Epilepsy - partial seizures and generalized tonic-clonic.
Composition:
1 tabl contains 15 mg or 100 mg of phenobarbital. The tablets contain lactose.
Action:
Phenobarbital is a derivative of barbituric acid. It reduces the sensitivity of the brain cortex and subcortical structures through increased presynaptic inhibition, probably due to its effect on GABAergic receptors. It has a calming, sleeping and anticonvulsant effect. It reduces smooth muscle tone, inhibits ACTH secretion and increases the secretion of antidiuretic hormone. It has an inhibitory effect on the respiratory center, reduces the number of breaths and breathing capacity. Phenobarbital enhances the activity of microsomal liver enzymes. Phenobarbital is easily absorbed from the gastrointestinal tract, penetrates easily into all tissue fluids, through the placenta barrier and into the breast milk of women. It reaches the maximum concentration about 8 hours after administration in adults (in children after 4 hours). T0,5 is 40-100 h and depends on the capacity of liver microsomal enzymes. Phenobarbital binds to 50% of plasma proteins. It is partially metabolised in the liver, most of it is excreted unchanged by the kidneys.
Contraindications:
Hypersensitivity to phenobarbital, other barbituric acid derivatives or any of the preparation's excipients. Respiratory failure. Severe hepatic failure. Hepatic coma. Porphyria. Alcoholism. Pregnancy and / or feeding period. acute poisoning with agents that inhibit O.u.n.
Precautions:
Phenobarbital inhibits the respiratory center and may exacerbate symptoms of dyspnoea. It should be used with caution in patients with asthma and for other diseases with dyspnoea, narrowing of the airways or with respiratory failure, in patients with liver disease (dose should be reduced) and with renal impairment, in patients with depression with suicidal tendencies, drug abuse, cerebral circulation disorders, severe anemia, hyperkinesia, hyperthyroidism, acute or chronic pain, diabetes, adrenal insufficiency, in weakened patients (may occur: agitation, depression, confusion). The use of phenobarbital can lead to mental and physical dependence. Abrupt discontinuation of phenobarbital may cause withdrawal symptoms such as: delirium, tremors, convulsions, insomnia, irritability, nightmares, even death. After long-term use, discontinuation of the drug should be done gradually. Long-term use of phenobarbital may reduce its effectiveness. Children and the elderly may react to phenobarbital with paradoxical arousal. Due to the lactose content, the preparation should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Phenobarbital must not be used during pregnancy because it crosses the placenta and may interfere with fetal development, increasing the risk of congenital malformations. Phenobarbital used in the third trimester of pregnancy may cause physical dependence and withdrawal symptoms and bleeding in the newborn. The risk of bleeding can be reduced by giving the mother vitamin K during labor and the newborn immediately after birth. Phenobarbital used during labor can cause respiratory distress in the newborn. Phenobarbital is contraindicated during breastfeeding due to the excretion of breastfeeding milk (may cause central nervous system depression in the infant).
Side effects:
Symptoms requiring contact with a physician: uncommon - confusion, depression (especially in elderly or debilitated people), paradoxical reactions such as agitation (especially in children, elderly or debilitated people); rarely - agranulocytosis, allergic reactions, exfoliative dermatitis, hallucinations, hypotension, megaloblastic anemia, Stevens-Johnson syndrome, thrombocytopenia; with long-term administration: liver damage,osteopenia or rickets. Symptoms that require contact with a doctor only in cases when they persist or are troublesome: often - an imbalance, feeling of dizziness or emptiness in the head, drowsiness, feelings similar to reactions after alcohol abuse; uncommon - anxiety or nervousness, constipation, drowsiness, headache, irritability, nausea or vomiting, nightmares or sleep disorders. Symptoms requiring contact with a doctor after stopping treatment: moderate symptoms occurring within 8-12 h - anxiety, muscle twitching, hand tremors, weakness, dizziness, blurred vision, nausea, vomiting, sleep disorders, increased dreams or nightmares orthostatic hypotension; severe symptoms occurring within 16 h and lasting up to 5 days - convulsions, hallucinations. There have been reports of a reduction in bone mineral density, osteopenia, osteoporosis and fractures in patients taking phenobarbital for a long time.
Dosage:
Orally. The dose should be selected individually so that seizures are effectively controlled, usually requires a serum concentration in the range of 15-40 μg / ml. Adults: usually 60-200 mg / day, in a single dose per night. When using a dose above 100 mg / day, you can prescribe a 100 mg dose. Children over 2 years of age who can swallow a tablet: 1-6 mg / kg / day in a single dose or in divided doses (for 15 mg tablets).
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