Adverse Reaction:
Cardiovascular-
Pericarditis, second degree heart block, hypertension, orthostatic hypotension, peripheral edema, chest pains, tachycardia, palpitations.
Parathesia, tremors, mood swings, irritability, fever, chills. Pancreatitis, rectal bleeding, flare in symptoms, rectal discomfort.
Photosensitivity, erythema, hot flushes,alopecia.
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
OLSALAZINE -Oral
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Olsalazine, mesalamine, sulsasalazine, or any salycylates eg aspirin,
Also tell your healthcare care professional if you are allergic to any other
substances such as foods. preservatives or dyes.
2.Pregnancy-
Olsalazine has not been done in pregnant women.However, before
taking this medicine, make sure that your doctor knows if you are
pregnant or if you may become pregnant
3. Breast-feeding-
It is not known whether olsalazine passes into human breast milk.
However, studies in rats have shown that olsalazine causes birth defects
and other problems at doses 5 to 20 times the human dose.
It may be necessry for you to use another medicine or to stop breast feeding
during treatment. Be sure you have discused the risks and benefits
with your doctor.
4.Children-
Studies of this medicine has been done only in adult patients and there is no specific
information comparing use of olsalazine in children with use in other age groups.
5.Older adults-
Although there is no specific information comparing use of olsalazine in the elderly
with use in other age groups, this medicine is not expected to cause different side
effects or problems than it does in younger adults.
6. Other medicines-
Tell your doctor if you are using any other prescription or non-prescription
(Over-the counter) OTC medicine.
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Kidney disease- use of olsalazine may cause damage to kidneys
Pharmacology/ Pharmacokinetics:
Pharmacology:
Olsalazine sodium is a sodium salt of a salicylate compound that is effectively bioconverted to 5-aminosalicylic acid(mesalamine;5-ASA) which has anti- inflammatory activity in ulcerative colitis Mechanism of mesalamine is unknown, but appears topical rather than systemic. It possibly diminishes colonic inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in bowel mucosa.
Pharmacokinetics:
Approximately 2.4% of a single dose 1g dose is absorbed. Maximum serum concentration appear after approximately 1 hour. Olsalazine has a short serum hal-life of abour 0.9 hours and more than 99% is bound to plasma proteins.