Negrustin - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 18,700 mg, cellulose - 6,200 mg, calcium hydrogen phosphate dihydrate - 40,500 mg, silicon dioxide colloid - 36,300 mg, magnesium stearate - 5,000 mg, talc - 10,000 mg;

composition of the capsule shell: gelatin - 79.827 mg, sodium lauryl sulfate - 0.194 mg, titanium dioxide (E171) - 1.216 mg, chlorophyll-copper (copper complex of chlorophyll E141) - 0.230 mg, iron (III) oxide red (E172) - 0.691 mg, iron oxide yellow (E172) - 0.115 mg, purified water 13.920 mg.

Description:

Hard gelatin capsules filled with a grayish-brown powder and / or granules with a characteristic aromatic odor.

Agglomeration of the contents of the capsule is acceptable.

The capsule case is red matte, the lid is matte green.

Pharmacotherapeutic group:An antidepressant of vegetable origin

ATX: & nbsp

A.13 Tetanus preparations

N.07.X.X Other drugs for the treatment of diseases of the nervous system

Pharmacodynamics:

Means of plant origin, has a sedative and antidepressant effect. The main active substances of St. John's wort - hypericin, pseudo-hypericin, hyperforin and flavonoids, have a positive effect on the functional state of the central and autonomic nervous system, which improves mood, increases mental and physical activity, normalizes sleep. The antidepressant effect is due to the ability to inhibit the reuptake of serotonin and other neurotransmitters, as well as the effect on melatonin metabolism.

Pharmacokinetics:

The herb extract of St. John's wort is a complex mixture of numerous components. After taking single doses of 300, 900 or 1800 mg of herb extract of St. John's wort, the maximum plasma concentrations (C_m_Oh) of hypericin were from 2 to 20 μg / l, pseudohypericin - from 3 to 30 μg / l. The rate of absorption of these substances is different (absorption of hypericin begins after 1.9 hours, pseudo-hypericin - after 0.4 hours).The half-life (T_1/2) is approximately 24-48 h for hypericin and 18-24 h for pseudo-hypericin.

Indications:

Psycho-vegetative disorders (accompanied by a decrease in mood, apathy, etc.), neurotic reactions, depressive states of mild and moderate severity.

The drug can be used with other psychotropic drugs.

Contraindications:

- Hypersensitivity to the extract of St. John's wort's herb and to other components of the preparation;

- Depression of severe severity;

- simultaneous administration with monoamine oxidase (MAO) inhibitors, cyclosporin, tacrolimus; indinavir and other HIV protease inhibitors; irinotecan, imatinib and other cytostatics; warfarin; other antidepressants;

- photosensitization (increased sensitivity of the skin to ultraviolet radiation, including in the anamnesis);

- children's age till 12 years;

- pregnancy and the period of breastfeeding;

- rare hereditary forms of intolerance to galactose, deficiency of lactase or impaired absorption of glucose-galactose (because the composition contains lactose).

Pregnancy and lactation:

The use of the drug Negrustin® during pregnancy and during breastfeeding is contraindicated in the absence of reliable clinical data,confirming the safety of the application of the herb extract of St. John's wort perforated during these periods.

Dosing and Administration:

Inside.

Capsules should be taken without chewing, squeezed with a sufficient amount of liquid (preferably 1 glass of water).

Adults and teenagers over 12 years of age: 1 capsule 1-2 times a day, regularly at the same time. When taking 2 times a day, the drug should be taken in the morning and in the evening.

The course of treatment is usually 4-6 weeks. If symptoms persist or worsen during 4 weeks after the onset of treatment, you should consult your doctor.

If you miss a single dose of the drug Negrustin® should take the drug as soon as possible. If the time of taking the next dose of the drug is appropriate, an additional dose of the drug should not be taken to compensate for the missed dose. Do not take two doses of the drug at the same time.

Side effects:

Disturbances from the skin and subcutaneous tissues: itching of the skin, skin rash, erythema, eczema; skin pigmentation, photosensitization (more often in HIV-infected patients); when taking Nezrustin® on skin areas,exposed to intense sunlight, due to photosensitivity, it is possible to develop skin reactions similar to sunburn (mainly in light-skinned patients).

