Pentasa (Page 3 of 3)

OVERDOSAGE

Single oral doses of mesalamine up to 5 g/kg in pigs or a single intravenous dose of mesalamine at 920 mg/kg in rats were not lethal.

There is no clinical experience with PENTASA overdosage. PENTASA is an aminosalicylate, and symptoms of salicylate toxicity may be possible, such as: tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting, and diarrhea. Severe intoxication with salicylates can lead to disruption of electrolyte balance and blood-pH, hyperthermia, and dehydration.

Treatment of Overdosage. Since PENTASA is an aminosalicylate, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. This includes prevention of further gastrointestinal tract absorption by emesis and, if necessary, by gastric lavage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained.

DOSAGE AND ADMINISTRATION

The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1g (4 PENTASA 250 mg capsules or 2 PENTASA 500 mg capsules) 4 times a day for a total daily dosage of 4g. Treatment duration in controlled trials was up to 8 weeks.

PENTASA capsules may be swallowed whole, or alternatively, the capsule may be opened and the entire contents sprinkled onto applesauce or yogurt. The entire contents should be consumed immediately. The capsules and capsule contents must not be crushed or chewed.

Safety and efficacy of PENTASA in pediatric patients have not been established.

HOW SUPPLIED

Product: 68151-4769

NDC: 68151-4769-8 1 CAPSULE in a PACKAGE

Mesalamine 250 mg CR caps

Label ImageLabel Image
PENTASA mesalamine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-4769(NDC:54092-189)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 250 mg
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL
SILICON DIOXIDE
STEARIC ACID
TALC
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C GREEN NO. 3
GELATIN
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (green) , BLUE (blue) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code PENTASA;250;mg;S429;250;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-4769-8 1 CAPSULE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020049 05/10/1993
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-4769)

Revised: 08/2016 Carilion Materials Management

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