Piracetam bufus Renewal solution 200mg/ml ampoules 5ml, 10pcs

Composition

>1 ml of the solution contains: Active ingredient: piracetam-200 mgsupport substances: sodium acetate-1 mgacetic acid-up to pH 5,8 water for injection – up to 1 ml

Pharmacological action

Pharmaco-therapeutic group: Nootropic sredstvofarmacological action

Nootropic agent. It has a positive effect on the metabolic processes and blood circulation of the brain. Increases glucose utilization, improves the course of metabolic processes, improves microcirculation in ischemic areas, inhibits aggregation of activated platelets. It has a protective effect on brain damage caused by hypoxia, intoxication, and electric shock. Improves integrative brain activity. It has no sedative or psychostimulating effect.

Pharmacokinetics

When taken orally, it is rapidly and almost completely absorbed from the gastrointestinal tract. _cmax in plasma is reached in approximately 30 minutes, in the cerebrospinal fluid – in 2-8 hours_{. The apparent} Vd is 0.6 l/kg. It does not bind to plasma proteins.

It is distributed in all organs and tissues, penetrates through the BBB and placental barrier. Selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal ganglia.

T_1/2 from plasma is 4-5 hours, from CSF – 6-8 hours. It is excreted unchanged by the kidneys. With renal failure, T1 / 2 increases.

Indications

• Symptomatic treatment of intellectual and mnestic disorders in the absence of an established diagnosis of dementia;

• reduction of cortical myoclonus manifestations in patients sensitive to piracetam, both as monotherapy and as part of complex therapy (in order to determine sensitivity to piracetam, a trial course of treatment can be performed in a particular case).

Use during pregnancy and lactation

Animal studies have shown no direct or indirect effects on pregnancy, embryo/fetus development, delivery, or postnatal development. Controlled studies of the use of the drug during pregnancy have not been conducted. Piracetam penetrates the placental barrier. The concentration of the drug in newborns reaches 70-90% of its concentration in the blood of the mother. Piracetam should be used during pregnancy only in exceptional cases, if the benefit to the mother exceeds the potential risk to the fetus, and the clinical condition of the pregnant woman requires treatment with piracetam. Piracetam passes into breast milk. Piracetam should not be used during breast-feeding, or breast-feeding should be discontinued when treated with piracetam. When deciding whether to stop breastfeeding or not to take piracetam treatment, the benefits of breastfeeding for the child and the benefits of therapy for the woman should be correlated.

Contraindications

• Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the drug.
• Huntington’s chorea.
• Acute cerebrovascular accident (hemorrhagic stroke).
• End-stage renal failure (with creatinine clearance less than 20 ml / min).
• Psychomotor agitation at the time of drug use.
• Children under 3 years of age.

With caution: impaired hemostasis; extensive surgery; severe bleeding.

Side effects

From the central nervous system and peripheral nervous system: motor disinhibition (1.72%), irritability (1.13%), drowsiness (0.96%), depression (0.83%), asthenia (0.23%).

In isolated cases-headache, insomnia, agitation, balance disorders, ataxia, exacerbation of epilepsy, anxiety, hallucinations, confusion.

From the cardiovascular system: increased or decreased blood pressure.

From the digestive system: in isolated cases – nausea, vomiting, diarrhea, abdominal pain (including gastralgia).

From the side of metabolism: weight gain (1.29%).

From the skin-dermatitis, itching, rashes.

Interaction

The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, since 90% of the drug is excreted unchanged by the kidneys. When used concomitantly with thyroid hormones, there have been reports of confusion, irritability, and sleep disturbance.

How to take, course of use and dosage

Intravenously. Intramuscularly.

Parenteral use of piracetam is prescribed when it is impossible to use oral forms of the drug (unconsciousness, difficulty swallowing).

Intravenous use is preferred.

Intravenous infusion of the daily dose is performed through a catheter at a constant rate for 24 hours a day. The total volume of the solution intended for use is determined taking into account the clinical indications and the patient’s condition.

Bolus intravenous use is performed for at least 2 minutes, and the daily dose is divided into several injections (2-4) at regular intervals so that the dose per use does not exceed 3 g.

Overdose

A single case of dyspeptic phenomena in the form of diarrhea with blood and abdominal pain was registered when taking the drug inside at a daily dose of 75 g.

Apparently, this was due to the use of a large total dose of sorbitol, which is part of the preparation previously for the dosage form of oral solution. No other cases of overdose of the drug were detected.

Treatment: in case of overdose, symptomatic therapy is recommended, which may include hemodialysis. There is no specific antidote.

The effectiveness of hemodialysis for piracetam is 50-60%.

Special instructions

Use with caution in patients with severe hemostasis disorders, major surgical operations and severe bleeding; with renal insufficiency.

Continuous monitoring of renal function indicators is recommended.

In case of sleep disorders, it is recommended to cancel the evening intake of piracetam, adding this dose to the daily intake.

Form of production

Solution for intravenous and intramuscular use.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 5 years.

Active ingredient

Piracetam

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion

Description

Children as prescribed by a doctor, Children over 3 years of age, Adults as prescribed by a doctor, For the elderly

Indications

Alzheimer’s disease, Delayed mental development in children, Poor learning ability, Impaired cerebral circulation, Stroke consequences, Epilepsy, Alcoholism, Schizophrenia, Acquired dementia, Concussion and other traumatic brain injuries, Mental disorders