Products

Choletimb

 Ezetimibe
 

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Active ingredient

Ezetimibe 10 mg
 

Indications

Primary Hypercholesterolemia 
Monotherapy:
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. 
Combination 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. 
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. 
 Choletimb is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. 
Also Choletimb reduces TG and increases HDL-C in patients with hypercholesterolemia. 
Prior to initiating therapy with Choletimb, secondary causes for dyslipidemia (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 placed on a standard cholesterol-lowering diet before receiving Choletimb and should continue on this diet during treatment with Choletimb. The recommended dose of Choletimb is 10 mg once daily.
  • Choletimb can be administered with or without food. Choletimb may 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 reductase inhibitor, according to the dosing recommendations for the HMG- CoA reductase inhibitor.
  • Patients with hepatic insufficiency: No dose adjustment is necessary in patients with mild hepatic insufficiently.
  • Patients with renal insufficiency: No dose adjustment is necessary in patients with mild renal insufficiently.
  • Geriatric patients: No dose adjustment is necessary in geriatric patients. 

Contraindication

  • 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 in serum transaminases.

Side effects

  • Choletimb (ezetimibe) has been evaluated for safety in more than 4700 patients in clinical trials.
  •  Clinical studies of Choletimb (administered alone or with a HMG-CoA reductase inhibitor) demonstrated that Choletimb was generally well tolerated. The overall incidence of adverse events reported with Choletimb was similar to that reported with placebo, and the discontinuation rate due to adverse events was also similar for Choletimb and placebo.

Drug Interaction

  • Fibrates: The safety and effectiveness of ezetimibe administered with fibrates have not been established.
  • HMG-CoA reductase inhibitors: No clinically significant pharmacokinetic interactions were seen when ezetimibe was co-administered with atorvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin. 

Pregnancy and Lactation

There are no adequate and well-controlled studies of ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Warning and Precaution

Overdose:
No over dosage with Choletimb have been reported in clinical studies administrated of ezetimibe, 50mg / day, to 15 healthy subjects for up to 14 days was generally well tolerated. In the event of overdose symptomatic and supportive measures should be employed.

Package and Storage

• A box of 14 tablets, each tablet contains 10 mg ezetimibe.
• Store at room temperature, Protect from moisture. 

Mother Company

Manufactured by Marcyrl