ezetimibe

e-ZET-i-mibe

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: cholesterol absorption inhibitors

REMS

Primary hyperlipidemia, including heterozygous familial hypercholesterolemia (as monotherapy [in adults only] or in combination with a statin).
Mixed hyperlipidemia (in combination with fenofibrate).
Homozygous familial hypercholesterolemia (in combination with a statin and other LDL-C-lowering therapies).
Familial sitosterolemia.

Inhibits absorption of cholesterol in the small intestine.

Therapeutic effects:

Reduction of LDL-C concentrations.
Reduction of sitosterol and campesterol concentrations.

Absorption: Following absorption, rapidly converted to ezetimibe-glucuronide, which is active. Bioavailability is variable.

Distribution: Unknown.

Metabolism/Excretion: Undergoes enterohepatic recycling, mostly eliminated in feces; minimal renal excretion.

Half-Life: 22 hr.

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	unknown

Contraindicated in:

Hypersensitivity;
When a statin, fenofibrate, or other LDL-C-lowering therapy is contraindicated (when used in combination with statin, fenofibrate, or other LDL-C-lowering therapy);
Moderate or severe hepatic impairment.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <10 yr (safety and effectiveness not established).

Derm: rash

GI: ↑liver enzymes, cholecystitis, cholelithiasis, nausea, pancreatitis

MS: myopathy, RHABDOMYOLYSIS

Misc: ANGIOEDEMA

Drug-drug:

Cholestyramine or other bile acid sequestrants may ↓ effectiveness.
Fibrates may ↑ levels and risk of cholelithiasis.
Cyclosporine may ↑ levels and risk of toxicity.
HMG CoA-reductase inhibitors may ↑ risk of rhabdomyolysis.

PO (Adults ): 10 mg once daily.

Renal Impairment

PO (Adults ): CCr <60 mL/min and concurrent use with simvastatin: Not to exceed simvastatin dose of 20 mg/day.

(Generic available)

Tablets: 10 mg
In combination with: bempedoic acid (Nexlizet); simvastatin (Vytorin); see Appendix [not included in this PDA edition].

Obtain a diet history, especially with regard to fat consumption.
Monitor for signs and symptoms of rhabdomyolysis (malaise, myalgia, muscle cramps/weakness, dark or tea-colored urine). If myopathy suspected, discontinue ezetimibe.

Lab Test Considerations:

Evaluate lipid panel before initiating, after 2–4 wk of therapy, and periodically thereafter.
- May ↑ liver transaminases when administered with HMG-CoA reductase inhibitors. Monitor liver enzymes prior to initiation and during therapy according to recommendations of HMG-CoA reductase inhibitor. Elevations are usually asymptomatic and return to baseline with continued therapy. Consider discontinuation of ezetimibe if ↑ ALT or AST ≥3 times upper limit of normal persists.

Do not confuse Zetia with Zestril.
PO: Administer without regard to meals. May be taken at the same time as HMG-CoA reductase inhibitors or fenofibrate. Administer ≥2 hr before or ≥4 hr after bile acid sequestrants.

Explain the purpose and side effects of ezetimibe. Instruct patient to take as directed, at the same time each day. Take missed doses as soon as remembered, but do not take more than one dose per day. Medication helps control but does not cure elevated serum cholesterol levels. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of change.
Emphasize the importance of follow-up exams to determine effectiveness and to monitor for side effects.
Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking. Ezetimibe does not assist with weight loss.
Instruct patient to notify health care professional if unexplained muscle pain, tenderness, or weakness occur. Risk may ↑ when used with HMG-CoA reductase inhibitors.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
Rep: Advise women of reproductive potential to notify health care professional promptly if pregnancy is planned or suspected or if breastfeeding. If regimen includes HMG-CoA reductase inhibitors, they are contraindicated in pregnancy.

Decrease in serum LDL-C and total cholesterol levels.

