Xeomin
Xeomin: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Xeomin
ATX code: M03AX01
Active ingredient: botulinum toxin type A (botulinum toxin type A)
Manufacturer: Merz Pharma GmbH & Co. KGaA (Germany)
Description and photo updated: 20.11.2018
Prices in pharmacies: from 5915 rubles.
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Xeomin is a peripheral muscle relaxant that inhibits the release of acetylcholine; in cosmetology it is used to correct mimic wrinkles.
Release form and composition
Xeomin is produced in the form of a lyophilisate for the preparation of a solution for intramuscular (i / m) administration: lyophilized powder from almost white to white [50 or 100 U (units of action) in a bottle, in a plastic tray 1 bottle, in a cardboard box with control of the first opening 1 pallet; 2, 3 or 6 packs in a cardboard box].
The composition of the lyophilisate contained in 1 bottle:
- active substance: botulinum toxin type A - 50 or 100 units;
- additional components: human serum albumin, sucrose.
Pharmacological properties
Pharmacodynamics
Xeomin is a botulinum toxin produced by a strain of the bacteria Clostridium botulinum type A, purified from complexing proteins. The drug has a muscle relaxant effect, selectively acting on peripheral cholinergic nerve endings, inhibits the production of acetylcholine. The implementation of the introduction into cholinergic nerve endings proceeds in 3 stages:
- Binding of the molecule to the outer components of the membrane.
- Internalization of the toxin through endocytosis.
- Translocation of the endopeptidase domain of the toxin molecule from the membrane intracellular organelle of the endosome into the cytosol (liquid content of the cell).
In the cytosol, the toxin endopeptidase domain selectively cleaves SNAP-25, which is an important protein component of the mechanism that controls membrane movement of exovesicles, thereby blocking the release of acetylcholine. The final effect of the drug is to relax the injected muscle.
The effect of the remedy begins to manifest itself approximately within 4-7 days after its administration. On average, the effect of each procedure is noted within 3-4 months, but its duration can also vary significantly.
Indications for use
- spastic torticollis (idiopathic cervical dystonia), mainly rotational;
- blepharospasm;
- spasticity of the muscles of the arm after a stroke;
- mimic wrinkles.
Contraindications
Absolute:
- increased body temperature;
- disorders of neuromuscular transmission (including Lambert-Eaton syndrome, myasthenia gravis);
- acute forms of diseases, infectious and non-infectious;
- age up to 18 years;
- pregnancy and lactation;
- hypersensitivity to the components of the drug.
Relative (Xeomin should be used with caution):
- amyotrophic lateral sclerosis;
- neurological diseases caused by degeneration of motor neurons;
- pathologies accompanied by disorders of neuromuscular transmission.
Instructions for the use of Xeomin: method and dosage
Xeomin is intended for intramuscular injection. Injections of the drug can only be done by doctors with special training, experienced in handling botulinum toxin and with devices for electromyography. The number of places for injections into the muscle and the dosage of the agent are determined by the doctor individually for each patient.
When opening the bottle, after removing the plastic cap, it is forbidden to remove the stopper. Before using Xeomin, you need to treat the central part of the stopper with alcohol and then, piercing it with a sterile needle, inject an isotonic 0.9% sodium chloride solution into the vial. Gently turning the bottle, mix the lyophilisate with the solvent until the drug is completely diluted. The prepared solution should be colorless, transparent and free of visible flakes and particles.
The lyophilized powder must be diluted in the following volume of solvent (volume in ml per vial containing 50/100 U, respectively):
- 20 U / 0.1 ml - 0.25 / 0.5;
- 10 U / 0.1 ml - 0.5 / 1;
- 5 U / 0.1 ml - 1/2;
- 4 units / 0.1 ml - 1.25 / 2.5;
- 2.5 U / 0.1 ml - 2/4;
- 1.25 U / 0.1 ml - 4/8.
The dosages recommended for Xeomin cannot be used for recalculation when prescribing other products containing botulinum toxin.
Since Xeomin does not contain antimicrobial agents, it is advisable to use it immediately after dilution. If necessary, store the prepared solution only in the original bottle, no more than 24 hours, at a temperature of 2-8 ° C (in the refrigerator), only if the dissolution was carried out under aseptic conditions.
