Valordin

General characteristics. Structure:

Active ingredients: 20 mg of ethyl ether of α-bromizovalerianovy acid and 20 mg of phenobarbital in 1 ml of solution.

Excipients: peppermint oil, hop oil, alcohol of ethyl 96%, the water purified.

Drug which depending on a dose render sedative and hypnotic effect and in high doses shows narcotic action.

Pharmacological properties:

Pharmacodynamics. The combined medicine containing ethyl ether of α-bromizovalerianovy acid and phenobarbital. Depending on a dose both of these substances render sedative, hypnotic effect, and in high doses show narcotic action.

The sedative and somnolent effect is connected with oppression by ethyl ether of α-bromizovalerianovy acid and phenobarbital of the activating impacts of a reticular formation of a mesencephalon on bark of big hemispheres and subcrustal structures.

Pharmacokinetics. Barbiturates are soaked up in a stomach. About 35% of phenobarbital contact protein of plasma. The part which did not contact protein is filtered by kidneys and at low acidity is soaked up repeatedly. Alkalization of urine complicates this return diffusion. The phenobarbital elimination half-life makes 3 days of plasma. 30% of phenobarbital are allocated with urine without changes, only its small volume is oxidized in a liver. At chronic use cumulation of phenobarbital and induction of enzymes of a liver is observed. Induction accelerates metabolism of barbiturates and other medicines. The bromine connected in ethyl ether of α-bromizovalerianovy acid is emitted very slowly. At prolonged use bromine kumulirutsya and collects in TsNS that leads to a bromism.

Indications to use:

- a symptomatic treatment of the neurosis-like states which are followed by an acrimony;

- the sleep disorders connected with excitement and concern if sedation is desirable also during the day. Medicine is shown for short-term treatment of sleep disorders as efficiency of therapy after two weeks of reception of medicine decreases.

Route of administration and doses:

Appoint inside with a small amount of liquid, the adult till 15-20 of drops 3 times a day before food (at sleep disorders the single dose can be raised to 30 drops). Medicine is shown for short-term treatment of sleeplessness as efficiency of therapy after two weeks of reception decreases.

Features of use:

Medicine contains 55 about. ethanol %. The elderly and weakened patients can react to phenobarbital development of the expressed excitement, depressions and confusions.

Phenobarbital can cause accustoming. Tolerance, mental and physical dependence can develop after long reception of phenobarbital.

Symptoms of chronic intoxication include confusion of consciousness, decrease in criticism, irritability, sleeplessness and somatic complaints.

Characteristics of drug addiction to phenobarbital include the following: (a) strong desire or requirement to continue to accept phenobarbital; (b) tendency to increase in a dose; (c) mental dependence on the effects connected with phenobarbital reception, value and individual judgment of these effects; (d) the physical dependence on effects of phenobarbital demanding its constant reception, development of a withdrawal in case of the medicine reception termination.

In order to avoid a withdrawal treatment of dependence on phenobarbital consists in careful and gradual cancellation of medicine. The sharp termination of reception of phenobarbital after prolonged use at the person with dependence can lead to development of an abstinence syndrome, including nonsense and spasms, the lethal outcome is possible.

The lethal dose of barbiturates decreases at a concomitant use of alcohol.

It is necessary to be careful at purpose of phenobarbital to patients with acute or chronic pain since paradoxical excitement can develop, and important clinical symptoms can be disguised.

Use at pregnancy and feeding by a breast. Contraindicated at pregnancy and feeding a breast. For the period of treatment by medicine breastfeeding needs to be stopped.

Reception of phenobarbital during pregnancy can cause anomalies of fetation. After intake phenobarbital easily gets through a placental barrier and is distributed on all fabrics of a fruit, high concentration are defined in a placenta, a liver and a brain. If phenobarbital was accepted during pregnancy or if pregnancy occurred during phenobarbital reception, the patient has to be informed on potential danger to a fruit. At phenobarbital reception by the nursing mother phenobarbital in small amounts is emitted with breast milk.

Influence on ability to drive the car and to work with mechanisms. Medicine contains alcohol and phenobarbital therefore the patients accepting Valordin are not recommended to be engaged in the activity connected with special attention and demanding speed of mental and motor reactions.

Side effects:

From TsNS: spasms, headache, dizziness, concern, weakness, unconscious condition, lack of coordination, excitement, confusion of consciousness, hyperkinesia, ataxy, oppression TsNS, nightmares, nervousness, mental disturbances, hallucinations, sleeplessness.

From respiratory system: hypoventilation, apnoea.

From the alimentary system: nausea, vomiting, locks, at prolonged use - an abnormal liver function.

From bodies of a hemopoiesis: agranulocytosis, megaloblastny anemia, thrombocytopenia.

