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Piracetam

Generic Name
Piracetam
Drug Type
Small Molecule
Chemical Formula
C6H10N2O2
CAS Number
7491-74-9
Unique Ingredient Identifier
ZH516LNZ10

Overview

Piracetam is a nootropic drug in the racetams group, with chemical name 2-oxo-1-pyrrolidine acetamide. It shares the same 2-oxo-pyrrolidone base structure with pyroglutamic acid and is a cyclic derivative of the neurotransmitter γ-aminobutyric acid (GABA). However its mechanism of action differ from that of endogenous GABA. Piracetam has neuroprotective and anticonvulsant properties and is reported to improve neural plasticity . Its efficacy is documented in cognitive disorders and dementia, vertigo, cortical myoclonus, dyslexia, and sickle cell anemia although the clinical application in these conditions is not yet established. Piracetam has effects on the vascular system by reducing erythrocyte adhesion to the vascular endothelium, hindering vasospasms and facilitating microcirculation . Originally marketed by UCB Pharma in 1971, piracetam was the first nootropic drug to modulate cognitive function without causing sedation or stimulation . It is not approved for any medical or dietary use by the FDA. In the UK, piracetam is prescribed mainly for myoclonus, but is used off-label for other conditions such as learning difficulties in children, memory loss or other cognitive defects in the elderly, and sickle-cell vaso-occlusive crises . Evidence to support its use for many conditions is unclear.

Background

Piracetam is a nootropic drug in the racetams group, with chemical name 2-oxo-1-pyrrolidine acetamide. It shares the same 2-oxo-pyrrolidone base structure with pyroglutamic acid and is a cyclic derivative of the neurotransmitter γ-aminobutyric acid (GABA). However its mechanism of action differ from that of endogenous GABA. Piracetam has neuroprotective and anticonvulsant properties and is reported to improve neural plasticity . Its efficacy is documented in cognitive disorders and dementia, vertigo, cortical myoclonus, dyslexia, and sickle cell anemia although the clinical application in these conditions is not yet established. Piracetam has effects on the vascular system by reducing erythrocyte adhesion to the vascular endothelium, hindering vasospasms and facilitating microcirculation . Originally marketed by UCB Pharma in 1971, piracetam was the first nootropic drug to modulate cognitive function without causing sedation or stimulation . It is not approved for any medical or dietary use by the FDA. In the UK, piracetam is prescribed mainly for myoclonus, but is used off-label for other conditions such as learning difficulties in children, memory loss or other cognitive defects in the elderly, and sickle-cell vaso-occlusive crises . Evidence to support its use for many conditions is unclear.

Indication

Indicated in adult patients suffering from myoclonus of cortical origin, irrespective of aetiology, and should be used in combination with other anti-myoclonic therapies .

Associated Conditions

  • Alcohol Dependency
  • Alcohol Withdrawal Syndrome
  • Cognitive Deficits caused by Injuries, Craniocerebral
  • Cognitive Dysfunctions
  • Cognitive Impairment (CI)
  • Comatose caused by Blood Vessel (Vascular) Dysfunction
  • Comatose caused by CNS Toxicity
  • Comatose caused by Traumas
  • Learning Disorders
  • Myoclonus
  • Sickle Cell Disease (SCD)
  • Giddiness caused by Injuries, Craniocerebral

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
CEBROTONIN TABLET 800 mg
SIN06408P
TABLET, FILM COATED
800 mg
7/4/1991
NOOTROPIL TABLET 1200 mg
SIN08988P
TABLET, FILM COATED
1200.00 mg
11/2/1996
NEUROCETAM CAPSULE 400 mg
SIN08477P
CAPSULE
400 mg
12/13/1995
NOOTROPIL TABLET 800 mg
SIN00574P
TABLET, FILM COATED
800.00 mg
4/29/1988
CETAM CAPSULE 400 mg
SIN10602P
CAPSULE
400 mg
1/6/1999
RACETAM CAPSULE 400 mg (Orange/white)
SIN10738P
CAPSULE
400 mg
2/11/1999
CETAM INJECTION 200MG/ML
SIN16054P
INJECTION
200MG/ML
11/30/2020

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Piracetam for Injection
国药准字H20050356
化学药品
注射剂
9/16/2023
Piracetam for Injection
国药准字H20050358
化学药品
注射剂
9/16/2023
Piracetam for Injection
国药准字H20040004
化学药品
注射剂
8/11/2020
Piracetam for Injection
国药准字H20158006
化学药品
注射剂
10/22/2020
Piracetam for Injection
国药准字H20041871
化学药品
注射剂
9/21/2020
Piracetam for Injection
国药准字H20041637
化学药品
注射剂
2/23/2021
Piracetam for Injection
国药准字H20050638
化学药品
注射剂
5/28/2020
Piracetam for Injection
国药准字H20056840
化学药品
注射剂
8/13/2020
Piracetam for Injection
国药准字H20041771
化学药品
注射剂(冻干粉针剂)
3/30/2020
Piracetam for Injection
国药准字H20050200
化学药品
注射剂
8/4/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
NOOTROPIL FILM-COATED TAB 800MG
N/A
N/A
N/A
3/5/1985

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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