Disorders from the gastrointestinal tract: nausea, abdominal pain (including in the epigastric region), dryness of the oral mucosa, flatulence, diarrhea or constipation, anorexia.

Disturbances from the nervous system: anxiety, fatigue, headache.

Violations of the blood and lymphatic system: Iron-deficiency anemia.

Other: increased sensitization to animal wool.

Overdose:

To date, no cases of drug overdose have been reported.

When using the drug in doses exceeding the recommended dose, it is possible to increase the severity of dose-dependent side effects (see section "Side effect").

There have been reports of seizures and confusion after taking up to 4.5 g of dry extract per day for 2 weeks and an additional 15 g of dry extract immediately before hospitalization. With significant overdoses, the development of phototoxic reactions is possible.

Treatment: symptomatic; avoid exposure to sunlight and UV irradiation for 1-2 weeks. Outdoor activities should be limited, using products and / or clothing that protects the skin from the sun.

Interaction:

St John's wort extract activates microsomal oxidation (cytochrome P450), therefore, when applied simultaneously, it reduces the plasma concentrations of the following drugs: digoxin theophylline; midazolam; tacrolimus; ciclosporin, irinotecan, imatinib and others cytostatics; indirect anticoagulants of the coumarin series (warfarin, fenprokumone); amitriptyline, nortriptyline, indinavir, and other inhibitors of HIV protease.

The use of dry extract of St. John's wort can lead to a reduction and / or shortening of the duration of the effect of medications (eg fexofenadine, benzodiazepine and its derivatives, methadone, simvastatin, finasteride), in the metabolism of which isoenzymes of cytochrome P450 CYP3A4, CYP2C9, CYP2C19 or P-glycoprotein. The increased enzymatic activity, as a rule, is restored within 1 week after the termination of application of a dry extract of St. John's wort.Increases the antidepressant effect of MAO inhibitors, while the risk of their side effects increases. The interval between taking the drug Negrustin® and the MAO inhibitor should be at least 14 days.

When used simultaneously with selective serotonin reuptake inhibitors (including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram), nefazodone, buspirone or tryptans, St. John's wort extract can potentiate the effect of these drugs, including the incidence of side effects (serotonergic effects) such as nausea, vomiting, anxiety, agitation and confusion (serotonin syndrome).

Reduces the hypotensive effect of reserpine.

Simultaneous reception with oral contraceptives can weaken them and lead to intermenstrual bleeding.

Simultaneous reception of photosensitizing agents can lead to increased phototoxic effects.

May enhance the effect of funds for general anesthesia and narcotic analgesics. Before surgical intervention, it is necessary to evaluate the potential the possibility of interaction with drugs used for local or general anesthesia. If necessary, stop taking the dry extract of St. John's wort.

If it is necessary to prescribe other medicines at the same time, tell your doctor about the use of St. John's Wort extract.

Special instructions:

With the simultaneous application of dry extract of St. John's wort with indirect coumarinic anticoagulants (such as fenprokumone), theophylline and digoxin may decrease their effectiveness. Careful monitoring of patients taking these medications (for example, monitoring the concentration in the blood plasma) is necessary in particular at the beginning and after the application of the drug.

The use of dry extract of St. John's wort can lead to the occurrence of intermenstrual bleeding in women taking oral contraceptives. It is necessary to use additional measures of contraception, since dry extract of St. John's wort can weaken the effect of oral contraceptives.

It is not recommended to take sun baths or use a solarium during treatment with the drug Negrustin®.

During treatment with the drug Negrustin®, you should refrain from drinking alcoholic beverages.

One capsule contains less than 0.01 XE, which must be taken into account at use of patients with diabetes mellitus.

Special precautions when destroying an unused product:

There is no need for special precautions when destroying an unused preparation.

Effect on the ability to drive transp. cf. and fur:

There is insufficient data on the effect of the drug on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.

Form release / dosage:

Capsules, 425 mg.

Packaging:

10 capsules per blister of polypropylene.

By 3, 4, 6 or 10 blisters together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014366 / 02

Date of registration:09.12.2011 / 23.04.2013

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp27.06.2018

Illustrated instructions

Instructions

Negrustin® (Negrustin®)