Prescription Drug Information: Simvastatin (Page 9 of 9)

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 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.

Simvastatin tablets 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

211.9

46.9

90.0

186.3

Simvastatin Tablets 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

203.8

47.7

78.3

179.9

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 tablets 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 10 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed “S 4” on one side and plain on other side.

NDC: 70518-0064-00

NDC: 70518-0064-01

NDC: 70518-0064-02

NDC: 70518-0064-03

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOX

PACKAGING: 1 in 1 POUCH

Storage

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

“Dispense in tight containers as defined in the USP”

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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 tablets.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

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 tablets.

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 tablets are 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 tablets, and thereafter when clinically indicated. All patients treated with simvastatin tablets 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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: simvastatin

GENERIC: simvastatin

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0064-0

NDC: 70518-0064-1

NDC: 70518-0064-2

NDC: 70518-0064-3

COLOR: red

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: S4

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • SIMVASTATIN 10mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • HYDROXYPROPYL CELLULOSE (110000 WAMW)
  • HYPROMELLOSE 2910 (5 MPA.S)
  • CROSCARMELLOSE SODIUM
  • FERRIC OXIDE RED
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • TALC
  • STARCH, CORN
  • BUTYLATED HYDROXYANISOLE
  • TITANIUM DIOXIDE
  • ASCORBIC ACID
  • CITRIC ACID MONOHYDRATE
  • TRIETHYL CITRATE
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
MM3
(click image for full-size original)
MM4
(click image for full-size original)
SIMVASTATIN simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0064(NDC:16729-004)
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
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (110000 WAMW)
HYPROMELLOSE 2910 (5 MPA.S)
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
STARCH, CORN
BUTYLATED HYDROXYANISOLE
TITANIUM DIOXIDE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
TRIETHYL CITRATE
Product Characteristics
Color red (Brick Red) Score no score
Shape OVAL (OVAL) Size 8mm
Flavor Imprint Code S4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0064-0 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70518-0064-1 30 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:70518-0064-2 30 POUCH in 1 BOX contains a POUCH (70518-0064-3)
3 NDC:70518-0064-3 1 TABLET, FILM COATED in 1 POUCH This package is contained within the BOX (70518-0064-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078155 12/14/2016
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2022 REMEDYREPACK INC.

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