ic blood pressure, and controlling convulsions. Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.
DOSAGE AND ADMINISTRATION
The usual dosage of TRENTAL in extended-release tablet form is one tablet (400 mg) three times a day with meals.
While the effect of TRENTAL may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.
Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of TRENTAL should be discontinued.
HOW SUPPLIED
TRENTAL (pentoxifylline) is available for oral administration as 400-mg pink film-coated oblong tablets imprinted Trental; supplied in bottles of 100 (NDC 0039-0078-10).
Store between 59 and 86° F (15 and 30° C).
Dispense in well-closed, light-resistant containers.
Rev. October 2007
US Patents 3,737,433 & 4,189,469
US Patent 3,737,433 patent term has been extended.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
©2007 sanofi-aventis U.S. LLC
PRINCIPAL DISPLAY PANEL - Label
NDC 0039-0078-10
Trental®
pentoxifylline
Tablets
400mg
100 Tablets
sanofi aventis
TRENTAL
pentoxifylline tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0039-0078
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pentoxifylline(pentoxifylline) pentoxifylline 400mg
Inactive Ingredients
Ingredient Name Strength
FD&C Red No. 3
hypromellose
magnesium stearate
polyethylene glycol
povidone
talc
titanium dioxide
hydroxyethyl cellulose (2000 CPS AT 1%)
Product Characteristics
Color PINK Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code TRENTAL
Contains
Packaging
NDC Package Description Multilevel Packaging
1 0039-0078-10 100TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018631 08/30/1984
Labeler -Sanofi-Aventis U.S. LLC(824676584)
Establishment
Name Address ID/FEI Operations
Patheon Pharmaceuticals Inc. 005286822 MANUFACTURE
Establishment
Name Address ID/FEI Operations
sanofi-aventis Canada Inc. 251046934 MANUFACTURE
