Universal reference book for medicines
Product name: PHENOBARBITAL

Active substance: phenobarbital

Type: Soporific and sedative.
Anticonvulsants
Manufacturer: TATHIMFARMPREPARATY (Russia)
Composition, form of production and packaging
Tablets
1 tab.

Phenobarbital 100 mg

6 pcs.
- Packings without cell contour.
6 pcs.
- Packings without glue contour (2) - packs cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Refers to the barbiturate group.
Interacts with the "barbiturate" site of the benzodiazepine-GABA-receptor complex, which increases the sensitivity of GABA receptors to GABA, leads to the opening of neuronal channels for chloride ions, which leads to an increase in their entry into the cell. Reduces the excitability of neurons in the epileptogenic focus and the spread of nerve impulses. It shows antagonism against a number of excitatory mediators (glutamate and others). Suppresses the sensory areas of the cerebral cortex, reduces motor activity, depresses the cerebral functions, including the respiratory center. Has no significant effect on the cardiovascular system. Reduces the tone of smooth muscles of the gastrointestinal tract. In small doses, the intensity of metabolic processes decreases somewhat, which can be manifested by a slight hypothermia.
It has anticonvulsant, sedative (in small doses), hypnotic, antihyperbilirubinemic, myorelaxing and spasmolytic action.
Being an inducer of enzymes of microsomal oxidation in the liver, it increases its detoxification function, reduces the concentration of bilirubin in the blood serum.
PHARMACOKINETICS

When ingested slowly absorbed, completely.
C max in blood plasma is determined after 1-2 hours, the connection with plasma proteins is 50%, in newborns 30-40%.Metabolized in the liver, induces microsomal liver enzymes CYP3A4, CYPZA5, CYP3A7 (the rate of enzymatic reactions increases 10-12 times). Cumulated in the body. T 1/2 is 2-4 days. It is excreted by the kidneys in the form of glucuronide, about 25% - unchanged. Penetrates into breast milk and through the placental barrier


INDICATIONS

- Epilepsy (all types of seizures except for absences), seizures of non-epileptic genesis;

- chorea;

- spastic paralysis;

- sleep disturbances, agitation, anxiety, fear.

DOSING MODE

Inside.

For adults , the following dosing regimens are recommended:

- sleep disorders: 0.1-0.2 g for 0.5-1 h before bedtime.

- as a sedative drug: 0.05 g 2-3 times a day.

- as an anticonvulsant: 0.05-0.1 g 2 times a day.
With a decrease in liver function should be administered in smaller doses.
SIDE EFFECT

From the side of the nervous system: asthenia, dizziness, general weakness, ataxia, nystagmus, paradoxical reaction (especially in elderly and weakened patients - agitation), hallucinations, depression, nightmares, sleep disturbances, syncope.

From the side of the musculoskeletal system: with prolonged use - violation of osteogenesis and development of rickets

On the part of the digestive system: nausea, vomiting, constipation, with prolonged use - a violation of liver function.

On the part of the organs of hematopoiesis: agranulocytosis, megaloblastic anemia, thrombocytopenia.

From the cardiovascular system: lowering blood pressure.

Allergic reactions: skin rash, hives, swelling of the eyelids, face and lips, shortness of breath, rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome).

Other: with prolonged use - drug dependence.

CONTRAINDICATIONS

- marked hepatic and / or renal insufficiency;

- drug dependence (including in history);

- hyperkinesis;

- Myasthenia gravis;

- severe anemia;

- porphyria;

- diabetes;

hypofunction of the adrenal glands;

- hyperthyroidism;

- Depression;

- bronchoobstructive diseases;

- active alcoholism;

- pregnancy and lactation;

- Children's age (due to the impossibility of accurate dosing);

- hypersensitivity to any of the components of the drug.

With caution: weakened patients (high risk of paradoxical arousal, depression and confusion, even with normal doses).

PREGNANCY AND LACTATION

Contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe hepatic insufficiency.

APPLICATION FOR CHILDREN

Contraindicated in childhood (due to the impossibility of accurate dosing).

SPECIAL INSTRUCTIONS

Avoid prolonged use of the drug in connection with the possibility of its cumulation in the body and the development of addiction.

To avoid the development of the syndrome of "withdrawal" (headaches, "nightmarish" dreams, drowsiness and / or insomnia), treatment should be discontinued gradually.
During treatment, it is not recommended to drive the car, and also engage in activities that require speed of psychomotor reactions.
OVERDOSE

Symptoms: nystagmus, ataxia, dizziness, headache, blockage, blurred speech, severe weakness, decreased or lost reflexes, pronounced drowsiness or agitation, increased or decreased body temperature, respiratory depression, shortness of breath, lowering blood pressure, pupil contraction (followed by parasitic enlargement ), oliguria, tachy- or bradycardia.
cyanosis. confusion, cessation of brain electrical activity, pulmonary edema, coma, later - pneumonia, arrhythmias, heart failure; when taking 2-10 g - a lethal outcome; with chronic toxicity - irritability, weakened ability to critical evaluation, sleep disorders, confusion.
Treatment: there is no specific antidote.
Gastric lavage, reception of activated charcoal, conduct of detoxification therapy, symptomatic treatment, maintenance of vital body functions.
DRUG INTERACTION

Phenytoin and valproate increase the content of phenobarbital in the blood serum.

Anticonvulsant effect of phenobarbital decreases with simultaneous reception with reserpine, increases when combined with amitriptyline, nialamide, diazepam, chlordiazepoxide.

Reduces the effectiveness of oral contraceptives and salicylates.

Reduces the blood levels of indirect angioagulants, glucocorticosteroids, griseofulvin, doxycycline.
estrogens and other drugs metabolized in the liver along the oxidation pathway (accelerates their destruction). Strengthens the effect of alcohol, neuroleptics, narcotic analgesics, muscle relaxants sedatives and hypnotics.
Acetazolamide, alkalinizing urine, reduces the reabsorption of phenobarbital in the kidneys and weakens its effect.

The hypnotic effect of phenobarbital decreases with simultaneous administration with atropine, belladonna extract, dextrose, thiamine, nicotinic acid, analgesics and psychostimulating drugs.

Reduces antibacterial activity of antibiotics and sulfonamides, antifungal action of griseofulvin.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Refers to the list of potent and poisonous substances (list of NKKN).
Keep in a cool, dry place, protected from light and out of the reach of children. Shelf life - 5 years.
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