COLESTID ORANGE 5G

Active substance: COLESTIPOL HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Colestid Orange 5g

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Colestipol Hydrochloride USP 5.0 gram

3.

PHARMACEUTICAL FORM
Granules for oral administration.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Colestid is indicated as adjunctive therapy to diet in the management of
patients with elevated cholesterol levels who have not responded adequately to
diet. It may be used alone or in combination with additional lipid lowering
agents.
Dietary therapy specific for the type of hypercholesterolaemia should be the
initial treatment of choice. Excess body weight may be an important factor and
weight reduction should be attempted prior to drug therapy in the overweight.
The use of drugs should be considered only when reasonable attempts have
been made to obtain satisfactory results with non-drug methods. When drug
therapy is begun, the patient should be instructed of the importance of
adhering to the correct diet.
Although Colestid is effective in all types of hypercholesterolaemia, it is
medically most appropriate in patients with Fredrickson’s type II
hyperlipoproteinaemia.

4.2.

Posology and Method of Administration
Route of administration: Oral, mixed with water or other fluids.
Adults:

The recommended initial daily adult dosage of colestipol hydrochloride is 5
grams either once or twice daily.
For adults colestipol hydrochloride is recommended in doses of 5-30 grams
taken as one dose or two divided doses. Initiation of therapy is recommended
at 5 grams either once or twice daily with 5 gram increments at one month
intervals. Appropriate use of lipid profiles including LDL-cholesterol and
triglycerides is advised so that optimal, but not excessive doses are used to
obtain the desired therapeutic effect on LDL-cholesterol level. If the desired
therapeutic effect is not obtained at a dose of 5-30 grams/day with good
compliance and acceptable side-effects, combined therapy or alternate
treatment should be considered.
Patients should take other drugs at least one hour before or four hours after
Colestid to minimise possible interference with their absorption. However,
Colestid and gemfibrozil may be used in the same patient when administered 2
hours apart. (See interactions).
Preparation:
Colestid should always be taken mixed in a liquid such as orange or tomato
juice, water, skimmed milk or non-carbonated beverage. The contents of the
sachet or level scoopful should be added to 100 ml or more of the preferred
aqueous vehicle and mixed thoroughly until dispersed. Colestid may also be
taken in soups or with cereals, pulpy fruits with a high water content or
yoghurt.
Elderly patients:
At present there are no extensive clinical studies with colestipol in patients
over the age of 65. Review of available data does not suggest that the elderly
are more predisposed to side-effects attributable to colestipol than the general
population; however, therapy should be individualised and based on each
patient’s clinical characteristics and tolerance to the medication.
Children:
Dosage in children has not been established.

4.3.

Contra-Indications
Colestipol is contra-indicated in individuals
demonstrated hypersensitivity to its use.

4.4.

who

have

previously

Special Warnings and Special Precautions for Use
Warnings:
Before instituting therapy with Colestid, diseases contributing to increased
blood cholesterol such as hypothyroidism, diabetes mellitus, nephrotic

syndrome, dysproteinaemias and obstructive liver diseases should be looked
for and specifically treated.
To avoid accidental inhalation or oesophageal distress, Colestid should not be
taken in its dry form.
Colestid Orange contains 0.0325 g aspartame per sachet or level scoopful.
This should be taken into consideration in patients suffering from
phenylketonuria since excessive amounts of aspartame may interfere with the
control of this condition.
Colestid may elevate serum triglyceride levels when used as sole therapy. This
elevation is generally transient but may persist in some individuals. A
significant rise in triglyceride level should be considered as an indication for
dose reduction, drug discontinuation, or combined or alternate therapy.
The use of Colestid in children has been limited; however, it does appear to be
effective in lowering serum cholesterol in older children and young adults.
Because bile acid sequestrants may interfere with the absorption of fat-soluble
vitamins, appropriate monitoring of growth and development is essential.
Dosage and long term safety in children have not been established.
Precautions:
Because it sequesters bile acids, Colestid may interfere with normal fat
absorption and thus may alter absorption of fat soluble vitamins such as A, D,
E and K. A study in humans found only one patient in whom a prolonged
prothombin time was noted. Most studies did not show a decrease in vitamin
A, D or B levels during the administration of Colestid; however, if Colestid is
to be given for a long period these vitamin levels should be monitored and
supplements given if necessary.

4.5.

