Piracetam tablets p / o 400mg, No. 60 Renewal

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

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

Inside. During meals or on an empty stomach with a liquid.

If oral administration is impossible, the drug is administered intravenously at the same dose.

With intellectual and mnestic disorders : 2.4-4.8 g / day in 2-3 doses.

Treatment of cortical myoclonus: treatment begins with a dose of 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day to a maximum dose of 24 g / day in 2-3 doses.

The use of other drugs for the treatment of myoclonus should be continued at the same dosage. Depending on the effect obtained, the dose of these drugs should be reduced if possible.

Treatment with piracetam should be continued as long as symptoms persist.

In patients with acute episodes of myoclonus, spontaneous improvement may occur, therefore, attempts should be made every 6 months to reduce the dose or discontinue the drug. To do this, gradually reduce the dose by 1.2 g / day every two days (in the case of Lance-Adams syndrome, every 3-4 days to prevent a possible sudden relapse or withdrawal syndrome).

Dosing in patients with impaired renal function: piracetam is excreted almost exclusively by the kidneys, caution should be exercised when treating patients with renal insufficiency or requiring monitoring of renal function. The half-life increases in direct proportion to the deterioration in renal function and creatinine clearance; this is also true for the elderly,
in whom the excretion of creatinine is dependent on age.

The dose should be adjusted depending on the amount of creatinine clearance.

Dosing in patients with impaired liver function: Patients with impaired liver function do not need dose adjustment. For patients with impaired renal
and liverfunction,dosing is carried out according to the scheme (see subsection 'Dosing for patients with impaired renal function') .

Active ingredient : piracetam - 400mg

Excipients: macrogol 6000 - 9.8500 mg, croscarmellose sodium - 8.3500 mg, colloidal silicon dioxide (aerosil) - 7.3500 mg, magnesium stearate - 1.0000 mg

Shell composition: hypromellose E5 - 8.0000 mg, titanium dioxide - 4.0000 mg, macrogol 400 - 0.8000 mg, hypromellose E50 - 0.4750 mg, macrogol 6000 - 0.1750 mg

• Hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug;

• chorea of ??Huntington;

• acute violation of cerebral circulation (hemorrhagic stroke);

• end-stage chronic renal failure.

Carefully

Violation of hemostasis; extensive surgical interventions; heavy bleeding; chronic renal failure (with creatinine clearance 20-80 ml / min).

Trade name: Piracetam

International non-proprietary or generic name: piracetam

Dosage form: film-coated tablets

Composition for one tablet

Active ingredient : piracetam - 200mg

Excipients: macrogol 6000 - 4.9250 mg, croscarmellose sodium - 4.1750 mg colloidal silicon dioxide (aerosil) - 3.6750 mg magnesium stearate - 0.5000 mg

Shell composition: hypromellose E5 - 4.0000 mg titanium dioxide - 2.0000 mg macrogol 400 - 0.4000 mg hypromellose E50 - 0.2375 mg macrogol 6000 - 0.0875 mg

Active ingredient : piracetam - 400mg

Excipients: macrogol 6000 - 9.8500 mg, croscarmellose sodium - 8.3500 mg, colloidal silicon dioxide (aerosil) - 7.3500 mg, magnesium stearate - 1.0000 mg

Shell composition: hypromellose E5 - 8.0000 mg, titanium dioxide - 4.0000 mg, macrogol 400 - 0.8000 mg, hypromellose E50 - 0.4750 mg, macrogol 6000 - 0.1750 mg

Description

For dosages of 200 mg and 400 mg

Round biconvex film-coated tablets of white or almost white color. Slight surface roughness is allowed. In cross section, the core is white or almost white.

For dosages of 800 mg and 1200 mg

Oval biconvex film-coated tablets of white or almost white color, with a line on one side. Slight surface roughness is allowed. In cross section, the core is white or almost white.

Pharmacotherapeutic group: nootropic agent.

ATX code: N06BX03

Pharmacological properties

Pharmacodynamics

Piracetam is a nootropic drug that acts on the central nervous system in various ways: it modifies neurotransmission in the brain, improves metabolic conditions that promote neuronal plasticity, improves microcirculation by affecting the rheological characteristics of the blood and not causing vasodilation.

Long-term or short-term use of piracetam in patients with cerebral dysfunction increases concentration and improves cognitive function, which is manifested by significant changes in the electroencephalogram.

The drug helps to restore cognitive abilities after various cerebral injuries due to hypoxia, intoxication or electroconvulsive therapy.

Piracetam is indicated for the treatment of cortical myoclonus both as monotherapy and as part of complex therapy.

Reduces the duration of provoked vestibular neuronitis.

Piracetam inhibits the increased aggregation of activated platelets and, in the case of pathological rigidity of erythrocytes, improves their deformability and filtration capacity.

Pharmacokinetics

Absorption

After oral administration, piracetam is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability is about 100%.

After a single dose of the drug in a dose of 2 g, the maximum concentration (Cmax) is reached after 30 minutes and is 40-60 ?g / ml, after 2-8 hours it is found in the cerebrospinal fluid.

