Colestipol

Chemical formula: C₁₁H₂₈ClN₅O  Molecular mass: 281.198 g/mol  PubChem compound: 62816

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 development, parturition or postnatal development, caution should be exercised when prescribing to pregnant women.

The use of colestipol in pregnancy or by women of childbearing age requires that the potential benefits of treatment be weighed against the possible hazards to the mother and child.

Nursing mothers

The safety of colestipol hydrochloride has not been established in breast-feeding women. Caution should be exercised when prescribing to breast-feeding women.

Carcinogenesis, mutagenesis and fertility

Fertility

There are no data on the effect of colestipol hydrochloride on fertility in humans. A study conducted in rats did not result in any differences in reproductive parameters that might imply reproductive effects attributable to colestipol hydrochloride.

Effects on ability to drive and use machines

No adverse effect has been reported.

Adverse reactions


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:

Metabolism and nutrition disorders

Uncommon: Decreased appetite

Psychiatric disorders

Uncommon: Insomnia

Nervous system disorders

Very common: Migraine, Sinus headache, Headache

Uncommon: Dizziness

Cardiac disorders

Uncommon: Angina pectoris, Tachycardia

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Gastrointestinal disorders

Very common: Constipation, Abdominal pain, Abdominal discomfort

Common: Haematochezia, Haemorrhoidal haemorrhage, Abdominal distention, Dyspepsia, Nausea, Vomiting, Diarrhoea, Flatulence, Eructation

Uncommon: Peptic ulcer and bleeding, Haemorrhoids, Impaction

Hepatobiliary disorders

Uncommon: Cholecystitis, Cholelithiasis

Skin and subcutaneous tissue disorders

Common: Rash

Uncommon: Urticaria, Dermatitis

Musculoskeletal and connective tissue disorders

Common: Arthritis, Arthralgia, Back pain, Musculoskeletal pain, Pain in extremity

General disorders and administration site conditions

Common: Fatigue

Uncommon: Chest pain, Oedema peripheral, Asthenia

Investigations

Uncommon: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased

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