SIDE EFFECTS
Gastrointestinal
The most common adverse reactions are confined to the
gastrointestinal tract. To achieve minimal GI disturbance
with an optimal LDL-C lowering effect, a gradual increase
of dosage starting with 2 grams, once or twice daily is
recommended. Constipation is the major single complaint
and at times is severe. Most instances of constipation
are mild, transient, and controlled with standard treatment.
Increased fluid intake and inclusion of additional dietary
fiber should be the first step; a stool softener may be
added if needed. Some patients require decreased dosage
or discontinuation of therapy. Hemorrhoids may be aggravated.
Other, less frequent gastrointestinal complaints consist
of abdominal discomfort (abdominal pain and cramping),
intestinal gas (bloating and flatulence), indigestion
and heartburn, diarrhea and loose stools, and nausea and
vomiting. Bleeding hemorrhoids and blood in the stool
have been infrequently reported. Peptic ulceration, cholecystitis,
and cholelithiasis have been rarely reported in patients
receiving colestipol hydrochloride granules, and are not
necessarily drug related.
Difficulty swallowing and transient esophageal obstruction
have been rarely reported in patients taking COLESTID
Tablets.
Transient and modest elevations of aspartate amino-transferase
(AST, SGOT), alanine aminotransferase (ALT, SGPT) and
alkaline phosphatase were observed on one or more occasions
in various patients treated with colestipol hydrochloride.
The following nongastrointestinal adverse reactions have
been reported with generally equal frequency in patients
receiving COLESTID Tablets, colestipol granules, or placebo
in clinical studies:
Cardiovascular
Chest pain, angina, and tachycardia have been infrequently
reported.
Hypersensitivity
Rash has been infrequently reported. Urticaria and dermatitis
have been rarely noted in patients receiving colestipol
hydrochloride granules.
Musculoskeletal
Musculoskeletal pain, aches and pains in the extremities,
joint pain and arthritis, and backache have been reported.
Neurologic
Headache, migraine headache, and sinus headache have
been reported. Other infrequently reported complaints
include dizziness, light-headedness, and insomnia.
Miscellaneous
Anorexia, fatigue, weakness, shortness of breath, and
swelling of the hands or feet, have been infrequently
reported.
DRUG INTERACTIONS
Since colestipol hydrochloride is an anion exchange resin,
it may have a strong affinity for anions other than the
bile acids. In vitro studies have indicated that colestipol
hydrochloride binds a number of drugs. Therefore, COLESTlD
Tablets may delay or reduce the absorption of concomitant
oral medication. The interval between the administration
of COLESTID Tablets and any other medication should be
as long as possible. Patients should take other drugs
at least one hour before or four hours after COLESTID
Tablets to avoid impeding their absorption.
Repeated doses of colestipol hydrochloride given prior
to a single dose of propranolol in human trials have been
reported to decrease propranolol absorption. However,
in a follow-up study in normal subjects, single-dose administration
of colestipol hydrochloride and propranolol and twice-a-day
administration for 5 days of both agents did not affect
the extent of propranolol absorption, but had a small
yet statistically significant effect on its rate of absorption;
the time to reach maximum concentration was delayed approximately
30 minutes. Effects on the absorption of other beta-blockers
have not been determined. Therefore, patients on propranolol
should be observed when COLESTID Tablets are either added
or deleted from a therapeutic regimen.
Studies in humans show that the absorption of chlorothiazide
as reflected in urinary excretion is markedly decreased
even when administered one hour before colestipol hydrochloride.
The absorption of tetracycline, furosemide, penicillin
G, hydrochlorothiazide, and gemfibrozil was significantly
decreased when given simultaneously with colestipol hydrochloride;
these drugs were not tested to determine the effect of
administration one hour before colestipol hydrochloride.
No depressant effect on blood levels in humans was noted
when colestipol hydrochloride was administered with any
of the following drugs: aspirin, clindamycin, clofibrate,
methyldopa, nicotinic acid (niacin), tolbutamide, phenytoin
or warfarin. Particular caution should be observed with
digitalis preparations since there are conflicting results
for the effect of colestipol hydrochloride on the availability
of digoxin and digitoxin. The potential for binding of
these drugs if given concomitantly is present. Discontinuing
colestipol hydrochloride could pose a hazard to health
if a potentially toxic drug that is significantly bound
to the resin has been titrated to a maintenance level
while the patient was taking colestipol hydrochloride.
Bile acid binding resins may also interfere with the
absorption of oral phosphate supplements and hydrocortisone.
|
|
