This document summarizes information about the drug sodium valproate, including its chemical properties, history of use, indications, dosing, mechanisms of action, side effects, contraindications, and considerations for special populations. Some key points are: - Sodium valproate is an anticonvulsant and mood stabilizer derived from valproic acid that is used to treat epilepsy and bipolar disorder. - It was first isolated in 1882 and first used clinically in 1964, gaining approval in various countries in the late 1960s and 1970s. - Its mechanisms of action involve increasing GABA transmission and blocking voltage-gated sodium channels. - Common side effects include weight gain,

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4. • Each film-coated controlled release
tablet contains: Sodium Valproate 333
mg and Valproic Acid 145 mg
(equivalent to Sodium Valproate 500
mg).

5. Valpoic Acid Sodium Valproate

6. b
Valproic acid (VPA) is
an organic weak acid
The conjugate base is
valproate
The sodium salt of the acid is
sodium valproate
VPA looses proton H+ and form

7. Separated(Burton) from juice of
Valeriana-1882

9. • For 80 years valporic acid is used as solvent
•After 80 years
First clinical trial in 1964( sodium
valproate and valporic acid)
It was launched in france in 1967 as
DEPAKINE
Britain-1973
USFDA approval-1978

10. • In the United States, AbbVie Inc.
(formerly Abbott Laboratories)
manufactures Depakine, and Depacon.
• In Europe, however, the drug is called
Depakine and is manufactured by Sanofi.

11. Indications
All types of epilepsy
VPA is extensively used in the treatment of
bipolar disorders
Other neurological conditions such as
migraine and neuropathic pain

12. 10-15 mg /kg/day
BID starting dose
Upto 600
mg/kg/day

13. 250 mg PO
q12hr;
adjust dose
based on clinical
response,
not to exceed
1000 mg/day

14. • VPA has been shown to reduce the
number of migraine attacks, as well
as their duration and intensity in 50
to 70% of patients for periods of
three months, up to one year or
longer

15. 750 mg/day PO in divided doses;
adjust dose as rapidly as possible to
desired therapeutic effect; not to
exceed 60 mg/kg/day

16. Acute mania or hypomania
• Step 1: Antipsychotic or valproate or lithium
• Step 2: add benzodiazepine
Prophylaxis bipolar
• First line : lithium
• Second line: valproate , antipsychotic

17. MOA

18. Carbamazepine
Lamotrigine
Oxcarbazepine
Phenytoin
Topiramate
Valproate
Ethosuximide
Levetiracetam
Pregabalin
Valproate
Barbiturates
Benzodiazepines
Gabapentin
Levetiracetam
Tiagabine
Topiramate
Valproate
Vigabatrin
Na+ Ca2+
GABA

19. MOA
There is no single mechanism of action that can explain valproate’s broad
effects on neuronal tissue. Its pharmacological effects include:
 increased gamma-aminobutyric acid transmission
 (GABA Trasaminase inhibitor, stimulates GABA
secretion)
 blockade of voltage-gated sodium channels
 modulation of dopaminergic and serotonergic
transmission

20. S/E
• Weight gain, Sleepiness, Tremors, Liver
injury, Dizziness, Paresthesia (tingling or
pricking sensation), Hypersensitivity, Anemia
(low number of red blood cells), Deafness,
Urinary incontinence, Decreased sodium level
in blood, Pain during periods

21. S/E
• VPA can cause direct bone marrow
suppression leading to aplastic anemia
• Hepatotoxicity: Regarding possible
hepatotoxicity of VPA, transient elevations of
hepatic enzymes without clinical symptoms
are seen in 15 to 30% of patients

22. C/I
When used by pregnant women, it has the
potential to harm their unborn children by
causing
still births,
 slowed neurological development,
and congenital birth defects.

23. C/I
• Pregnancy
• Lactating mothers
• Hepatic Disease

24. Elderly
• Increased sleepiness.
• More people stopped the medication for this
reason. Additional side effects of weight loss
and decreased food intake were also
associated with one-half of people who
become sleepy

25. Polycystic ovary syndrome (PCOS) is a
condition in which the ovaries produce an
abnormal amount of androgens, male sex
hormones that are usually present in
women in small amounts.

26. PCOS
• PCOS regarded as a controversial issue in
women with epilepsy.
• The syndrome is characterized by endocrine
dysfunction such as irregular menstruation or
amenorrhoea, hirsutism and infertility, but its
pathogenesis and clinical symptoms are
heterogeneous, and the syndrome is also
related to obesity, regardless of drug treatment

27. • polycystic ovary syndrome appear
to be more common with VPA as
compared to other AEDs

28. Valprot
• CNS India(Top 30)
• CNS Nepal

29. Target Customer
Psychiatrist
Neurologist
Who are prescribing Sodium Valprate

30. Strategy
• Identification of customer
• List preparation
• Launching
• Conversion from other brand to Valrot

31. Weakness/ Strength
• Brand Name
• Strong compititors
• Leveteracetam / Mind set

32. strength
• Bioequivalence study
• Strong recognition from psychiatrit / Strong
bonding

33. High Volume Product after long time
• IN
• SOLAR

35. •Thank
you