ZOCOR (Page 8 of 8)

14.2 Clinical Studies in Adolescents

In a double-blind, placebo-controlled study, 175 patients (99 adolescent boys and 76 post-menarchal girls) 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolemia (HeFH) were randomized to simvastatin (n=106) or placebo (n=67) for 24 weeks (base study). Inclusion in the study required a baseline LDL-C level between 160 and 400 mg/dL and at least one parent with an LDL-C level >189 mg/dL. The dosage of simvastatin (once daily in the evening) was 10 mg for the first 8 weeks, 20 mg for the second 8 weeks, and 40 mg thereafter. In a 24-week extension, 144 patients elected to continue therapy with simvastatin 40 mg or placebo.

ZOCOR significantly decreased plasma levels of total-C, LDL-C, and Apo B (see Table 8). Results from the extension at 48 weeks were comparable to those observed in the base study.

Table 8: Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia (Mean Percent Change from Baseline)
Dosage Duration N Total-C LDL-C HDL-C TG * Apo B
*
median percent change
Placebo 24 Weeks 67 % Change from Baseline (95% CI) 1.6(-2.2, 5.3) 1.1(-3.4, 5.5) 3.6(-0.7, 8.0) -3.2(-11.8, 5.4) -0.5(-4.7, 3.6)
Mean baseline, mg/dL (SD) 278.6(51.8) 211.9(49.0) 46.9(11.9) 90.0(50.7) 186.3(38.1)
ZOCOR 24 Weeks 106 % Change from Baseline (95% CI) -26.5(-29.6, -23.3) -36.8(-40.5, -33.0) 8.3(4.6, 11.9) -7.9(-15.8, 0.0) -32.4(-35.9, -29.0)
Mean baseline, mg/dL (SD) 270.2(44.0) 203.8(41.5) 47.7(9.0) 78.3(46.0) 179.9(33.8)

After 24 weeks of treatment, the mean achieved LDL-C value was 124.9 mg/dL (range: 64.0-289.0 mg/dL) in the ZOCOR 40 mg group compared to 207.8 mg/dL (range: 128.0-334.0 mg/dL) in the placebo group.

The safety and efficacy of doses above 40 mg daily have not been studied in children with HeFH. The long-term efficacy of simvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.

16 HOW SUPPLIED/STORAGE AND HANDLING

No. 8146 — Tablets ZOCOR 10 mg are peach, oval, film-coated tablets, coded MSD 735 on one side and plain on the other. They are supplied as follows:

NDC 0006-0735-31 unit of use bottles of 30

NDC 0006-0735-54 unit of use bottles of 90.

No. 8147 — Tablets ZOCOR 20 mg are tan, oval, film-coated tablets, coded MSD 740 on one side and plain on the other. They are supplied as follows:

NDC 0006-0740-31 unit of use bottles of 30

NDC 0006-0740-54 unit of use bottles of 90.

No. 8148 — Tablets ZOCOR 40 mg are brick red, oval, film-coated tablets, coded MSD 749 on one side and plain on the other. They are supplied as follows:

NDC 0006-0749-31 unit of use bottles of 30

NDC 0006-0749-54 unit of use bottles of 90.

No. 6577 — Tablets ZOCOR 80 mg are brick red, capsule-shaped, film-coated tablets, coded 543 on one side and 80 on the other. They are supplied as follows:

NDC 0006-0543-31 unit of use bottles of 30

NDC 0006-0543-54 unit of use bottles of 90.

Storage

Store between 5-30°C (41-86°F).

17 PATIENT COUNSELING INFORMATION

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised about substances they should not take concomitantly with simvastatin [see Contraindications (4) and Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking ZOCOR.

17.1 Muscle Pain

All patients starting therapy with ZOCOR should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing ZOCOR. Patients using the 80-mg dose should be informed that the risk of myopathy, including rhabdomyolysis, is increased with use of the 80-mg dose. The risk of myopathy, including rhabdomyolysis, occurring with use of ZOCOR is increased when taking certain types of medication or consuming grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.

17.2 Liver Enzymes

It is recommended that liver function tests be performed before the initiation of ZOCOR, and thereafter when clinically indicated. All patients treated with ZOCOR should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

17.3 Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using ZOCOR. Discuss future pregnancy plans with your patients, and discuss when to stop taking ZOCOR if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking ZOCOR and call their healthcare professional.

17.4 Breastfeeding

Women who are breastfeeding should not use ZOCOR. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

By:
MERCK SHARP & DOHME LTD.
Cramlington, Northumberland, UK NE23 3JU

For patent information: www.merck.com/product/patent/home.html

Copyright © 1999-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0733-t-1910r068

PRINCIPAL DISPLAY PANEL — 5 mg Tablet Bottle Label

NDC 0006-0726-31

Zocor® (Simvastatin) Tablets

5 mg

Each tablet contains 5 mg of simvastatin.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL -- 5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

NDC 0006-0735-31

Zocor® (Simvastatin) Tablets

10 mg

Each tablet contains 10 mg of simvastatin.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Tablet Bottle Label

NDC 0006-0740-31

Zocor® (Simvastatin) Tablets

20 mg

Each tablet contains 20 mg of simvastatin.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL -- 20 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

NDC 0006-0749-31

Zocor® (Simvastatin) Tablets

40 mg

Each tablet contains 40 mg of simvastatin.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL -- 40 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

NDC 0006-0543-31

Zocor® (Simvastatin) Tablets

80 mg

Each tablet contains 80 mg of simvastatin.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL -- 80 mg Tablet Bottle Label
(click image for full-size original)
ZOCOR simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0726
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 5 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (BUFF) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code MSD;726;ZOCOR;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0726-31 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019766 12/23/1991 04/30/2018
ZOCOR simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0543
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color RED (BRICK RED) Score no score
Shape OVAL (CAPSULE SHAPED) Size 18mm
Flavor Imprint Code 543;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0543-31 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0006-0543-54 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019766 12/23/1991
ZOCOR simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0749
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color RED (BRICK RED) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code MSD;749
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0749-31 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0006-0749-54 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019766 12/23/1991
ZOCOR simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0740
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (TAN) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code MSD;740
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0740-54 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0006-0740-31 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019766 12/23/1991
ZOCOR simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0735
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (PEACH) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code MSD;735
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0735-31 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0006-0735-54 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019766 12/23/1991
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 10/2019 Merck Sharp & Dohme Corp.

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