Interaction with other Medicinal Products and other Forms of Interaction
In man, Colestid may delay or reduce the absorption of certain concomitant
oral drugs (digitalis and its glycosides, propranolol, chlorothiazide and
hydrochlorothiazide, tetracycline hydrochloride, penicillin G, gemfibrozil and
furosemide). Particular caution should be taken with digitalis preparations
since conflicting results have been obtained for the effect of Colestid on the
availability of digoxin and digitoxin. Colestid has been shown not to interfere
with the absorption of clindamycin, clofibrate, aspirin, tolbutamide, warfarin,
methyldopa and phenytoin. The clinical response to concomitant medication
should be closely monitored and appropriate adjustments made.
Repeated doses of Colestid 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 Colestid
and propranolol or multiple dose administration of both agents did not affect
the extent of propranolol absorption. Effects on the absorption of other beta-

blockers have not been determined. Patients on propranolol should be
observed when Colestid is either added or deleted from a therapeutic regimen.

4.6.

Pregnancy and Lactation
Safety for use in pregnant women has not been established. The use of
Colestid in pregnancy or lactation or by women of childbearing age requires
that the potential benefits of treatment be weighed against the possible hazards
to the mother and child.

4.7.

Effects on Ability to Drive and Use Machines
No adverse effect has been reported.

4.8.

Undesirable Effects
Side-effects:
The most common adverse reactions reported with Colestid have been of a
functional gastro-intestinal nature. The most frequent is constipation which is
usually mild, transient and responsive to the usual adjunctive measures. At
times, constipation can be severe and may be accompanied by impaction. As
such, haemorrhoids can be aggravated, and infrequent blood in the stools has
been reported. Less frequent gastro-intestinal complaints are abdominal
discomfort, belching, flatulence, indigestion, nausea, vomiting and diarrhoea.
Rarely, peptic ulceration and bleeding, cholelithiasis and cholecystitis have
been reported, although these are not necessarily drug related.
Transient and modest elevation of SGOT and alkaline phosphatase have been
observed. No medical significance is attached to these observed changes.
Although not necessarily drug-related, the following non-gastro-intestinal
medical events have been reported during clinical trials at a similar incidence
to placebo.
Cardiovascular: Chest pain, angina, and tachycardia have been infrequently
reported.
Hypersensitivity: Rash has been infrequently reported. Urticaria and dermatitis
have been rarely noted.
Musculoskeletal: Musculoskeletal pain, aches and pains in the extremities,
joint pain and arthritis, and backache have been reported.

Neurological: Headache, migraine headache and sinus headache have been
reported. Other infrequently reported complaints include dizziness, lightheadedness, and insomnia.
Miscellaneous: Anorexia, fatigue, weakness, shortness of breath, and swelling
of the hands or feet, have been infrequently reported.

4.9.

Overdose
No toxic effects due to overdosage have been reported. Should overdosage
occur, obstruction of the gastro-intestinal tract would be expected to occur.
Treatment should be determined by the location and degree of obstruction.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Ion exchange resin which lowers plasma cholesterol through binding with bile
acids in the intestinal lumen.

5.2.

Pharmacokinetic Properties
Colestid is not absorbed; its action is limited to the lumen of the gastrointestinal tract, and it is passed in the faeces. It binds bile acids in the intestinal
lumen and causes them to be excreted in the faeces together with the polymer.
When the enterohepatic circulation of bile acids is interrupted, cholesterol
conversion to bile acids is enhanced and plasma cholesterol levels are thereby
lowered.

5.3.

Pre-clinical Safety Data
Both clinical usage and animal studies with Colestid have provided no
evidence of drug related intestinal neoplasms. Colestid is not mutagenic in the
ames test.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Mannitol
Methylcellulose (J5CPS)
Citric Acid
Orange Durarome Wonf
Aspartame Powder
Maltol
Ethyl Vanillin
Beta Carotene 1%
Glycerol
Purified Water

6.2.

Ph. Eur.
Ph. Eur.
Ph. Eur.
HSE
NF
HSE
NF
HSE
Ph. Eur.
Ph. Eur.

Incompatibilities
None.

6.3.

Shelf-Life
24 months.

6.4.

Special Precautions for Storage
Store at controlled room temperature (15-30°C).

6.5.

Nature and Contents of Container
HDPE bottle with plastic caps or tinplate screwcaps containing 450 grams or
foil sachets in packs of 8, 28, 30, 56, 60 and 250 sachets.

6.6.

Instructions for Use, Handling and Disposal
None.

7

MARKETING AUTHORISATION HOLDER
Pharmacia Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00032/0172

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/10/2002

10

DATE OF REVISION OF THE TEXT
27/06/2007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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