Simvastatin (Page 8 of 8)


3
D.R. Taves, Minimization: a new method of assigning patients to treatment and control groups. Clin. Pharmacol. Ther. 15 (1974), pp. 443-453

14.2 Clinical Studies in Adolescents

In a double-blind, placebo-controlled study, 175 patients (99 adolescent boys and 76 post-menarchal girls) 10 to 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 LDL­C 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.

Simvastatin 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.

Figure 9
(click image for full-size original)

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

Simvastatin Tablets, USP 5 mg are white to off white, oval, biconvex, film-coated tablets with the logo “B300” debossed on one side and “5” on the other side. They are supplied as follows:

NDC 70377-001-12 bottles of 30

NDC 70377-001-13 bottles of 45

NDC 70377-001-14 bottles of 90

NDC 70377-001-15 bottles of 1000

Simvastatin Tablets, USP 10 mg are peach to dark peach, oval, biconvex, film-coated tablets with the logo “B301”debossed on one side and “10” on the other side. They are supplied as follows:

NDC 70377-002-12 bottles of 30

NDC 70377-002-13 bottles of 45

NDC 70377-002-14 bottles of 90

NDC 70377-002-15 bottles of 1000.

Simvastatin Tablets, USP 20 mg are orange to dark orange, oval, biconvex, film-coated tablets with the logo “B302” debossed on one side and “20” on the other side. They are supplied as follows:

NDC 70377-003-12 bottles of 30

NDC 70377-003-13 bottles of 45

NDC 70377-003-14 bottles of 90.

NDC 70377-003-15 bottles of 1000

Simvastatin Tablets, USP 40 mg are light pink to pink, oval, biconvex, film-coated tablets with the logo “B303” debossed on one side and “40” on the other side. They are supplied as follows:

NDC 70377-004-12 bottles of 30

NDC 70377-004-13 bottles of 45

NDC 70377-004-14 bottles of 90.

NDC 70377-004-15 bottles of 1000

Simvastatin Tablets, USP 80 mg are pink to dark pink, capsule-shaped, film-coated tablets with the logo “B304” debossed on one side and “80” on the other side. They are supplied as follows:

NDC 70377-005-12 bottles of 30

NDC 70377-005-13 bottles of 45

NDC 70377-005-14 bottles of 90

NDC 70377-005-15 bottles of 1000.

Storage

Store between 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature].

Dispense in a tightly-closed container as defined in the USP.

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 simvastatin.

17.1 Muscle Pain

All patients starting therapy with simvastatin tablets 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 simvastatin. 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 simvastatin 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 simvastatin, and thereafter when clinically indicated. All patients treated with simvastatin 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 simvastatin tablets. Discuss future pregnancy plans with your patients, and discuss when to stop taking simvastatin tablets if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking simvastatin tablets and call their healthcare professional.

17.4 Breastfeeding

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

Manufactured for:

Biocon Pharma Inc,

Iselin, NJ 08830-3009 USA

Manufactured by:

PuraCap Caribe

Dorado, PR 00646 USA

Rev. 10-2020

BP0141

BPCM0017/07

PRINCIPAL DISPLAY PANEL

Simvastatin Tablets, USP 5 mg

5 mg -- 90s count
(click image for full-size original)

Simvastatin Tablets, USP 10 mg

10 mg -- 90s count
(click image for full-size original)

Simvastatin Tablets, USP 20 mg

20 mg -- 90s count
(click image for full-size original)

Simvastatin Tablets, USP 40 mg

40 mg -- 90s count
(click image for full-size original)

Simvastatin Tablets, USP 80 mg

80 mg -- 90s count
(click image for full-size original)
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-001
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
ANHYDROUS CITRIC ACID
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Starch, Pregelatinized Corn
TALC
TITANIUM DIOXIDE
ALCOHOL
Povidone
TRIETHYL CITRATE
Silicon Dioxide
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (biconvex) Size 6mm
Flavor Imprint Code B300;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-001-12 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-001-13 45 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-001-14 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70377-001-15 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078034 12/17/2015
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-002
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
ANHYDROUS CITRIC ACID
HYPROMELLOSES
FERRIC OXIDE YELLOW
Alcohol
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Starch, Pregelatinized Corn
Silicon Dioxide
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
TRIETHYL CITRATE
Povidone
Product Characteristics
Color ORANGE (peach to dark peach) Score no score
Shape OVAL (biconvex) Size 9mm
Flavor Imprint Code B301;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-002-12 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-002-13 45 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-002-14 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70377-002-15 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078034 12/17/2015
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-003
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
ANHYDROUS CITRIC ACID
HYPROMELLOSES
FERRIC OXIDE RED
Alcohol
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Starch, Pregelatinized Corn
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Povidone
Silicon Dioxide
TRIETHYL CITRATE
Product Characteristics
Color ORANGE (orange to dark orange) Score no score
Shape OVAL (biconvex) Size 11mm
Flavor Imprint Code B302;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-003-12 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-003-13 45 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-003-14 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70377-003-15 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078034 12/17/2015
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-004
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
Anhydrous Citric Acid
HYPROMELLOSES
FERRIC OXIDE YELLOW
Alcohol
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Starch, Pregelatinized Corn
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Silicon Dioxide
Povidone
TRIETHYL CITRATE
Product Characteristics
Color PINK (light pink to pink) Score no score
Shape OVAL (biconvex) Size 14mm
Flavor Imprint Code B303;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-004-12 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-004-13 45 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-004-14 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70377-004-15 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078034 12/17/2015
SIMVASTATIN
simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-005
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
ANHYDROUS CITRIC ACID
Povidone
HYPROMELLOSES
Alcohol
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Starch, Pregelatinized Corn
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Silicon Dioxide
TRIETHYL CITRATE
Product Characteristics
Color PINK (pink to dark pink) Score no score
Shape CAPSULE (capsule-shaped, film-coated) Size 18mm
Flavor Imprint Code B304;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-005-12 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-005-13 45 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-005-14 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70377-005-15 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078034 12/17/2015
Labeler — Biocon Pharma Inc, (080000063)
Registrant — Biocon Limited (650173537)
Establishment
Name Address ID/FEI Operations
Caribe Holdings (Cayman) Co. Ltd. DBA PuraCap Caribe 080230346 manufacture (70377-001), manufacture (70377-002), manufacture (70377-003), manufacture (70377-004), manufacture (70377-005)
Establishment
Name Address ID/FEI Operations
Biocon Limited 915076162 api manufacture (70377-001), api manufacture (70377-002), api manufacture (70377-003), api manufacture (70377-004), api manufacture (70377-005)

Revised: 10/2021 Biocon Pharma Inc,

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