyphrine
International name: Oxymetazoline&, (Oxymetazoline)
Pharmacological group: anticongestive agent - alpha-adrenergic agonist
Pharmacodynamics:
Oxymetazoline belongs to the group of alpha-agonists for topical use. Has a vasoconstrictor effect. When administered intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract and nasal discharge. Restores nasal breathing.
Elimination of swelling of the nasal mucosa helps restore aeration of the paranasal sinuses and middle ear cavity, which reduces the likelihood of bacterial complications (sinusitis, sinusitis, otitis media). When used locally intranasally in therapeutic concentrations, it does not irritate or cause hyperemia of the nasal mucosa.
Oxymetazoline begins to act quickly, within a few minutes. Duration of action is up to 12 hours.
Pharmacokinetics:
When administered locally intranasally, oxymetazoline does not have a systemic effect. The half-life of oxymetazoline when administered intranasally is 35 hours. 2.1% of oxymetazoline is excreted in the urine and about 1.1% in the feces.
Indications for use:
-.-.treatment of acute respiratory diseases accompanied by a runny nose,
-.-.allergic rhinitis,
-.-.vasomotor rhinitis,
-.-.to restore drainage in case of inflammation of the paranasal sinuses, eustachitis, otitis media,
-.-.to eliminate swelling before diagnostic manipulations in the nasal passages.
Contraindications:
-.-.hypersensitivity to the components of the drug,
-.-.atrophic (dry) rhinitis,
-.-.angle-closure glaucoma,
-.-.condition after transsphenoidal hypophysectomy, surgical interventions on the dura mater (history).
Carefully:
In patients suffering from diseases of the cardiovascular system (arterial hypertension, coronary heart disease, chronic heart failure, severe atherosclerosis, tachycardia, arrhythmias), impaired carbohydrate metabolism (diabetes mellitus), impaired thyroid function (hyperthyroidism), pheochromocytoma, chronic renal failure , prostatic hyperplasia with clinical symptoms (urinary retention), increased intraocular pressure, porphyria, as well as in patients taking monoamine oxidase inhibitors during the previous 2 weeks and within 2 weeks after their discontinuation, tricyclic antidepressants, bromocriptine.
Dosage regimen:
Oxyphrine, nasal drops 0.01% is intended for use in children under 1 year of age.
Intranasally.
Children under 4 weeks of age are prescribed 1 drop of the drug in each nasal passage 2-3 times a day. From the 5th week of life to 1 year - 1-2 drops in each nasal passage 2-3 times a day.
1 drop of the drug contains 2.8 mcg of oxymetazoline hydrochloride.
The bottle should be inverted before use. The drug should be instilled with the child's head tilted back.
The following procedure has also been proven effective: depending on age, 1-2 drops of the drug are applied to cotton wool and wiped over each nasal passage.
If symptoms worsen or improvement does not occur within 3 days, you should consult your doctor. Use the recommended dose for no more than 7 days without consulting a doctor.
Doses higher than recommended can only be used under medical supervision.
With frequent and prolonged use of the drug, the feeling of nasal congestion may reappear or worsen. If these symptoms appear, you should stop treatment and consult a doctor.
Side effects:
Burning or dryness of the mucous membranes of the nasal cavity, dryness of the mucous membranes of the mouth and throat, sneezing, an increase in the volume of secretions released from the nose, nosebleeds, after the effect of using the drug wears off, a feeling of “stuffiness” in the nose (reactive hyperemia).
Side effects caused by the systemic effect of the drug: increased blood pressure, headache, dizziness, palpitations, tachycardia, restlessness, anxiety, fatigue, drowsiness, sedation, irritability, sleep disturbance (in children), nausea, insomnia, exanthema, blurred vision (if it gets into the eyes), hallucinations, Quincke's edema, itching, convulsions, respiratory arrest (in infants).
Long-term continuous use of vasoconstrictor drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent swelling of the nasal mucosa (rhinitis medicamentosa).
If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.
Overdose:
If the drug is accidentally ingested or overdose, the following symptoms may appear: anxiety, restlessness, hallucinations, convulsions, decreased body temperature, lethargy, drowsiness, coma, constriction or dilation of the pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, decreased blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.
Treatment: gastric lavage, taking activated carbon (in case of accidental ingestion of the drug), symptomatic.
Interaction:
When used concomitantly with monoamine oxidase inhibitors (during the previous 2 weeks and within 2 weeks after their discontinuation), tricyclic antidepressants or other drugs that increase blood pressure, an increase in blood pressure may occur.
The drug slows down the absorption of local anesthetic drugs and prolongs their effect.
Co-administration of other vasoconstrictor drugs increases the risk of side effects.
