8.3 Nursing MothersIn rat studies, exposure to total ezetimibe in nursing pups was up to half of that observed in maternal plasma. It is not known whether ezetimibe is excreted into human breast milk.

It is not known whether atorvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Nursing rat pups had plasma and liver atorvastatin levels of 50% and 40%, respectively, of that in their mother's milk. Because of the potential for adverse reactions in nursing infants, women taking LIPTRUZET should not breast-feed [see Contraindications (4)].

8.4 Pediatric UseLIPTRUZET

Safety and effectiveness have not been established in pediatric patients.

Ezetimibe

Based on total ezetimibe (ezetimibe + ezetimibe-glucuronide) there are no pharmacokinetic differences between adolescents and adults. Pharmacokinetic data in the pediatric population <10 years of age are not available.

advertisementAtorvastatin
Pharmacokinetic data in the pediatric population are not available.

8.5 Geriatric UseOf the patients who received ezetimibe coadministered with atorvastatin in clinical studies, 1166 were 65 and older (this included 291 who were 75 and older). The effectiveness and safety of LIPTRUZET were similar between these patients and younger subjects. Greater sensitivity of some older individuals cannot be ruled out. Since advanced age (≥65 years) is a predisposing factor for myopathy, LIPTRUZET should be prescribed with caution in the elderly. [See Clinical Pharmacology (12.3).]

In geriatric patients, no dosage adjustment of LIPTRUZET is necessary.

8.6 Hepatic ImpairmentLIPTRUZET is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels [see Contraindications (4), Warnings and Precautions (5.2), and Clinical Pharmacology (12.3)].

8.7 Renal ImpairmentA history of renal impairment may be a risk factor for statin-associated myopathy. These patients merit closer monitoring for skeletal muscle effects [see Warnings and Precautions (5.1)].

In patients with renal impairment, no dosage adjustment of LIPTRUZET is necessary.

10 OVERDOSAGELIPTRUZET

No specific treatment of overdosage with LIPTRUZET can be recommended. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.

Ezetimibe

In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, 40 mg/day to 18 patients with primary hyperlipidemia for up to 56 days, and 40 mg/day to 27 patients with homozygous sitosterolemia for 26 weeks, was generally well tolerated. One female patient with homozygous sitosterolemia took an accidental overdose of ezetimibe 120 mg/day for 28 days with no reported clinical or laboratory adverse events.

Atorvastatin

Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

11 DESCRIPTIONLIPTRUZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor.

The chemical na