Noopept (Ombreracetam) 10 mg, 50 pcs.

Otisifarm, Russia

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Product Overview

Composition

Active substance: 

Oberacetam (noopept) - 10.0 mg;

Excipients: 

lactose monohydrate - 55.0 mg, 

potato starch - 13.5 mg, 

microcrystalline cellulose 101 - 21.2 mg, 

magnesium stearate - 0.3 mg, 

povidone (polyvinyl-pyrrolidone, povidone K-25) - 0.0008 mg.

pharmachologic effect

Pharmacotherapeutic group: nootropic agent.

ATX Code: N06BX

Pharmacological properties

Pharmacodynamics

Noopept ® has nootropic and neuroprotective properties. Improves learning ability and memory, acting on all phases of processing: initial processing of information, consolidation, extraction. It prevents the development of amnesia caused by electric shock, blockade of central cholinergic structures, glutamatergic receptor systems, deprivation of the paradoxical phase of sleep. 

The neuroprotective (protective) effect of Noopept ®  is manifested in increasing the stability of brain tissue to damaging effects (trauma, hypoxia, electroconvulsive, toxic) and weakening the degree of damage to brain neurons. 

The drug reduces the volume of the focus on the thrombotic model of stroke and prevents the death of neurons in the tissue culture of the cerebral cortex and cerebellum exposed to neurotoxic concentrations of glutamate, free radical oxygen. 

Noopept ®  has an antioxidant effect, blocks the potential-dependent calcium channels of neurons, weakening the neurotoxic effect of excess calcium, improves the rheological properties of blood, possessing antiplatelet, fibrinolytic, anticoagulant properties.

The nootropic effect of the drug is associated with the formation of cycloprolylglycine, which is similar in structure to an endogenous cyclic dipeptide with antiamnestic activity, as well as with the presence of cholinopositive action.

Noopept ®  increases the amplitude of the transcallosal response, facilitating the associative connections between the cerebral hemispheres at the level of cortical structures. It contributes to the restoration of memory and other cognitive functions impaired as a result of damaging effects - brain injury, local and global ischemia, prenatal injuries (alcohol, hypoxia).

Therapeutic effect of the drug in patients with organic disorders

the central nervous system is manifested starting from 5-7 days of treatment. Initially, the anxiolytic and mild stimulating effects available in the Noopept ® activity spectrum are realized , which are manifested in the reduction or disappearance of anxiety, increased irritability, affective lability, and sleep disturbances. After 14-20 days of therapy, a positive effect of the drug on cognitive functions, attention and memory parameters is revealed.

Noopept ®  has a vegetonormalizing effect, helps to reduce headaches, orthostatic disorders, tachycardia.

When the drug is canceled, there is no "withdrawal" syndrome.

It does not have a damaging effect on internal organs; does not lead to a change in the cellular composition of blood and biochemical parameters of blood and urine; does not have immunotoxic, teratogenic effects, does not exhibit mutagenic properties.

Pharmacokinetics

Omberacetam, absorbed in the gastrointestinal tract, enters the systemic circulation unchanged, penetrates the blood-brain barrier, is detected in the brain in higher concentrations than in the blood. The time to reach maximum concentration on average is 15 minutes. 

The half-life from blood plasma is 0.38 hours. It is partially preserved unchanged, partially metabolized to form phenylacetic acid, phenylacetylproline and cycloprolylglycine. It has a high relative bioavailability (99.7%), does not cumulate in the body, and does not cause drug dependence.

Indications

Impaired memory, attention, other cognitive functions and emotionally labile disorders (including in elderly patients) with:

 

  • consequences of traumatic brain injury,

  • post-commotion syndrome

  • cerebrovascular insufficiency (encephalopathies of various origins),

  • asthenic disorders

  • other conditions with signs of decreased intellectual productivity.

Pregnancy and lactation

The drug is contraindicated in pregnancy.

If it is necessary to use the drug during breastfeeding, it is necessary to decide on the termination of breastfeeding.

Contraindications

Pregnancy, the period of breastfeeding. Age to 18 years. Hypersensitivity to the components of the drug. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption. Severe impaired liver and kidney function.

Side effects

Allergic reactions are possible.

In patients with arterial hypertension, mainly of a severe degree, an increase in blood pressure may be observed while taking the drug.

Interaction

No interaction of Noopept ® with alcohol, hypnotics and hypotensive drugs and psychostimulating drugs has been established.

How to take, course of administration and dosage

Noopept® is used orally after meals.
Treatment begins with a dose of 20 mg, divided into two doses of 10 mg during the day (morning and afternoon). 
With insufficient effectiveness of therapy and with good tolerability of the drug, the dose is increased to 30 mg (see. "Special Instructions"), distributing it into three doses of 10 mg per day. 
You should not take the drug later than 18 hours. The duration of the course of treatment is 1.5 to 3 months.
A second course of treatment, if necessary, can be carried out after 1 month.

Overdose

Specific manifestations of an overdose have not been established.

Special instructions

If you need to increase the dose of the drug (up to 30 mg / day), with prolonged use, as well as with simultaneous use with other drugs, the appearance of adverse reactions or worsening conditions, you should consult a doctor.

 

Influence on the ability to drive vehicles, mechanisms 

Noopept ® does not affect the ability to drive mechanisms and vehicles.

Release form

Tablets, 10 mg.

25 tablets per blister pack of polyvinyl chloride film and aluminum foil.

2 blister strip packaging along with instructions for use are placed in a pack of cardboard.

Storage conditions

At a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life

3 years

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