The recommended dosage regimen of Xeomin, depending on the indications:
- blepharospasm: the prepared solution should be injected with a sterile 27-30 G needle into each injection site at an initial dose of 1.25-2.5 U (0.05-0.1 ml); the drug is injected into the lateral and medial areas of the circular muscle of the eye (m. orbicularis oculi) of the upper eyelid, and into the lateral area of the lower one. In the case when vision is impaired due to spasms in the upper part of the face, in the lateral zones of the circular muscle of the eye and in the forehead, additional injections into these areas are allowed. The onset of action of the drug is noted already 4 days after the injection, the effect is observed on average within 3-4 months; if after the first injection the effect of Xeomin lasts less than 2 months, with a repeated procedure it is possible to increase the dose by 2 times, while the initial dose for one eye should be no more than 25 U, the maximum amount of the drug,injected into each place - 5 units, total dosage for 12 weeks of therapy - 100 units;
- spasticity of the arm muscles after a stroke: to inject the solution into deep-lying muscles, it is recommended to use sterile needles No. 22 G, 75 mm long and 0.7 mm in diameter, into superficial muscles - needles No. 26 G, 37 mm long and 0.45 mm in diameter; electromyography may be required to identify the muscles involved; in order to evenly cover the muscle areas prone to dystonia, Xeomin should be injected into several places (especially in the case of injections into large muscles). Dosages are selected individually, taking into account the size, location and number of muscles involved, the presence of local muscle weakness and the level of severity of spasticity. The total dosage for a course of therapy can vary from 170 to 400 U, taking into account the location of the spasmodic muscles. Improvement is noted during the first two weeks and reaches a maximum by the beginning of the fourth,the effect lasts, as a rule, 12 weeks;
- spastic torticollis: the dosage should be set individually by the doctor, while taking into account the localization of pain, the position of the head and neck, muscle volume (atrophy, hypertrophy) and the patient's body weight. For one procedure in the practice of treatment, the maximum dose should usually be no more than 200 U, but if necessary, it can be increased to 300 U, it is not recommended to inject Xeomin at a dose of more than 50 U in the same place. In the course of treatment, injections are made into the scalene muscles, into the levator scapula muscle, into the sternocleidomastoid muscle, the belt and / or trapezius muscle; to reduce the risk of adverse reactions (in particular, dysphagia), inject the solution in one procedure into both sternocleidomastoid muscles or in doses exceeding 100 units, it is not recommended, the number of injection sites is determined by the size of the muscle;the drug should be injected into the superficial muscles with needles No. 25, 27 and 30 G, and into deep ones - with a needle No. 22 G. Electromyography can be prescribed to identify the muscles involved; the onset of Xeomin's action is observed approximately within 7 days after the procedure, the effect lasts for approximately 3-4 months, the repeated procedure can be carried out no earlier than 10 weeks after the previous one;
- mimic wrinkles (hyperkinetic folds) of the face: for the treatment of glabellar wrinkles (vertical wrinkles between the eyebrows), injections are carried out into each of 5 sites at a dose of 4 U (0.1 ml) - 1 injection into m.procerus and 2 injections into m. corrugator on both sides, the total dose is 20 IU, in some cases it may be increased to 30 IU. During the introduction of Xeomin, the needle must be directed upward and medially, before injection, and during it, press with the thumb and forefinger below the upper edge of the orbit in order to prevent diffusion of the solution into this area; to reduce the threat of ptosis of the eyelids, it is recommended to avoid injection near the muscle that lifts the upper eyelid and at the site of attachment of the circular muscle of the eye. In m.corrugator injections are made in the central region of the abdomen of the muscle and in its medial section at a level not less than 1 cm above the upper edge of the orbit. The severity of glabellar wrinkles decreases, as a rule, within 2-3 days, the maximum effect is achieved 30 days after the procedure and lasts for 4 months, the intervals between injections should be at least 3 months. In case of insufficient effect of Xeomin, they resort to alternative methods of treatment.
Side effects
Undesirable reactions, the appearance of which is possible against the background of the use of Xeomin for therapy according to indications:
- blepharospasm: often - dry eyes, ptosis; infrequently - headache, skin rash, conjunctivitis, paresthesia, dry mouth, muscle weakness;
- spastic torticollis: often - back pain, muscle weakness, dysphagia (of varying severity, can be observed for 2-3 weeks after administration, it develops in a dose-dependent manner, rarely observed at a dose below 200 units per procedure); infrequently - pressing sensations or inflammation at the injection site, increased sweating, headache, tremor, asthenia, hoarseness, vomiting, colitis, dry mouth, diarrhea, myalgia, bone pain, peeling skin, itching, skin rashes, eye pain;
- hand spasticity after a stroke: often - a feeling of heat, impaired sensitivity, headache;
- hyperkinetic folds of the face: often - headache, itching, a feeling of heaviness, muscle dysfunction at the injection site; infrequently - a feeling of tension at the injection site, local weakness of the facial muscles, muscle twitching and spasms, a feeling of nodules in the skin, flu-like symptoms, rhinopharyngitis, bronchitis, nausea, blurred vision, ptosis, eyelid edema, raising an eyebrow.
