Universal reference book for medicines
Product name: NEGRUSTIN ® (NEGRUSTIN)

Active substance: Hyperici herba

Type: Phytopreparation with antidepressant activity

Manufacturer: SANDOZ (Slovenia) manufactured by SALUTAS PHARMA (Germany)
Composition, form of production and packaging
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Capsules hard gelatinous, with a red matte body and a green matte lid; the contents of the capsules are greyish-brown granules and / or powder with a characteristic aromatic odor.
1 caps.

dry extract of St. John's wort (3.5-6.0: 1) 425 mg

Excipients: lactose monohydrate - 18.7 mg, cellulose - 6.2 mg, calcium hydrophosphate dihydrate - 40.5 mg, silicon dioxide colloid - 36.3 mg, magnesium stearate - 5 mg, talc - 10 mg.

The 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) 0.23 mg, iron (III) oxide red (E172) 0.691 mg , iron oxide yellow (E172) - 0.115 mg, purified water - 13.92 mg.

10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the print edition of 2007.

PHARMACHOLOGIC EFFECT

Herbal preparation with antidepressant activity.
It has a beneficial effect on the functional state of the central and autonomic nervous system.
The main component of St. John's wort extract is hypericin.
It is suggested that hypericin is able to inhibit the activity of MAO type A. Flavonoids, which are part of St. John's wort extract, bind to benzodiazepine receptors and have a sedative effect.
With the use of the drug, mood improves, mental and physical performance improves, sleep normalizes.

PHARMACOKINETICS

The effect of the drug Negrustin is the cumulative effect of its components, therefore it is not possible to carry out kinetic observations;
all components can not be traced with the help of markers and bioassays.
INDICATIONS

- Depressive states of mild and moderate severity;

- anxiety and anxiety;

- psycho-vegetative disorders.

DOSING MODE

Adults and children over 12 years of age, the drug is prescribed 1 caps.
1-2 times / day or 1 ml of solution 3 times / day.
The course of treatment is 6-8 weeks.
If necessary, repeated courses of treatment are possible.
Capsules should be taken with food, without chewing and drinking with a sufficient amount of liquid.

The solution can be taken undiluted or with a small amount of liquid during meals.

SIDE EFFECT

From the digestive system: the phenomenon of dyspepsia.

Dermatological reactions: photosensitization.

Other: allergic reactions.

CONTRAINDICATIONS

- endogenous depression;

- photosensitization for taking St. John's wort preparations in anamnesis;

- Hypersensitivity to the drug.

PREGNANCY AND LACTATION

Despite the lack of data on the harmful effects of the drug, the intake of Negrustin during pregnancy and lactation is possible only if the potential benefit to the mother exceeds the potential risk to the fetus or newborn.

APPLICATION FOR CHILDREN

Children over 12 years of age, the drug is prescribed 1 capsule.
1-2 times / day or 1 ml of solution 3 times / day.
Do not prescribe the drug to children under the age of 12 due to the lack of sufficient data.

SPECIAL INSTRUCTIONS

During the period of taking the drug, especially in fair-skinned patients, prolonged exposure to sunlight and visits to sunbeds should be avoided.

It should avoid the simultaneous use of other means that cause photosensitivity.

In connection with the presence of sorbitol in the solution for oral administration, it should be borne in mind that with every intake of the drug, about 121 mg of sorbitol is supplied to the body.

When appointing a solution for oral administration to patients with diabetes mellitus, it should be borne in mind that 1 ml corresponds to 0.01 XE.

Care should be taken when administering the solution for oral administration to patients with fructose intolerance.

It is not recommended to use Nerustin simultaneously with MAO inhibitors.

Use in Pediatrics

Do not prescribe the drug to children under the age of 12 due to the lack of sufficient data.

Impact on the ability to drive vehicles and manage mechanisms

The drug may affect the psychophysical capabilities of the patient, especially when taking concomitantly with tranquilizers or alcohol.

OVERDOSE

To date, there are no data on cases of overdose of the drug Negrustin.

Symptoms: may increase the described side effects.

Treatment: in case of taking the drug in high doses, avoid exposure to sunlight for 1-2 weeks.

DRUG INTERACTION

With the simultaneous use of Neruzin with cyclosporine, indinavir, protease inhibitors, indirect anticoagulants (fenprokumone, warfarin), digoxin, theophylline, amitriptyline, nortryptinum, the effect of Negrustin may be weakened.

With the simultaneous use of Neurustin with other antidepressants (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram), there may be an increase in side effects (nausea, vomiting, fear, psychomotor agitation).

Simultaneous reception of photosensitizing agents may lead to increased photosensitization.

Simultaneous intake of oral contraceptives can lead to bleeding.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored at a temperature of no higher than 25 ° C.
Shelf life of capsules is 3 years. Shelf life of the solution is 4 years.
Conditions of leave from pharmacies

The drug is approved for use as a means of OTC.

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