Distribution

The volume of distribution (Vd) is about 0.6 l / kg. Does not bind to blood plasma proteins. Piracetam crosses the blood-brain and placental barriers, as well as hemodialysis membranes. In a study on animals, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal nuclei.

Metabolism

Not metabolized.

Withdrawal

Plasma half-life (T1 / 2) is 4-5 hours and 8.5 hours? from the cerebrospinal fluid. T1 / 2 is lengthened in renal failure.

It is excreted unchanged by the kidneys. Renal excretion is almost complete (> 95%)
within 30 hours.

The total clearance of piracetam in healthy volunteers is 86 ml / min.

Indications for use

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

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

Contraindications

• Hypersensitivity to piracetam or pyrrolidone derivatives, as well as other components of the drug;

• chorea of ??Huntington;

• acute violation of cerebral circulation (hemorrhagic stroke);

• end-stage chronic renal failure.

Carefully

Violation of hemostasis; extensive surgical interventions; heavy bleeding; chronic renal failure (with creatinine clearance 20-80 ml / min).

Application during pregnancy and during breastfeeding

Pregnancy

There is no sufficient data on the use of piracetam during pregnancy. Animal studies have not shown any direct or indirect effects on pregnancy, embryo / fetal development, labor or postnatal development. Piracetam crosses the placental barrier. The plasma concentration of piracetam in newborns reaches 70-90% of that of the mother. Piracetam should be prescribed during pregnancy only in exceptional cases, if the benefit to the mother outweighs the potential risk to the fetus, and the clinical condition of the pregnant woman requires treatment with piracetam.

Breastfeeding period

Piracetam passes into breast milk. The drug should not be used during breastfeeding, or breastfeeding should be discontinued during treatment with piracetam. When deciding whether to stop breastfeeding or stop piracetam treatment, the benefits of breastfeeding for the child should be weighed against the benefits of therapy for the woman.

Method of administration and dosage

Inside. During meals or on an empty stomach with a liquid.

If oral administration is impossible, the drug is administered intravenously at the same dose.

With intellectual and mnestic disorders : 2.4-4.8 g / day in 2-3 doses.

Treatment of cortical myoclonus: treatment begins with a dose of 7.2 g / day, every 3-4 days the dose is increased by 4.8 g / day to a maximum dose of 24 g / day in 2-3 doses.

The use of other drugs for the treatment of myoclonus should be continued at the same dosage. Depending on the effect obtained, the dose of these drugs should be reduced if possible.

Treatment with piracetam should be continued as long as symptoms persist.

In patients with acute episodes of myoclonus, spontaneous improvement may occur, therefore, attempts should be made every 6 months to reduce the dose or discontinue the drug. To do this, gradually reduce the dose by 1.2 g / day every two days (in the case of Lance-Adams syndrome, every 3-4 days to prevent a possible sudden relapse or withdrawal syndrome).

Dosing in patients with impaired renal function: piracetam is excreted almost exclusively by the kidneys, caution should be exercised when treating patients with renal insufficiency or requiring monitoring of renal function. The half-life increases in direct proportion to the deterioration in renal function and creatinine clearance; this is also true for the elderly,
in whom the excretion of creatinine is dependent on age.

The dose should be adjusted depending on the amount of creatinine clearance.

Dosing in patients with impaired liver function: Patients with impaired liver function do not need dose adjustment. For patients with impaired renal
and liverfunction,dosing is carried out according to the scheme (see subsection 'Dosing for patients with impaired renal function') .

Side effect

On the part of the blood and lymphatic system: frequency unknown: bleeding.

From the immune system: frequency unknown anaphylactoid reactions, hypersensitivity.

From the side of the central nervous system and psyche: often hyperactivity, nervousness; infrequently drowsiness, depression; frequency unknown agitation, anxiety, confusion, hallucinations, ataxia, imbalance, exacerbation of epilepsy, headache, insomnia, tremor.

On the part of the organ of hearing and the labyrinth: the frequency is unknown vertigo.

From the side of the cardiovascular system: rarely, thrombophlebitis, arterial hypotension (only with parenteral administration).

On the part of the digestive system: the frequency is unknown: abdominal pain
(including in the upper sections), diarrhea, nausea, vomiting.

Skin and subcutaneous tissue disorders : frequency unknown ngioneurotic edema, dermatitis, pruritus, urticaria.

On the part of the reproductive system: the frequency is unknown; increased sexual desire.

General disorders and disorders at the injection site: infrequently asthenia.

Laboratory and instrumental data: often an increase in body weight.

It is important to report the development of adverse reactions in order to ensure
continuous monitoring of the relationship between the benefits and risks of the drug.
If any of the side effects indicated in the instructions are aggravated,
or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Health care providers report adverse
drug reactions through national ADR systems
.

Overdose

Symptoms: a single case of development of dyspeptic phenomena in the form of diarrhea with blood and abdominal pain was registered when taking piracetam orally in a daily dose of 75 g, presumably due to the large total dose of sorbitol previously contained in piracetam preparations. Sorbitol is absent in this preparation, but care should be taken when taking piracetam and sorbitol together. No other symptoms of overdose have been reported.