Special instructions:
Avoid getting the drug into your eyes.
To avoid the spread of infection, it is necessary to use the drug individually.
USE IN PREGNANCY AND BREASTFEEDING
When used during pregnancy or breastfeeding, do not exceed the recommended dose. The drug can only be used in cases where the potential benefit to the mother outweighs the potential risk to the fetus and child.
INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS
After long-term use of cold remedies containing oxymetazoline in doses higher than recommended, a general effect on the cardiovascular system and central nervous system cannot be excluded. In these cases, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Be careful - nasal drops for children!
For whom are vasoconstrictor nasal drops most dangerous?
Nasal drops that quickly relieve swelling and restore nasal breathing contain a drug from the group of so-called alpha-2 adrenergic agonists. They constrict the blood vessels of the mucous membrane of the nasal passages and reduce the production of inflammatory serous or mucous secretions. But these substances are easily absorbed into the blood. And then, along with the desired local effect, their pronounced side effect on the entire cardiovascular system appears. The worst thing is that they affect the brain in such a way that they reduce blood pressure until the development of hypotonic shock. Think about it: simply putting drops into your nose can cause severe poisoning!
The younger the child, the smaller the dose of adrenergic agonist required for the baby to require emergency assistance. Therefore, the most vulnerable age is children from one to two years (about half of all cases). The second place in the frequency of serious complications is occupied by infants under one year old and children from 2 to 3 years old.
How does hypotonic shock manifest in children?
A stuffy nose causes a lot of trouble for a child. He cannot breathe normally, and therefore is capricious during meals and games, during daytime sleep, and often wakes up crying at night. It would seem that there is nothing unusual in the fact that after an adrenergic agonist is instilled into the nose, the baby stops snoring and quickly falls asleep. Therefore, the first signs of a decrease in blood pressure - drowsiness and lethargy - in case of poisoning, as a rule, are missed by parents. According to statistics, the most common complaint when seeking help is “the child does not wake up” or “it was difficult to wake up, but falls asleep again.”
The greater the number of vasoconstrictor drops in the nose that are absorbed into the systemic bloodstream, the more pronounced will be the general pallor of the skin, blueness around the mouth, sweating, and coldness of the extremities. In children, breathing becomes rare and barely noticeable to the eye, as if they are not breathing at all. The body is relaxed, any movement is difficult for them. In severe cases, an epileptic seizure or cerebral coma may develop.
What are the dangers of nasal drops during pregnancy?
A nasal spray with an adrenergic agonist narrows not only the superficial vessels of the nasal mucosa. To a lesser extent, but certainly, the lumen of the vessels feeding the placenta is spasmed. As a result, it becomes easier for the mother to breathe briefly, while the baby experiences a lack of oxygen at this time.
Which vasoconstrictor drops are most dangerous?
Naphazoline. It is part of drugs called Naphazolin ferein, Naphthyzin, Opkon-A, Sanorin, Sanorin with eucalyptus oil.
Xylometazoline. These are Brizolin, Galazolin, Grippostad Rino, Dlynos, Doctor Theiss Nazolin and Rinotais, Influrin, Xilen, Xylobene, Ximelin, Nosolin, Olint, Rizaksil, Rinomaris, Rinostop, Suprima-NOZ, Tizin xylo.
Oxymetazoline. These are 4-Wey, Afrin, Nazivin, Nazol and Nazol Advance, Nazosprey, Nesopin, Noxprey, Fazin, Fervex spray for the common cold.
When nasal drops cause poisoning in a child
The main reason is an overdose of the drug. When this happens:
- a solution containing a higher concentration of adrenergic agonists is used than is permitted at a certain age. A typical mistake is to spray “adult” drops into the baby’s nose;
- the drug is used with the correct pediatric dosage, but in a very large volume. For example, after instilling drops from the nose, mucus is removed and the medicinal spray is immediately reused;
- the medicine is used more often than recommended in the instructions for the drug.
Accidental poisonings also occur in children when a bottle of spray is left within reach and the child drinks the medicine. Even one sip of an adrenergic agonist, especially on an empty stomach, is enough to cause severe poisoning to develop.
How to protect your baby from dangerous nasal drops
The basic rule is to comply with the requirements for age, quantity and frequency of use of the drug specified in the annotation for the drug. Try not to buy sprays containing naphazoline, xylometazoline and oxymetazoline at the pharmacy. Remember that vasoconstrictor drops do not treat a runny nose, but only facilitate nasal breathing when the mucous membrane is swollen. This is usually observed in the first 1–3 days of a viral infection. Before instilling an adrenergic agonist, you need to clear the nasal passages of mucus using a saline solution or sea water and a suction bulb. Perhaps this procedure will be enough to make the child’s nose “breathe.”
