Composition
Tablets – 1 tab. :
- Active ingredients:
- phenobarbital 25 mg,
- bromizoval 100 mg,
- caffeine sodium benzoate 7.5 mg,
- papaverine hydrochloride 15 mg,
- calcium gluconate 250 mg.
- Auxiliary substances:
- potato starch,
- calcium stearate.
Pharmacological action
Combined antiepileptic drug.
Phenobarbital interacts with the “barbiturate” site of the benzodiazepine-GABA receptor complex, thereby increasing the sensitivity of GABA receptors to GABA, leading to the opening of neuronal channels for chlorine ions, which leads to an increase in their entry into the cell. Reduces the excitability of epileptogenic focus neurons and the spread of nerve impulses.
It shows antagonism towards a number of excitatory mediators (glutamate and others). It suppresses sensory areas of the cerebral cortex, reduces motor activity, and inhibits cerebral functions, including the respiratory center.
Reduces the tone of smooth muscles of the gastrointestinal tract. It has anticonvulsant, sedative, hypnotic and antispasmodic effects.
Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, and stimulates metabolic processes in organs and tissues, including muscle tissue and the central nervous system.
Papaverine hydrochloride is an antispasmodic, has a hypotensive effect. Reduces the tone and relaxes the smooth muscles of internal organs and blood vessels.
Calcium gluconate makes up for the lack of calcium ions necessary for the transmission of nerve impulses.
Bromizoval has a sedative and moderate hypnotic effect.
Indications
-epilepsy.
Contraindications
— severe hepatic and/or renal failure;
drug dependence (including in the anamnesis);
— hyperkinesis;
— myasthenia gravis;
— severe anemia;
— porphyria;
— diabetes;
— hypoadrenalism;
— hyperthyroidism;
— depression;
— bronchial obstructive disease;
active alcoholism;
— pregnancy;
— lactation period;
— hypersensitivity to any component of the drug.
This dosage form is not used in children under 3 years of age.
The drug should be used with caution in debilitated patients (there is a high risk of paradoxical agitation, depression and confusion, even when prescribed in normal doses).
Side effects
Nervous system disorders: Â dizziness, general weakness, ataxia, dysarthria, nystagmus, paradoxical reaction (especially in elderly and debilitated patients – agitation), hallucinations, sleep disorders.
From the digestive system: Â nausea, vomiting, constipation or diarrhea, increased activity of hepatic transaminases.
From the hematopoietic system: Â agranulocytosis, megaloblastic anemia, thrombocytopenia.
From the cardiovascular system: Â decrease or increase in blood pressure, tachycardia, arrhythmia (including extrasystole), AV block.
Other services: Â allergic reactions, with prolonged use – drug dependence.
Interaction
Phenytoin and valproates increase the content of phenobarbital in the blood serum.
The effect of phenobarbital decreases when taken simultaneously with reserpine, increases when combined with amitriptyline, nialamide, diazepam, chlordiazepoxide.
Reduces the effectiveness of oral contraceptives and salicylates.
Reduces the blood content of indirect anticoagulants, corticosteroids, griseofulvin, doxycycline, estrogens and other drugs that are metabolized in the liver by oxidation (accelerates their metabolism).
Increases the effect of ethanol, neuroleptics, narcotic analgesics, muscle relaxants, sedatives and sleeping pills.
Acetazolamide, by alkalizing the urine, reduces the reabsorption of phenobarbital in the kidneys and weakens its effect.
Reduces the antibacterial activity of antibiotics and sulfonamides, the antifungal effect of griseofulvin.
How to take, course of use and dosage
The drug is taken orally after a meal.
Pagluferal ® -1 is prescribed to children aged 3-4 years-1 tab. 2 times/day; children aged 5-6 years-1.5 tablets. 2 times/day; children aged 7-9 years – 2 tablets. 2 times/day; children aged 10-14 years-3 tablets. 2 times/day; children from 14 years of age and adults – 4 tablets each. 2 times/day.
Pagluferal ® -2 is prescribed to children aged 3-4 years-1 tab. 2 times/day; children aged 5-6 years-1.5 tablets. 2 times/day; children aged 7-9 years – 2 tablets. 2 times/day; children aged 10-14 years-2.5 tablets. 2 times/day; children from 14 years of age and adults – 4 tablets each. 2 times/day.
Pagluferal®-3 is prescribed to children aged 7-9 years-1 tab. 2 times/day; children aged 10-14 years-1.5 tablets. 2 times/day; children from 14 years of age and adults – 2 tablets. 2 times/day. List B. The drug should be stored in a dry place, protected from light and inaccessible to children at a temperature not exceeding 25°C.
Overdose
Symptoms: Â increased severity of side effects.
Treatment: Â gastric lavage, taking activated charcoal, symptomatic therapy.
Special instructions
Patients with minor hypercalciuria, reduced glomerular filtration rate, or a history of nephrolithiasis should be prescribed the drug under the control of the content of calcium in the urine, which is due to the presence of calcium gluconate in the drug.
Alcohol consumption is not recommended during therapy.
Influence on the ability to drive motor vehicles and manage mechanisms
During treatment, you should refrain from performing work that requires rapid psychomotor reactions (including driving a car).
Storage conditions
List B. The drug should be stored in a dry place, protected from light and inaccessible to children at a temperature not exceeding 25°C.
Shelf life
2 years
Active ingredients
: Calcium Gluconate, Bromizoval, Caffeine, Papaverine, Phenobarbital
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
Children as prescribed by a doctor, Adults as prescribed by a doctor, Children over 3 years of age
Indications
Epilepsy
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Side effects of Pagluferal 1, pills, 20pcs.
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