olsalazine, Dipentum
GENERIC NAME: olsalazine
BRAND NAME: Dipentum
DRUG CLASS AND MECHANISM: Olsalazine is a derivative of
salicylic acid. Inactive by itself, it is converted by the
bacteria in the
colon to mesalamine. Mesalamine works as an anti-inflammatory
agent in
treating inflammatory diseases of the intestines. Its benefit
is believed
to be due to a local effect from within the bowel and,
therefore,
following oral administration very little (less than 10%) is
absorbed.
Mesalamine is thought to be the active component of
sulfasalazine
(Azulfidine). Olsalazine was approved by the FDA in July,
1990.
PRESCRIPTION: yes
GENERIC AVAILABLE: no
PREPARATIONS: Capsules (beige-orange) containing
250mg.
STORAGE: The capsules should be kept at room
temperature, 15-30°C
(59-86°F).
PRESCRIBED FOR: Olsalazine is used for the treatment of
mild to
moderately severe ulcerative colitis.
DOSING: Olsalazine is usually administered at a dose of
500mg
(two capsules) twice daily. It is taken with meals.
DRUG INTERACTIONS: There are no known drug interactions
with
olsalazine.
PREGNANCY: It is not known whether olsalazine crosses
the
placenta to the fetus.
NURSING MOTHERS: It is not
known whether olsalazine is secreted into breast milk.
SIDE EFFECTS: Gastrointestinal disturbances commonly
occur in
persons who take olsalazine. Diarrhea occurs in about 1 of every
6 persons who take it; about one in 20 need to discontinue therapy because the
diarrhea is severe. Abdominal pain or cramps occur in 1 in 10 persons, and
nausea or vomiting occurs in 1 in 20. Other side effects, including dizziness, depression, and headache, occur less frequently than
gastrointestinal effects during therapy. Rashes occurs in 2.3%
of persons
and joint pain in 4%.
Reference: FDA Prescribing Information
Last Editorial Review: 12/31/1997
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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