From cardiovascular system: bradycardia, the lowered arterial pressure, thrombophlebitis, faints.

Others: vision disorder, allergic reactions (Quincke's edema, skin rash, exfoliative dermatitis), fever, damage of a liver.

At prolonged use – medicinal dependence.

At prolonged use of high doses development of chronic poisoning with bromine which manifestations are is possible: depressive mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, lack of coordination of movements.

After long reception megaloblastny anemia can develop.

Interaction with other medicines:

At simultaneous use of medicine Valordin with sedatives - strengthening of effect. Simultaneous use with neuroleptics and tranquilizers strengthens, and with stimulators of the central nervous system – weakens action of each of medicine components. Alcohol Valordin strengthens effects of medicine and can increase its toxicity. Existence in composition of medicine of phenobarbital can induce liver enzymes, and it does undesirable its simultaneous use with medicines which are metabolized in a liver as their concentration, and respectively efficiency will decrease as a result of more accelerated metabolism (indirect anticoagulants, antibiotics, streptocides, etc.).

In combination with coumarin derivatives, griseofulvin, glucocorticoids or oral contraceptives, thanks to the content in medicine Valordin of phenobarbital, as their undesirable interaction can be observed the accelerated weakening of effect of above-mentioned medicines. Increases toxicity of the pharmaceutical medicines containing a methotrexate.

Effect of phenobarbital on metabolism of Phenytoinum is unpredictable, it is necessary to control concentration of Phenytoinum and phenobarbital in blood if these medicines are appointed at the same time. Valproatum of sodium and valproic acid reduce phenobarbital metabolism therefore concentration of phenobarbital in blood has to be checked, and if necessary correction of doses is carried out. Monoamine oxidase inhibitors extend effect of phenobarbital because of oppression of his metabolism.

Non-hormonal methods of contraception have to be offered the women accepting phenobarbital.

Contraindications:

— hypersensitivity to bromine, other components of medicine;
— heavy abnormal liver functions and/or kidneys;
— porphyria;
— children's age up to 18 years (clinical data on use of medicine for children and teenagers are absent);
— feeding period breast;
— pregnancy;
— the alcoholism, epilepsy, a craniocereberal injury and other diseases of a brain which are followed by decrease in a convulsive threshold.

Overdose:

The phenobarbital and ethyl ether of α-bromizovalerianovy acid which are contained in medicine of substance can cause development of intoxication.

Symptoms of acute intoxication barbiturates (easy and moderate severity): dizziness, slackness, deep deep sleep. Symptoms of acute heavy intoxication barbiturates: the deep coma which is followed by a fabric hypoxia; shallow breathing (at the beginning accelerated, then slowed down), the increased heart rate, the disturbance of a cordial rhythm, low arterial pressure, a collapse weakened or the dying-away reflexes. In the absence of treatment death is caused by a stop of blood circulation, paralysis of breath or a fluid lungs.

Treatment of acute poisoning: at acute poisoning with medicine Valordin the same measures are undertaken, as at poisoning with somnolent medicines or barbiturates, depending on weight of symptoms of intoxication. It is necessary to bring the patient to intensive care unit. It is necessary to normalize breath and blood circulation. Respiratory insufficiency is eliminated by means of artificial ventilation of the lungs, shock - by means of infusion of plasma or blood substitutes. Monitoring of the vital functions and a water balance is necessary. If the patient is in consciousness and did not lose an emetic reflex, vomiting can be caused. After end of vomiting absorbent carbon (30 g) in a glass of water can be appointed. If vomiting is contraindicated, the gastric lavage can be executed. Absorbent carbon can be left in the emptied stomach and salt purgatives are appointed. If function of kidneys of a sokhrann, can be carried out an artificial diuresis. Alkalization of urine increases renal excretion of phenobarbital. In cases of heavy intoxication by barbiturates or at development of an anury, the hemodialysis can be carried out.

At long reception of organic compounds of bromine there is a danger of intoxication bromine which is expressed in a condition of confusion of consciousness, an ataxy, apathy, a depression, conjunctivitis, cold, an acne and hemorrhages in skin.

Treatment of poisoning with bromine: reception of solution of table salt with a concomitant use of saluretics accelerates removal from a bromine organism.

Storage conditions:

To store in the place protected from light at a temperature from + 8 °C to + 15 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

Without recipe

Packaging:

On 25,0 ml, 30,0 ml, 35,0 ml and 50,0 ml in the bottles corked by the traffic jams droppers or traffic jams of the P8 type, with covers screwed, placed together with a leaf insert for the consumer in packs from a cardboard. In case of corking of a bottle in a pack from a cardboard the stopper dropper is located with a stopper of the P8 type.