* Indications:
# Primary Hypercholesterolemia:
– Choletimb, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total-C,
LDL-C and Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.
– Choletimb therapy with HMG-CoA reductase inhibitors: Choletimb, administered in combination with an HMG-CoA
reductase inhibitor, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, and
Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.
– Also Choletimb reduces TG and increases HDL-C in patients with hypercholesterolemia.
# Homozygous Familial Hypercholesterolemia (HoFH): The combination of Choletimb and statins, is indicated
for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering
treatments (e.g., LDL apheresis) or if such treatments are unavailable.
# Homozygous Sitosterolemia: Choletimb is indicated as adjunctive therapy to diet for the reduction of elevated
sitosterol & campesterol levels in patients with homozygous familial sitosterolemia.
. Prior to initiating therapy with Choletimb, secondary causes for dyslipidemias (i.e. diabetes, hypothyroidism,
obstructive liver disease, chronic renal failure, and drugs that increase LDL-C and decrease HDL-C
[progestins, anabolic steroids, and corticosteroids]), should be excluded or, if appropriate, treated.
* Dosage and Administration:
– The patient should be on an appropriate lipid-lowering diet before receiving Choletimb and should continue on
this diet during treatment with Choletimb.
– The recommended dose of Choletimb is 10mg once daily.
– Choletimb can be administered with or without food.
– Choletimb can be administered with an HMG-CoA reductase inhibitor for incremental effect. For convenience,
the daily dose of Choletimb may be taken at the same time as the HMG-CoA inhibitor, according to the dosing
recommendations for the HMG-CoA reductase inhibitor.
– Patients with Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild hepatic insufficiency.
– Patients with Renal Insufficiency: No dosage adjustment is necessary in patients with renal insufficiency.
– Geriatric Patients: No dosage adjustment is necessary in geriatric patients.
* Contraindications:
– Hypersensitivity to any component of this medication.
– The combination of Choletimb with an HMG-CoA reductase inhibitor is contraindicated in patients with active
liver disease or unexplained persistent elevations of serum transaminases.
* Store at room temperature. Protect from moisture.
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