Korvalol-Pharma

General characteristics. Structure:

Active ingredient: 20 mg of ethyl ether of α-bromizovalerianovy acid and 18,26 mg of phenobarbital.

Excipients: peppermint oil, alcohol the hydroxide rectified from food raw materials, sodium, the water purified.

The combined medicine. Renders the complex sedative, soft sleeping pill and spasmolytic action caused by the components which are its part.

Pharmacological properties:

Pharmacodynamics. The combined medicine. Renders the complex sedative, soft sleeping pill and spasmolytic action caused by the components which are its part.

The sedative and soft 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. At oral administration medicine is quickly soaked up in digestive tract, the effect develops in 20-40 minutes. Phenobarbital is quickly absorbed from a GIT. Linkng with proteins of plasma makes about 30-60%. Metabolism is carried out preferential in a liver. About 30% of phenobarbital are allocated in not changed view with urine. The elimination half-life makes 48-144 hours. At prolonged and regular use there is an accumulation of phenobarbital in an organism, and also induction of enzymes of a liver. As a result of it process of oxidation of phenobarbital and many other medicines accelerates. Complex effect of medicine remains on average within 6-8 hours. It is removed, generally by kidneys.

Indications to use:

1. A symptomatic treatment of the neurosis-like states which are followed by an acrimony;
2. The sleep disorders connected with acute and chronic stress, excitement and concern.

Medicine is shown for short-term use since efficiency of therapy decreases after two weeks of administration of drug and there is a danger of development of dependence.

Route of administration and doses:

Doses and duration of reception are established individually. Korvalol-Pharma appoint inside to food 2-3 times a day till 15-30 of drops with a small amount of water or on a sugar piece. If necessary the single dose can be increased till 40-50 drops.

Reception of Korvalola-Pharma is not recommended more than two weeks since efficiency of means after two weeks of therapy decreases.

Features of use:

Korvalol-Pharma contains not less than 50,0% (about/about) ethanol and phenobarbital which can break the accuracy and speed of reactions at the persons performing the work demanding high coordination of movements and the speed of response (drivers, dispatchers, etc.). At prolonged use there can be signs of medicinal dependence, accumulation of bromine in an organism and development of poisoning with it is possible.

It is necessary to avoid the simultaneous use of alcoholic drinks with Korvalolom-Pharma.

The elderly and weakened patients can react to phenobarbital development of the expressed excitement, depressions and rateryannost.

Phenobarbital can cause development of accustoming, mental and physical dependence. 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.

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

Messages on development of zhizneugrozhayushchy skin reactions were received (Stephens's syndrome – Johnson and a toxic epidermal necrolysis) at use of the medicines containing phenobarbital. Patients should be informed on signs and symptoms of skin reactions and to observe carefully. If signs or symptoms of a syndrome of Stephens-Johnson or a toxic epidermal necrolysis appeared (for example, the progressing skin rash, it is frequent with bubbles or damage of mucous membranes), reception of medicine it is necessary to stop and see a doctor immediately. The best results at treatment of a syndrome of Stephens – Johnson or a toxic epidermal necrolysis were received at early diagnosis and immediate phase-out of the suspected medicine. These patients should not resume use of Korvalol-Pharma medicine more.

Use during pregnancy and a lactation. 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.

Side effects:

For phenobarbital. Nervous system: excitement, confusion of consciousness, hyperkinesia, ataxy, oppression TsNS, nightmares, nervousness, psychiatric disturbances, hallucinations, sleeplessness, concern, dizziness

Respiratory system: hypoventilation, apnoea.

Cardiovascular system: bradycardia, lowering of arterial pressure, faints.

Alimentary system: nausea, vomiting, locks.

Other reactions: a headache, allergic reactions (a Quincke's edema, skin rash, exfoliative dermatitis), fever, damage of a liver, megaloblastny anemia after long reception of phenobarbital.

At prolonged use of high doses development of chronic poisoning with bromine which manifestations happen is possible: the depressive mood, apathy, rhinitis, konjyuktivit, hemorrhagic diathesis, a lack of coordination of movements, medicinal dependence.

At use of the medicines containing phenobarbital messages on development of zhizneugrozhayushchy skin reactions (Stephens-Johnson's syndrome and a toxic epidermal necrolysis) were received.

Interaction with other medicines:

At simultaneous use of Korvalola-Pharma 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 strengthens effects of Korvalola-Pharma and can increase its toxicity. Existence in structure of Korvalola-Pharma of phenobarbital can induce liver enzymes, and it does undesirable its simultaneous use with drugs 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 contents in Korvalole-Pharma of phenobarbital, as their undesirable interaction the accelerated weakening of effect of above-mentioned drugs can be observed. Increases toxicity of the pharmaceutical drugs containing a methotrexate.

Effect of phenobarbital on metabolism of Phenytoinum it is unpredictable, it is necessary to control concentration of Phenytoinum and phenobarbital in blood if these drugs 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, heavy renal and/or liver failure, porphyria, the lactation period, pregnancy, children's age up to 18 years.

In connection with the ethanol content of Korvalol-Pharma it is contraindicated to patients with alcoholism, epilepsy, a craniocereberal injury and other diseases of a brain with decrease in a convulsive threshold.

Overdose:

Symptoms - the overdose is expressed by intoxication of varying severity.
Intoxication symptoms:
- acute (from easy to average degree) intoxication barbiturates: dizziness, fatigue, even a deep sleep from which the patient cannot be woken.
- acute heavy intoxication: the deep coma which is followed by a fabric hypoxia, the shallow breathing which is speeded up at the beginning, later slowing down. Tachycardia, cardiac arrhythmia, low blood pressure, vascular insufficiency, weak reflexes or their absence. If not to treat intoxication, there can come death from vascular insufficiency, respiratory paralysis or a fluid lungs.

Treatment of intoxication:
- cases of acute intoxication of Korvalolom-Pharma it is necessary to treat by the same method, as intoxications somnolent drugs and barbiturates, depending on weight of symptoms of intoxication. It is necessary to wash out a stomach, to accept absorbent carbon.

It is necessary to normalize breath and blood circulation. Respiratory insufficiency is overcome by means of an artificial respiration, shock – by means of the infusion of plasma or substances added for increase in volume of plasma. If there did not pass a lot of time from the moment of reception of a barbiturate, the gastric lavage is appointed (to pour in solution of two full tablespoons of absorbent carbon and sodium sulfate). To accelerate removal of a barbiturate from an organism, the forced alkalizing diuresis and a hemodialysis and/or hemoperfusion is appointed.

Storage conditions:

To store in the place protected from light at a temperature not above 15 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

Without recipe

Packaging:

On 25 ml, 30 ml, 35 ml and 50 ml in the bottles placed together with a leaf insert in packs from a cardboard.