Chemical formula: C₇H₁₁ClN₂O Molecular mass: 174.056 g/mol
Colestilan interacts in the following cases:
No in vivo data are available on the possible interaction of colestilan on the absorption of the immunosuppressant medicinal products mycophenolate mofetil, ciclosporin or tacrolimus. However, decreased blood concentrations have been reported for medicinal products with a similar mechanism of action to colestilan. Caution should be exercised when prescribing colestilan to patients receiving immunosuppressants.
Patients with seizure disorders were excluded from clinical trials with colestilan. Caution should be exercised when prescribing colestilan to patients also taking anti-seizure medicinal products.
Colestilan did not induce a clinically relevant reduction in folate absorption during clinical studies of up to one year. However, intestinal folate absorption may be impaired during long-term treatment of colestilan. In these patients, monitoring serum folate status and supplementation with folic acid should be considered.
Caution should be exercised when treating patients with conditions which predispose to gastrointestinal haemorrhage, such as recent history of gastrointestinal haemorrhage, gastrointestinal ulcers, gastritis, diverticulosis, colitis and haemorrhoids.
Close monitoring of patients with hypothyroidism is recommended when levothyroxine is co-administered with colestilan.
Colestilan did not induce any clinically relevant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year. However, caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies, such as patients with malabsorption syndromes and patients treated with coumarin anticoagulants (e.g. warfarin). In these patients, monitoring of vitamin A, D and E concentrations or assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Colestilan is not absorbed and is not systemically available. No direct effects of colestilan are thus anticipated. However, other effects of colestilan may affect pregnant women.
No data are available to assess the safety and efficacy in pregnant women. Patients that become pregnant and where a benefit/risk assessment confirms continued treatment with colestilan, supplementation of vitamins may be required.
Colestilan is not absorbed and is not systemically available. No direct effects of colestilan are thus anticipated. However, other effects of colestilan may affect breast-feeding women.
No data are available to assess the safety and efficacy in breast-feeding women. Patients that breast-feed and where a benefit/risk assessment confirms continued treatment with colestilan, supplementation of vitamins may be required.
Colestilan is not absorbed and is not systemically available. No direct effects of colestilan are thus anticipated. However, other effects of colestilan may influence fertility.
No data are available to assess the potential influence of colestilan on fertility.
Colestilan has no or negligible influence on the ability to drive and use machines.
The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with colestilan for up to one year constituted the safety population. Patients received doses of up to 15 g per day, in three divided doses of 5 g.
Approximately 30% of patients experienced at least one adverse reaction. The most serious adverse reactions were gastrointestinal haemorrhage (uncommon) and constipation (common). The most frequently reported adverse reactions were nausea, dyspepsia and vomiting (all common). The frequency of adverse reactions increased with dose.
A tabulated list of frequencies was defined using the following convention: 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Uncommon: Gastroenteritis
Uncommon: Hyperparathyroidism
Common: Hypocalcaemia, decreased appetite
Uncommon: Folate deficiency, hypertriglyceridaemia, polydipsia
Rare: Vitamin K deficiency, calciphylaxis, electrolyte imbalance, fluid overload
Uncommon: Insomnia
Uncommon: Tremor, dizziness, headache, dysgeusia
Rare: Coronary artery disease
Uncommon: Haematoma, hypotension
Common: Constipation, abdominal pain, vomiting, abdominal distension, nausea, gastritis, dyspepsia, diarrhoea, flatulence, abdominal discomfort
Uncommon: Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth
Rare: Intestinal obstruction*
Uncommon: Hepatic enzymes increased
Uncommon: Urticaria, rash, pruritus, dry skin
Rare: Allergic dermatitis, guttae psoriasis
Uncommon: Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities
Uncommon: Asthenia
* A single case with a fatal outcome
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