Neuroplant 300 mg tablets # 20

Author Ольга Кияница

2017-05-11

Amount in a package 20
Product form Pills
Manufacturer Schwabe (Germany)
Registration certificate UA/0414/01/01
The main medicament -
morion code 59714

Neuroplant instructions for use

Composition

active ingredient: 1 coated tablet contains 300 mg of Hypericum perforatum L. extract (3-7: 1) extractant (methanol 80% (v / v))
auxiliary substances: ascorbic acid; cellulose microcrystalline sodium croscarmellose; hypromellose; lactose; macrogol 4000; magnesium stearate saccharin sodium silicon dioxide talc vanillin; titanium dioxide (E 171) iron oxide yellow (E172) corn starch; emulsion antifoam (contains methylcellulose, simethicone, sorbic acid).

Dosage form

The tablets covered with a cover.

Basic physical and chemical properties:

round brownish-yellow (ocher color) coated tablets.

Pharmacological group

Antidepressants. ATX Code N06A X25.

Pharmacological properties

Pharmacodynamics.

Dry extract from the herb of St. John's wort inhibits the synaptosomal absorption of neurotransmission into serotonin, norepinephrine, dopamine. Subchronical treatment leads to a weakening of the regulation of beta-adrenergic receptors;this changes the behavior of animals in some antidepressant models (eg, forced swimming test) similar to synthetic antidepressants. Naphthodiantrons (eg, hypericin, pseudo-hypericin), derivatives of floroglucin (for example, hyperphorin) and flavonoids responsible for this action.

Pharmacokinetics.

The pharmacokinetics of hypericin and pseudo-hypericin, the characteristic markers of St. John's Wort preparations, was studied in a 300-mg hypericlane study at an equilibrium concentration: maximum daily plasma levels of 2.3-7.6 ng / ml were obtained with a 10-day application of 1200 mg of methanolic extract of St. John's wort, ml of hypericin and 1.1-7 ng / ml of pseudo-hypericin.

The pharmacokinetic data of hyperforin were obtained after administration of this ethanol extract (3-6% hyperforin): after oral administration of single doses, 600 mg and 1200 mg of extract were determined, maximum plasma levels of 301.8 ng / ml after 3.5 hours and 437.3 ng / ml after 2.8 hours respectively. The half-life was 8.5 hours and 9.6 hours, respectively. With continuous treatment for 8 days using 900 mg of extract once a day, the minimum blood plasma level, which is 35.5 ng / ml, and the maximum plasma level of 246 ng / ml - were detected on the 8th day treatment. The half-life was 11.2 hours.

Indications

Psycho-vegetative disorders (mental disorders that worsen the physical condition), depressive states, anxiety and / or constant nervous tension.

Contraindications

Hypersensitivity to the components of the drug. Increased sensitivity of the skin to light. Simultaneous treatment with cyclosporine, tacrolimus, indinavir or other protease inhibitors used to treat HIV infection, irinotecan, imatinib, and other agents that inhibit cell growth and are used to treat cancer, warfarin and other antidepressants. Do not use in cases of severe depression. Arterial hypertension.

Special security measures

The effect of coumarin type anticoagulants (eg, fenprocumone, warfarin), digoxin, theophylline and some antidepressants may decrease with the simultaneous application of a Neuroplant. Treatment of patients with drugs containing one of these substances should be controlled (for example, to determine the concentration of these substances in the plasma or in the entire blood) at the beginning and after treatment.

During the Neuroplus treatment, exposure to intense UV radiation (prolonged sun baths, tanning beds, ultraviolet light) should be avoided.

With simultaneous reception of hormonal contraceptives and Neuroplus in women, intermenstrual bleeding can occur, the contraceptive effect can be reduced.

With the simultaneous use of certain antidepressants (nefazodone, paroxetine, sertraline) in some cases, adverse reactions (nausea, vomiting, fear, anxiety and confusion) can be clearly observed.

Patients with a rare hereditary intolerance to galactose, a deficiency of lactase or a violation of absorption of glucose-galactose should not take a Neuroplant.

Indication for patients with diabetes: 1 tablet, coated with a shell, contains 0.048 g of carbohydrates.

Before surgical intervention, 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.

Interaction with other drugs and other interactions

With the simultaneous administration of Neuroplus, the effectiveness of such drugs may decrease: coumarinic anticoagulants (eg fenprokumone, warfarin) amitriptyline, nortriptyline; midazolam; theophylline; antibiotics sulfonamides; calcium channel blockers; female sex hormones, hypoholesterolemic agents (statins), cardiac glycosides, so their simultaneous use is not recommended.

When simultaneous oral contraceptives can be observed intermenstrual bleeding, the reliability of contraceptives can be reduced.

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

Drugs containing St. John's wort extract can reduce the concentration in the blood plasma of drugs metabolized by cytochrome-P4500ZA4, CYP2C9, CYP2C19 and P-glycoproteinam (for example, fexofenadine, benzodiazepines and their derivatives, methadone, simvastatin, finasteride.

Application features

Use during pregnancy and lactation

Since there is insufficient research, the Neuroplant should not be used during pregnancy and lactation.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Unknown.

Dosing and Administration

Adults and patients of advanced age

Single dose - 300 mg.

Frequency of admission - 3 times a day.

The daily dose is 900 mg.

Duration of treatment

To achieve a clear improvement in symptoms, treatment is necessary within 4 weeks. If the symptoms do not disappear for more than four weeks or if the condition worsens, despite the correct reception, you should consult your doctor.

The tablets covered with a cover, it is necessary to accept, not chewing, squeezed with a sufficient quantity of a liquid.The intake of tablets does not depend on the intake of food.

Children

Do not use the drug for children.

Overdose

No cases of overdose have been reported.

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 (shorten the time spent outdoors, use outerwear and sunscreen products with a high protection factor). Treatment of phototoxic skin reactions is symptomatic.

There were reports of seizures and confusion after taking 4.5 g of dry extract per day for two weeks, as well as an additional 15 g of dry extract before hospitalization. Sensation of bitterness in the mouth, unpleasant sensation in the liver.

Adverse Reactions

From the skin, subcutaneous tissue / immune system: allergic reactions (redness, swelling, itching, rash). Because of the possible hypersensitivity to light, the Neuroplant can rarely cause, especially in people with tender skin, reactions similar to sunburn in areas of skin exposed to intense sunlight.

From the nervous system: apathy or anxiety.

Symptoms from the gastrointestinal tract can rarely appear.

If other adverse reactions occur, consult a doctor.

Shelf life

2 years. Do not use after the expiration date printed on the package.

Storage conditions

Store at a temperature not higher than 25 ° C in a place inaccessible to children.

Packaging

Blisters of 20 tablets, coated with 1 or 2 blisters in a package.

Category of leave

Without recipe.

 


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