Zetia

Ezetrol

NDC Code

0591- Actavis Pharma, Inc.
- 0591-3713-
  - 0591-3713-00- 100000 TABLET in 1 BOX (0591-3713-00)

0591- Actavis Pharma, Inc.
- 0591-3713- Ezetimibe
  - 0591-3713-05- 500 TABLET in 1 BOTTLE (0591-3713-05)

0591- Actavis Pharma, Inc.
- 0591-3713- Ezetimibe
  - 0591-3713-19- 90 TABLET in 1 BOTTLE (0591-3713-19)

0591- Actavis Pharma, Inc.
- 0591-3713- Ezetimibe
  - 0591-3713-30- 30 TABLET in 1 BOTTLE (0591-3713-30)

0615- NCS HealthCare of KY, LLC dba Vangard Labs
- 0615-8300- Ezetimibe
  - 0615-8300-05- 15 TABLET in 1 BLISTER PACK (0615-8300-05)

0615- NCS HealthCare of KY, LLC dba Vangard Labs
- 0615-8300- Ezetimibe
  - 0615-8300-39- 30 TABLET in 1 BLISTER PACK (0615-8300-39)

0781- Sandoz Inc
- 0781-5690- Ezetimibe
  - 0781-5690-05- 500 TABLET in 1 BOTTLE (0781-5690-05)

0781- Sandoz Inc
- 0781-5690- Ezetimibe
  - 0781-5690-31- 30 TABLET in 1 BOTTLE (0781-5690-31)

0781- Sandoz Inc
- 0781-5690- Ezetimibe
  - 0781-5690-92- 90 TABLET in 1 BOTTLE (0781-5690-92)

0904- Major Pharmaceuticals
- 0904-7103- Ezetimibe
  - 0904-7103-04- 30 BLISTER PACK in 1 CARTON (0904-7103-04) / 1 TABLET in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-7103- Ezetimibe
  - 0904-7103-10- 20 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACK

10135- Marlex Pharmaceuticals, Inc.
- 10135-787- Ezetimibe
  - 10135-787-05- 500 TABLET in 1 BOTTLE (10135-787-05)

10135- Marlex Pharmaceuticals, Inc.
- 10135-787- Ezetimibe
  - 10135-787-30- 30 TABLET in 1 BOTTLE (10135-787-30)

10135- Marlex Pharmaceuticals, Inc.
- 10135-787- Ezetimibe
  - 10135-787-90- 90 TABLET in 1 BOTTLE (10135-787-90)

14501- MSN Laboratories Private Limited
- 14501-0008-
  - 14501-0008-2- 50 kg in 1 DRUM (14501-0008-2)

15894- Teva API India Private Ltd
- 15894-0011-
  - 15894-0011-0- 1 kg in 1 CARTON (15894-0011-0)

16714- NorthStar Rx LLC
- 16714-813- Ezetimibe
  16714-813-01- 30 TABLET in 1 BOTTLE (16714-813-01)

16714- NorthStar Rx LLC
- 16714-813- Ezetimibe
  - 16714-813-02- 90 TABLET in 1 BOTTLE (16714-813-02)

16714- NorthStar Rx LLC
- 16714-813- Ezetimibe
  - 16714-813-03- 500 TABLET in 1 BOTTLE (16714-813-03)

16729- Accord Healthcare Inc.
- 16729-433- EZETIMIBE
  - 16729-433-10- 30 TABLET in 1 BOTTLE (16729-433-10)

31722- Camber Pharmaceuticals, Inc.
- 31722-628- EZETIMIBE
  - 31722-628-01- 100 TABLET in 1 BOTTLE (31722-628-01)

31722- Camber Pharmaceuticals, Inc.
- 31722-628- EZETIMIBE
  - 31722-628-05- 500 TABLET in 1 BOTTLE (31722-628-05)

31722- Camber Pharmaceuticals, Inc.
- 31722-628- EZETIMIBE
  - 31722-628-10- 1000 TABLET in 1 BOTTLE (31722-628-10)

31722- Camber Pharmaceuticals, Inc.
- 31722-628- EZETIMIBE
  - 31722-628-30- 30 TABLET in 1 BOTTLE (31722-628-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-628- EZETIMIBE
  - 31722-628-31- 100 BLISTER PACK in 1 CARTON (31722-628-31) / 10 TABLET in 1 BLISTER PACK

31722- Camber Pharmaceuticals, Inc.
- 31722-628- EZETIMIBE
  - 31722-628-34- 100 BLISTER PACK in 1 CARTON (31722-628-34) / 10 TABLET in 1 BLISTER PACK

31722- Camber Pharmaceuticals, Inc.
- 31722-628- EZETIMIBE
  - 31722-628-90- 90 TABLET in 1 BOTTLE (31722-628-90)

33342- Macleods Pharmaceuticals Limited
- 33342-373- Ezetimibe
  - 33342-373-07- 30 TABLET in 1 BOTTLE (33342-373-07)

33342- Macleods Pharmaceuticals Limited
- 33342-373- Ezetimibe
  - 33342-373-10- 90 TABLET in 1 BOTTLE (33342-373-10)

33342- Macleods Pharmaceuticals Limited
- 33342-373- Ezetimibe
  - 33342-373-15- 500 TABLET in 1 BOTTLE (33342-373-15)

50090- A-S Medication Solutions
- 50090-3422- Ezetimibe
  - 50090-3422-0- 30 TABLET in 1 BOTTLE (50090-3422-0)

50090- A-S Medication Solutions
- 50090-3422- Ezetimibe
  - 50090-3422-1- 90 TABLET in 1 BOTTLE (50090-3422-1)

50090- A-S Medication Solutions
- 50090-3657- Ezetimibe
  - 50090-3657-0- 30 TABLET in 1 BOTTLE, PLASTIC (50090-3657-0)

50090- A-S Medication Solutions
- 50090-3657- Ezetimibe
  - 50090-3657-1- 90 TABLET in 1 BOTTLE (50090-3657-1)

50090- A-S Medication Solutions
- 50090-6630- Ezetimibe
  - 50090-6630-0- 30 TABLET in 1 BOTTLE (50090-6630-0)

50090- A-S Medication Solutions
- 50090-6630- Ezetimibe
  - 50090-6630-1- 90 TABLET in 1 BOTTLE (50090-6630-1)

50090- A-S Medication Solutions
- 50090-6631- Ezetimibe
  - 50090-6631-0- 90 TABLET in 1 BOTTLE (50090-6631-0)

50090- A-S Medication Solutions
- 50090-7099- Ezetimibe
  - 50090-7099-0- 90 TABLET in 1 BOTTLE (50090-7099-0)

50090- A-S Medication Solutions
- 50090-7236- Ezetimibe
  - 50090-7236-0- 90 TABLET in 1 BOTTLE (50090-7236-0)

50090- A-S Medication Solutions
- 50090-7338- Ezetimibe
  - 50090-7338-0- 90 TABLET in 1 BOTTLE (50090-7338-0)

50090- A-S Medication Solutions
- 50090-7339- Ezetimibe
  - 50090-7339-0- 30 TABLET in 1 BOTTLE (50090-7339-0)

50090- A-S Medication Solutions
- 50090-7339- Ezetimibe
  - 50090-7339-1- 90 TABLET in 1 BOTTLE (50090-7339-1)

50090- A-S Medication Solutions
- 50090-7689- EZETIMIBE
  - 50090-7689-0- 90 TABLET in 1 BOTTLE (50090-7689-0)

50090- A-S Medication Solutions
- 50090-7690- EZETIMIBE
  - 50090-7690-0- 30 TABLET in 1 BOTTLE (50090-7690-0)

50090- A-S Medication Solutions
- 50090-7690- EZETIMIBE
  - 50090-7690-1- 90 TABLET in 1 BOTTLE (50090-7690-1)

50228- ScieGen Pharmaceuticals Inc
- 50228-379- Ezetimibe
  - 50228-379-05- 500 TABLET in 1 BOTTLE (50228-379-05)

50228- ScieGen Pharmaceuticals Inc
- 50228-379- Ezetimibe
  - 50228-379-10- 1000 TABLET in 1 BOTTLE (50228-379-10)

50228- ScieGen Pharmaceuticals Inc
- 50228-379- Ezetimibe
  - 50228-379-30- 30 TABLET in 1 BOTTLE (50228-379-30)

50228- ScieGen Pharmaceuticals Inc
- 50228-379- Ezetimibe
  - 50228-379-90- 90 TABLET in 1 BOTTLE (50228-379-90)

50268- AvPAK
- 50268-298- Ezetimibe
  - 50268-298-12- 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-298-12) / 1 TABLET in 1 BLISTER PACK (50268-298-11)

51660- Ohm Laboratories Inc.
- 51660-200- Ezetimibe
  - 51660-200-05- 500 TABLET in 1 BOTTLE (51660-200-05)

51660- Ohm Laboratories Inc.
- 51660-200- Ezetimibe
  - 51660-200-30- 30 TABLET in 1 BOTTLE (51660-200-30)

51660- Ohm Laboratories Inc.
- 51660-200- Ezetimibe
  - 51660-200-90- 90 TABLET in 1 BOTTLE (51660-200-90)

55111- Dr. Reddy's Laboratories Limited
- 55111-079-
  - 55111-079-00- 2 kg in 1 DRUM (55111-079-00)

58032- Neuland Laboratories Limited
- 58032-2004-
  58032-2004-0- 1 kg in 1 DRUM (58032-2004-0)

59651- Aurobindo Pharma Limited
- 59651-052- Ezetimibe
  59651-052-05- 500 TABLET in 1 BOTTLE (59651-052-05)

59651- Aurobindo Pharma Limited
- 59651-052- Ezetimibe
  - 59651-052-30- 30 TABLET in 1 BOTTLE (59651-052-30)

59651- Aurobindo Pharma Limited
- 59651-052- Ezetimibe
  - 59651-052-90- 90 TABLET in 1 BOTTLE (59651-052-90)

59651- Aurobindo Pharma Limited
- 59651-056-
  - 59651-056-37- 50 kg in 1 DRUM (59651-056-37)

59651- Aurobindo Pharma Limited
- 59651-698-
  59651-698-37- 50 kg in 1 DRUM (59651-698-37)

60429- Golden State Medical Supply, Inc.
- 60429-982- Ezetimibe
  60429-982-05- 500 TABLET in 1 BOTTLE (60429-982-05)

60429- Golden State Medical Supply, Inc.
- 60429-982- Ezetimibe
  - 60429-982-30- 30 TABLET in 1 BOTTLE (60429-982-30)

60429- Golden State Medical Supply, Inc.
- 60429-982- Ezetimibe
  - 60429-982-90- 90 TABLET in 1 BOTTLE (60429-982-90)

60687- American Health Packaging
- 60687-373- Ezetimibe
  - 60687-373-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-373-21) / 1 TABLET in 1 BLISTER PACK (60687-373-11)

63629- Bryant Ranch Prepack
- 63629-7413- Ezetimibe
  - 63629-7413-1- 30 TABLET in 1 BOTTLE (63629-7413-1)

63629- Bryant Ranch Prepack
- 63629-7413- Ezetimibe
  - 63629-7413-2- 90 TABLET in 1 BOTTLE (63629-7413-2)

63629- Bryant Ranch Prepack
- 63629-7413- Ezetimibe
  - 63629-7413-3- 28 TABLET in 1 BOTTLE (63629-7413-3)

63629- Bryant Ranch Prepack
- 63629-7413- Ezetimibe
  - 63629-7413-4- 18 TABLET in 1 BOTTLE (63629-7413-4)

63629- Bryant Ranch Prepack
- 63629-7413- Ezetimibe
  - 63629-7413-5- 60 TABLET in 1 BOTTLE (63629-7413-5)

64176- MSD International GmbH (Singapore Branch)
- 64176-0042-
  - 64176-0042-0- 1 BAG in 1 DRUM (64176-0042-0) / 21 kg in 1 BAG

64176- MSD International GmbH (Singapore Branch)
- 64176-0933-
  64176-0933-0- 300000 TABLET in 1 DRUM (64176-0933-0)

65015- MYLAN LABORATORIES LIMITED
- 65015-812-
  65015-812-61- 100 kg in 1 DRUM (65015-812-61)

65096- Synthimed Labs Private Limited
- 65096-0113-
  65096-0113-1- 1 kg in 1 DRUM (65096-0113-1)

65096- Synthimed Labs Private Limited
- 65096-0113-
  65096-0113-2- 5 kg in 1 DRUM (65096-0113-2)

65096- Synthimed Labs Private Limited
- 65096-0113-
  65096-0113-3- 10 kg in 1 DRUM (65096-0113-3)

65096- Synthimed Labs Private Limited
- 65096-0113-
  65096-0113-4- 20 kg in 1 DRUM (65096-0113-4)

65096- Synthimed Labs Private Limited
- 65096-0113-
  65096-0113-5- 25 kg in 1 DRUM (65096-0113-5)

66022- Symed Labs Limited
- 66022-0212-
  66022-0212-1- 25 kg in 1 CONTAINER (66022-0212-1)

66039- Glenmark Life Sciences Limited
- 66039-839-
  66039-839-03- 50 kg in 1 DRUM (66039-839-03)

66039- Glenmark Life Sciences Limited
- 66039-869-
  66039-869-04- 1 kg in 1 DRUM (66039-869-04)

66039- Glenmark Life Sciences Limited
- 66039-896-
  66039-896-04- 1 kg in 1 DRUM (66039-896-04)

67296- RedPharm Drug
- 67296-2059- Ezetimibe
  67296-2059-9- 90 TABLET in 1 BOTTLE (67296-2059-9)

67877- Ascend Laboratories, LLC
- 67877-490- Ezetimibe
  - 67877-490-01- 100 TABLET in 1 BOTTLE (67877-490-01)

67877- Ascend Laboratories, LLC
- 67877-490- Ezetimibe
  - 67877-490-05- 500 TABLET in 1 BOTTLE (67877-490-05)

67877- Ascend Laboratories, LLC
- 67877-490- Ezetimibe
  - 67877-490-30- 30 TABLET in 1 BOTTLE (67877-490-30)

67877- Ascend Laboratories, LLC
- 67877-490- Ezetimibe
  - 67877-490-55- 5000 TABLET in 1 BOTTLE (67877-490-55)

67877- Ascend Laboratories, LLC
- 67877-490- Ezetimibe
  - 67877-490-90- 90 TABLET in 1 BOTTLE (67877-490-90)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-773- ezetimibe
  - 68382-773-01- 100 TABLET in 1 BOTTLE (68382-773-01)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-773- ezetimibe
  - 68382-773-05- 500 TABLET in 1 BOTTLE (68382-773-05)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-773- ezetimibe
  - 68382-773-06- 30 TABLET in 1 BOTTLE (68382-773-06)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-773- ezetimibe
  - 68382-773-10- 1000 TABLET in 1 BOTTLE (68382-773-10)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-773- ezetimibe
  - 68382-773-16- 90 TABLET in 1 BOTTLE (68382-773-16)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-773- ezetimibe
  - 68382-773-77- 10 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-226- Ezetimibe
  - 68462-226-05- 500 TABLET in 1 BOTTLE (68462-226-05)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-226- Ezetimibe
  - 68462-226-10- 1000 TABLET in 1 BOTTLE (68462-226-10)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-226- Ezetimibe
  - 68462-226-11- 10 BLISTER PACK in 1 CARTON (68462-226-11) / 10 TABLET in 1 BLISTER PACK

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-226- Ezetimibe
  - 68462-226-30- 30 TABLET in 1 BOTTLE (68462-226-30)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-226- Ezetimibe
  - 68462-226-90- 90 TABLET in 1 BOTTLE (68462-226-90)

68554- Hetero Labs Limited
- 68554-0085-
  - 68554-0085-1- 20 kg in 1 DRUM (68554-0085-1)

68554- HETERO LABS LIMITED
- 68554-0152-
  68554-0152-1- 5 kg in 1 DRUM (68554-0152-1)

68554- HETERO LABS LIMITED
- 68554-0180-
  68554-0180-1- 20 kg in 1 DRUM (68554-0180-1)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Pill Image

Code ⬆