Neuroplant

Pharmacological properties

dry extract from St. Johns wort herb inhibits synaptosomal absorption of neurotransmitters serotonin, norepinephrine, dopamine. subchronic treatment causes a weakening of the regulation of β-adrenergic receptors; this changes the behavior of animals in some antidepressant models (for example, a forced swimming test) similar to synthetic antidepressants. naptodiantrons (e.g. hypericin, pseudohypericin), phloroglucin derivatives (e.g. hyperforin), and flavonoids are responsible for this action.

Pharmacokinetics The pharmacokinetics of hypericin and pseudo-hypericin, characteristic markers of St. Johns wort, was studied in a study of 300 mg hyperiplant at an equilibrium concentration: with 10-day use of 1200 mg of methanol extract of hypericum per day, maximum plasma levels of 2.3-7.6 ng / ml hypericin were obtained and 1.1–7 ng / ml pseudohypericin.

The 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 extract, the maximum plasma levels were determined at 301.8 ng / ml after 3.5 hours and 437.3 ng / ml after 2.8 hours, respectively. T_½ amounted to 8.5 and 9.6 hours, respectively. With continuous treatment for 8 days with 900 mg of the extract once a day, the minimum level in the blood plasma, which was 35.5 ng / ml, and C_max in blood plasma - 246 ng / ml - detected on the 8th day of treatment. T_½ was 11.2 hours

Indications

Treatment of mild depressive episodes.

Application

Adults and elderly patients: single dose - 300 mg. frequency of admission - 3 times a day. daily dose - 900 mg.

Duration of treatment. To achieve a clear reduction in symptoms, treatment is required for 4 weeks. If the symptoms do not disappear for more than 4 weeks or the condition worsens, despite the correct reception, you should consult your doctor.

Coated tablets should be taken without chewing with a sufficient amount of liquid. Taking pills is independent of food intake.

Contraindications

Hypersensitivity to the drug. increased sensitivity of the skin to light, photosensitivity. simultaneous treatment using drugs that are metabolized by cytochrome p450 3a4, cyp 2c9, cyp 2c19 and p-glycoproteins:

• protease inhibitors for treating HIV infection (cyclosporine, tacrolimus, indinavir or others);
• hepatitis C virus protease inhibitors;
• immunosuppressants;
• drugs that inhibit cell growth and are used to treat cancer (irinotecan, imatinib and others);
• amitriptyline, nortriptyline;
• midazolam;
• theophylline;
• hypocholesterolemic agents (statins);
• cardiac glycosides;
• coumarin anticoagulants (warfarin);
• other antidepressants;
• oral contraceptives, injectable contraceptives and implant contraceptives.

Severe depressive states. AH.

Side effects

From the skin, subcutaneous tissues, immune system: allergic reactions (redness, swelling, itching, rash). hypersensitivity to light: in isolated cases, the neuroplant can cause, especially in individuals with delicate fair skin, reactions similar to tanning in areas of the skin exposed to intense sunlight or other types of UV radiation (photosensitivity), and dysesthesia (for example, pinching, sensitivity to cold or pain, burning).

From the nervous system: apathy or anxiety.

Gastrointestinal disorders can rarely appear.

If any adverse reactions occur, discontinue treatment and consult a doctor.

special instructions

The effect of coumarin-type anticoagulants (e.g., fenprocoumone, warfarin), digoxin, theophylline, and certain antidepressants may be reduced while it is used with a neuroplant.treatment of patients with preparations containing one of the above substances should be carried out under control (for example, determine the concentration of these substances in the blood) at the beginning of treatment and after its completion.

During the reception of the Neuroplant, intensive exposure to sunlight for a long time, if the skin is not protected, and procedures using UV radiation (quartz, UV lamps, solarium) should be avoided.

With simultaneous use with certain antidepressants (nefazodone, paroxetine, sertraline), in some cases, adverse reactions (nausea, vomiting, fear, anxiety and confusion) may occur.

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 drugs that are used for general and local anesthesia. If necessary, the drug should be discontinued.

Preparations containing St. Johns wort herb extract should be taken with caution simultaneously with serotonin inhibitors or other serotonergic drugs, 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 (e.g., excitement, disorientation) and motor changes (e.g., trembling or myoclonia).

Since there is insufficient data, the use of the drug for children and adolescents under the age of 18 is not recommended.

During pregnancy and breastfeeding. Since there are not enough studies, the drug can not be used during pregnancy and lactation.

Influence on the ability to drive vehicles or other mechanisms. Unknown

Children. The drug is not used in children.

Interactions

With the simultaneous administration of a neuroplant, the effectiveness of such drugs may decrease: coumarin-type anticoagulants (for example, fenprocoumon, warfarin); amitriptyline, nortriptyline; midazolam; theophylline; antibiotics sulfonamides; calcium channel blockers; female sex hormones, hypocholesterolemic agents (statins), cardiac glycosides, therefore their simultaneous use is contraindicated.

With the simultaneous administration of oral contraceptives, intermenstrual bleeding is possible; contraceptive reliability may be reduced.

In the case of concomitant therapy with the use of drugs that affect the increased sensitivity of the skin to light, an increase in sensitivity to light is possible.

Medicines containing extract of St. Johns wort perforated can reduce the concentration in the blood plasma of drugs that are metabolized by cytochrome P450 3A4, CYP 2C9, CYP 2C19 and P-glycoproteins (e.g. amitriptyline, nortriptyline, fexofenadine, benzodiazepines and their derivatives, metristidetin, metastide , antidepressants and other serotonergic substances (such as buspirone, citalopram, escitalopram, fluoxetine, sertraline, triptans, nefazodone, tramadol, etc.).

Overdose

After taking excessive doses of the drug, phototoxic phenomena may occur. in this case, the skin should be protected from sunlight and UV rays for a week (reduce the time spent outdoors, use outerwear and sunscreen with a high coefficient of protection). symptomatic treatment of phototoxic skin reactions.

There were 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.A feeling of bitterness in the mouth, an unpleasant sensation in the liver.

Storage conditions

At a temperature not exceeding 25 ° c out of the reach of children.

Exclusive Distributor: Naturfarm, ul. Lesnaya, 30a, Kiev, Pushcha-Voditsa, 04075; phone: (044) 401-81-03.

Supplier: Alpen Pharma AG (Switzerland).