COLESTID Granule for oral suspension (2020)
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Περιεχόμενα
Name of the medicinal product
Colestid granules for oral suspension 5 g.
Qualitative and quantitative composition
Each level scoopful or sachet contains 5 g of colestipol hydrochloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Granules for oral suspension. Light yellow, tasteless and odourless granules.
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 ...
Posology and method of administration
Route of administration Oral, mixed with water or other fluids. Posology Adults The recommended initial daily adult dosage of colestipol hydrochloride is 5 g either once or twice daily. For adults colestipol ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and 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 ...
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 and hydrochlorothiazide, tetracycline hydrochloride, penicillin G, gemfibrozil ...
Fertility, pregnancy and lactation
Pregnancy No clinical data are available on the use of colestipol hydrochloride in pregnant women. Though animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal ...
Effects on ability to drive and use machines
No adverse effect has been reported.
Undesirable effects
Adverse events are described by system organ class and frequency (very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; rare ≥1/10,000 to <1/1,000; very rare <1/10,000) in the table below: ...
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 would be determined by the location and ...
Pharmacodynamic properties
Pharmacotherapeutic group: bile acid sequestrants ATC code: C10AC02 Ion exchange resin which lowers plasma cholesterol through binding with bile acids in the intestinal lumen.
Pharmacokinetic properties
Colestid is not absorbed; its action is limited to the lumen of the gastro-intestinal tract, and it is passed in the faeces. It binds bile acids in the intestinal lumen and causes them to be excreted in ...
Preclinical safety data
Both clinical and animal studies with Colestid have provided no evidence of drug related intestinal neospasms. Colestid is not mutagenic in the Ames test. Reproduction and teratologic studies in animals ...
List of excipients
Colloidal anhydrous silica
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Paper/Aluminium foil/vinyl sachets of 5 g (in packs of 10 or 30 sachets). Pack size: 5 g. Amber glass bottle with screw cap or HDPE bottle with screw cap or tamper-evident cap. Pack size: 250 g.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0950
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 October 1992 Date of latest renewal: 16 June 2010
Date of revision of the text
07/2020
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