DIACOMIT Capsule / Powder for suspension Ref.[10826] Active ingredients: Stiripentol

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Table 3. Description:

Proprietary Name DIACOMIT
Established Name Stiripentol
Route of Administration Oral
Chemical Name 4,4-dimethyl-1-[3,4-(methylendioxyphenyl)-1-pentene-3-ol
Structural Formula

Stiripentol is a white to pale yellow crystalline powder with a bitter taste; it is practically insoluble in water (at 25°C), sparingly soluble in chloroform, and soluble in acetone, ethanol, ether, acetonitrile, and dichloromethane. The melting point is approximately 75°C. The pKa is 14.2, and measurement of the partition coefficient (water-octanol) provides a Log P value of 2.94. The molecular formula is C14H18O3 and the molecular weight is 234.3.

Capsules

DIACOMIT capsules contain 250 mg (size 2: pink) or 500 mg (size 0: white) of stiripentol. Capsules also contain the following inactive ingredients: erythrosine (250 mg capsule only), gelatin, indigotine (250 mg capsule only), magnesium stearate, povidone, sodium starch glycolate, titanium dioxide.

Powder for Suspension

DIACOMIT powder for oral suspension packets contain 250 mg or 500 mg of stiripentol. DIACOMIT packets also contain the following inactive ingredients: aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, fruit flavor (acacia, Bergamot oil, hypromellose, maltodextrin, sorbitol, and vanillin).

Dosage Forms and Strengths

Capsules:

  • 250 mg: size 2, pink, and imprinted with “Diacomit” and "250mg"
  • 500 mg: size 0, white, and imprinted with “Diacomit” and "500mg"

Powder for Oral Suspension:

  • Pale pink fruit flavored powder packaged in packets. Each packet contains either 250 mg or 500 mg of stiripentol
How Supplied

DIACOMIT Capsules

  • 250 mg: size 2, pink, and imprinted with “Diacomit” and “250mg” are supplied as follows: Bottles of 60 NDC 68418-7939-6
  • 500 mg: size 0, white, and imprinted with “Diacomit” and “500mg” are supplied as follows: Bottles of 60 NDC 68418-7940-6

Powder for Oral Suspension

  • 250 mg: pale pink fruit flavored powder packaged in packets are supplied as follows: Cartons of 60 NDC 68418-7941-6
  • 500 mg: pale pink fruit flavored powder packaged in packets are supplied as follows: Cartons of 60 NDC 68418-7942-6

DIACOMIT Capsules and DIACOMIT Powder for Suspension manufactured by: BIOCODEX
1, avenue Blaise Pascal, 60000 BEAUVAIS, France.

Drugs

Drug Countries
DIACOMIT Austria, Australia, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States, South Africa
 
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