Treatment: in case of a significant overdose, the stomach should be flushed or vomited. There is no specific antidote. Symptomatic therapy is recommended, which may include hemodialysis. The effectiveness of hemodialysis for piracetam is 50-60%.

Interaction with other medicinal products

Thyroid hormones

With the simultaneous use of piracetam with thyroid hormones (triiodothyronine + thyroxine), confusion, irritability and sleep disturbance were noted.

Acenocoumarol

In a published blind clinical study in patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g / day does not affect the dose of acenocoumarol required to achieve an international normalized ratio of 2.5-3.5, but compared to the effects of acenocoumarol alone , the addition of piracetam at a dose of 9.6 g / day significantly reduces platelet aggregation, the release of ?-thromboglobulin, the concentration of fibrinogen and von Willebrand factor (VIII: C; VIII: vW: Ag; VIII: vW: RCo), as well as the viscosity of whole blood and plasma.
Pharmacokinetic interactions

At a concentration of 142, 426 and 1422 ?g / ml, piracetam does not inhibit cytochrome P450 isoenzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 4A9 / 11) in vitro.
At a concentration of 1422 ?g / ml, minimal inhibition of the CYP isoenzyme 2A6 (21%) and 3A4 / 5 (11%) was observed. However, the values ??of the inhibition constant (Ki) are likely to go well beyond the concentration of 1422 ?g / ml.

Thus, metabolic interactions of piracetam with other drugs are unlikely. The possibility of changing the pharmacokinetics of piracetam under the influence of other drugs is low, since 90% of piracetam is excreted unchanged in the urine.

Anticonvulsants

Taking piracetam at a dose of 20 g / day for 4 weeks in patients with epilepsy who took constant doses of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, and valproic acid) did not change their maximum concentration and minimum concentration.

Alcohol

Concomitant use with alcohol did not affect the plasma concentration of piracetam; when taking 1.6 g of piracetam, the concentration of ethanol in plasma did not change.

special instructions

Effect on platelet aggregation

¬следствие антиагрегатного эффекта (смотри раздел Ђ‘армакодинамикаї), пирацетам следует назначать с осторожностью пациентам с т¤желыми геморрагическими нарушени¤ми, риском кровотечений (например, при ¤зве желудка), нарушени¤ми гемостаза, у пациентов с хирургическими вмешательствами, включа¤ стоматологические вмешательства, у пациентов, принимающих антикоагул¤нты и антиагреганты, в том числе низкие дозы ацетилсалициловой кислоты.

ѕочечна¤ недостаточность

ѕоскольку пирацетам выводитс¤ почками, следует соблюдать осторожность при назначении препарата пациентам с почечной недостаточностью (смотри раздел Ђ—пособ применени¤ и дозыї).

ќтмена терапии

ѕри лечении кортикальной миоклонии следует избегать резкого прерывани¤
лечени¤, поскольку это может вызвать возобновление приступов. ѕроникает через фильтрующие мембраны аппаратов дл¤ гемодиализа.

Ќатрий

ѕри лечении пациентов, наход¤щихс¤ на гипонатриевой диете, рекомендуетс¤ учитывать, что таблетки пирацетама в дозе 24 г содержат 46 мг натри¤.

ѕожилые пациенты

ѕри длительной терапии у пациентов пожилого возраста рекомендуетс¤ регул¤рный контроль функции почек, при необходимости провод¤т коррекцию дозы в зависимости от клиренса креатинина. ѕирацетам проникает через фильтрующие мембраны аппаратов дл¤ гемодиализа.

¬ли¤ние на способность управл¤ть транспортными средствами, механизмами

¬ период лечени¤ необходимо соблюдать осторожность при вождении автотранспорта и зан¤тии другими потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций.

‘орма выпуска

“аблетки, покрытые пленочной оболочкой, 200 мг, 400 мг, 800 мг, 1200 мг.

ѕо 10 таблеток в контурную ¤чейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой (дл¤ дозировки 200 мг, 400 мг).

ѕо 6 таблеток в контурную ¤чейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой (дл¤ дозировки 800 мг, 1200 мг).

2, 6 контурных ¤чейковых упаковок по 10 таблеток с инструкцией по применению помещают в пачку из картона (дл¤ дозировки 200 мг, 400 мг).

5 контурных ¤чейковых упаковок по 6 таблеток с инструкцией по применению помещают в пачку из картона (дл¤ дозировки 800 мг).

3, 4 blister packs of 6 tablets with instructions for use are placed in a carton box (for a dosage of 1200 mg).

Storage conditions

In a pack at a temperature not exceeding 25 ? —.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiration date.

Vacation conditions

Dispensed by prescription.

Name, address of the manufacturer of the medicinal product and the address of the place of manufacture of the medicinal product:

Marketing authorization holder, manufacturer:

JSC 'Industrial pharmaceutical company Obnovlenie'

Legal address: 633621, Novosibirsk region, Suzunsky district, rp. Suzun,
st. Commissar Zyatkov, 18.