Violations that were noted against the background of the use of similar preparations containing botulinum toxin type A, and used in clinical trials simultaneously with Xeomin (it is assumed that when injecting the latter, these undesirable effects may also develop):
- blepharospasm: often - lagophthalmos, superficial keratitis, lacrimation, photophobia, skin irritation; infrequently - diplopia, ectropia, keratitis, volvulus of the eyelid, disturbances / blurred vision, weakness of the facial muscles, focal paralysis of the facial nerves, diffuse skin rashes / dermatitis, fatigue, dizziness; rarely - local swelling of the eyelid skin; extremely rare - corneal ulceration, acute angle-closure glaucoma;
- spastic torticollis: very often - pain; often - general malaise, colds, general weakness, high blood pressure, dizziness, headache, numbness, nausea, dry mouth, upper respiratory tract infections, rhinitis, irritation at the injection site, muscle stiffness; infrequently - speech disorders, fever, shortness of breath, diplopia, ptosis;
- hand spasticity after a stroke: often - muscle weakness, local pain, irritation / hemorrhage at the injection site, ecchymosis, hypertonicity; infrequently - orthostatic hypotension, vertigo, amnesia, impaired coordination, paresthesia, sleep disturbances, anxiety, depression, asthenia, nausea, rash, pruritus, dermatitis, bursitis, arthralgia, pain, peripheral edema, hypersensitivity at the injection site (some disorders may be caused by underlying disease);
- hyperkinetic folds of the face: infrequently - photosensitivity, eye pain, blepharitis, dizziness, paresthesia, infection, dry skin, dry mouth;
- general adverse reactions: extremely rare - arrhythmia, myocardial infarction (including death); single case - anaphylactic shock; the dependence of the effects by the action of the drugs has not been confirmed - psoriasis-like rashes, urticaria, exudative polymorphic erythema, allergic reactions, itching.
Overdose
In the case of the use of high doses of Xeomin, severe muscle paralysis may develop in areas remote from the injection sites, the manifestations of which may be: diplopia, ptosis, general weakness, difficulty speaking and swallowing, paralysis of the respiratory muscles, which causes the development of aspiration pneumonia.
If an overdose is suspected, hospitalization is required with general supportive measures. If there is paralysis of the muscles of the respiratory system, intubation and artificial ventilation of the lungs are performed until the condition normalizes.
special instructions
Immediately after the completion of the procedure, the reduced solution remaining in the syringe or in the vial must be inactivated with a solution of sodium hydroxide (0.1 N NaOH). In case of contact of the drug with any auxiliary materials, for at least 18 hours, they are subject to autoclaving or inactivation with sodium hydroxide solution. Spilled product must be wiped off with an absorbent cloth soaked in this solution.
Influence on the ability to drive vehicles and complex mechanisms
Due to the nature of the diseases for which Xeomin is used for the treatment, the ability to drive vehicles and various complex equipment may be reduced. It can also be adversely affected by adverse drug reactions, in connection with which the patient is advised to refrain from driving complex equipment and a car until his ability to perform these activities is fully restored.
Application during pregnancy and lactation
According to the instructions, Xeomin is contraindicated during pregnancy. If necessary, treatment during lactation is required to stop breastfeeding.
Pediatric use
The use of Xeomin is contraindicated in patients under the age of 18.
Use in the elderly
The use of Xeomin for the treatment of facial wrinkles in patients over 65 is not recommended due to the lack of clinical experience.
Drug interactions
- 4-aminoquinoline derivatives: reduce the effectiveness of botulinum toxin type A;
- aminoglycosides, spectinomycins: these combinations are not recommended;
- muscle relaxants of peripheral action: it is possible to enhance the action of Xeomin (should be combined with caution).
Analogs
Xeomin's analogues are: Dysport, Botox, Relatox, Lantox.
Terms and conditions of storage
Store out of the reach of children at a temperature not exceeding 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Xeomin
Reviews about Xeomin are mostly good. Users note a gradual, but pronounced effect of the drug, a small number of contraindications, good tolerability of the procedure, no side effects (including the absence of allergic reactions). When compared with Botox, according to reviews, the drug does not lead to a mask effect and allows the expression of emotions to be preserved on the face.
The disadvantages of Xeomin include short-term results and slow action. It is pointed out that it is only effective against external, shallow wrinkles. Some users believe the tool is still poorly understood.
Price for Xeomin in pharmacies
The price for Xeomin can be approximately: 50 units in a bottle - 6140–6360 rubles; 100 PIECES in a bottle - 9530-10600 rubles.
Xeomin: prices in online pharmacies
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Drug name Price Pharmacy |
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Xeomin 50 IU lyophilisate for preparation of a solution for intramuscular administration 1 pc. 5915 RUB Buy |
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Xeomin lyof. d / r-ra v / m 50 units n1 6438 RUB Buy |
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Xeomin 100 IU lyophilisate for preparation of a solution for intramuscular administration 1 pc. RUB 9499 Buy |
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Xeomin lyof. d / r-ra v / m 100 units n1 10641 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
