Stresam ® (Stresam®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceEthifoxineEthifoxine
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  • Stresam ®
    capsules inwards 
    BIOCODEX     France
    • Dosage form: & nbsp

    capsules 50 mg

    Composition:

    1 capsule contains:

    Ethifoxine hydrochloride 50 mg

    Lactose Monohydrate 119 mg

    Talc 15 mg

    Microcrystalline cellulose 10 mg

    Silica dioxide colloidal anhydrous 3 mg

    Magnesium stearate 3 mg

    The composition of the capsule shell: titanium dioxide; gelatin; indigo carmine

    Description:

    smooth glossy gelatin capsules number 2 with a white body and blue lid. Content - white or white powder with a light yellowish hue of color.

    Pharmacotherapeutic group:anxiolytic (tranquilizer).
    ATX: & nbsp

    N.05.B.X   Other anxiolytics

    N.05.B.X.03   Ethifoxine

    Pharmacodynamics:

    a benzoxazine derivative, has an anxiolytic activity, to a lesser extent has a sedative effect. Does not cause addiction and withdrawal symptoms. Selective effect on SG channels (chloric channels) supramolecular GABA-benzodiazepine-chlorinophore receptor complex, inhibiting GABA-ergic transmission.

    Pharmacokinetics:

    quickly absorbed from the digestive tract, quickly metabolized in the liver before the formation of several metabolites. One of the metabolites (diethylethoxifin) is active and its half-life is about 20 hours.

    Penetrates through the placental barrier.

    Time to reach the maximum concentration in the blood - 2-3 hours, half-life - about 6 hours.

    It is excreted mainly with urine in the form of metabolites, and also in unchanged form in small amounts. Also excreted with bile.

    Indications:

    It is used to eliminate anxiety, fear, internal tension, increased irritability, decreased mood, including somatic diseases, especially cardiovascular nature.

    Contraindications:

    shock conditions, myasthenia gravis, severe impaired liver and / or kidney function, hypersensitivity. It is not recommended to use at the age of 18 years.

    Carefully:

    Pregnancy and lactation:

    it is not recommended to apply the drug during pregnancy. If pregnancy is detected while taking the drug, you should consult your doctor about the continuation of treatment.

    It is not recommended to use the drug when breastfeeding.

    Dosing and Administration:

    inside, with a little water.

    The dose of the drug is determined by the doctor, individually, depending on the patient's condition.

    Usually 1 capsule is given 3 times a day, or 2 capsules 2 times a day. (150-200 mg / day)

    The duration of treatment is from a few days to 4-6 weeks, depending on the condition of the patient.

    Side effects:

    slight drowsiness, which appears in the first days of admission and usually disappears independently during the treatment; rarely skin rashes, as well as allergic reactions in the form of urticaria and edema Quincke.

    Overdose:

    symptoms: lethargy, excessive drowsiness. Treatment: washing the stomach with plenty of water, symptomatic treatment. There is no specific antidote.

    Interaction:

    potentiates the effects of drugs that depress the central nervous system, such as opioid analgesics, barbiturates, hypnotics, antihistamines, neuroleptics, etc. It also increases the effects of alcohol.

    Special instructions:

    due to the presence of lactose in the formulation, the drug should not be used for galactosemia, glucose malabsorption syndrome and galactose, and also in the case of lactase deficiency.

    If you miss a drug, do not double the dose at the next appointment.

    NOT RECOMMENDED TO TAKE PREPARATION COOPERATIVELY WITH ALCOHOLIC BEVERAGES.

    DO NOT EXCEED PRESCRIBED DOCTOR.

    Effect on the ability to drive transp. cf. and fur:In connection with the risk of drowsiness, during the treatment should avoid the management of vehicles and activities that require increased attention, for example, the management of various mechanisms.
    Form release / dosage:

    capsules;

    Packaging:12 capsules in PVC / aluminum blisters, 2 blisters each with instructions for use in cardboard packs; or 20 capsules in PVC / aluminum blisters, 3 blisters each with instructions for use in cardboard packs.
    Storage conditions:

    at a temperature of 15 ° C to 25 ° C. Keep out of the reach of children!

    Shelf life:3 years.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005103/08
    Date of registration:01.07.2008
    The owner of the registration certificate:BIOCODEX BIOCODEX France
    Manufacturer: & nbsp
    BIOCODEX France
    Representation: & nbspBIOCODEX BIOCODEX France
    Information update date: & nbsp06.10.2015
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