Instructions for Mezanext 25 mg/ml eye drops 5 ml
Composition
active ingredient: phenylephrine hydrochloride;
1 ml of solution contains phenylephrine hydrochloride in terms of 100% substance - 25 mg;
excipients: benzalkonium chloride calculated as 100% substance, disodium edetate, sodium metabisulfite (E 223) calculated as 100% substance, boric acid, sodium hydroxide and/or hydrochloric acid, water for injections.
Dosage form
Eye drops, solution.
Main physicochemical properties: clear liquid.
Pharmacotherapeutic group
Means acting on the sensory organs. Means used in ophthalmology. Mydriatic and cycloplegic agents. Sympathomimetics, except antiglaucoma drugs. Phenylephrine.
ATX code S01F B01.
Pharmacological properties
Pharmacodynamics.
Mechanism of action
Phenylephrine is a direct-acting sympathomimetic that stimulates α-adrenergic receptors.
Pharmacodynamic effects
When applied to the eye, it causes mydriasis, and usually does not have a cycloplegic effect. The period of onset of complete mydriasis is usually 15–60 minutes.
The maximum duration of induced mydriasis is 60–90 minutes. Full recovery occurs within 3–7 hours after application.
Thymoxamine antagonizes the mydriatic effect.
Pharmacokinetics.
At physiological pH values, phenylephrine is a weak base. The degree of penetration through the tissues and structures of the eye determines the condition of the cornea. A healthy cornea acts as a physical barrier to the penetration of phenylephrine, and this effect is complemented by some metabolic activity of this structure of the eye.
If the integrity of the corneal epithelium is compromised, the degree of absorption of phenylephrine may increase.
There is evidence that after topical application of phenylephrine (10% solution) to the eyes, the maximum concentration in blood plasma occurs on average 10 minutes after instillation and is about 10.2 ± 7.9 ng/ml.
Indication
MesaNext is used to dilate the pupil during diagnostic and/or therapeutic procedures; in uveitis - to rupture posterior synechiae or to prevent their occurrence; during surgical interventions; for the study of refraction without cycloplegia; during fundus examinations and other diagnostic procedures.
Contraindication
Hypersensitivity to any component of the drug.
Significant disorders of the cardiovascular system (heart disease, hypertension, aneurysm, tachycardia), especially in elderly patients.
Thyrotoxicosis.
Insulin-dependent diabetes mellitus.
Hyperthyroidism.
Concomitant use of monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of treatment with MAOIs.
Concomitant use with tricyclic antidepressants, antihypertensive drugs (including β-blockers).
Congenital deficiency of glucose-6-phosphate dehydrogenase.
Hepatic porphyria.
Angle-closure glaucoma (except in cases of previous iridectomy) and patients with a narrow anterior chamber angle who are at increased risk of developing glaucoma when using mydriatics.
Use in premature and low-birth-weight newborns.
Use in newborns and infants with cardio- or cerebrovascular disorders.
Use in elderly patients with severe atherosclerotic, cardiovascular or cerebrovascular diseases.
Additional pupil dilation during surgery in patients with impaired eyeball integrity or impaired tear function.
Interaction with other medicinal products and other types of interactions
Antihypertensives (including β-blockers)
Topical phenylephrine may cause a reversible antihypertensive effect, which in some cases can be fatal, and hypertension, so its simultaneous use with topical phenylephrine is contraindicated. Systemic side effects are more common in patients taking β-blockers such as propranolol.
MAO inhibitors
Phenylephrine is contraindicated during use of MAO inhibitors and for 2 weeks after discontinuation of MAO inhibitors. Concomitant use with MAO inhibitors within 21 days after discontinuation of their use should be carried out with caution, since the development of systemic adrenergic effects is possible.
Tricyclic antidepressants
Their simultaneous use with phenylephrine is contraindicated.
The vasopressor effect of adrenergic agents (there is a risk of cardiac arrhythmia, including within a few days after discontinuation of their use) may be increased in patients taking tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa and m-cholinoblockers.
Inhalation anesthesia
Increased risk of ventricular fibrillation. Phenylephrine should be used with caution during general anesthesia with anesthetics such as halothane (fluorothane), which cause increased myocardial sensitivity to sympathomimetics and may potentiate cardiovascular depression during inhalation anesthesia.
Cardiac glycosides or quinidine
Increased risk of arrhythmia.
The mydriatic effect of phenylephrine is enhanced by topical atropine and attenuated by topical other miotics. Concomitant use may potentiate the adrenergic effect and even cause tachycardia in some patients, particularly children.
Application features
MezaNext is for topical ocular use only. The solution should not be administered subconjunctivally or directly into the anterior chamber of the eye.
