Pharmacodynamics. Dry extract from the herb St. John's wort inhibits the synaptosomal absorption of neurotransmitters serotonin, norepinephrine, dopamine. subchronic treatment causes a weakening of the regulation of β-adrenergic receptors; this alters the behavior of animals in some antidepressant models (eg forced swim test) similar to synthetic antidepressants. naptodianthrons (eg hypericin, pseudohypericin), phloroglucinol derivatives (eg hyperforin) and flavonoids are responsible for this action.
Pharmacokinetics. The pharmacokinetics of hypericin and pseudohypericin, characteristic markers of St. John's wort preparations, was studied in a study of hyperiplant 300 mg at an equilibrium concentration: with 10-day use of 1200 mg of methanol extract of St. John's wort per day, maximum plasma levels of 2.3-7.6 ng / ml of hypericin were obtained and 1.1-7 ng / ml of pseudohypericin.
Pharmacokinetic data of hyperforin were obtained after administration of the indicated ethanol extract (3–6% hyperforin). After oral administration of single doses of 600 and 1200 mg of the extract, the maximum plasma levels were determined as 301.8 ng / ml after 3.5 hours and 437.3 ng / ml after 2.8 hours, respectively. T½ was 8.5 and 9.6 hours, respectively. With continuous treatment for 8 days with the intake of 900 mg of the extract once a day, the minimum level in the blood plasma, which was 35.5 ng / ml, and Cmax in the blood plasma - 246 ng / ml - were revealed on the 8th day of treatment. T½ was 11.2 hours.
Treatment of mild depressive episodes.
Adults and elderly patients: single dose - 300 mg. the frequency of admission is 3 times a day. the daily dose is 900 mg.
Duration of treatment. To achieve a clear reduction in the severity of symptoms, treatment is necessary for 4 weeks. If symptoms persist for more than 4 weeks or if the condition worsens despite correct administration, you should consult your doctor.
The film-coated tablets should be taken without chewing with a sufficient amount of liquid. Taking pills does not depend on food intake.
Hypersensitivity to the components of the preparation. increased sensitivity of the skin to light, photosensitivity. simultaneous treatment with preparations that are metabolized by cytochrome p450 3a4, cyp 2c9, cyp 2c19 and p-glycoproteins:
On the part of the skin, subcutaneous tissues, the immune system: allergic reactions (redness, swelling, itching, rash). hypersensitivity to light: in rare cases, the neuroplant can cause, especially in persons with delicate fair skin, reactions similar to tanning, on areas of the skin exposed to intense exposure to sunlight or other types of UV radiation (photosensitivity), and dysesthesia (for example, tingling, sensitivity to cold or pain, burning).
From the nervous system: apathy or anxiety.
Rarely, gastrointestinal disorders may appear.
If any adverse reactions occur, you should stop treatment and consult your doctor.
The effect of coumarin-type anticoagulants (for example, phenprocoumon, warfarin), digoxin, theophylline and some antidepressants may decrease when used simultaneously with a neuroplant. treatment of patients with preparations containing one of the above substances should be carried out under control (for example, to determine the concentration of these substances in the blood) at the beginning of treatment and after its completion.
While taking Neuroplant, one should avoid intense exposure to sunlight for a long time, if the skin is not protected, and procedures using UV radiation (quartz, UV lamps, solarium).
When used simultaneously with certain antidepressants (nefazodone, paroxetine, sertraline), in some cases, adverse reactions may occur (nausea, vomiting, fear, anxiety and confusion).
Patients with rare hereditary galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not take Neuroplant.
Information for patients with diabetes mellitus: 1 coated tablet contains 0.048 g of carbohydrates.
Before surgery, it is recommended to determine the possibility of interaction with preparations that are used for general and local anesthesia. If necessary, the preparation should be discontinued.
Preparations containing St. John's wort extract should be taken with caution at the same time as serotonin inhibitors or other serotonergic preparations, since in very rare cases, side effects (serotonin syndrome) in the form of autonomic dysfunctions (for example, increased sweating, tachycardia, diarrhea, fever) may occur, mental (eg excitement, disorientation) and motor changes (eg tremors or myoclonus).
Since there is insufficient data, the use of the preparation for children and adolescents under the age of 18 is not recommended.
During pregnancy and breastfeeding. Since there is insufficient research, the preparation should not be used during pregnancy and lactation.
Influence on the ability to drive vehicles or other mechanisms. Unknown.
Children. The preparation is not used in children.
With the simultaneous administration of a neuroplant, the effectiveness of such preparations may decrease: coumarin anticoagulants (for example, phenprocoumon, warfarin); amitriptyline, nortriptyline; midazolam; theophylline; antibiotics; sulfonamides; calcium channel blockers; female sex hormones, cholesterol-lowering preparations (statins), cardiac glycosides, therefore, their simultaneous use is contraindicated.
With the simultaneous use of oral contraceptives, intermenstrual bleeding is possible; contraceptive reliability may be impaired.
In the case of concomitant therapy with preparations that affect the increased sensitivity of the skin to light, an increase in sensitivity to light is possible.
Medicines containing St. John's wort extract can reduce the plasma concentration of preparations that are metabolized by cytochrome P450 3A4, CYP 2C9, CYP 2C19 and P-glycoproteins (for example, amitriptyline, nortriptyline, fexofenadine, benzodiazepines and their derivatives, methadistatine) , antidepressants and other serotonergic substances (such as buspirone, citalopram, escitalopram, fluoxetine, sertraline, triptans, nefazodone, tramadol, etc.).
After taking excessive doses of the preparation, phototoxic phenomena may occur. in this case, the skin should be protected from sunlight and UV rays for a week (shorten the time spent outdoors, use outerwear and sunscreens with a high protection factor). treatment of phototoxic skin reactions is symptomatic.
There have been reports of seizures and confusion after taking 4.5 g of dry extract per day for 2 weeks, as well as an additional 15 g of dry extract before hospitalization. Feeling of bitterness in the mouth, unpleasant sensation in the area of the liver.
At a temperature not exceeding 25 ° C, out of the reach of children.
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