ZETIA Tablet (2021)

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1. Indications and Usage

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. ...

2. Dosage and Administration

2.1 General Dosing Information The recommended dose of ZETIA is 10 mg once daily. ZETIA can be administered with or without food. 2.2 Concomitant Lipid-Lowering Therapy ZETIA may be administered with a ...

3. Dosage Forms and Strengths

10 mg tablets are white to off-white, capsule-shaped tablets debossed with 414 on one side.

4. Contraindications

ZETIA is contraindicated in the following conditions: The combination of ZETIA with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase ...

5. Warnings and Precautions

5.1 Use with Statins or Fenofibrate Concurrent administration of ZETIA with a specific statin or fenofibrate should be in accordance with the product labeling for that medication. 5.2 Liver Enzymes In ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the label: Liver enzyme abnormalities [see Warnings and Precautions (5.2)] Rhabdomyolysis and myopathy ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.2. Postmarketing Experience

Because the reactions below are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...

7. Drug Interactions

[See Clinical Pharmacology (12.3)]. 7.1 Cyclosporine Caution should be exercised when using ZETIA and cyclosporine concomitantly due to increased exposure to both ezetimibe and cyclosporine. Cyclosporine ...

8.1. Pregnancy

Teratogenic effects section Pregnancy Category C. There are no adequate and well-controlled studies of ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit ...

8.3. Nursing Mothers

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

8.4. Pediatric Use

The effects of ZETIA coadministered with simvastatin (n=126) compared to simvastatin monotherapy (n=122) have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia ...

8.5. Geriatric Use

Monotherapy Studies Of the 2396 patients who received ZETIA in clinical studies, 669 (28%) were 65 and older, and 111 (5%) were 75 and older. Statin Coadministration Studies Of the 11,308 patients who ...

8.6. Renal Impairment

When used as monotherapy, no dosage adjustment of ZETIA is necessary. In the Study of Heart and Renal Protection (SHARP) trial of 9270 patients with moderate to severe renal impairment (6247 non-dialysis ...

8.7. Hepatic Impairment

ZETIA is not recommended in patients with moderate to severe hepatic impairment [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)]. ZETIA given concomitantly with a statin is ...

10. Overdosage

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 ...

11. Description

ZETIA (ezetimibe) is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3 ...

12.1. Mechanism of Action

Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. In a 2-week clinical study in 18 hypercholesterolemic patients, ZETIA inhibited intestinal cholesterol ...

12.2. Pharmacodynamics

Clinical studies have demonstrated that elevated levels of total-C, LDL-C and Apo B, the major protein constituent of LDL, promote human atherosclerosis. In addition, decreased levels of HDL-C are associated ...

12.3. Pharmacokinetics

Absorption After oral administration, ezetimibe is absorbed and extensively conjugated to a pharmacologically active phenolic glucuronide (ezetimibe-glucuronide). After a single 10-mg dose of ZETIA to ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

A 104-week dietary carcinogenicity study with ezetimibe was conducted in rats at doses up to 1500 mg/kg/day (males) and 500 mg/kg/day (females) (~20 × the human exposure at 10 mg daily based on AUC ...

13.2. Animal Toxicology and/or Pharmacology

The hypocholesterolemic effect of ezetimibe was evaluated in cholesterol-fed Rhesus monkeys, dogs, rats, and mouse models of human cholesterol metabolism. Ezetimibe was found to have an ED50 ...

14. Clinical Studies

14.1 Primary Hyperlipidemia ZETIA reduces total-C, LDL-C, Apo B, non-HDL-C, and TG, and increases HDL-C in patients with hyperlipidemia. Maximal to near maximal response is generally achieved within 2 ...

16.1. How Supplied

No. 3861 Tablets ZETIA, 10 mg, are white to off-white, capsule-shaped tablets debossed with 414 on one side. They are supplied as follows: NDC 66582-414-31 bottles of 30 NDC 66582-414-54 ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F) [See USP Controlled Room Temperature]. Protect from moisture.

17. Patient Counseling Information

See FDA-Approved Patient Labeling (Patient Information). Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic ...