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Colestipol oral

Presentation

Oral formulations of colestipol hydrochloride

Drugs List

  • colestipol granules sugar-free
  • Therapeutic Indications

    Uses

    Treatment of primary hypercholesterolaemia resistant to diet

    To be used as adjunctive therapy to diet in the management of patients with hypercholesterolaemia with an inadequate response to dietary changes. Use of colestipol is most appropriate in patients with Fredrickson's type II hyperlipoproteinaemia.

    To be used alone or with additional lipid lowering drugs.

    Dosage

    Adults

    Initially, 5g mixed with at least 100ml fluid once or twice daily. Increase in 5g increments at monthly intervals, up to a recommended dose of 5g to 30g daily. Dose to be taken in one to two divided doses.

    Appropriate use of lipid profiles including LDL cholesterol and triglycerides is advised so that the optimum but not excessive dose is used. If the desired therapeutic effect is not obtained at a dose of 30g daily with good patient compliance and acceptable side effects, combined therapy or alternate treatment should be considered.

    Children

    Familial hypercholesterolaemia (unlicensed)
    Children aged 12 to 18 years
    Initially, 5g once or twice daily. If necessary, increase dose monthly in 5g increments, to a maximum of 30g daily in one to two divided doses.

    Contraindications

    Children under 12 years

    Precautions and Warnings

    Children aged 12 to 18 years
    Breastfeeding
    Phenylketonuria
    Pregnancy

    Some formulations contain aspartame - caution in phenylketonuria
    Exclude secondary causes of hypercholesterolaemia before treatment
    Administer concurrent drugs 1 hour before or 4-6 hrs after this medication
    Monitor serum triglyceride concentration
    Supplements of fat-soluble vitamins A,D,E and K may be required
    Dietary restrictions should be maintained
    This product should not be taken in the dry form-mix with fluid as directed

    Appropriate dietary therapy should be the initial treatment of choice. Weight reduction should be attempted in patients with excess body weight prior to drug treatment.

    Before instituting therapy patients should be evaluated and treated for any diseases which contribute to increased blood cholesterol such as hypothyroidism, diabetes mellitus, nephrotic syndrome, dysproteinaemias and obstructive liver diseases.

    Colestipol may cause elevation of serum triglyceride levels when used as sole therapy. This may be transient but may persist in some patients. If a significant rise in triglycerides occurs, consider dose reduction, drug discontinuation, or combined or alternative therapy.

    Pregnancy and Lactation

    Pregnancy

    Use colestipol with caution in pregnancy. Safety for its use has not been established.

    Briggs (2015) suggests that less than 0.17% of a dose is absorbed systemically, therefore it is not expected to produce foetal harm when administered in recommended doses during pregnancy. Animal studies in rats and rabbits showed no adverse effects to the foetus. However the prolonged usage of colestipol may cause reduced maternal absorption of the fat soluble vitamins A, D, E and K. Cessation of colestipol during pregnancy will not impact upon the long-term treatment of hyperlipidaemia and so it is probably best to halt the use of colestipol during pregnancy.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use colestipol with caution in breastfeeding.

    Colestipol is not absorbed in significant amounts into the systemic circulation and is unlikely to enter the breast milk and so is not considered to pose a risk for the breastfed infant.

    Briggs (2015) suggests that the long-term use of colestipol may cause reduced maternal absorption of the fat soluble vitamins A, D, E and K. The resulting maternal deficiencies would be reflected in the amounts of these vitamins in her milk. Cessation of this medication during breastfeeding will not impact upon the long-term treatment of hyperlipidaemia, therefore the use of colestipol should be reviewed during breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Counselling

    Patients should be advised to take other drugs at least one hour before or four hours after colestipol.
    Patients should be advised of the importance of adhering to the dietary restrictions.

    Patients should be advised of the suitable fluids for suspension of the colestipol granules which include water, fruit juices, skimmed milk or non-carbonated beverages. Colestipol granules may also be taken in soups, or with cereals, pulpy fruits with a high water content or yoghurt.

    Side Effects

    Abdominal discomfort
    Angina
    Anorexia
    Arthritis
    Backache
    Belching
    Blood in stool
    Breathlessness
    Chest pain
    Cholecystitis
    Cholelithiasis
    Constipation
    Dermatitis
    Diarrhoea
    Dizziness
    Elevated triglyceride levels
    Exacerbation of haemorrhoids
    Faecal impaction
    Fatigue
    Flatulence
    Gastrointestinal bleeding
    Headache
    Increase in alkaline phosphatase
    Increased bleeding tendency
    Increases in serum transaminases (transient)
    Indigestion
    Insomnia
    Joint pain
    Light-headedness
    Migraine
    Musculoskeletal pain
    Nausea
    Painful extremities
    Peptic ulceration
    Rash
    Slight swelling of hands and feet
    Tachycardia
    Urticaria
    Vomiting
    Weakness

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: February 2017

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Colestid granules for oral suspension. Pfizer Limited. Revised February 2015.

    Summary of Product Characteristics: Colestid Orange 5g. Pfizer Limited. Revised February 2015.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 June 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Colestipol oral. Last revised: 7 September 2013
    Last accessed: 28 February 2017

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