Instruction for use: Life 900

Dosage form: coated tablets

Active substance: Deerslayer perforated herb extract (Hyperici perforati herbae extract)

Composition

1 tablet contains:

Active component

Hypericum perforated herb extract in ratio of medicinal raw materials - extract: 3-6: 1, extractant ethanol 80% (ml / ml) - 612.00 mg.

Excipients:

core tablet:

silicon dioxide - 20.00 mg, talc - 30.13 mg, titanium dioxide (E 171) - 28.49 mg, sodium hydrogen carbonate - 96.00 mg, sodium carboxymethyl starch - 12.00 mg, croscarmellose sodium - 12.15 mg , magnesium stearate - 10,15 mg;

tablet shell:

Eudragit E 100 (butyl methacrylate, dimethylaminoethyl methacrylate and methyl methacrylate copolymer [1: 2: 1]) - 17.01 mg, macrogol 4 000 - 2.25 mg, riboflavin (E 101) - 5.57 mg.

Pharmacological group

Antidepressant agent of plant origin.

Pharmacodynamics

The drug has antidepressant, anxiolytic and sedative effect. The therapeutic effect of St. John's wort is mainly associated with the presence in it of naphthodianthrenes hypericin and pseudo-hypericin, a derivative of floroglucin hyperphorin and flavonoids. Thanks to them, the drug positively affects the functional state of the central and autonomic nervous system, which improves mood and attention, increases mental and physical activity, normalizes sleep in patients with depression.

The leading mechanism that causes the antidepressant effect of St. John's wort is oppression of the reuptake of norepinephrine, serotonin and dopamine.

Pharmacokinetics

Hypericin and pseudo-hypericin:

After a single intake of 1 tablet Layf® 900, the maximum concentration of hypericin in the blood plasma (3.8 ± 1.4 ng / ml) is detected after 7.9 ± 1.3 hours. After 2.7 ± 0.7 hours, the maximum concentration pseudohypericin (10.2 ± 3.9 ng / ml). The half-life is 18.7 ± 4.8 h for hypericin and 17.2 ± 8.4 h for pseudohypericin.

Hypericins, due to their lipophilic nature, penetrate the hemato-encephalic barrier.

Hyperforin:

After a single ingestion of 1 tablet Layf® 900, the maximum concentration in blood plasma (122 ± 45.5 ng / ml) is observed after 4.5 ± 1.2 hours. The half-life period is 17.5 ± 4.5 hours.

With the daily application of Life 900 (1 tablet per day), the equilibrium concentration of hypericin, pseudo-hypericin and hyperforin in the blood plasma is reached within 14 days.

Hypericin, pseudo-hypericin and hyperphorinum do not accumulate in the body.

Indications

Major depressive episodes of mild to moderate severity.

Contraindications

Allergies to St. John's wort or to any of the auxiliary substances of the drug, hypersensitivity of the skin to light (including in the anamnesis), depressive episodes of severe degree.

Simultaneous use of cyclosporine, sirolimus, tacrolimus or indinavir and other protease inhibitors used to treat HIV, irinotecan and other cytotoxic agents, as well as antidepressants.

It is not recommended to use in patients under the age of 18 years.

Use during pregnancy and during breastfeeding is not recommended.

Application in pregnancy and lactation

Use during pregnancy and during breastfeeding is not recommended.

It is not recommended to use in patients under the age of 18 years.

Dosing and Administration

Dosing regimen, mode of administration, time of drug intake, duration of treatment

Tablets are taken orally, without chewing, with a small amount of liquid, after breakfast.

If not prescribed otherwise, it is recommended to use 1 tablet 1 time per day for 4-6 weeks.

The decision to increase the daily dose or duration of treatment should be made only by the attending physician.

Since the action of the drug develops gradually, during the first 14 days, it must be taken continuously.

Side effects

The drug, as a rule, is well tolerated in recommended doses. Side effect develops rarely, not more than 1-3% of patients, and is represented mainly by the following undesirable phenomena:

From the skin:

photosensitization (more often in HIV-infected patients and patients with fair skin), allergic skin reactions (skin itching, skin rash, urticaria).

From the central nervous system:

anxiety, fatigue, headache.

From the digestive system:

nausea, abdominal pain (including in the epigastric region), flatulence, diarrhea, or constipation. In the literature it is reported that St. John's wort can cause dryness of the oral mucosa and anorexia, but so far they have not been observed with the use of the preparation Life® 900.

Overdose

To date, there are no data on cases of overdose of the preparation Life® 900. In case of taking the drug in excessive doses, it is necessary to protect the skin from sunlight or UV irradiation for 2 weeks.

Features of the drug at the first admission or when it is canceled

Features of the drug during the first admission or when it was canceled was not noted.

The actions of the doctor (paramedic), the patient in the admission of taking one or more doses of the drug

If a person misses one or more doses, the patient should take the next dose prescribed by the doctor next time or indicated in the "Dosage regimen" section.

Interaction

Pharmacokinetic interaction

St. John's Wort preparations induce the activity of the enzymes of the cytochrome P 450 system. This can lead to a weakening and / or shortening of the clinical effect of the coumarin anticoagulants (eg fenprocumone, warfarin), immunosuppressants (eg, cyclosporin, sirolimus, tacrolimus), digoxin, indinavir and other inhibitors proteases used for the treatment of HIV, irinotecan and other cytostatics, amitriptyline, midazolam, theophylline.

In women with simultaneous application of St. John's wort with low-dose hormonal contraceptives, intermenstrual bleeding is possible.

Pharmacodynamic interaction

With the simultaneous application of St. John's wort with a number of antidepressants (nefazodone, paroxetine, sertraline), the pharmacological effect of the latter can be intensified. In some cases, unwanted (serotonergic) effects such as nausea, vomiting, a sense of fear, restlessness, confusion may increase.

It is theoretically possible to enhance the phototoxic effect of St. John's wort, when combined with photosensitizing preparations.

The simultaneous application of St. John's wort with cyclosporine, sirolimus, tacrolimus or indinavir and other protease inhibitors used for HIV treatment, irinotecan and other cytostatics, as well as antidepressants is not recommended (see Contraindications section).

In all cases where other medicines are prescribed, it is necessary to consult a doctor.

Precautionary measures

During the reception of the drug, patients should avoid intense UV radiation (prolonged exposure to the sun, under a UV lamp, in a solarium) or to conduct the necessary sun protection measures.

When used simultaneously with low-dose hormonal contraceptives for the period of treatment with the drug, the use of additional non-hormonal methods of contraception is recommended.

Special instructions

Influence on ability to drive vehicles, mechanisms

During the period of treatment, it is not recommended to operate vehicles and mechanisms.

Storage conditions

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Special precautions when destroying an unused preparation

Special precautions for the destruction of unused medication are not provided.

Shelf life

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

Conditions of leave from pharmacies

On prescription.