The drug should be prescribed with caution to patients with diabetes mellitus, cerebral atherosclerosis and long-term asthma, as well as to children and the elderly.
Some elderly patients have had reflex miosis after instillation of phenylephrine, and additional instillation resulted in less than initial mydriasis. This effect may be of clinical importance in elderly patients when dilating the pupils before cataract extraction or retinal detachment surgery.
After instillation of phenylephrine, especially at high doses, cases of transient appearance of pigment particles in the anterior chamber may occur in elderly patients. This is explained by the strong effect of the drug on the pupillary dilator and may mimic anterior chamber uveitis or microscopic hyphema.
Since the effect of dilation of the pupil may last for 1–3 hours, patients may experience photophobia, therefore, until complete recovery of vision, it is necessary to protect the eye(s) from bright sunlight, including the use of sunglasses. It is necessary to exclude visual strain (reading, watching television) until the disappearance of residual manifestations of mydriasis.
In elderly patients with cardiovascular diseases, blood pressure should be monitored. The drug should be used with caution in children with heart defects.
To prevent unpleasant sensations when using MezaNext, you can apply drops with a local anesthetic a few minutes before instillation.
To reduce the risk of exacerbation of angle-closure glaucoma, a preliminary assessment of the anterior chamber angle is necessary before using the drug.
Conjunctival hyperemia and damage to the corneal epithelium increase the absorption of phenylephrine when applied topically and increase undesirable systemic effects.
Exceeding the recommended dose, as well as the use of phenylephrine after surgery in patients with eye injuries and diseases, reduced tear secretion, and during anesthesia may increase its absorption and cause a systemic vasopressor response.
Corneal opacity is possible when using phenylephrine in higher concentrations (10%) in patients with corneal epithelial disorders.
The product contains benzalkonium chloride as an excipient, which may cause eye irritation. Contact with soft contact lenses should be avoided. They should be removed before using the product and wait at least 15 minutes before reinserting them. Benzalkonium chloride is known to discolour contact lenses.
This medicine contains sodium metabisulfite, which may rarely cause hypersensitivity reactions and bronchospasm.
Childhood.
The minimum dose necessary to obtain the desired effect should always be used. Parents should be advised to avoid getting the product in the child's mouth or on the cheeks and to wash their hands and the child's hands and cheeks after administration. In general, children, and especially infants with low birth weight and premature infants, are at increased risk of developing systemic adverse reactions, including a transient increase in blood pressure, which increases the risk of intraventricular hemorrhage. The infant should be monitored after instillation and adequate rescue measures should be taken if necessary.
Use during pregnancy or breastfeeding
Pregnancy
The safety of phenylephrine during pregnancy in humans has not been established, so the drug can be used during this period only if the expected benefit to the mother outweighs the risk to the fetus.
Breastfeeding period
The safety of phenylephrine during breastfeeding has not been established, therefore the drug can be used during this period only if the expected benefit to the mother outweighs the risk to the newborn. Breastfeeding should be discontinued during treatment with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
As with any ophthalmic drug, temporary blurred vision or other visual disturbances may occur after taking MezaNext, which may affect the ability to drive and use machines.
The patient should be informed that if his vision becomes blurred after using MezaNext, he should wait until it clears before driving or operating complex machinery.
Method of administration and doses
Dosage
Adults
Vasoconstriction and pupil dilation
Instill 1 drop of solution into the affected eye(s).
To avoid local irritation and further thinning of the tear fluid, it is recommended to use a local anesthetic a few minutes before instilling MezaNext.
The use of MezaNext is particularly appropriate when it is necessary to eliminate conjunctival blood vessel congestion and rapid and powerful pupil dilation without cycloplegia.
Uveitis and posterior synechiae
Use to prevent or treat the formation of synechiae. Their formation can be prevented by strong dilation of the pupil with phenylephrine, atropine, or other cycloplegic agents.
Instill 1 drop of the solution into the affected eye 1–2 times a day. The maximum dose should not exceed 3 drops per day. If necessary, the treatment can be repeated the next day.
If such treatment yields positive results, warm compresses and atropine can be included in the treatment regimen.
Glaucoma
In patients with open-angle glaucoma, MezaNext can be used simultaneously with miotics, since phenylephrine enhances their hypotensive effect and reduces their side effect on visual acuity, as it expands the narrowed visual field.
Instill 1 drop of solution into the affected eye(s).
Surgical interventions
The drug can be used in cases where it is necessary to achieve strong short-term pupil dilation. Instill 1 drop into the affected eye(s) 30–60 minutes before surgery.
Refraction
Phenylephrine enhances the mydriatic effect of homatropine, cyclopentolate, tropicamide, and atropine.
