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Dosage form: & nbspdrops for oral administration
Composition:

1 ml of solution contains

active substances: ethyl bromoisovalerianate (ethyl ester of a-bromizovaleric acid) 20 mg in terms of 100% substance, phenobarbital 18 mg, peppermint peppermint oil (peppermint oil) 1.4 mg, hops southerly oil (hop oil) 0.2 mg;

Excipients: ethanol rectified (ethanol (96%)) - 0.62 ml (corresponding to anhydrous ethanol - 470.8 mg (0.597 ml)), stabilizer (sodium isovalerianate) - 0.2 mg in terms of dry matter, purified water up to 1 ml.

Description:
Transparent colorless liquid with a specific odor.
Pharmacotherapeutic group:Sedative remedy
ATX: & nbsp
  • Other sleeping pills and sedatives
  • Pharmacodynamics:

    Combined drug, the effect of which is due to the properties of its constituent substances.

    Ethyl ester of alpha-bromizovaleric acid has sedative (similar to the valerian effect) and spasmolytic effect due to stimulation of the predominantly oral and nasopharyngeal receptors, a decrease in reflex excitability in the central parts of the nervous system, and increased inhibition in cortical neurons and subcortical structures of the brain, as well as a decrease in activity central vasomotor centers and direct local antispasmodic effect on smooth muscles.

    Phenobarbital enhances the sedative effect of other components, helps to reduce excitation of the central nervous system (CNS) and facilitates the onset of sleep.

    Peppermint oil has a reflex vasodilating, spasmolytic, mild choleretic, antiseptic effect. The mechanism of action is associated with the ability to irritate the "cold" receptors of the oral mucosa and reflexively expand primarily the vessels of the heart and brain. Eliminates the phenomena of flatulence due to irritation of the receptors of the mucous membrane of the gastrointestinal tract (GIT), strengthening the peristalsis of the intestine.

    Hop oil has a reflex vasodilator and spasmolytic effect, has a sedative effect.

    Pharmacokinetics:Not studied.
    Indications:Functional disorders of the cardiovascular system (including cardialgia, sinus tachycardia), neuroses accompanied by irritability, anxiety, fear; insomnia (difficulty falling asleep); excitation conditions, accompanied by pronounced vegetative reactions.
    Contraindications:Hypersensitivity to any of the components of the drug; severe renal / hepatic impairment; hepatic porphyria; severe heart failure; alcoholism; craniocerebral injury or brain disease. Children under 3 years.
    Carefully:
    Children age over 3 years.
    Pregnancy and lactation:It is not recommended to use the drug during pregnancy and breastfeeding. If you need to use the drug during breastfeeding, you should decide whether to stop breastfeeding.
    Dosing and Administration:

    Is taken orally, before meals, with a small amount of liquid. Doses of the drug are set individually. Adults usually appoint 15-20 drops 3 times a day.

    With disturbed sleep, the dose can be increased to 30 drops.

    Children from 3 years of age use 1 drop per year of life of the child 1 time per day. The need for a repeated dose is determined by the doctor depending on the clinical picture of the disease.

    Duration of the drug is determined by the doctor individually.

    Side effects:

    Corvaldine®, as a rule, is well tolerated, even with prolonged use.

    - From the side of the digestive tract: a feeling of heaviness or overflow, nausea;

    - from the nervous system: drowsiness, dizziness, decreased concentration of attention;

    - from the side of the immune system: allergic reactions;

    - from the cardiovascular system: slowing of the heart rate. These phenomena are eliminated by reducing the dose.

    With long-term admission - the phenomenon of bromism, addiction, drug dependence, withdrawal syndrome.

    Overdose:

    Symptoms: depression of the central nervous system, nystagmus, ataxia, lowering of arterial pressure, excitation, chronic intoxication with bromine (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements).

    Treatment: symptomatic, with CNS depression - caffeine, nikethamide.

    Interaction:Drugs that depress the central nervous system (including sedatives, antipsychotics, tranquilizers) increase the effect of the drug. Stimulants of the central nervous system weaken the action of the drug. Phenobarbital (inducer of microsomal oxidation) can reduce the effectiveness of drugs metabolized in the liver (including coumarin derivatives, griseofulvin, glucocorticoids, oral contraceptives),strengthens the action of local anesthetic, analgesic and hypnotics. With simultaneous application with valproic acid, the effect of valproic acid is enhanced. With simultaneous use with methotrexate, the toxicity of the latter increases.
    Special instructions:You should avoid the simultaneous use of alcoholic beverages. Ethyl alcohol enhances the effect of the drug and can increase its toxicity. In a single dose of the drug (15-20 drops) contains 0.27-0.36 grams of absolute ethyl alcohol, in a maximum daily dose (90 drops) - 1.62 grams of absolute ethyl alcohol.
    Effect on the ability to drive transp. cf. and fur:The preparation contains 62% by volume of ethyl alcohol and phenobarbital, in connection with which the use of the drug should refrain from engaging in potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (including vehicle management, work with moving mechanisms).
    Form release / dosage:
    Drops for ingestion.
    Packaging:

    To 25 ml in bottles of light-protective glass, sealed with stoppers-droppers and caps screw-capping with the control of the first opening.

    Each bottle, along with instructions for medical use, is placed in a pack of cardboard.

    Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N012044 / 01
    Date of registration:10.10.2011 / 03.07.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:FARMAK, JSC FARMAK, JSC Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp03.02.2018
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