Instill 1 drop of solution into the affected eye(s).
Ophthalmoscopy
15–30 minutes after instillation of 1 drop of the solution, adequate mydriasis lasting 1–3 hours is ensured.
Provocative test for angle-closure glaucoma
MezaNext can be used to diagnose chronic glaucoma. Before and after dilation of the pupil caused by phenylephrine, intraocular pressure should be measured and gonioscopy should be performed.
A significant increase in intraocular pressure in combination with a narrow anterior chamber angle established by gonioscopy raises suspicion of glaucoma. It should be noted that a negative test result does not exclude its presence.
Retinoscopy
Use in cases where pupil dilation without cycloplegia is required.
With any of the procedures described above, irises with more intense pigmentation require the use of higher doses of phenylephrine.
Diagnostic washout test
Two drops of the solution are instilled into the hyperemic eye, perilimbal hyperemia can be observed within 5 minutes after instillation. Fading is characteristic of the conjunctiva, superficial hyperemia is more characteristic of conjunctivitis, not iridocyclitis.
Elderly patients (65 years and older)
No dose adjustment is necessary for this group of patients. In most cases, repeated instillations may produce less pronounced mydriasis. Typically, one drop of phenylephrine should be instilled 5 minutes after the chosen cycloplegic agent.
Method of application
Drops should be instilled into the conjunctival sac. To avoid absorption of the drug through the nasal mucosa and enhance the local effect, particularly in infants, children, and the elderly, the nasolacrimal duct should be pressed with a finger for 2–3 minutes or the eyes should be closed for 3 minutes after instillation.
When instilling drops into the affected eye(s), do not touch the tip of the dropper to the eyelids, skin around the eyes, or other surfaces to avoid contamination.
Children.
In pediatric practice, for diagnostic procedures (ophthalmoscopy, retinography), the drug can be used in children from the first days of life. Use in premature infants is possible with caution after a doctor assesses the benefit/risk ratio, no more than 1 drop in each eye.
Overdose
Even with topical use of MezaNext, systemic effects of phenylephrine may occur. Severe toxic reactions associated with phenylephrine overdose occur rapidly and are short-lived. They are usually manifested by sympathetic stimulation - palpitations, tachycardia followed by bradycardia, hypertension, pulmonary edema, or cardiac arrest.
Treatment should be symptomatic. Rapid intravenous administration of a fast-acting α-blocker such as phentolamine (2–5 mg IV) is recommended. In case of reflex bradycardia, atropine should be used (in children, 0.01–0.02 mg/kg body weight).
Side effects
The following standard was used to classify side effects in terms of frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10000 to <1/1000), very rare (<1/10000), unknown (frequency cannot be estimated from the available data).
The following adverse reactions have been reported with phenylephrine eye drops 25 mg/ml. The frequency cannot be estimated from the available data. When grouped, adverse drug reactions are listed in order of decreasing seriousness.
On the part of the organs of vision:
unknown - eye pain, irritation, temporary blurred vision and other visual disturbances, photophobia, conjunctival hypersensitivity, allergic reactions, eye hyperemia.
From the cardiovascular system:
unknown - palpitation, tachycardia, extrasystole, cardiac arrhythmia and arterial hypertension.
Serious cardiac disorders, such as coronary artery spasm, ventricular arrhythmias, tachycardia, and myocardial infarction, have been reported with the use of eye drops containing 10% phenylephrine.
These adverse reactions, which can sometimes be fatal, usually occur in patients with cardiovascular disease and in elderly patients.
A sudden increase in blood pressure has been reported in premature, low-birth-weight infants and in children and adults with idiopathic, orthostatic hypotension.
On the part of the immune system:
unknown - hypersensitivity.
From the nervous system:
unknown - headache, agitation, dizziness, tremor, paresthesia, insomnia.
Skin and subcutaneous tissue disorders:
unknown – contact dermatitis.
Respiratory, thoracic and mediastinal disorders:
not known – pulmonary edema, dyspnea.
Pediatric population:
Not known (frequency cannot be estimated from the available data): periorbital pallor in premature patients.
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
After first opening, store for 28 days at a temperature not exceeding 25 ºС in a place protected from light.
Storage conditions
Store in the original packaging in a place protected from light at a temperature not exceeding 25 ° C. Do not freeze!
Keep out of reach of children.
Packaging
5 ml in a white plastic dropper bottle, closed with a screw cap with a protective ring; 1 dropper bottle in a cardboard pack.
Vacation category
According to the recipe.
Producer
BALKANPHARMA-RAZGRAD JSC.
Location of the manufacturer and address of its place of business.
68 Aprilsko Vastanie Blvd., Razgrad 7200, Bulgaria.
